"Notes" "VAERS ID" "VAERS ID Code" Adverse Event Description Lab Data

"153914-1" "153914-1" "Received injection in 2 stages. On May 13, 2000

hands, forearms swollen, joints ached, shoulder sore, very tired. Used Benadryl
also was given Cicsorex for pain. That did not help. Was given Advil 800 mg. As of
6/4/2000 pt still has fatigue, swelling and pain." "CBC, chemistry, X-ray"
"201048-1" "201048-1" "Patient died on 3/19/03. Cause of death SIDS. Death
occurred two days after immunizations. No problems reported before or after shots."
"No lab data for this event."
"263163-1" "263163-1" "Hepatitis B 3/16/07 Received copy of Death
Certificate from reporter which states COD as cirrhosis & fatty metamorphosis of
liver with pulmonary emphysema as contributing factor. Also noted corrected DOB &
DOD. Immediate cause disease or condition resulting in death. Cirrhosis and fatty
metomorphsis of liver. Cancer to liver. Pulmonary emphysemo. He die of pulmonary
emphysome and the vaccine cause to get worse." "Hepatitis B. Cirrhosisand fatty
metamorphosis of liver."
"265563-1" "265563-1" "Pt received flu vaccine on 10/25/06. Today was
stroke like symptoms. Left sided weakness et paralysis. CT neg for stroke. Seen in
ER with suspicion of stroke. Doing well until found this morning with left facial
droop and left side hemiparesis. Presented with extreme weakness of left side. PMX
significant for many episodes of ITA, HX of atrial fibrillation. Has a pacemaker.
HTN. CT head in 2005 showed chronic changes of white matter without any acute
changes suggestion of stroke or hemorrhage. PE: WNL except for unable to elicit
Babinski signs. Neurological exam obvious droop to left, weakness, strength is 1/5
in left and upper extremities. Responds to commands, follows commands. Alert but
somulant. Assessment: TIA versus CVA. Transferred to stroke center at St. Alexius.
At time of injection patient lived in assisted living, after adverse event she was
hospitalized and later died." "Seen in ER with suspicion of stroke. Doing well
until found this morning with left facial droop and left side hemiparesis.
Presented with extreme weakness of left side. PMX significant for many episodes of
ITA, HX of atrial fibrillation. Has a pacemaker. HTN. CT head in 2005 showed
chronic changes of white matter without any acute changes suggestion of stroke or
hemorrhage. Blood sugar 144. PE: WNL except for unable to elicit Babinski signs.
Neurological exam obvious droop to left, weakness, strength is 1/5 in left and
upper extremities. Responds to commands, follows commands. Alert but somulent.
Assessment: TIA versus CVA. CT scan without contrast: prominent deep white matter
changes. Compared to study of 3/28/05: significant degree of decreased density in
subcortical and perventricular deep white matter regions bilaterally suggesting
chronic small vessel ischemic changes. No evidence of mass, hemorrhage or definite
areas of acute ischemia."
"268093-1" "268093-1" "Infant Died within 24 hours of receiving routine
child hood immunizations." "Medical Examiner report pending"
"272228-1" "272228-1" "Pt was found dead of unknown cause the morning after
immuns were given. Child was sleeping in bed with mom. 4/20/07 Received Autopsy
Report which reveals COD as asphyxia, cannot exclude parental overlay. Patient
found face doen position after co-sleeping w/parents. Final dx also included
dilation of left renal pelvis." "Autopsy is planned"
"272363-1" "272363-1" "Pt with history of prematurity, non surgical
necrotizing enterocoloitis and omphalocele. Recieved routine 2 month immunizations
- Pediarx, Hib, Prevnar and Rotateq on 11/28/06. On 12/9/06 presented to ER
isseptic shock secondary to necrotic bowel. Patient dies. 2/16/07 Received
medical records from reporter/provider which reveal patient was in usual state of
health on day of vax. Complicated PMH, see below. Seen next on 12/5 for parental
concern re pallor. Afebrile, fussy, + weight gain, abdomen was mildly tympanic but
soft w/+BS. Return for vs on 12/7 & parents reported patient had improved at home,
no further pallor episodes. temp stable, good appetite, no vomiting. Had seen peds
surgeon that day for f/u on omphalocele. Next scheduled visit was for 12/21.
2/16/07 Received Death Summary & Autopsy Report from reporter/provider which
reveals on 12/9/06 patient experienced pallor, spitting up since afternoon of
admit, fussy, irritable. Exam in ER revealed rectal temp of 91.7, mottled skin,
shallow breathing & in acute distress. Had extremely rigid abdomen w/no bowel
sounds. Developed cardiac arrhythmias & seizures. Transfused w/PRBCs. Then
omphalocele ruptured & had significant bleeding, continuing arrhythmias & finally
asystole with unsuccessful resuscitation effort. Autopsy Report reveals probable
COD is multisystem organ failure from septic shock secondary to ischemic small
intestine within an unresolved omphalocele." "LABS: initial ABG revealed pH
6.77, pCO2 72. K 7.1. Severe anemia."
"272729-1" "272729-1" "It was reported in a published article, title as
stated above that 1 child experienced true vaccination failure and developed
invasive Hib disease, also referred to as meningitis, despite vaccination with
doses of PedvaxHib. (manufacturer unknown). It was reported that the patient
experience death, cause unspecified. No further information was available at the
time of this report. No outcome information was reported. Upon internal review,
invasive Hib disease was determined to be an other important medical event.
Additional information has been requested." "UNK"
"272731-1" "272731-1" "It was reported in a published article, that 2
children developed invasive Hib disease, after being partially immunized with a
median of 1 dose of PedvaxHib (OMPC) (manufacturer unknown) (range 1-2 doses). It
was reported that 2 infants died because of nontypeable H influenzae invasive
disease. No further information was available at the time of this report. Upon
internal review, invasive Hib disease was determined to be an other important
medical event. Additional information has been requested." "Unknown"
"272947-1" "272947-1" ""Information has been received from a physician
concerning a 3 month old female who, ""five weeks ago,"" on approximately 11-JAN-
2007, was vaccinated with a first 2ml oral dose of ROTATEQ. In the ""first week of
February,"" on approximately 01-FEB-2007, the patient died of volvulus. At the time
of the report the physician was still awaiting the autopsy report. Unspecified
medical attention was sought. No product quality complaint was involved. The
patient's experience was considered to be immediately life-threatening by the
reporter. Additional information is not expected. 2/27/07 Received t/c from ME
office with prelim COD: 1. Infarct of a major portion of the small intestine. 2.
Obstruction by congenital fibrous band. Manner of death was natural. 6/5/07
Received Autopsy Report which reveals COD as infarct, major part of small intestine
due to congenital obstructing fibrous band, 28 cm distal to the pylorus and 3 cm
proximal to the ileocecal valve; and transmural hemorrhagic ischemis changes
throughout the obstructed small bowel. 7/10/07-vac rec received."" "Unknown"
"272954-1" "272954-1" "Initial report received on 14 February 2007 from a
health care provider who has acquired the information from a newspaper article. Per
the newspaper article, it has been reported by the state department of health that
an eight year old child, who had received a flu vaccination and had unspecified
underlying health problems, died from the disease influenza on 12 February 2007.
Additional information was not provided related to this case. (The firefighter that
was also reported in the title of the article had not been vaccinated." "No
lab data for this event."
"273384-1" "273384-1" "Information has been received from a physician
concerning a 15-month-old male with a history of jaundice at birth, who on 24-JAN-
2007 was vaccinated with a 0.5ml dose of ProQuad (lot #656160/1396F, expiration
date 16-MAY-2008). Concomitant vaccinations included: Prevnar (lot #B08639A),
Tripedia (lot # C2552AA) and Comvax (lot reported as 653660/0257F). Subsequently,
on 11-FEB-2007 the patient experienced a mental state change and was hospitalized.
The patient underwent a CT scan that was non conclusive at the time of this report.
It was reported that the patient experienced unexpected rapid deterioration and
died on 12-FBE-2007. An autopsy was performed, however, results were not yet
available. The cause of death was unknown at the time of this report. The patients
adverse experiences were considered to be life threatening and disabling.
Additional information has been requested. 4/24/07 Received medical records from
PCP which reveal patient experienced good health on day of vax. Later on day of
vax developed swollen left leg & patient had difficulty walking that day. Next day
was resolved when seen by PCP. Dx suspected Prevnar reaction. On 1/26 seen in ER
for abdominal distention, vomiting & diarrhea. ER dx w/ileus. Seen by PCP 1/27 &
dx w/resolving ileus secondary to acute gastroenteritis. Next note is of t/c from
parent that patient deceased on 2/12/07. PCP requested autopsy report on 2/28/07.
Vax record included w/med records from PCP. 4/24/07 PCP also forwarded med records
from 2/12/07 hospitalization which reveal patient experienced altered mental
status, fussiness, congestion, swollen face, increased sleepiness & pallor.
Patient had been seen at outying Urgent Care center then transported to outlying ER
via ambulance for fever, wheezes & respiratory difficulty w/a single apneic period
reported. Child then transported to another hospital for PICU higher level of
care. On admit there, very lethargic, pale, crying & opening eyes intermittently.
There was crusty nares, inspiratory wheezing & crackles & coarse breath sounds, no
neck rigidity, hypotonia. Started on antibiotics & LP obtained. Seizures were
noted in PICU & loaded w/dilantin. Emergently intubated following AM for dilated
pupils, responsiveness to deep pain w/decerebrate posturing & respiratory
difficulty. Treated w/high dose steroids for possible ADEM. Condition
deteriorated over the day, patient declared brain dead & deceased. ER DX:
meningitis vs encephalitis. PICU Dx: brain stem dysfunction. 10/2/07 Reviewed
Autopsy Report which revals COD as undetermined & manner of death as undetermined."
"computed axial 02/11?/07 - Non-conclusive LABS: from outlying ER, WBC 10.3,
neutros 48, bands 4, lymphs 39. CT of brain, abdomen & pelvis were WNL. Blood
c/s, urine c/s & RSV were all pending. Urine tox neg. LFTs were WNL. CSF showed 0
WBC & RBC, protein 155, glucose 70. EEG was severely abnormal w/evidence of slowing
but no seizure activity. Rapid influenza was neg. Repeat CT scan showed no edema
but extensive deep white matter abnormalities, probably congenital in origin,
mitocondrial antibody type disorder was suspected as not typical of neoplastic or
inflammatory process. MRI was recommended but due to continued deterioration was
not able to be performed. Cerebral perfusion scan showed no blood flow."
"273879-1" "273879-1" "Infant found in crib not breathing and cyanotic,
parent began CPR and call 911. Child placed on life support and later declared
brain dead. Taken off life support and pronounced dead. Child treated with various
medication for infection , blood pressure. 7/20/07 Received Autopsy Report which
reveals COD as unexplained sudden death; ischemic brain injury & diffuse cerebral
edema; coagulopathy; metabolic acidosis; & stool positive for rotavirus (possible
false (+) secondary to vax 5 days prior. Patient had undergone organ retrieval &
autopsy was limited to lungs, uterus, ovaries, trachea, esophagus, distal colon &
brain." "No lab data for this event."
"273989-1" "273989-1" ""Information has been received from a physician
concerning an 83 year old female who ""within the last six months,"" in
approximately 2007, was vaccinated with a dose of Zostavax. Subsequently the
patient developed shingles. It was also reported that the patient was deceased from
causes unrelated to the experience with Zostervax. Additional information has been
requested. 3/22/07 Received Death Certificate which reveals COD as sepsis, right
lower lobe pneumonia with contributing conditions of COPD & s/p right mastectomy
for breast cancer. 6/8/07 Received medical records from PCP which included
hospital records from 2/20-2/23/07 hospitalization after patient experienced SOB,
nonproductive cough, chest pain, fever & chills, decreased appetitem malaise &
weakness w/multiple falls while home. Family brought to ER & dx w/pneumonia.
Admitted to ICU due to episode of hypotension & started on IV antibiotics.
Respiratory status declined, developed respiratory acidosis & was intubated.
Consult w/pulmonology & cardiology. Renal function then declined. Consult
w/nephrology. Continued to decline, developed atrial fibrillation & arrested.
Resuscitation efforts were unsuccessful & patient was pronounced. FINAL DX: Sepsis
due to RLL pneumonia; respiratory failure due to sepsis & RLL pneumonia. PCP office
visit of 11/15/06 notes that patient had recently received Zosavax & now had faint
eruption of shingles. Tx w/Valtrex at that time. 2/2/07 office visit notes post
herpes polyneuropathy tx w/cymbalta & lyrica."" "UNK LABS from PCP: 1/31/07 ck
elevated at 159; HDL elevated at 63, LDL elevated at 108, triglycerides elevated at
162. LS spine series o 12/06 revealed DDD, muscle spasm & atheroscerotic vascular
dx w/prior renal artery stent placement. LABS from hospital 2/20/07: CXR revealed
right pleural effusion & RLL pneumonia. WBC 18,000 w/left shift; H/H 11.9/33.1,
creatinine 1.5, Na 130 EKG revealed left anterior hemiblock & complete right BBB
w/degree of interventricular conduction delay. Blood, sputum & urine c/s done,
results not reported."
"274046-1" "274046-1" "Baby found dead in crib less than 24 hours after
vaccine administered. Had minimal temp to 100F prior to being put down to bed at 2
AM was found dead at 8 am. 08/21/07 Received autopsy report which states COD as
SIDS & co-sleeping w/parents. Tox screen neg except for therapeutic amount of
acetaminophen." "None. Autopsy in progress"
"275990-1" "275990-1" ""Information has been received from a physician's
assistant (PA), via a company representative, concerning a female patient who was
vaccinated (date unspecified) with a dose of Gardasil the PA reported that ""the
patient died of a blood clot 3 hours after getting the Gardasil vaccine."" The PA
clarified that the patient was not vaccinated at her office. Additional information
has been requested."" "Unknown"
"276742-1" "276742-1" "Truncus arteriosis S/P partial repair. On Lasix and
Captopril, Being followed by GI, cardiology. 8/3/07 Received Autopsy Report which
reveals COD as failure to thrive due to congenital heart disease, s/p correction of
truncus arteriosus." "Not Available"
"277175-1" "277175-1" "Baby was DOA at hospital. Death certificate listed
bruises found on head and cause of death as traumatic injuries of head and abdomen.
4/29 Autopsy states COD as traumatic injuries of head & abdomen. Manner of death:
homicide. 4/29/08 Autopsy report states patient experienced irritability, fever,
vomiting & diarrhea since vaccination w/o medical attention. Patient had been to
ER x 3 for vomiting 3 times since birth, last on 12/7/2006. Contusion in center of
forehead noted in ER w/o explanation by parents. Findings at autopsy included:
extensive nearly transmural lacerations of the liver w/hemoperitoneum; mod soft
tissue bleeding in abdomen, pelvis & lower chest including involvement of left
lung; mid-mod SAH; healing posterior paravertebral fractures of right ribs 7 & 11
and left ribs 3-8; mild-mod contusions & abrasions of skin & sq tissue of head,
torso & right leg; mild bronchitis & mild trachitis. Metabolic, chemical & tox
tests neg. These injuries resulted in a significant amount of bleeding on the
surface of the brain & into the abdominal cavity." "2/19/07 Wt 15-9 ht 253/4' -
Recertified for WIC"
"277805-1" "277805-1" "Baby received 5 shots and died the next day of
unknown cause - pending coroner report. 6/8/07 Received Autopsy Report which
reveals COD as SIDS." "None at present time"
"278274-1" "278274-1" "Broke out in red rash all over body called Dr office
to report it -2 days later was told it wasn't caused by vaccine, no treatment
recommended. Had pneumonia 3 wks later. 5/15/07 Received medical records from
pulmonologist which reveal patient experienced dyspnea, cough, night sweats &
dysphagia for approx 6 mos when initially evaluated on 3/15/06. He also complained
of occasional HA, daytime hypersomnolence, occasional constipation. Exam revealed
velcro type rales in bases & clubbing of extremities. Patient referred for open
lung biopsy but deferred. Started on supplemental O2. Spirometry done 8/06 &
10/06 revealed worsening restrictive disease. FINAL DX of pulmonologist: idiopathic
pulmonary fibrosis. 6/12/07 Received hospital medical records which reveal patient
experienced acute flare of interstitial fibrosis; acute renal failure; pneumonia;
idiopathic pulmonary fibrosis; prostrate cancer; & GERD. Had increasing SOB,
fever/chills, HA & productive cough x 15 days. Admitted 11/20-12/4/06. Treated
w/high dose steroids, IV antibiotics & high flow O2. Pulmonary & ID consults done.
Very gradually stabilized & was d/c to home on continued oral antibiotics &
steroids w/hospice care for poor prognosis. FINAL DX: Acute flare of interstitial
fibrosis; acute renal failure; pneumonia; idiopathic pulmonary fibrosis; prostrate
cancer; & GERD. 7/17/07 Received Death Certificate which reveals COD as pulmonary
fibrosis." "Pulmonogist LABS: PFTs done 3/06 revealed restrictive disease & ABG
revealed hypooxygenation. CT of chest done 2/06 revealed pulmonary fibrosis &
enlarged mediastinal lymph nodes. ANA significantly elevated. EGD revealed
esophageal stricture. Bronchoscopy 5/10/06 biopsies & c/s done was non-diagnostic.
AFB smear & c/s were neg US of chest revealed interstitial thickening c/w pulmonary
fibrosis. Repeat CT scan of chest 6/2/06 was essentially unchanged except for few
scatter areas of ground glass opacities. PPD 8/06 was neg. Hospital LABS:
creatinine up at 1.4. WBC 14.3 on admit. Blood c/s neg. Sputum c/s grew
Aspergillus."
"278371-1" "278371-1" ""This case was reported by a nurse, and described
the occurrence of influenza in a subject of unspecified age and gender who was
vaccinated with influenza virus vaccine for prophylaxis. The subject's medical
history, concurrent conditions, and concurrent medications were not reported. On an
unspecified date, the subject received unspecified dose of Flu vaccine (unknown).
The reporting nurse did not have the name of the Flu vaccine that was administered.
At an unspecified time after vaccination with Flu vaccine, the subject experienced
influenza and lack of efficacy. It was reported that the subject ""died from the
flu, however, it was unknown which strain of flu the subject died from"". It was
unknown whether an autopsy was performed. No further information was provided at
the time of reporting."" "UNK"
"278571-1" "278571-1" "Death within 24 hours. 5/18/07 Received medical
records from PCP which reveal patient initial exam in office placed her on wt
percentile 2 & ht percentile 14 w/weight of 5 lbs 10 oz. Next vs of 4/12 for
parent concern of weight loss. Wt was 5 lbs 8 oz. MD instructed on feeding &
planned to hospitalize patient on 4/16 if not improved. Next vs on 5/3 day of vax
after having been seen in ER for abdominal pain & received suppositories in ER
w/good results. Dx w/constipation. Weight 6 lbs 13 oz. 6/12/07 Rceived vax record
from pcp which confirms lot & dose # as reported. 6/21/07 Received autopsy report
which reveals COD as SIDS." "No lab data for this event."
"278670-1" "278670-1" "Irritability and Death from unknown cause within 24-
48 hrs of vaccine administration 5/29/07 Received hospital medical records which
reveal patient experienced fussiness, crying & then stopped breathing. EMS found
patient in asystoly & started CPR & intubated. Resuscitation effort were
unsuccessful & patient was pronounced. 6/1/07 Received medical & vax records from
PCP which reveal patient received only Hib, Lot # 0408F on 1/9/07. VAERS database
updated w/same. Medical records were cardiology clinic reports to PCP. Last report
was 1/17/07 which indicated the patient was doing well. Weight was 3.6 kg. O2 sat
was 86%. Precordium was overactive & continuous murmur & shunt were noted. Liver
was not down. Pulses were intact & accentuated throughout. 6/8/07 Received Death
Certificate which reveals COD as cardiopulmonary arrest and congenital heart
disease." "LABS: ECG revealed normal PR, QRS & QT intervals & right ventricular
hypertrophy. 2D echocardiogram revealed large VSD, essentially univentricular heart
w/normal atrial & ventricular situs & looping w/D-transposed great arteries &
pulmonary atresia & systemic-to-pulmonary supply provided by systemic-to-pulmonary
artery shunt w/functioning & confluent but small central & brance pulmonary
arteries s/o signes of excessive pulmonary over-circulation. BNP was WNL."
"278688-1" "278688-1" "Information has been received from a medical
assistant concerning a patient who approximately one month ago on 03-APR-2007 was
vaccinated with a dose of zoster vaccine live. Within a week, the patient died of a
heart attack. No additional information was provided. Additional ifnormation has
been requested. 5/18/07 Received records from reporter which included Death
Certificate which reveals COD as Inferior myocardial infarction. Records from PCP
incidate patient had tetanus updated 1/24/07. Records from ER of 3/16/07 indicate
patient seen for syncope or unresponsiveness when passed out in church after
complaining to friends that she did not feel well for several days because of her
gallbladder. EMS called. BP was unobtainable. Started on Dopamine & given IV
fluid bolus. Denied pain & good respiratory effort but restless. O2 sats remained
in high 80's but w/poor perfusion signal. Preparing to administer thrombolytics
when became unresponsive & lost pulse. Intubated & coded but unsuccessful
resuscitation. FINAL ER DX: acute myocardial infarction, perhaps remote w/continued
expansion of infarct leading to cardiopulmonary decline." "Unknown LABS: EKG
showed ST elevations. Troponin 4.44. CXR showed clear lungs. AST 69, Ca 7.7, t.
protein 4.4. RBC 3.02, H/H 9.7/29.9, lymphs 5.9, monos 0.8. HBA1C 8.2, free
testosterone 7.1"
"278873-1" "278873-1" "Unsure of adverse events. Patient died on 5/5/07.
11/16/07 Received autopsy report which states COD as sudden infant death while co-
sleeping and hippocampal dysplasia. Sleeping on parent's chest in prone position
and found unresponsive. Had been seen in ER 4/13/07 for apneic episodes. Autopsy
also revealed mild laryngopharyngitis & recent history of cold symptoms. 5/29/08
Received vax record which confirms as reported." "No lab data for this event."
"279592-1" "279592-1" "Information has been received from a licensed
visiting nurse via a nurse practitioner. The nurse practitioner was told by a
friend that a female patient was vaccinated with Gardasil and two weeks alter
developed a blood clot. Subsequently the patient died. The cause of death was from
the blood clot. The reporting licensed visiting nurse considered the blood clot to
be immediately life-threatening and disabling. Additional information has been
requested." "No lab data for this event."
"280163-1" "280163-1" ""Information has been received from a nurse
practitioner who heard from an emergency room (ER) nurse that an 11 year old female
was vaccinated ""within in the past month"" in approximately May 2007 with a first
dose of Gardasil. Subsequently, 3 days after vaccination the patient presented to
an ER. She experienced cardiac arrest, required lung bypass (ECMO) and ""may not
have expired."" It was also reported by the same nurse that the physician from the
hospital said that ""the death was due to an anaphylactic reaction to Gardasil.""
The anaphylactic reaction and cardiac arrest were considered to be life threatening
by the reporter. Additional information has been requested."" "No lab data for
this event."
"280676-1" "280676-1" ""This case was received from a consumer on 22 May
2007. A consumer reported that ""her friend's child died from a DPT shot"". No
additional information was provided."" "No lab data for this event."
"281033-1" "281033-1" ""Information regarding Prevnar vaccine was received
from a consumer, the mother of a 16-month-old female patient who on 21-Dec-2006,
received a dose of Prevnar along with a dose of Hib (manufacturer unknown), a dose
of Varivax (manufacturer unknown), and a dose of M-M-R II (Merck Sharp & Dome). On
the same day, the patient experienced lethargy, possible seizure, irritability, was
not acting normally, had jerky movements and clenched hands. On 22-Dec-2006, the
child would not respond and on 24-Dec-2006, the child died. On 21-Dec-2006, the
patient with a history of influenza like illness, pyrexia, virus (unspecified) and
tremor of hands, was evaluated at the physician's office for those symptoms and was
also administered Prevnar along with Hib, Varivax, and M-M-R II. Later that day,
the child was lethargic and experienced a possible seizure, irritability, was not
acting normally, had jerky movements and clenched hands. On 22-Dec-2006, child
would not respond and was taken to the hospital and placed on life-support for two
days. On 24-Dec-2006, the child died. The cause of death was not reported. The
reporter stated she ""feels that her daughter had an adverse reaction to Prevnar.""
No additional information was available at the time of this report."" "Reported
Cause of Death unknown"
"282747-1" "282747-1" "Information has been received from a physician who
attended a conference that mentioned two patients who were vaccinated with
Gardasil. Subsequently the patients died. The cause of death not reported. Attempts
are being made to obtain additional identifying information to distinguish the
individual patients mentioned in this report. Additional information will be
provided if available. Additional information has been requested." "Unknown"
"282926-1" "282926-1" "baby was administered the Pediarix,Hib,pcv and
Rotavirus;before and after the vaccine administration baby appeared in good
health,stable;no adverse effect observed in clinic or home;the next morning,after
being fed and put to sleep on his tummy, baby was found unconscious, face down in
crib and expired in E.R. 7/3/07 Received vax records which confirm RO lot & dose #
as reported. 11/27/07 Reviewed autopsy report which states COD as undetermined &
manner of death undetermined. Diagnoses included: sudden death of 2 mo old baby
boy sleeping prone in bassinet on blanket found face down with anterior fixed
lividity on abdomen & surrounding nose & mouth; atrial septal defect, secundum
type; 6 fingers on each hand." "baby was recovering after a viral syndrome;T-
98.8;full clinical exam normal the day of immunization."
"283066-1" "283066-1" "Grandmother found baby not breathing after nap
around 3:55 pm. EMS notified and CPR began 10 minutes after discovery. Baby
transported with CPR in progress. Baby pronounced dead at 4:31 pm. 7/10/07
Received vax records from HD which confirms RO dose & lot # as reported. 10/2/07
Autopsy Report reviewed which states COD as SIDS." "No lab data for this event."
"283502-1" "283502-1" ""Information has been received from a physician
concerning a 2-month-old patient who was vaccinated with a dose of Rotateq (lot
number not provided). Concomitant therapy on that same day included ""several other
shots"" (not further specified). The physician reported that, within 24 hours of
vaccination, the patient had bloody stools and within 48 hours died. Upon internal
review, bloody stools was determined to be an other important medical event. No
further information is available."" "Unknown"
"284759-1" "284759-1" "On 6/28/07, received report of infant death from
Coroner's Office. 7/17/07 T/C to coroner to request prelim COD: stated as
Undetermined. Patient was sleeping in bassinet using pillows & blankets as
mattress & was found face down. 8/24/07 Received vax record which confirms RO dose
& lot # as reported. 11/6/07 Received death certificate & autopsy report which
state COD as undetermined in setting of non-standard (home made mattress) bedding
in which patient was placed face down." "No lab data for this event."
"284994-1" "284994-1" "Infant death. Infant discovered in crib by parents
on 7/16/07 expired. No conclusive findings on post. 8/24/07 Received autopsy
report which reveals COD as undetermined & manner of death as undetermined." "No
lab data for this event."
"286402-1" "286402-1" ""7/26/07 routine exam, TD & Zostavax immun given,
7/28/2007 reported to family members aches, chills, ""can't get warm"", did not
contact medical personnel nor feel need to seek emergent care. retrospective report
from family member. 7/29/2007found by family member in AM within a few hours after
death. 8/3/07 Received pcp medical records which reveal patient seen 7/5 & 7/26 in
office for right foot pain, RUQ abdominal pain. X-ray of right foot revealed
arthritic changes. US of gallbladder revealed sludge. Labs revealed decreased
kidney function c/w chronic kidney disease III. Urine c/s neg. Lipids
significantly increased as patient had stopped on her own the statin drug
presribed. CXR was WNL w/streaking due to scarring. EKG unchanged from prior
tracings revealed right axis deviation & borderline R-wave progression. Last seen
by nephrologist 4/06 & was d/c from service due to resolution of condition.
Records include vax records which confirm dose & lot #s as reported. 9/11/07
Received Autopsy Report which states COD as hemopericardium w/cardiac tamponade due
to acute MI w/cardiac rupture due to arteriosclerotic heart disease. Pathological
diagnoses included: I. Arteriosclerotic heart disesae A. Atherosclerosis of
coronary arteries w/acute thrombus. B. Acute MI w/cardiac rupture. C.
Hemopericardium w/cardiac tamponade. II. Systemic atherosclerosis A.
Atherosclerosis of cerebral arteries. B. Atherosclerosis of aorta. III.
Nephrosclerosis. IV. Fibroma of ovary. V. Hyperlipidemia by clinical history. VI.
IBS by clinical history. VII. Osteoporosis by clinical history."" "N/A"
"286834-1" "286834-1" ""Information has been received from a consumer
concerning his friend, a 73 year old male with a ""deteriorating heart"" and no
known allergies who on 23-JUL-2007 at ""about 07:30"" was vaccinated once SC with a
0.65 mL dose of Zostavax. Concomitant therapy included COUMADIN and oxygen (started
""a few days before this happened""). Two hours after vaccination the patient
""died from a heart attack when his aorta ruptured."" It was reported that the
patient was revived with CPR but when the patient got to the hospital the doctor
stated that he had ""died instantly."" There was no product quality complaint
involved. No further information was provided. Additional information has been
requested. The reporter considered the patient's to be serious as other important
medical events. The patient's events were also considered serious for death.""
"Unknown"
"287884-1" "287884-1" ""Information has been received from a physician
concerning a 2-month-old male who on 22-JUN-2007 was vaccinated with a 2mL PO dose
of Rotateq (Lot # ""2028U""). Suspect therapy that day included a dose of HIB conj-
hepatitis B vaccine, a dose of PREVNAR, a dose of diphtheria toxoid (+) pertussis
acellular vaccine (unspecified) (+) tetanus toxoid, and a dose of ""ITV"". On 30-
JUN-2007 the patient passed away. CPR was noted. The autopsy medical examiner gave
verbal to the mother stating that no cause has been determined. At the time of the
report, the physician still did not have the autopsy report. No further information
was provided. There was no product quality complaint. The event was considered to
be an other important medical event by the reporter. Additional information has
been requested."" "Unknown"
"287888-1" "287888-1" ""Information has been received from a nurse
practitioner concerning a 22 year old female patient with no pertinent medical
history or drug allergies who on 21-MAY-2007, was vaccinated IM with a 0.5ml dose
of Gardasil (Lot# 657736/0389U). Concomitant therapy included hormonal
contraceptives (unspecified) (""MERCET""). On 23-MAY-2007, the patient died
suddenly. The cause of death was unknown. Unspecified medical attention was sought.
Laboratory diagnostic studies included an autopsy which showed no findings. No
product quality complaint was involved. The reporter stated that Gardasil did not
cause the patient's death. Additional information is not expected. 7/2/08-records
received-Adverse effect of drugs.Toxicology survey findings:urine positive for
methadone, benzodiazepines, benzoylecgonine (from cocaine), cannabinoids, nicotine,
diphenhydramine and naproxen."" "autopsy - no findings"
"288181-1" "288181-1" "Patient was found August 9,2007 in between both
parents unresponsive. 8/17/07 Received call from provider, will not send vax
record but read lot #s to check against report. RO dose & lot # correct as
reported; however, 2 other lot #s corrected in VAERS database. 9/25/07 Reviewed
Autopsy Report which reveals COD as traumatic asphyxia due to entrapment of head
between mattress & headboard. Manner of Death: accident." "No lab data for this
event."
"288631-1" "288631-1" ""Information has been received from a pharmacy
technician concerning a 75 year old (previously reported as ""about 75 year old"")
female ""in poor health"" with heart problems and a history of stroke and other
unspecified medical conditions who on 02-AUG-2007 was vaccinated with a dose of
Zostavax. For an unspecified amount of time after vaccination the patient was
observed for any reaction. The patient then left the pharmacy without any signs of
an untoward reaction. Several days later the pharmacy technician read in the paper
obituaries that the patient passed away on 06-AUG-2007. The cause of death was not
reported. There was no product quality complaint involved. No further information
was available. Additional information has been requested. 08/23/2007 Per email from
FDA: A 75 y/o female in poor health with heart problem and a hx of stroke died 3
days after receiving Zostavax. Her name was in newspaper obituaries. She did not
experience any immediate AEs after vaccination. Called Meck for follow up
information including cause of death. 8/27/07 FDA obtained patient name & DOB from
Merck. No autopsy was done. COD was intracranial hemorrhage. Merck will provide
additional medical records. 9/7/07 Reviewed pcp medical records which reveal
patient on chronic anticoagulant therapy for mitral valve replacement & was seen
approx every 2 weeks for labs & eval. Weight & vital signs stable. 10/29/07
Reviewed Death Certificate which states COD as subdural hematoma with
anticoagulation for valvular heart disease as contributing factor."" "Unknown
LABS: last done 7/26/07, CBC & chemistry WNL. Glucose elevated 142. Digoxin WNL.
PT/INR therapeutic."
"288632-1" "288632-1" ""It was report in a published article, title as
stated above, that ""A 20-year-old pregnant woman was admitted to this hospital at
26 weeks of gestation because of dizziness, confusion, and difficulty walking. Ten
weeks before admission, the patient had a positive result on a home pregnancy test
and presented to a neighborhood health center for prenatal screening. Tests for
sickle cell trait, syphilis, and human immunodeficiency virus (HIV) and hepatitis B
and C virus antibodies were negative. Serologic tests for varicella-zoster virus
and rubella IgG were positive. Two weeks later, an endocerival specimen was
positive for Chlamydia trachomatis infection and negative for gonorrhea. The
patient missed follow-up appointments and treatment with azithromycin was initiated
4 weeks later. (She) was happy, with a childlike affect, a poor memory, confusion,
and odd movements of her head. During the next 2 weeks, nausea and vomiting
occurred daily and were controlled with metoclopramide. Four days before admission,
dizziness and weakness on the left side developed; she began to fall to her left
and vomited several times. The next day, she went to the ED of another hospital. On
evaluation, the patient was oriented to location but not to date, day, or month,
and she provided inconsistent information about her medical history. The uterus was
gravid, and he remainder of the physical examination was normal. An EKG revealed
sinus tachycardia and counterclockwise rotation with T waves in the right
precordial leads. Urinalysis showed a protein level of 30 mg per deciliter and a
glucose level of 100 mg per deciliter (5.6 mmol per liter). Tricyclic metabolites
were present on toxicology screening of a urine specimen. CT scanning of the head
revealed a slight, diffuse prominence of the ventricular system. There was no
intracranial mass or other focal brain lesion. On the second hospital day, the
patient was alert, calm, cooperative, and oriented to person, location, and current
events but was not aware of details of her life. There were no tremors or
extrapyramidal signs. Ultrasonographic examination revealed normal fetal anatomy
and growth, corresponding to a gestation of 25 weeks 6 days. On the third day, the
weakness, nausea and vomiting had resolved, and the patient was thought to have
returned to her baseline mental status. She was discharged to the shelter with a
recommendation to schedule a follow-up neurologic evaluation. At the shelter, she
was dizzy, had difficulty walking, and fell into a chair. That evening, she was
brought to the emergency department of this hospital. In the emergency department,
the patient reported feeling ""woozy"" and nauseated. She noted a mild headache of
gradual onset, extending bandlike across the brow. The history as given by the
patient was inconsistent; the history was then provided by staff members of the
shelter, and many details were lacking. She had had measles at 4 months of age and
varicella infection in childhood. at 7 years of age, she injured her head in a fall
but was said to have recovered fully. Immunizations included polio vaccine and
diphtheria, pertussis, and tetanus vaccine series; measles vaccine felt (at 11
months of age); measles, mumps and rubella vaccine combination; and hepatitis B
vaccine (between 2 and 3 years before admission, on enrollment in high school). She
had no known allergies and did not use alcohol, illicit drugs, or tobacco. On
examination in the ED, the patient was alert but somewhat uncooperative, with
involuntary head movements. Her mental status was not formally assessed, but her
level of cognitive function was said by a friend to be at baseline. The abdomen was
soft, gravid, and not tender; the fetus appeared to be healthy. The 1st cranial
nerve was not tested, and the 2nd through 12th nerves were intact. Strength was
intact, and the gait was unsteady. The remainder of the examination was normal.
After premedication with lorazepam at a dose of 1 mg to control involuntary
movements, MRI of the brain was performed without administration of contrast
material. On T2-weighted, FLAIR images, hyperintense signal was seen in the left
hippocampus and parahippocampal gyrus as well as in the posterior limb of the left
internal capsule. There was no evidence of restricted diffusion. Examination by a
neurology consultant showed that the patient was oriented to person and place, with
a childlike affect. Her speech was fluent, and naming was intact. She could read a
short sentence and do simple addition. She was left-handed, could write her name
but not a sentence, and followed simple and complex commands. Her attention was
variable, and testing of her memory showed recollection of zero of three items at 5
minutes on repeated examination. Smell and taste were not tested. The function of
the other cranial never was intact. There were choreiform movements of the head and
neck, poor performance of rapid alternating movements, and apraxia. Hypertonia and
hyperreflexia with clonus were noted in the right leg. The gait was wide-based,
with postural instability and leaning toward the left. She was unable to stand on
one foot. She was admitted to the neurology service. On the second hospital day, a
lumbar puncture was performed. An enzyme-linked immunosorbent assay for serum
antibodies against HIV was negative. An EEG showed diffuse theta slowing and
frontal intermittent rhythmic delta activity, which was more prominent in the right
hemisphere than in the left. There was no epileptiform activity. Repeated MRI of
the brain after the administration of gadolinium showed no changes and no evidence
of abnormal enhancement. Acyclovir was administered IV. The next day, a serum Lyme
antibody test, a test of a throat swab for Mycoplasma pneumoniae nucleic acid, and
cultures of blood and urine were negative. On the fifth day, the patient's
condition appeared to be improved. She was oriented and remembered details of her
past; dysmetria and truncal ataxia were reduced. Results on a repeated EEG were
unchanged. The next day, a repeated lumbar puncture was performed. Between the 7th
and 18th hospital days, the patient's motor function gradually worsened, right-
sided neglect developed, she became unable to feed herself, her responsiveness and
ability to follow commands decreased, and she became incontinent. She began lying
in a fetal position, moaning and crying out unintelligible sounds. A skin test for
tuberculosis, a test of a nasopharyngeal specimen for respiratory viral antigens,
and a viral culture of a stool specimen were negative. Nucleic acid testing for HIV
RNA and tests for antinuclear antibodies were negative. Levels of free and total
thyroxine were normal, and the thyroglobulin level was elevated (54.7 ng per
milliliter). On the 12th day, the acyclovir was discontinued, and ceftriaxone, at a
dose of 2 g, was administered IV. A repeated EEG study showed increased attenuation
of background activity and less abundant frontal intermitt""head computed axial -
slight, diffuse prominence of ventricular system, no intracranial mass or other
focal brain lesion, blood pressure - 107/81, magnetic resonance - hyperintense
signal in left hippocampus and parhippocampal gyrus, electroencephalography -
diffuse theta slowing and frontal intermittent rhythmic delta activity R >L,
venography - head-normal, magnetic resonance - new hyperintense signal in pons and
middle cerebellar peduncles with assoc. restricted diffuse, electroencephalography
- increase attenuation of background activity and less abundant frontal
intermittent delta activity, neutrophil count 72% 40-62, lymphocyte count 21% 27-
40, serum creatinine 0.5 mg/d 0.5 - 1.5, serum globulin test 4.2 g/dL 2.6 - 4.1,
serum lipase test 7.5U/dL 1.3 - 6.0, total iron-binding 464 ug/d 228 - 428, urine
ceruloplasmin 84 mg/d 27- 50, serum ferritin assay 9 ng/d 10-200, serum transferrin
test 361 mg/d 188 - 341, serum antistreptolysin 208 IU/m <200, serum protein 1490
mg/d 614 - 1295 IgG, serum herpes simple"
"288921-1" "288921-1" "See ER notes attached. 11/27/07 Reviewed autopsy
report which states COD as encephalomyelitis due to enterovirus (EV 71) & manner of
death as natural. States history as: found supine in crib, unresponsive; no recent
illness; no previous medical history;brain swelling; SDH, minimal; SAH, bilateral;
microglial clusters, neuronal loss, neuronophagia & mild perivascular lymphocytic
infiltrate w/gliosis in keeping with a viral poliomyelitis." "See ER notes
attached"
"289100-1" "289100-1" "Patient died two days after receiving vaccines.
Infant had multiple problems including failure to thrive, and developmental delays.
Was admitted with complete heart block. 8/28/07 Spoke w/the reporter on this case
who will provide medical records from clinic & hospital as well as a copy of the
Death Certificate. No autopsy was done. Reporter stated this child had multiple
medical problems & was being followed by several clinic specialists including
geneticist. Sibling of this child also had multiple problems & expired at unknown
time. 9/7/07 Reviewed medical records & Death Certifiate from reporter. COD
stated as complete heart block w/microcephaly & failure to thrive as contributing
factors. Vax record confirms dose & Lot # of all vax as reported. Had
microcephaly, hypertonia & contractures of UEs noted on d/c from birth hospital.
Referred by birth hospital to Easter Seals for developmental therapy eval 7/07.
Medical records show that on day of vax had cough & sneeze along w/very slow
feeding & poor growth noted. Referred for feeding eval. PCP records indicate
patient on home monitor. Neuro, Genetic & Cardio consults. Very slowly gained
weight & remained significantly underweight. Genetics eval done 7/07.
Developmental delay. Cardiac consult on day of death reveals patient admitted 8/24
for diarrhea & poor feeding then developed slow heart rate & complete heart block.
FINAL DX: complete heart block, microcephaly & failure to thrive." "LABS: MRI
at birth showed areas of hypoplasia of corpus callosum. Echocardiogram done during
resuscitation revealed very wide QRS & bradycardia which progressed to EMD w/o any
mechanical cardiac funation. Abdomen KUB revealed nonspecific nonobstructive bowel
gas patter w/paucity of small bowel gas. CXR WNL. Blood c/s (+) for bacillus
species but may have been contaminant."
"289148-1" "289148-1" "12 hr after receiving the vaccine-baby found dead in
hotel bed next to his mother Autopsy Dx: SIDS. 8/31/07 Received vax record from
pcp which confirm dose & lot as reported. 1/15/08 Reviewed autopsy report which
states COD as Undetermined. Found dead in bed. Findings at autopsy included:
SIDS; petechial hemorrhages of thymus & pleura; pulmonary edema & congestion;
cerebral edema; & patent ductus arteriosus." "No lab data for this event."
"289874-1" "289874-1" "Subject in pneumococcal vaccine trial died
approximately one month after vaccination alone in his home. Cause unknown. No
autopsy. 1/18/08 Received death certificate which states COD as hypertensive
cardiovascular disease & COPD as contributing factor." "No lab data for this
event."
"290566-1" "290566-1" ""Initial report received on 10 September 2007 from a
health care professional. A four-month-old infant with no concurrent illnesses, no
known allergies, and who had no pre-existing medical history, had received a second
intramuscular dose of ActHib, lot number UF160AA (Sanofi Pasteur SA lot number
A0122-2) in the left thigh; a second intramuscular dose of Daptacel, lot number
C2650AA in the right thigh; a second intramuscular dose of IPOL, lot number Z0872-2
(reported as Z0872), in the right thigh; and a second intramuscular dose of Prevnar
(manufacturer Wyeth), lot number B97283B, in the left thigh. The patient had not
experienced any adverse events following prior vaccinations. Later that evening the
patient was ""found expired."" Reportedly, an autopsy will be completed. 3/19/08
Reviewed autopsy report which states COD as complications of congenital pulmonary
malformation. 3/19/08 Autopsy states pathologic diagnoses as: I. Congenital
Pulmonary malformation with A. Microscopic characteristics most c/w congenital
cystic adenomatoid malformation, Type I B. lymphocytic & macrophage peri-
bronchial inflammation, mod to marked C. Intraalveolar hemorrhage, marked
D. pulmonary edema, marked III. Abnormal 17 hydroxyprogesterone study w/o
microscopic abnormality of adrenal glands."" "No lab data for this event."
"290655-1" "290655-1" "This is a 7-day report. This case was unblinded, the
patient received Prevnar. Information regarding Prevnar was received from an
investigator regarding a 2-month-old male participant in a study who experienced
death. The participant received the first dose on 30-AUG-2007. On 11-Sep-2007, the
patient was found in the crib at Day Care on his back, unresponsive, blue and not
breathing. Day Care workers initiated cardiopulmonary resuscitation and contacted
911 emergency response. Upon emergency medical response arrival , the child was
noted to be apneic and pulseless. The patient was intubated without difficulty and
cardiopulmonary resuscitation was continued. An intraosseous line was placed in the
left lower extremity that was infusing well. A total of 4 doses of epinephrine were
given without any response. The child remained apneic and pulseless. Upon arrival
to the emergency room the child had blood pooling on the posterior back and neck
area. On physical examination pupils were fixed at approximately 2-3 mm.
bilaterally and no pulse was noted. The physician also noted hypothermia and
stiffness. The patient was pronounced dead at 12:42 in the afternoon at the
hospital. The cause of death was reported as unknown. The parents reported the
child had been completely healthy up to this point. No additional information was
available at the time of this report. The investigator(s) considered death possibly
related to the study product. The medical monitor(s) considered death not related
to the study product because temporal relationship 12 days after vaccination does
not suggest causal relationship." "Body temperature (results: 92.2 deg. F.) was
done on 11-Sep-2007."
"290672-1" "290672-1" ""Mother stated ""gave breathing medicine to my baby
at 5 PM Friday and baby began to choke and cough. Took baby to the ER and she died
at midnight."" 9/25/07 Reviewed medical records provided by reporter which reveal
patient in good health on day of vax. Admitted to ER on 3/22/07 w/difficulty
breathing & vomiting. Family noted hospitalization x 5-6 days for RSV
bronchiolitis & d/c 3 days prior to ER visit. Tx w/nebs & supplemental O2 w/initial
improvement but then worsened again. Mottled cool skin w/sluggish cap refill,
tachycardic, prolonged expiratory phase respiration, tracheal tugging, intercostal
& subcostal retractions, fever 105. Multiple attempts to establish IV access & to
obtain ABG were unsuccessful. Intubated emergently. Had to start chest
compressions secondary to EMD. Epi administered via interosseos access as well as
endotracheal w/o initiation of perfusing rhythm or spontaneous breathing.
Reporter notes indicate patient expired w/dx respiratory arrest secondary to RUL
pneumonia. 12/4/07 Received autopsy report which states COD as acute
bronchopneumonia due to viral respiratory infection. Manner of death: natural.
Findings at autopsy: chronic inflammation, upper & lower airways; acute & chronic
otitis media; and acute bronchopneumonia. Had been seen hospitalized 3/15-
3/19/2007 w/RSV pneumonia. Worsened 3/22/07 & taken back to ER where she
arrested."" "Infant had been hosp 3-17-07/3-19-07 with dx of viral pneumonia
according to mother."
"290781-1" "290781-1" "None stated. 9/18/07 T/C to reporter/provider to
clarify reported death. Box 7 blank on form. Message left for return call.
9/20/07 T/C to reporter. Message left. 9/25/07 T/C to reporter. Stated patient
did expire. Autopsy requested. Preliminary COD is pending but coroner indicated
to MD that is probably SIDS. Reporter stated patient had no health problems or
birth complications. Letter faxed to request vax record./ss 9/28/07 Linked
w/291475. 10/9/07 Reviewed pcp medical records which reveal patient experienced
good health on day of vax. Vax records indicate RO dose & lot # correct as
reported but other vax corrections made in VAERS database. 11/6/07 Reviewed
Autopsy report which states COD as sudden unexplained death in infancy. Had been
placed in crib face up & then found unresponsive when later checked." "None"
"290869-1" "290869-1" "Shot (vaccine) given 7/6/07. 7/7/07 Somewhat not
responding to conversation. 7/8/07 - Very sleepy, hard time answering questions,
difficulty getting out of chair - as the next 20 days progressed, she experienced
feeling of weakness, some facial droop, swallowing difficulties, unable to answer
questions (stare, then a shrug [I don't know]), confusion, incontinence, walk very
slowly, occasional dragging of foot. Just before she died (approx 17 hours
earlier), she described some things that she did at rehab. Her descriptions were
rather odd - after she said them, she realized they sounded odd and stated she
thought she must be going crazy - she knew something wasn't right. She went from
being able bodied, alert, communicative, capable person to unable to do simple
personal tasks. An otherwise healthy person does not have a rapid change as this
one without a reason. All tests run came back perfectly normal - 3 Cat scans showed
nothing wrong. Blood work - that of a 50 year old. No evidence of stroke. Drs -
both primary MD and Hospital staff said vaccine couldn't have done it. Symptoms
occurred w/in 24 hours of getting vaccine. 9/25/07 Received medical records &
death certificate from pcp which reveals COD as cardio-respiratory arrest with
atrial fibrillation, mitral regurgitation, HTN, hypothyroid, anemia as contributing
factors. Medical records reveal patient in usual state of health & on Coumadin for
a. fib when received zostavax on 7/6/07 but no lot # provided. Returned to pcp on
7/9/07 after a fall 7/8/07 & now w/trouble ambulating & speech & memory were slow.
No hx of neuro problems & no current head injury, but w/bruising of right arm. Dx
at that time: syncope. Admitted directly to hospital. Returned to pcp on 7/18 for
hospital f/u. Receiving home health RN, PT/OT & was doing poorly w/dysphagia,
lethargy/sleepiness & incontinence. Readmitted to hospital directly. 10/9/07
Reviewed hospital medical records which reveal patient experienced fall at AL
facility, seen in pcp office & direct admitted to hospital for mental status
changes & inability to transfer or ambulate. Admitted 7/9-7/11/2007. Symptoms
resolved w/med changes. FINAL DX: syncope, atrial fibrillation, bradycardia, HTN,
deconditioning." "Complete Blood Work, Blood Cultures, on heart monitor, CT scan
of Brain (3x), EEG - all normal LABS: EKG revealed a-fib & bradycardia."
"290946-1" "290946-1" ""On 9/19/07 between 11:30-12N child received 4
vaccinations (see below). Dr saw infant 3 hrs later and he appeared well. Parents
state between 6p-8p infant fussy. In AM of 9/20/07 child found ""blue"" 911 called
but infant died."" "2 month complete physical exam - WNL"
"291337-1" "291337-1" "Reported to immunization staff by a physician. A
mother refused vaccine due to a death the mother heard about. All the information
on this case at this time. 11/27/07 Reviewed autopsy report which states COD as
Sepsis, blood culture positive for Klebsiella pneumoniae." "No lab data for this
event."
"291391-1" "291391-1" "This case was reported by a healthcare professional,
via a sales representative, and described the occurrence of Stevens Johnson
syndrome in a female subject aged between 20 and 29 years old who was vaccinated
with Flu vaccine, manufacturer unspecified) for prophylaxis. Co-suspect medication
included Lamotrigine (Lamictal). On an unspecified date the subject received
unspecified dose of Flu vaccine (unknown). In 2006, at an unspecified time after
vaccination with Flu vaccine, the subject experienced Stevens Johnson syndrome,
organ failure, flu-like symptoms, and fever. The subject was hospitalized. The
subject died from Stevens Johnson syndrome. An autopsy was performed. The patient
developed flu-like symptoms but had just been given the flu vaccine. She then
spiked a fever of 106 degrees and was hospitalized. Lamictal was not discontinued
because the providers were originally associating the events with the flu vaccine.
The patient went into organ failure and was placed in the intensive care unit and
then died. The autopsy results indicated that the patient died of Stevens Johnson
syndrome which might have been caused by Lamictal use. 10/2/07 Received patient
demographics from FDA. 10/5/07 Reviewed MD medical records which reveal patient
made emergency visit on 11/30/2006 3 days s/p flu shot at unknown facility. Day
after flu shot, developed severely high fever, shaking & chills follwed by SOB,
chest discomfort & decreased urine output over past couple of days. Had started
Lamictal 14 days prior. Temp in office 107 via ear by MD. Face & chest were red &
patient considered extremely toxic w/shaking chills, cracked dry lips, dry mucous
membranes. MD called ambulance & sent to ER. Also called pts psychiatrist. MD
FINAL DX: malignant hyperthermia, unclear etiology. possible reaction to flu
vaccine, possible drug reaction to Lamictal or possible Stevens Johnson syndrome.
possible reaction to psychiatric medication. 10/19/07 Received autopsy report which
states COD as complication of probable drug hypersensitivity syndrome due to
Lamictal therapy for treatment of bipolar disorder & manner of death as therapeutic
complication. Final Dx: I. Probable drug hypersensitivity syndrome. A. recent
initiation (approx 7-10 days prior to clinical presentation) of Lamictal therapy
for treatment of bipolar disorder. B. hospital admission 11/30/06 in acute
distress, febrile w/generalized rash & facial & lip swelling. C. progressive
deterioration w/multi-organ system failure. D. S/P attempted resuscitation.
E. scattered petechiae of head, torso & extremities F. diffuse alveolar damage
of lungs G. centrizonal hepatic nectosis H. multifocal infarcts of spleen.
I. autolysis of stomach & pancreas. J. focal ischemic changes of small & large
intestine. II. Cardiac enlargement. 12/14/07 Reviewed hospital medical records
which reveal patient experienced fever, chills & facial rash. Tx empirically for
UTI w/IV antibiotics. DX: anticonvulsant hypersensitivity syndrome, renal failure
& progressive ARDS. To ICU on vent. Continued fever spikes, DIC & generalized
body rash. Tx w/antihistamine & steroids w/some rash improvement. Pulmonary
failure progressed & developed bilat pleural effusions. Emergent bronchoscopy done
& bilat chest tubes placed. Continued to deteriorate w/progressive acidosis,
cardiomyopathy & ischemic bowel. Coded & expired. FINAL HOSPITAL DX:
anticonvulsant hypersensitivity reaciton; DIC; ischemic bowel; cardiomyopathy;
renal failure; ARDS; fungemia; pulmonary failure; hx of bipolar disease." "UNK
MD office LABS: EKG sinus tachycardia. pulse ox unable to register. Hospital LABS:
Blood cultures (+) for fungemia."
"291804-1" "291804-1" "Information has been received from a physician
concerning a female who on an unknown date was vaccinated with the first dose of
Gardasil (yeast, unknown lot number) and in July 2007, was vaccinated with the
second dose of Gardasil. In September 2007, the patient died. No further details or
symptoms were known regarding the patient's death. The physician mentioned that an
autopsy would be done however, had not received the results yet. The reporting
physician felt that the patient's death was not related to therapy with Gardasil.
Additional information has been requested. 10/11/2007 Patient demographics
provided by CDC. 10/15/07 Received vax record from pcp. VAERS database updated
w/same. 10/15/07 Received pcp & hospital medical records from CDC which reveal
patient experienced vomiting with elevated blood sugars who became unresponsive &
pulseless. CPR started & taken to ER on 9/19/07. Resuscitation was unsuccessful &
patient pronounced 9/19/07. 10/26/07 Reviewed autopsy report which reveals COD as
diabetic ketoacidosis & manner of death as natural. Patient had been found by
parent unresponsive at home. History of severe diabetes mellitus. Vitreous
glucose 667 (H)." "Unknown Vitreous glucose 667 (H)."
"292125-1" "292125-1" "Information has been received from a nurse
practitioner (N.P.) concerning a 93-year-old immunocompromised female who was
vaccinated with a 0.65 ml dose of Zostavax. Concomitant therapy included an
unspecified antibiotic. It was reported that the patient was just out of the
hospital for pneumonia, received Zostavax. Subsequently, the patient died. The
cause of death was unknown. No further information was available at the time of
this report. No product quality complaint was involved. Additional information has
been requested. 10/16/07 Reviewed ER medical records of 8/19/07 which reveal
patient seen for UTI. Exam revealed bilateral basilar rales & cool purple feet.
Tx w/IV antibiotics & IVF. Foley catheter inserted. D/C to nursing home to
continue IV antibiotics x 5 more days. 4/1/08 Reviewed death certificate which
states COD as urosepsis." "Unknown LABS: WBC 21.21, neutros 93.6 (H), lymphs
3.7 (L), monos 2.3 (L), segs 91 (H). UA (+) for UTI. Blood c/s neg."
"292236-1" "292236-1" "Initial and follow up information has been received
from a Registered Nurse concerning a 96 year old female patient with a congestive
heart failure. On 01-OCT-2007 the nurse reported that patient's son reported that
on 27-JUN-2007, the patient who lived at a long term care facility received five
times the recommended dose of Pneumovax 23. Prior to the vaccination, the patient
was walking independently and doing her own care. After vaccination, the patient
developed multiple aches, pain, fatigue and labored breathing. It had been reported
that her vital signs would be monitored on 27-JUN-2007 through 29-JUN-2007. On 08-
JUL-2007, the patient died. The cause of death was unknown. No further information,
including lot number, was available. Additional information has been requested."
"Unknown"
"292395-1" "292395-1" "vaccine given 9/27/07 died in sleep 9/29/07 presumed
cardiac arrest by autopsy. 1/15/08 Reviewed autopsy report which states COD as
occlusive coronary artery disease with HTN & sleep apnea as contributing factors.
Findings at autopsy included: RCA 70% occluded; LAD 80-90% occluded; LCA 70%
occluded; microscopic evidence of ischemic heart disease w/increased fibrosis in
tissue; fatty infiltration into RV wall of heart; and chronic HTN. Patient died in
his sleep after recently c/o being tired." "None"
"292566-1" "292566-1" "fatal meningococcal disease serogroup C confirmed by
BOL. 10/19/07 Reviewed hospital medical records 9/6-9/9/2007. FINAL DX: Neisseria
bacterial meningitis, serogroup C Records reveal patient experienced URI, sore
throat, HA, stiff neck & high fever. Seen in ER on 9/6/07 where LP done. D/c to
home w/dx viral infection. Smptoms worsened & became lethargic. Returned to ER.
Admitted 9/8-9/9/2007. Tx w/IV antibiotics, antivirals & steroids. Cerebral edema
increased after 2nd LP. Neurology & neurosurgery consults done (reports not
available). Pupils were fixed & dilated. Declared brain dead then experienced
ventricular fibrillation & resuscitation unsuccessful. Family refused autopsy.
11/09/2007 Received death certificate which states COD as cerebral edema +/-
herniation: Bacterial Meningitis; cerebral edema; brain herniation." "culture,
serogrouping LABS: CSF 9/6/07 protein 44, glucose 52, WBC 0, RBC 21. LABS:
9/8/07 WBC 14.5. LP repeated & CSF showed WBC 310 w/100% segmented neutrophils,
RBC 160, protein 415 & glucose 29. CT of head showed cerebral edema. Blood &
urine c/s neg."
"292942-1" "292942-1" "This is a newborn (10/3/07) WF by emergency C-
section that received a single dose of Fluarix (lot AFLUA302BA exp 6/30/08) on 10/5
instead of Engerix B (the syringes look alike). The error was discovered on 10/9.
The patient was treated with IV genatmicin and ampicillin from days one through
three to rule out sepsis. Blood cultures were negative and the patient was
discharged on 10/6. The patient was brought in for a baby check on 10/8/07. She
appeared lethargic, jaundiced and dehydrated. She had bouts of apnea with cyanosis.
She was given fluids and electrolytes and transferred to Children's Medical Center.
The patient expired on 10/10/07. The initial impression is enteral viral sepsis
without a definitive cause at this point. Cause from the flu vaccine is doubtful
but unknown. 10/16/07 T/C to reporter who provided patient demographics. 10/18
Linked w/293414./ss 10/26/07 Hospital medical records including vax record reviewed
which reveal lot number correct as reported. D/C to home 10/6 with f/u scheduled
for 10/8. 11/13/07 Received hospital medical records which reveal patient
experienced poor feeding & apnea/cyanosis events at home. Lethargic w/multiple
apneic events at pcp office on 10/8/07. WBC 16.8, platelets 20,000 in pcp poffice.
Pcp placed on O2 & called EMS. Blood c/s done & IV antibiotics given. Admitted
10/8-10/10/2007. Admit exam revealed overriding sutures, irritable with minimal
suck & response to pain. Had multiple apneic & bradycardic episodes & was
intubated. Unable to convert SVT, blood pressure dropped, expired. 11/13/07
Received autopsy report with hospital records which states COD as myocarditis;
massive acute hemorrhage, liver; meningitis; extensive lung hemorrhages, bilateral
pneumonia & pleural effusions." "10/8 CXR negative LABS: echocardiogram. EKG
revealed SVT. Troponin 36.8.Liver enzymes (H). Bilirubin 12.2. H/H 9.7/27.8. D-
dimer (+). Transfused w/PRBCs & FFP."
"293120-1" "293120-1" "Patient received influenza vaccine at 1105 AM
10/15/2007 and was found asystolic and unresponsive in the parking lot at 1138 AM.
Resuscitative efforts were unsuccessful." "none"
"293387-1" "293387-1" ""Information has been received from a consumer
concerning a 60 or 70 year old female who was vaccinated SC once with a 0.65 ml
dose of Zostavax (Oka/Merck). The reporter stated that ""her friend told her that
she had heard of another person who died after receiving Zostavax (Oka/Merck).""
The reporter stated that it was unknown whether the death was related to
vaccination, and the reporter noted that she did not have complete adverse
information. Additional information is not expected."" "Unknown"
"293388-1" "293388-1" ""This case was received from a health care
professional on 10 October 2007. Additional information was received from a
newspaper article. An 18-year-old female patient received a meningococcal vaccine
(name, manufacturer, and lot number not reported) on an unspecified date. The
patient, who was a college freshman, travelled on 05 October 2007 to visit her
family for the weekend. She reportedly felt ""slightly ill"" upon her arrival, and
subsequently took an aspirin and went to bed, awakening at 1:30pm the following
afternoon 'appearing refreshed"". She became feverish again that night, and awoke
at 1:00am the morning of 07 October 2007 with chills and a severe headache,
complaining that ""my head is about to explode"". She was taken to a local
hospital, where a CAT scan of the brain revealed meningococcal disease in her brain
and brain stem. She was immediately transferred to another hospital, and died that
evening of 07 October 2007 due to complications of meningitis. The health
department noted that ""lab tests have not yet confirmed the strain of meningitis""
but that it was ""likely the type not prevented by the vaccination"". Past medical
history and concomitant medications were unknown: it was not known if the patient
was ill at the time of vaccination. 10/18/07 Patient name received from FDA.
10/18/07 Received death certificate from funeral home which states COD as brain
death due to cerebral herniation and meningoencephalitis. 10/26/07 Received vax
record from pcp which indicates patient received HPV & Menactra on 5/10/2007.
VAERS database updated w/same. Vax record indicates patient also received 2nd dose
of HPV 6/13/2007, Lot # 0523U, left arm. 11/27/07 Reviewed hospital medical
records which reveal patient experienced HA, fever & neck pain x 1 day. Had come
home from college 10/5 & developed chills next day. Seen in outlying ER where LP
showed high pressure, grossly purulent CSF growing meningococcus. Intubated & IV
antibiotics started & transferred to higher level of care. Neurosurgery & ID
consults done. Pupils dilated & nonreactive. Diffuse cerebral edema leading to
brain herniation & death. 12/4/07 Reviewed ER medical records which reveal patient
seen 10/7/2007. Patient experienced pale, nausea, fever, chills, HA, neck
stiffness, back ache & photophobia. Temp in ER max 104.7 Became nonresponsive
w/posturing in ER. Intubated. Started on IV antibiotics & transferred to higher
level of care."" "07/Oct/2007: Brain CT showed meningococcal disease ER LABS: CT
scan & CXR WNL. WBC 14.9 (H), Neutros 87.2 (H), lymphs 6.4 (L). Creatinine 1.2
(H), ALT 27 (L). CSF WBC 4455 (H), RBC 171 (H), neutros 100% (H), glucose 29 (L),
protein 371 (H). Blood & urine cultures neg. CSF (+) neisseria meningitidis.
Hospital LABS: bronchoscopy & echocardiogram done prior to organ donation were WNL.
CSF gram stain revealed neisseria species. WBC 19.1, neutros 86 (H), lymphs 5 (L).
CRP 19.3 (H)."
"293421-1" "293421-1" "Death 11/27/07 Reviewed vax record which confirms
dose & lot #s as reported. 4/15/08 Autopsy report states COD as anoxic/hypoxic
encephalopathy & bronchopneumonia due to infantile reflux & aspiration while
sleeping." "No lab data for this event."
"293594-1" "293594-1" "Client presented to drive through flu exercise for
influenza vaccination. Gave history of having had flu shots in past without
incident. No contraindications to vaccinations identified. Client was vaccinated
and returned home. At some time after returning home client went to Hospital
emergency room where he coded and expired. 10/23/07 Reviewed hospital medical
records which reveal patient experienced weakness & decreased respirations upon
arriving home s/p flu shot. Collapsed in seat of pickup truck. EMS intubated,
started CPR & transported to hospital. CXR revealed right pneumothorax & chest
tube placed. 1/8/08 Reviewed autopsy report which states COD as COPD with
atherosclerotic cardiovascular disease & CHF as contributing factors." "CXR right
pneumothorax."
"294274-1" "294274-1" ""Patient's daughter called after the event and
reported that patientexperienced wheezing, cough and syncope ""later that day""
after he returned home from flu clinic. She did not indicate which, if any,
hospital he was taken to, but that she had called his physician. Cardiologist. She
reported that her father died on Sunday 10-21-2007 11/6/07 Received hospital clinic
& cardiology medical records which reveal patient experienced CAD, s/p CABG (1982 &
1990) & severe LVD s/p ICD biventricular deployment; chronic back problems;
hyperlipidemia; diabetes type 2; & controlled HTN. Cardiac cath of 4/2006 revealed
patent left internal mammary arter to LAD bypass graft w/other grafts being
occluded. Had been hospitalized 7/07 for pacemaker device discharge. Had DOE at
that time. Pacer rate was increased due to myocardial ischemia. Developed chest
pain, nausea & additional DOE. Dx w/unstable angina 7/11/07 & admitted to
hospital. 1/18/08 Reviewed ER records of 10/22/07 which reveal patient fell & had
witnessed cardiac arrest at home 50 min prior to arrival in ER. Had been intubated
& IV access placed in field. ECG revealed V-fib & then asystole & patient expired
10/22/07. 1/29/08 Cardiac arrest per death certificate."" "No lab data for this
event."
"294509-1" "294509-1" "Mother awakened in early morning and noticed that
patient was not breathing or moving. Resuscitation attempted by father and by EMS
and hospital personnel. By report, first recorded temperature during resuscitation
was 102 F. Pulse was never reported to have been attained. 4/1/08 Autopsy report
states COD as sudden unexplained infant death & manner of death not determined.
Report states patient had recent URI. Found unresponsive on soft pillow on couch
w/parent." "Autopsy results pending."
"294659-1" "294659-1" "My child was very fussy with a runny nose for two
days then she was very unresponsive on the third. On the fourth day she stopped
breathing. The on call physicians only advice for treatment was baby tylenol.
11/18 Death certificate states COD as severe hypoxic ischemic injury w/cardiac
arrest & complex cyanotic heart disease as contributing factors. 11/13/07 Reviewed
hospital medical records which also included birth records. Admitted 5/29-5/30/2007
s/p cardiopulmonary arrest at home. Seen initially in outlying ER & transferred
for higher level of care s/p resuscitation, intubation & interosseus dopamine drip.
IV & a-line established & placed on ventilator. Transfused PRBCs & FFP. Acidotic,
hypoglycemic & hypocalcemic on admit. Tx w/antibiotics. EEG showed very low
voltage activity. Extubated & patient expired quickly w/parents in attendance."
"No lab data for this event."
"294789-1" "294789-1" "Information regarding Prevnar was received from a
healthcare professional regarding a 3-month-old patient who experienced
pneumococcal meningitis. The patient received a dose in 2007. The patient developed
pneumococcal meningitis on an unspecified date in 2007. It was reported that the
child expired close to the date of 01-Sep-2007. The cause of death was reported as
meningitis pneumococcal. 12/18/07 Received vax records. 1/18/07 Reviewed autopsy
report which states COD as bacterial meningitis (days)." "Meningitis
pneumococcal"
"294842-1" "294842-1" "1 week after administration found dead at home.
History of COPD and squamous cell lung cancer RUL with obstruction of airway and
s/p palliative treatment. Daughter felt he became more lethargic 24 hours after
vaccination and requested we report this. No autopsy performed by medical examiner
and death certificate pending. 11/27/07 Reviewed death certificate which states
COD as right lung pancoast tumor due to chronic obstructive pulmonary disease.
1/4/08 Reviewed medical records which reveal patient experienced cough, recurrent
RUL infections which responded to antibiotic tx, RUE pain s/p brachial plexus
involvement, poor appetite on 10/18/07. Dx w/RUL lung Pancoast squamous cell
carcinoma, stage B & tx w/chemo & radiation tx." "none"
"294848-1" "294848-1" "patient was not acutely ill but was found dead in
her chair within 24 hours of flu vaccine. 1/15/08 Death certificate states COD as
acute myocardial infarction w/chronic ischemic heart disease as contributing
factor." "lot # aflla062aa"
"294850-1" "294850-1" "Patient found dead in his chair 36 hours after
vaccine. Had not been acutely ill prior to vaccination. 11/02/07 Received medical
records from reporter which reveal patient w/extensive medical hx. H&P of 5/07
indicates had recent diarrhea, apple core lesion in mid to distal sigmoid colon,
severe dementia, SOB & extremely poor appetite who had been admitted to hospital
then transferred to LTC due to lethargy, fatigue & falls. Had cellulitis &
inflammation of lower leg but afebrile on day of vax. Next day had congested
productive cough w/green phlegm & vomiting. 10/28 had increased congestion,
unresponsive w/dusky color. BP 89/66 & placed on O2 due to sats of 50-60%. Taken
to hospital. 11/16/07 Received hospital ER medical records of 10/28/2007. FINAL ER
DX: respiratory failure, sepsis Records reveal patient experienced fever, lethargy
altered mental status & abdominal guarding. Exam revealed bilateral diffuse
rhonchi, increased respiratory rate, diffuse abdominal tenderness & guarding,
decreased bowel sounds, pitting edema of LE's & tachycardia, temp 101.3. Patient
was DNR & comfort measures provided until expiration. ME declined case." "LABS:
Sodium 131, BUN 45, creatinine 2.9. CXR pulmonary edema. KUB distended bowel
loops. Amylase 108, lipase 31"
"295031-1" "295031-1" "A small sore appeared on baby's left eye. When he
was in for circumcision 11-21-05 doctor mentioned it looked like herpes but did
nothing. On 11-25 he began to get upset tummy and on 11-26 Mom took him to
emergency for test. On Tuesday 11-29-05 doctor called parents and told them to take
him to hospital for treatment with IV Acyclovir. Contracted strep in hospital and
died. 5/29 Autopsy states COD as ischemic hemorrhagic colitis of small bowel;
peritoneal surfaces demonstrate focal adhesions; neonatal herpes (c/s +). 12/14/07
Reviewed hospital medical records which reveal patient seen in ER on 11/26/2005
after experienced small spot on lateral edge of left eye x 3 days. Area had opened
up & then crusted over, eyes reddened & became slightly swollen. Viral c/s
obtained & tx w/Bactroban & was to be seen by pcp next day. Both hospital records
for admission of 11/29/2005 included. Eye lesion had cleared but then developed
blistering lesions on outside of left eye & base of penis. PCP wanted patient
transferred to higher level of care but family declined. After culture (+) for
herpes, returned to hospital & agreed to transfer to higher level of care.
Admitted 11/29-12/4/2007. Tx w/IV antivirals & peds optho consult done. Optho dx:
herpetic keratitis & herpetic dermatitis of eyelid. Condition deteriorated,
intubated & admitted to PICU. Taken to OR 12/4/05 secondary to abdominal
distention due to sepsis. Penrose drain inserted & drained approx 200 cc of clear
straw colored fluid. Cultures sent. Continued to deteriorate & developed bloody
drainage from abdominal drain. Taken back to OR for exp lap & found total
intestinal ischemia from ligament of Treitz to descending left colon. Suspected a
vascular insult due to underlying disease process." "11-26-05 Positive for herpes
LABS: viral culture (+) for herpes."
"295043-1" "295043-1" "Child had flu shot @ about 10 am. Waited in office
for 20 minutes. Went home w/mother and private duty nurse. Nurse reported he was
fussy after the immunization. She held him until he went to sleep. They put child
to bed in parental bedroom upstairs. Nurse went to kitchen to get g-tube feeds
ready. Apnea alarm went off shortly thereafter. When RN got to the child, he was
face down in the bed and blue. They administered CPR, called 911. He was airlifted
to hospital, where he was pronounced dead approximately two hours after receiving
the flu shot. 11/13/07 Received autopsy report which reveals COD as complications
of cerebral dysgenesis of indeterminate etiology; arthrogryposis multiplex
congenita was a significant contributing factor. Had been placed on side for nap
but was found prone. Disabilities rendered unable to lift head/body to protect
airway. 11/16/07 Received vax records from pcp. VAERS database updated w/same."
"No lab data for this event."
"295076-1" "295076-1" "Approx. 45 min after injection, mother noted child
was not acting correctly and returned to the office with him. He was noted to be
having a seizure and was transported to the hospital where he suffered resp.
failure and cardiac arrest. He is currently on life support. Died 10-30-07.
5/16/08 Autopsy report states COD as sudden unexplained child death associated
w/acute pneumonia. Autopsy findings include: hypoxic-ischemic encephalopathy; wide
spread acute pneumonia; phenytoin & lorazepam; no trauma. Patient had witnessed
seizure followed by respiratory distress, intubation & subsequent cardiac arrest.
Short hospitalization & expired despite therapeutic intervention. 11/1/07 Received
medical records from CDC which reveal patient experienced shaking & unresponsive
behavior after being seen in pcp office for vax. Returned to pcp & exam revealed
patient having right sided seizure w/eyes deviated to right & right extremity
twitching. Taken to ER after seizing for approx 15-20 min. Received 2 doses of
ativan, intubated, received versed, paralytics, Pb, epi, bicarb, mannitol, lasix,
solumedrol & atropine along w/IVF. Transferred by flight to higher level of care.
11/2/07 Received hospital medical records from CDC which contain PICU Death
Summary. Reveals patient admitted s/p seizure & cardiac arrest. Multiple episodes
of ventricular fibrillation, lidocaine & defibrillation during transport from
outlying ER. Arrived at hospital hypotensive w/weak femoral pulses & quickly coded
again for approx 5 min & pulse returned. BP maintained on epi drip until brain
death pronounced. 11/6/07 Reveiwed pcp medical records from CDC which confirm dose
& lot # as reported. Patient reported to be in usual state of health on day of vax
but a little sleepy & cranky. Returned to office approx 45 min s/p vax with
patient having right sided seizure w/eyes deviated to right. Office unable to
obtain ativan, taken to ER, given O2 & IM ativan, then IV ativan when IV access
obtained. Seizure stopped w/n 4 min & patient became apneic & was intubated.
Stable for aprox 30-40 min then O2 sat dropped, bradycardia & then asystole. CPR
started. Remained asystolic for approx 1 hour & then regained pulse. Developed
ventricular fibrillation on the way to the helicopter & was converted back in ER.
Then transported to higher level of care." "ER LABS: CXR revealed fine ground
glass opacity throughout & numerous air bronchograms bilaterally. Hospital LABS:
Head CT showed diffuse loss of gray-white differentiation, bilateral cerebral
infarction w/herniation, indicating global hypoxic/ischemic event. Echocardiogram
revealed severe LV dysfunction, septal posterior & anterior wall hypokinesis.
Ejection fraction of 26%. CXR showed perihilar edema. PT/PTT very prolonged. PCP
LABS: lead <3 10/05, Hgb 13.3 (N) 10/05, RSV (+) 12/04."
"295195-1" "295195-1" "Client passed away today. Cause of death unknown at
this time. An autopsy is to be performed down state. 8/18/09 Autopsy report
11/02/06. Additional information abstracted: Medical complications of omphalocele.
History of repair of congenital omphalocele. Severe abdominal adhesions with
extensive dilation of loops of small and large intestine. Status post gastrostomy
tube placement. Acute proximal and distal convoluted tubular necrosis of kidneys.
Extensive intersitial calcification of kidneys." "No lab data for this event."
"295485-1" "295485-1" ""Information has been received from the author of a
published article. It was reported that, ""a 5-year-old black male with sickle B -
thalassemia born to a mother with sickle cell trait and a father with B-thalassemia
trait was admitted to the hospital for fever and pain of the left arm and back. He
had a history of 2 prior admissions: one for moderately severe vaso-occlusive
crisis of the legs and another for fever of unknown origin. He received Pneumovax
23 at the age of 2 years and was on folic acid oral supplementation. There was no
history of acute chest syndrome or splenic sequestration and no history of blood
transfusions. Review of his medical records showed a baseline hemoglobin level of
7.5 (+/- 0.6) g/dL and a pretransfusion hemoglobin electrophoresis showed
hemoglobin S >82 percent; F 12 percent to 16 percent; A2 3.9 percent to 7,8
percent; and no detectable A1. At presentation, the child was febrile to 39 degrees
C with an oxygen saturation of 98 percent on room air by pulse oximetry. The
physical examination showed erythema of the oropharynx, and notably no hepatomegaly
was appreciable by either the admitting or the inpatient physician. Pain was
assessed as 6 on a scale of 1 to 10, thus morphine sulfate was given intravenously
and acetaminophen orally. Hemoglobin level was 7.1 g/dL, hematocrit was 21.6
percent, total white blood cell count was 16,700/ uL, and platelet count was
115,000/uL. A chest x-ray was normal. Ceftriaxone 50 mg/kg was given intravenously
after blood cultures were collected. Four hours after admission, he complained of a
severe headache, was found to be more lethargic, toxic looking, and had a
persistent tachycardia and tachypnea. His lips were pale. The abdomen was slightly
distended in comparison with his initial assessment but soft and firm liver edge
was palpable 4 cm below the costal margin in the mid-clavicular line. A blood
sample showed profound anemia (hemoglobin 3.2 g/dl, repeat in 30 min was 2.1 g/dL)
and thrombocytopenia (17,000/uL) with a drop in the initial white count to 4600/uL.
Ceftriaxone-induced acute hemolysis was considered and ruled out with the
appropriate testing. Packed red blood cell (PRBC) transfusion was started promptly.
The hemoglobin levels dropped rapidly after each transfusion. The liver enlarged
progressively, and within 2 hours is spanned 8 cm in the right mid-clavicular line.
Liver enzymes were 12-fold increased whereas bilirubin measured 4 mg/dL (mostly
conjugated). An abdominal ultrasound showed massive hepatomegaly (14 cm vertical
span), thickened gallbladder wall, and edema of the bowel loops. Doppler study of
the liver showed no detectable hepatic vein, portal vein, or hepatic arterial blood
flows. The inferior vena cava maintained a good flow. The patient subsequently
became hemodynamically unstable and needed cardiorespiratory support in addition to
repeated transfusion of PRBC, platelets, and fresh frozen plasma. This picture was
consistent with sepsis. After 14 hours of incubation, the blood culture grew gram-
positive diplococci, later identified as S. pneumoniae serotype 13. Although the
hemoglobin level seem to plateau above 12 g/dL, the patient's condition worsened
progressively with maximal cardiorespiratory support, massive hepatomegaly (12 cm
below the costal margin in the mid-clavicular line), and a very tense abdominal
wall. He died 18 hours after admission. Postmortem examination was performed. The
liver was significantly enlarged weighing 1089 g. almost twice the normal weight
for age (normal weight for age = 596 g), with a red smooth homogenous surface and
focal areas of necrosis. Microscopic examination showed markedly dilated sinusoids
packed with red blood cells the majority of which were sickle-shaped. However, a
fair number of normal erythrocytes were also present, probably donor RBCs form
blood transfusions. The spleen weighted only 20.5 g (normal weight for age = 47 g).
All other organs examined were congested and hemorrhagic, consistent with terminal
disseminated-intravascular-thrombosis. The authors reported that, ""hepatic
sequestration was preceded by pneumococcal sepsis. The role of the pneumococcal
bacteremia as a possible triggering factor for the sequestration process and as a
major contributor to the irreversible hemodynamic decompensation should be taken
into consideration."" No further information is available. A copy of the published
article is attached as further documentation of the patient's experience.""
"physical examination - See narrative; chest X-ray - Normal; diagnostic
laboratory - profound anemia; hepatic ultrasound - Inferior vena cava maintained a
good flow; hepatic ultrasound - No detectable hepatic vein, portal vein, or hepatic
arterial blood flows; abdominal ultrasound - See narrative; autopsy - See
narrative; diagnostic laboratory - Ceftriaxone-induced acute hemolysis ruled out;
temperature measurement - febrile to 39 degrees C; hemoglobin 7.1 g/dl; hemoglobin
3.2 g/dL - profound anemia; platelet count 17,00 uL - thrombocytopenia; hemoglobin
- hemoglobin levels dropped rapidly after each transfusion; total serum bilirubin 4
mg/d - mostly conjugated; hemoglobin 7.5 g/dL - baseline; hemoglobin - S >82%, F
12-16%, A2 3.9-7.8%, no detectable A1; hemoglobin - Plateau above 12 g/dL; blood
culture - After 14 hours grew gram-positive diplococci (later identified as S.
Pneumoniae serotype 13); hepatic function tests - 12-fold increased; WBC count 4600
uL; hemoglobin 2.1 g/dL - profound anemia; WBC count 16"
"296073-1" "296073-1" "We received from a health care professional via the
agency following information on 29 OCT 2007: A 89-year-old man, born on 15 JUL
1918, was vaccinated with Fluvirin, batch-no. 78428, i.m. on 23 OCT 2007. The
patient died shortly after the vaccination after he left the facility and walked
down the hall. Caller felt that individual was properly screened, reported no
allergies to any component, and filled out the waiver for the vaccine prior to
administration, and had prior flu vaccinations. The reporter felt the death was
coincidental based on the age and history of the patient. Company assessment:
Seriousness criterion: death. Causality: insufficient data. Expectedness assessment
according to manufacturer label: Death after Fluvirin is not expected. No change in
benefit-risk-ratio. No measure necessary. Addendum We received from a health care
professional via the medical agencies additional information on 29 OCT 2007: The
batch-no. was 78478 (and not 78428 as previously reported). No change in
assessment. NA07-005622" "No lab data for this event."
"296231-1" "296231-1" "A 25-year-old patient, with no reported concurrent
illnesses, pre-existing medical conditions, or use of other medications, had
received a left deltoid (route not provided) dose of Adacel (lot number C2758AA),
and a dose (route not provided) of FluMist (manufacturer MedImmune) (lot number
500486P) on 17 October 2007. Fifteen days post-vaccinations, on 01 November 2007,
the patient expired in his sleep. At the time of the report, the autopsy was not
complete. No cause of death has been determined at this time. 12/14/07 Received
vax record from provider which confirms lot #s as reported. 1/18/08 Reviewed
autopsy report which states COD as idiopathic mitral prolapse. Findings at autopsy
included: enlarged dilated heart w/LVH & clean coronaries; parachute deformity
w/hooding of anterior mitral cusp & lengthening of the chordae tendineae w/mild
white thickening of the septal endocardim behind mitral valve; hyperinflated lungs;
pneumomediastinum; enlarged liver/spleen/hepatic portal lymph nodes." "No lab data
for this event."
"296240-1" "296240-1" "Unknown 11/16/07 Reviewed death certificate which
reveals COD as liver cancer." "None"
"296690-1" "296690-1" "oct.28.2007 treated for upper respritory viral
infected.sept.10 2007recieved influensa vaccine.sept.17 2007treated for viral
infection complecated by influensa vaccine.oct.27 2007died heart failer complecated
by virial infection 11/16/07 Reviewed vaccine record from pcp & VAERS database
updated w/same. 11/27/07 ER Final dx: cardiac arrest, expired. Reviewed hospital
medical records which reveal patient experienced chest & left arm pain, cold &
clammy, skin mottled, nauseated, felt faint & passed out when EMS arrived. EMS
rhythm strip revealed BBB w/ST segment depression. In ER, vomited & had diarrhea.
EKG revealed atrial fib w/rapid ventricular response. DX w/acute bronchitis &
atrial fib w/RVR. Became unresponsive & developed cardiac arrest. Resuscitated &
intubated. While being tansferred to higher level of care via helicopter, coded
again. Returned to ER & unable to resuscitate. 3/7/2008 Judge states he signed
death certificate as directed by state law when patient is not in hospital & only
seen in ER but paper copy no longer available. States COD as undetermined & manner
of death natural. 3/11 Death certificate reviewed & states COD as undetermined &
manner of death as natural." "LABS: WBC 18.3 (H), segs 81%(H), monos 3% (L),
lymphs 16% (L), platelets 482 (H). CK 24, CKMB 17.8, troponin neg. AST 37, LDH
234. PT/PTT 17.6/26l6, INR 2.0. Dig level 1.0. Blood glucose 451(H), K 5.4 (H),
BUN 28 (H), creat 1.3, Cl 93 (L), CO2 16.7 (L), NA 130 (L). CXR revealed
cardiomegaly, mild failure w/minimal bilateral perihilar infiltrates. Repeat CXR
revealed increased failure w/diffuse pulmonary edema & bilateral infiltrates
suggesting aspiration pneumonia."
"297079-1" "297079-1" "received phone call that infant had expired. 2/5/08
Reviewed Autopsy Report & death certificate which accompanied autopsy report which
states COD consistent w/Sudden Infant Death Syndrome (Group B) in co-sleeping
infant. Findings included: sudden death in 2 mo old co-sleeping infant; hx of
parental drug abuse (opiates per parents); post mortem tox exam neg for drugs or
alcohol; hx of preemie, 36 wk, 5 lbs, 4 oz." "No lab data for this event."
"297178-1" "297178-1" "Child started with high fever, 48 C, post
vaccination and died on 11/12/2007. 12/11/2007 Reviewed autopsy report which
states COD as acute bronchopneumonia complicated by acute gastroenteritis. Blood
c/s neg." "Electrolytes with mild dehydrate. Histology shows acute
gastroenteritis and broncho-pneumonia"
"297225-1" "297225-1" "It was reported in a published article, title as
stated above, that an 18 month old female with medical history significant for
preterm delivery at 32 weeks' gestation via cesarean section, secondary to maternal
prolactinoma and polyhydramios. At birth she was noted to have choanal atresia and
a patent ductus arteriosus; a choroid plexus cyst was also noted on computed
tomography of the head, and bilateral renal calculi were seen on ultrasound. The
result of prenatal testing of the patient's mother for HIV antibody was negative,
and the result of testing of the patient for HIV antibody as part of the state's
newborn screening program was also negative. In the early postnatal period she
required both a traceheostomy and gastrostomy-tube placement. Although her
anomalies suggested a congenital syndrome, a specific diagnosis was not established
at birth or through subsequent investigation. The finding of persistent lymphopenia
on serial lymphocyte count and the absence of a thymic shadow on chest radiograph
raised the suspicion of DiGeorge anomaly, but results of a fluorescent in situ
hybrization study to detect the 22q11.2 deletion were negative. However, initial
determination of lymphocyte subsets revealed severe depletion of both CD4 and,
particularly, CD8 subsets, with normal or increased B cells (CD19) and natural
killer cells (CD56). Lymphocyte-proliferation assays also revealed absent
proliferation to standard mitogens. That trend would persist, albeit with some
normalization of CD4 percentage, until the admission. In additional to her deficits
in cellular immunity, the patient also had severe humoral dysregulation. Although
her immunoglobuin (Ig)G, IgM, and IgA concentrations were within normal limits for
her age, she failed to produce protective antibody titers to tetanus toxoid and
Haemophilus influenza type B after immunization. Further workup of her
immunodeficiency included testing for genotypes of severe combined
immunodeficiency, such as ZAP-70 deficiency and associated promoter mutations, all
of which were unremarkable. Because of the nursing care her tracheostomy required,
she was placed in a chronic care facility. The patient had been hospitalized
multiple times. During several admissions for exacerbations of chronic reactive
airway disease, test results of nasopharyngeal aspirates were positive for
respiratory syncytial virus. On 1 of those admissions, at 9 months of age, the
patient suffered an exacerbation of her chronic ichthyosiform rash that was
manifested by diffuse erythroderma, alopecia, and electrolyte disturbances.
Quantitative Igs at that time revealed markedly elevated serum IgE (36000 IU);
however her clinical course was not felt to be compatible with Job syndrome because
of absent history of deep organ abscess. A diagnosis of Netherton syndrome was
considered but not supported by the results of skin biopsy and hair-shaft
examination. Furthermore, molecular testing results were negative for mutation on
SPINKS. The diagnosis of Omenn syndrome was also considered, but testing for RAG1
and RAG2 was not performed. Despite the gastrostomy tube, she continued to suffer
from failure to thrive and weighed only 8.6 kg at 18 months of age, with profound
developmental delay. No cause for her immunodeficiency was ever elucidated, but
because of this condition, her physician advised that she receive no live vaccines.
Nevertheless, 5 weeks before her admission she was vaccinated with Varivax
(Oka/Merck). The patient was admitted with a 4-day history of fever and increasing
numbers of papulovesicular/pustular skin lesions. The rash was first noted on the
patient's trunk 6 days before admission when she began having intermittent fevers.
At that time, she was seen by her primary physician as an outpatient and evaluated
by a pediatric dermatologist. Since that time, the lesions had become generalized,
and on admission they covered her entire body including her scalp, palms, and
soles. A culture from blood drawn 4 days before admission did not grow any
bacteria, but a culture from 1 of the pustules revealed infection with methicillin-
resistant Staphylococcus aureus. Three days before admission, she was started on
benzathine penicillin and erythromycin, but the rash continued to progress. On the
evening before the admission she was brought to the emergency department because of
a fever of 103F. On admission the patient was awake, alert, responsive, and moving
all extremities. She was afebrile but hypertensive, tachycardic, and tachypneic and
had a blood pressure of 120/80 mm Hg, a heart rate of 150 beats per minute, and
respiratory rate of 45/minute on 28% O2 via a tracheostomy collar. There were
generalized erythematous-based vesicles and pustules, including on her palms,
soles, scalp, and trunk, with the highest concentration being in the genital area.
Her breath sounds were coarse, with occasional wheezes; her liver was palpable 3 cm
below the costal margin, but laboratory testing on admission revealed a normal
complete blood count, chemistry, and liver function. The patient was admitted with
a preliminary diagnosis of staphylococcal pustulosis, but because of the mixed
nature of the lesions and the history of varicella immunization, treatment was
begun with intravenous vancomycin, intravenous ceftriaxone, and intravenous
acyclovir. A 3-mm punch biopsy was performed by the pediatric dermatology service,
2 vesicles on the dorsum of the left foot were unroofed for bacterial, fungal, and
viral cultures, and a Tzanck smear was obtain; the results of these tests were
negative. On hospital day 4, fluid obtained from 1 of the vesicles was sent for
diagnostic polymerase chain reaction and viral strain determination. New lesions
continued to appear for >1 week, for a total of >14 days after initial appearance
of the rash, and the patient continued to have low-grade fevers and mild
respiratory distress. A chest radiograph on hospital day 4 revealed bilateral
patchy consolidation. Two punched-out ulcers appeared on her left flank and another
on her left frontal scalp; all 3 were >1 cm in diameter and surrounded by 3 to 4 cm
of erythema and induration. On hospital day 4, the pathology report on the biopsy
reported results consistent with a herpesvirus infection, although differentiation
between herpes simplex virus and varicella zoster virus (VZV) was not possible. On
the 4th day hospital day, the PCR was reported positive for vaccine-strain (Oka)
varicella. After the 9th hospital day, new lesions gradually diminished, and by the
17th hospital day, the punched-out ulcers began to fill with granulation tissue.
Although the patient's hospital course was complicated by S. aureus bacteremia and
candidemia, as well as methicillin-resistant S. aureus superinfection of the
primary lesions, her varicella continued to improve after this point. After a
lengthy and difficult hospital course, she was discharged back to her chronic care
facility on the 55th hospital day. The patie" "blood pressure 120/8 mm,
diagnostic laboratory Tzanck smear negative, total heartbeat count 150 beat,
respiratory rate 45/min, VZV strain positive for vaccine-strain (Oka) varicella,
arterial blood O2 28%, viral culture negative, fungal culture negative"
"297528-1" "297528-1" "Information has been received from a physician's
assistant concerning a 12 year old female with no reported medical history who on
approximately 15-SEP-2007 was vaccinated with Gardasil. It was noted that this was
not where the vaccine was administered, rather they were the patient's family
physician. On 06-OCT-2007 the patient died in her sleep. No further information was
provided. No lot number was given. Additional information has been requested."
"Unknown"
"298905-1" "298905-1" "Patient collapsed while eating breakfast at home.
He was taken to the ER and pronounced dead. 12/18/07 Reviewed hospital ER
records which reveal patient in usual state of health on 11/27 when coughed & then
collapsed at home. Was unresponsive in ER & resuscitation unsuccessful. ER COD
stated as sudden cardiac death. 1/21/08 Reviewed autopsy report which states COD
as complication from congenital cardiac disease (probable arrhythmia." "No lab data
for this event."
"299262-1" "299262-1" "On 12/2 at 10:00am, patient attended an appt w/ Dr.
as a follow-up for previous stroke monitoring. The doctor administered a mini-check
up and with a series of cognitive exercises. They ended their appt and planned for
another follow-up appt. in January or February of 2004. The next day, patient was
taken to an 1:30 afternoon appt at her regular physician. She saw him for a brief
10 minutes as he administered a flu innoculation in her upper left arm. On
Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and
keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started
experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to
her bed. On wednesday eve, 12/10,after not being able to retain any food, soup of
liquids, her children got her ready to take to the hospital. On Thursday morn,
patientwas alert, coherent, but very weak and her family made attempts to drive
her quickly to Emegency Room for treatment. She went downhill and expired the
following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final
diagnosis:massive hematemesis and or hemoptysis secondary to coumadin. Presented
to ED with increased shortness of breath, nausea and hemoptysis. Since then had
progressive loss of energy. Increasing confusion and agitation. Nonproductive
cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding
secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple
organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski.
Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic
acidosis with increased anion gap most likely seconary to lactic acidosis,
hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death
pneumonia. Diabetes Mellitus" "The emergency room doctors took x-rays of her
lungs and found bleeding areason one side of the lung. It was uncontrollable and
they attempted to suction it off first, then called a surgeon in to operate. The
surgery was unsuccessfull and she never regained consciousness. records received
12/26/07-INR of 9. CT of head no acute intracranial hemorrhage detected. Pumonary
hemorrahge noted on CT."
"299540-1" "299540-1" ""Information has been received from a physician
concerning a female with ""some health troubles"" who on 30-NOV-2007 was vaccinated
with Zostavax single dose of the series. The patient had a heart attack and died.
The physician mention that she does not think it was due to Zostavax as the patient
had ""some health trouble before."" Additional information is not expected.""
"Unknown"
"300018-1" "300018-1" "Information regarding Prevnar was received from a
healthcare professional regarding a female infant (between 0 and 6 months) who on
26-NOV-2007, received a first dose of Prevnar along with a dose of Haemophilus
Influenzae B (manufacturer unknown), a dose of Pediarix and a dose of Rotarix. On
26-Nov-2007, the patient received a dose of Prevnar along with other childhood
vaccines. On 28-Nov-2007, approximately 48 hours post-vaccination, the child died.
The cause of death was unknown. An autopsy was performed, but results were not
provided. No additional information was available at the time of this report.
1/22/08 Reviewed ER medical records of 11/28/07 which reveal patient found in crib
by family. Transported to ER via EMS & pronounced DOA. 1/24/08 Reviewed pcp
medical records which reveal patient in good health on 11/26/07 except for slight
weakness of left arm & suspected brachial plexus birth injury. Note indicates
patient received Pediarix, Prevnar, Hib & Rotavirus vaccines but no vax record
included w/notes. 2/12/08 Received vax records. 5/6/08 Autopsy report states COD
as SIDS. Manner of death: natural." "death, unknown"
"300036-1" "300036-1" "INFANT DECEASED 16 HRS. POST IMMUNIZATION
ADMINISTRATION. NO ADVERSE SIGNS OR SYMPTOMS DESCRIBED BY MOTHER. AUTOPSY DID NOT
IDENTIFY ANY SIGNS OF ADVERSE REACTION. 12/26/2007 Vax record and MR received from
PCP. Vax record as reported on VAERS report. 1/11/2008 Autopsy Report received
with Child Fatality Investigation Report. COD: Sudden Unexpected Death in Infancy.
Infant had been sleeping on sofa with mother. Mother felt child was warm and gave
Tylenol. Respiratory Distress was noted by mom. EMS notified and CPR initiated
however child was pronounced dead upon arrival at medical center. Unsafe sleeping
conditions documented. Distinction between SIDS and subtle forms of asphyxia could
not be made by autopsy alone." "INVESTIGATION, AUTOPSY AND TOXICOLOGY
COMPLETED"
"300066-1" "300066-1" "Information has been received from a physician
concerning a large female who received one dose of Gardasil. Subsequently, the
patient was found dead in her truck from a blood clot that traveled from her legs
to her lungs. The cause of death was reported to be a blood clot. Additional
information has been requested. 3/5/08 Autopsy states COD as pulmonary
thromboembolus w/deep vein thrombosis of right leg & obesity as contributing
factor." "Unknown"
"300259-1" "300259-1" "Complex congenital heart (hypoplastic (L)) repair
with a modified normal/sano content. Vaccination 12/5 county on K/G expired en
route to hospital 12/7. No post done at hospital. Vaccines were all #2 except
Synagis #1.12/26/07-ER notes from facility for DOS 12/7/07-12/26/07-DX: cardiac
arrest. Congenital heart anomaly. No autopsy performed. 12/27/07-COD hypoplastic
left ventricle. CHF." "No lab data for this event."
"300400-1" "300400-1" "Patient died the night he was given immunizations;
he had a chronic neurological condition of unknown etiology. 5/2/08 Reviewed ER
medical records which consisted of EKG strip showing asystole & a copy of death
certificate which states DOD as 12/12/2007 & COD stated as cardiopulmonary arrest;
aspiration; congenital brain malformation. No autopsy was done." "No lab data
for this event."
"300760-1" "300760-1" "Patient expired on 12/8/07 after an accidental
suffocation at home." "No lab data for this event."
"300774-1" "300774-1" "Found Dead in Crib 2/27/2008 Autopsy Summary
received with COD: Sudden Infant Death Syndrome (SIDS). Contributing: Acute
Bilateral Otitis Media." "Autopsy"
"300901-1" "300901-1" ""Information has been received from a nurse
practitioner, concerning an infant (gender and specific age not reported) who on an
unknown date was vaccinated with a dose of PedvaxHIB (lot # not reported) and the
day after vaccination died in the hospital, from meningitis (no details available).
The NP stated there were ""rumors in the community"" that the death was related to
PedvaxHIB. She felt it was possibly related to the vaccine recall, and had received
""no definitive information."" No further details were provided. Additional
information has been requested. 12/28/07 No autopsy done per Decedant Affairs rep
at hospital./pc 12/31/2007 Vax record and WCC of 12/04/2007 received from CDC. No
concerns at this time. Temp 99.1'F. PE WNL. 01/04/2008 Death Cert received. COD:
meningitis. 01/22/2008 MR received from hospital for DOS 12/11-12/2008. Child
presented to ER after transfer from local hospital with DX: Meningitis and altered
mental status. Initially seen by PCP on 12/7/07 for fever/vomiting. Pt has
several 2-3 min seizure-like episodes: eyes rolling back and spacing out x 1
minute. No T-C activity. (+) irritability. Presented again to local hospital
12/9/07 with increasing irritability, emesis with nuchal rigidity. Pt admitted to
ICU with (+) eye rolling, responsive only to painful stimuli. Pt had further
seizures. Transferred following head CT showing large bi-hemispheric strokes.
Intubated and sedated. Externalized ventricular shunt placed for CSF drainage.
Neuro condition deteriorated progressively (posturing, not responsive to any
stimuli) to brain death. Pt was extubated and care withdrawn per parent request. Pt
expired at 1712. Assessment: Polybacterial meningitis, Hydrocephalus. 01/29/2008
D/C summary received for above hospitalization. Principal Final DX: Escherichia
coli meningitis. Additional DX: Bilateral cerbral infarcts and hydrocephalus with
increased intracranial pressure and seizures."" "Unknown. Labs and Diagnostics:
WBCs on 12/7 9.0 and UA (-). LP revealed purulent CSF with glucose 1, protein 232,
WBCs 145,600 (82 polys) 149,000 RBCs with GPC (unidentified) and GNR (E.coli) on
Gram stain. Many intra and extracellular bacteria. CBC showed WBCs 22, BMP and UA
WNL. Blood cx (+) for E. coli. Head CT with mildly dilated ventricles and
evidence of meningitis. F/U head CT showed large areas of infarction bilat with
hydrocephalus."
"300933-1" "300933-1" "At 10:30, patient assessed for contraindications for
vaccine. No contraindications, consent signed, vaccine given. No s/d of reaction.
13:50, patient found by staff, unresponsive, no pulse, no respiration's. MD
notified. Stated patient expired due to disease and secondary diagnosis. 6/3/08
Death certificate states COD as cardiac arrhythmia R/T atherosclerosis, atrial
fibrillation, CHF & cerebrovascular disease." "Unknown"
"300934-1" "300934-1" "vomiting started after vaccine no fever for 2 days-
soft stools tarry oral hydration done at hosp with Pedialyte 1/7/08-records
received for DOS 12/23/07-Presented to ED with cardiac arrest. The patient was
found by family in cardiac arrest, unresponsive, abdomen distended. Vomiting day
before. 3/28/08-COD:Complications of a small bowel obstruction. Extensive small
bowel adhesions involving the spleen, pancreas, stomach, liver and large bowel.
Exucdate in patchy distribution over the surface of the small bowel, liver and
retroperitoneal fat. Small bowel luminal narrowing and serosal congestion and
hemorrhage. Bilateral cystic dilation of kidneys and ureters." "No lab data for
this event."
"301744-1" "301744-1" ""This case was reported by a lawyer and described
the occurrence of arthralgia in a male subject of unspecified age who was
vaccinated with LYMErix for prophylaxis. A physician or other health care
professional has not verified this report. On an unspecified date the subject
received unspecified dose of LYMErix (unknown). An unspecified time after
vaccination with LYMErix, the subject experienced arthralgia, body aches and pains,
swollen joints, and rheumatologic, neurologic and or cognitive impairment of an
autoimmune, immune-mediated or other mechanism. At the time of reporting the
outcome of the events was unspecified. The information in this case was received
via a Statement of Injuries. Follow up information was received on 27 December 2007
via medical records. The subject's history included non-small cell lung carcinoma,
chronically elevated liver function tests, chronic obstructive pulmonary disease,
osteoarthritic spurring of the lumbar vertebrae, and back pain. The subject
received his first, second, and third doses of LYMErix (all administered
intramuscularly in the left deltoid , 0.5 cc) on 16 June 1999, 05 July 1999, and 30
August 2000. Approximately 10 months after the third LYMErix injection on 08 July
2001, the subject presented to the emergency room due to pain in elbow. Right elbow
radiology results were normal. On 23 July 2001, he was seen for follow up of right
elbow swelling and was diagnosed with bursitis. Treatment included Celebrex. In
early August 2002, the subject developed pain in the upper back over the right
shoulder area. A subsequent x-ray revealed a mass in the apex of the left lung, and
a bone scan was recommended in light of shoulder pain. He was diagnosed with non
small cell lung cancer. The subject was hospitalized on 08 July 2004 with a chief
complaint of generalized seizure (according to the subject's wife) after
experiencing tonic clonic activity and urinary incontinence. He had reportedly
experienced irritability and personality changes in the preceding few months. In
the emergency department, he exhibited agitation and delirium. He was ""striking
out"" and required four-point restraint. Treatment included Dilantin and Valium.
His oncologist was consulted due to end-stage non small cell lung cancer, and
reported that the subject had undergone radiation therapy and chemotherapy
following his diagnosis of small cell lung cancer, and his disease was reportedly
""at a standstill"". At the time of admission medications included Neurontin for
arm neuropathy in addition to potassium chloride, Endocet, Ambien, oxandrine,
Bextra, Ritalin, Prilosec, and ""a variety of herbs and supplements"". His pain
medications were reported for treatment of neck pain. The indications for these
medications, with the exception of Neuronton and pain medications, were not
provided. A computed tomography scan was of poor quality but was suggestive of
cerebral metastasis. It was noted that ""metastases may certainly explain the
seizure"". Impression was of 1) non small cell carcinoma of lung, metastatic to
brain with new onset seizures status post radiation and chemotherapy and 2) chronic
neck and shoulder pain from metastatic lung cancer. He was discharged on 11 July
2004 with a final diagnosis of grand mal seizure and secondary diagnoses of
multiple cerebral metastases, one and a half year history of non small cell lung
cancer, and brachial plexopathy status post chemotherapy and radiation therapy. He
returned to the emergency department on 27 September 2004 with increasing weakness
and lethargy and bilateral plexopathies secondary to metastatic disease. He
reported ""several seizures"" over the past several weeks, and increased dyspnea on
exertion. At that time he was diagnosed with pneumonia ""most likely post-
obstructive from tumor"". He was admitted with diagnoses including seizure disorder
""secondary to his metastatic lung cancer"", acute renal failure secondary to
dehydration, coagulopathy with strong suspicion of liver metastases, anemia, and
cancer pain. Renal function improved, but pulmonary status did not. His white blood
cell count increased despite antibiotic therapy, and he experienced decreased
responsiveness and restlessness. He died on 30 September 2004. Due to the original
claim of arthralgia, body aches and pains, swollen joints, and rheumatologic,
neurologic and or cognitive impairment associated with LYMErix vaccinations, the
events of seizures and associated symptoms, arm neuropathy, personality change,
irritability, delirium, and agitation were reported as adverse events. The events
of seizures and urinary incontinence were assessed to be medically significant.
However, due to the subject's diagnosis of metastatic non small cell lung cancer
with brain and possibly liver metastases and the lack of identification of an
association with LYMErix vaccination, the remaining events and the subject's
hospitalization and death in September 2004 were considered to be incidental
findings."" ""Antinuclear antibody, 28Aug2001, negative; erythrocyte, sedimentation
rate, 29Jul1998, 10 mm/hr; erythrocyte sedimentation rate, 01Sep1998, 7 mm/hr;
erythrocyte sedimentation rate, 17Dec1998, 16 mm/hr; erythrocyte sedimentation
rate, 16Jun1999, 20 mm/hr; erythrocyte sedimentation rate, 28Aug2001, 9 mm/hr.
Diagnostic results: August 2002: A subsequent X-ray revealed mass in the apex of
the left lung, and a bone scan was recommended in light of shoulder pain. 27
September 2004: His white blood cell count increased despite antibiotic therapy.
28 August 1998: Lyme Ab IgG and IgM by Western blot, ""A diagnosis of Lyme disease
is not confirmed; if early Lyme disease is suspected, recommend retesting in 2 to 4
weeks"". 09 July 2001: Synovial fluid analysis revealed 1390 white blood cells/uL
and ""moderate"" red blood cells, 20 percent mononuclear leukocytes, and 80 percent
polymorphonuclear leukocytes. X-rays of right elbow showed normal results. 08
July 2004: Computed tomography scan of the head without intr"
"302022-1" "302022-1" "Information has been received from a nurse
practitioner concerning an 18 month old female with mental retardation, pulmonary
hypertension, ventricular septal defect, congestive heart failure, patent ductus
arteriosus and no known allergies who on 02-OCT-2007 was vaccinated intramuscularly
in the right arm with the 1st 0.5ml dose of PEDVAXHIB (lot#656521/0436U). The nurse
practitioner was calling from a long term care facility for mental retardation. The
reporter stated that the patient was on numerous medications but did not specify
them. On 08-OCT-2007, the patient went into cardiac arrest and was rushed to a
local hospital 10 miles away. On the same day the child was transported via
helicopter to another hospital. on 13-OCT-2007 at 7:30 pm, the patient died at the
hospital. The cause of death was cardiac arrest and multiple symptom organ failure.
Cardiac arrest and multiple symptom organ failure were considered to be immediately
life-threatening, disabling, other important medical events and congenital
anomalies by the nurse practitioner. Additional information has been requested.
1/11/08 Reviewed hospital medical records from initial hospital which reveals
patient arrived in cardiac arrest w/cpr in progress on 10/8/2007. Reportedly
playing in state school home when suddenly became unresponsive & apneic/pulseless.
Resuscitated & transferred to higher level of care. FINAL ER Dx: cardio-pulmonary
arrest. 1/11/08 Reviewed hospital medical records from transfer hospital which
reveal patient admitted to PICU on pressors, antibiotics & ventilator. Developed
multi-system organ failure includeing renal failure, liver failure, cardiac
failure, respiratory failure & refractory shock. Admitted 10/9-10/13/2007 when
expired. 5/15/09 Death certificate states COD as brain death; hypoxic ischemic
injury; multiple congenital anomalies." "Unknown LABS: WBC 16.8 (H), H/H 7.7/25.6
(L), lymphs 55.3 (H), segs 38 (L). CXR showed cardiomegaly."
"302699-1" "302699-1" ""Information has been received from a lawyer
concerning a male child with a history of febrile convulsion who on an undisclosed
date was vaccinated with MMR II. Ten days after being vaccinated with MMR II the
child was found dead in his cot. It was reported that the general practitioner
immunized the child when he had a fever and history of febrile convulsion. The post
mortem found ""MV"" in his lungs and various other infections. No further details
were provided."" "Autopsy - MV in lungs, and other infections"
"302724-1" "302724-1" "Pt. died in bed approx. 48 hours after receiving 1st
set of 3 immunizations. Records received 3/31/08-final autopsy report. COD:
Probably Sudden Infant Death Syndrome. Petechial hemorrhages, epicardial, pleural."
"No lab data for this event."
"303166-1" "303166-1" ""Information regarding Prevenar was received from a
Complaint Coordinator from the FDA regarding a 2-month-old male patient who
experienced death. The patient received a dose in Dec-2007. On the same day, the
patient received a dose of Haemophilus influenzae B (manufacturer unknown) and a
dose of Pediarix (GlaxoSmithKline) in Dec-2007. The patient received a dose of
Rotarix one day prior to the other vaccines in Dec-2007. Relevant medical history
was not provided. Concomitant medications were not reported. Approximately two
weeks after receiving Prevnar and three other vaccines the patient died on 26-Dec-
2007. No explanation was given for the death. No additional information was
available at the time of this report. The cause of death was unexplained and the
autopsy cause of death was not reported. 4/15/2008 Per FDA: ""The cause of death
was SIDS, although we don't have a copy of the death certificate. I don't think we
need anything else for this case."" Lengthy investigative report received from FDA.
Infant seen 12/11/07 with hx of cough, runny nose and congestion. Dx'd with
bronchiolitis and started on nebs. Infant received Rotovirus vaccine 12/11/07.
Seen in F/u next day with improved sx and given Pediarix, Hib, and Prevnar
12/12/07. Infant had fed normally in the early morning hours of 12/26/2007 and gone
to sleep in parent's bed, and when parent awoke the next morning, the infant was
dead. DX: SIDS."" "Autopsy results, not reported"
"303292-1" "303292-1" ""Information has been received from a physician
concerning an approximately 5 month old male with a history of ""reflux"" who in
approximately October 2007, was vaccinated orally with a second dose of Rotateq.
Two weeks post vaccination, on 08 NOV 2007, the patient was seen ""in the office""
at which time the patient was ""congested with on an off vomiting"". The patient
presented with ""a good bowel movement"" and was given amoxicillin and sent home.
Approximately 16 hours later the patient was taken to the emergency room (ER).
""The child passed away on 10 NOV 2007"". The patient's status was not recovered.
The reported cause of death was ""necrotic bowel"". The adverse events reported
were considered to be, Disabling, immediately life threatening by the reporter.
Additional information has been requested. 1/25/08 Received vax record which
reveal patient also received Pediarix #2 AC21B133AA, Hib #2 Merck lot # 0436U,
Prevnar #2 B54007H & Rotateq #2 0670U.. 1/29/08 Reviewed ER medical records of
11/9/07 which reveal patient arrived in cardiopulmonary arrest having been brought
to hospital by parent. Had voided & had bloody stool, possibly vomited & had been
lethargic prior to coding. Was in severe acidosis, shock, dehydration,
hypercarbia, arrhythmia, infection. Resuscitated & transferred to higher level of
care ER. FINAL Initial ER DX: abdominal castrophe; respiratory/cardiac arrest; and
septic shock. 2/1/08 Reviewed hospital med records which reveal patient transferred
from outlying hospital in critical shock condition. Admitted 11/9-11/10/2007 to
ICU. Had 36 hour hx of poor feeding, increased crying & developed bilious emesis &
bloody stools. Intubated & emergent laparotomy & ileocecectomy was performed in
ICU. Finding at surgery: IS extending to hepatic flexure w/small area of necrosis
in cecum & entire small bowel w/diffusely involved ischemia thought likely
secondary to shock & cardiac arrest. Bowel remained dusky at end of procedure &
abdomen left open w/bowel wrapped in order to visulize recovery. developed
compartment syndrome of bilateral legs. Deteriorated, developed hepatic failure,
DIC, fixed & dilated pupils, seizures & absent reflexes. Defibrillated numerous
times & expired 11/10/07. Preliminary autopsy report included w/medical records
reveals COD as Intussusception leading to ischemic bowel resulting in sepsis
complicated by prolonged cardiac arrest & multiorgan failure. Findings included:
ischemic bowel; diffuse alveolar damage,mild; sepsis; hepatic failure; DIC; renal
petechiae; gastric mucosal petechiae; bilateral lower extremity ischemic damage;
hyperemic lower extremities."" "Unknown ER LABS: ABG pH 6.85 (H). CXR &
abdominal x-ray revealed multiple dilated loops of air-filled small bowel & free
intraperitoneal air. 4/15/08 Additional labs received from CDC: small intestine
w/marked & extensive congestion of submucosa w/hemorrhages & necrosis; congestion
of liver & spleen. Adenovirus, Rotavirus & haemophilus all neg."
"304128-1" "304128-1" ""Information has been received from a nurse
concerning an 80 year old male patient who on an unspecified date was vaccinated
with a dose of Pneumovax 23, (lot # not reported) (manufacturer unknown). The
nurse reported that the patient received the Pneumovax 23 and developed a
""Guillain-Barre syndrome"" which made him develop pneumonia and the patient died
as a result. She reported that the patient was not treated or vaccinated at that
practice and was not sure if it was Pneumovax 23, she said it was a pneumonia shot
(manufacturer unknown). No further information was reported. Additional
information is not expected."" "Unknown"
"304418-1" "304418-1" "She was immediately sick. Very sick for 4 more
days. Kept getting worse. Dec 20 put in hospital. Dec 25 to ICU. Dec 27
respirator. Died 1/17/08. 2/21/08 Reviewed hospital medical records which
included clinic visit & vax record of 11/28/07. Database updated. Patient
w/palpitations intermittently when anxious or blood sugar low, 10# wt loss over
past several months since the death of parent. H&P indicates patient experienced
sinusitis, fever, chills, sore throat, nasal congestion, postnasal drip, swollen
cervical lymph nodes & productive cough x 3 wks. Dx w/bronchitis & pneumonia & tx
w/oral antibiotics as outpatient w/o increasing fever, SOB & weakness. Admitted
12/20/07-01/17/2008 w/community acquired pneumonia & dehydration. Consults by
pulmonogy, surgery & ID. Conditioned worsened & was intubated & transferred to
ICU. Developed pneumothorax s/p transbronchial biopsy & had chest tube placed.
Developed acute ARDS & was trached 1/8/08. Continued to deteriorate & expired
1/17/2008. FINAL DX: none provided on D/C summary. No autopsy done per med
records. Death certificate requested from funeral home. 2/21/08 Reviewed death
certificate which states COD as respiratory failure with pneumonia as underlying
cause." "LABS: Admit CBC w/WBC 7/9 (N), H/H 11.2/32.7 (L), neutros 82.1% (H),
lymphs 6.9% (L), eos 6.7 (H). Admit Chem: Na 134 (L)CT chest scan revealed
bilateral nodular lung inflitrates. CT chest angio r/o pulmonary emboli.
Bronchoscopy revealed hemorrhagic secretions. Transbronchial biopsy. Lung biopsy
via thoracotomy revealed interstitial pneumonitis. FANA (+) w/titer speckled
pattern 1:160 (H). Neut cyto aby IgG <1:20 (H). EKG abnormal. Echocardiogram
abnormal w/RV dilation & dysfunction."
"305043-1" "305043-1" "On 11/21 the husband noticed that patient was having
confusion and forgetting little things. The husband notified the PCP who advised
him to take the patient to the hospital. Prior to this the patient was treated on
10/24/07 for pneumonia with 7 days of Avelox. On 11/5 the patient came to the
clinic complaining of myalgias. This was ruled to be a viral process. On 11/16 the
patient recieved the influenza vaccine in the clinic. The morning of 11/21 the
patient woke up with a headache and progressively became disoriented with muscle
weakness and by 4pm that day could not talk. Once at the hospital the patient was
given steroids, antibiotics, and antifungals. The patient improved for two days
and then got progressively worse each day after that. The patient became
completely unresponsive, pupils fixed and dilated by 11/28. Patient expired on
11/28. Diagnosis was unclear. Patient with definite demylinating process and
encephalopathy, so vaccine reaction was in the differential. However some of the
symptoms did start prior to receiving the vaccine. 8/26/08 Death certificate
states COD as acute disseminated encephalomyelitis. 2/19/08 Reviewed hospital
medical records of 11/21-11/28/2007. FINAL DX: acute disseminated
encephalomyelitis; hyperlipidemia; pre-diabetes; & HTN. Records reveal patient
experienced confusion, disorientation & loss of speech x 1 day Admitted 11/21-
11/28/2007 when she expired. Exam revealed inability to speak but was able to
mime; cranial nerve exam WNL, general muscle weakness w/reflexes intact. Tx
w/antibiotics, steroids, antivirals & prophylactic antiseizure meds. Received IVIG
x 2. By hospital day #4, conditioned worsened & was unresponsive w/left side
weakness. C/S neg & antibiotics/antivirals were d/c. Continued to deteriorate &
on vent. Family decision to withdraw tx as condition contined to worsen & pt
expired. 5/2/08 Reviewed pcp medical records which included vax record that
confirms as reported. Office note of 11/16/07 was for flu shot only, no pcp note.
10/24 vs for URI s/s x approx 1 week. Runny nose, facial tenderness,
lightheadedness, cough, LBP, poor appetite. Apouse had been ill w/viral syndrome.
CXR that day revealed patchy RUL infiltrate; CBC WNL. 10/29 visit reveals patient
seen in f/u for pneumonia, dermatitis & pain in left shoulder. She had less cough
& improved appetite but was still tired. CXR that day revealed near resolution of
pneumonia. Records also included some hospital medical records. Neurosurgery &
neurology consults done. Patient w/fever on admission." "LABS: CT of head & MRI
of brain c/w ADEM. CSF WBCs 789(H), polys 89%. Repeat CT scan revealed worsening
demyelination. Blood & CSF c/s neg. Brain biopsy revealed ADEM. WBC 15,500. CT
abdomen/pelvis revealed fatty liver & gallbladder distension, both mild. CXR WNL."
"305097-1" "305097-1" ""Information has been received from a pharmacist and
a pharmacy tech concerning a 50-year-old female patient with no pertinent medical
history, allergies or previous drug reactions, who on 28-JAN-2008 was vaccinated in
the right upper arm with a dose of Mumpsvax II (659616/1982U) (Enders-Edmonston,
Jeryl Lynn, Wistar RA 27/3). Concomitant therapy included TYLENOL, ROCEPHIN,
VICODIN, NALOXONE and ""afzavelrd"". On 02-FEB-2008 the patient experienced
nausea, vomiting, headache, light headedness, fever and cough which lasted 4-5
days. On 06-FEB-2008 the patient developed swelling and pain of the right upper
extremity at the injection site, and the left lower extremity was swollen. On 08-
Feb-2008, the patient was admitted to the hospital with a diagnosis of cellulitis
and vomiting. She developed respiratory failure, and became septic, likely due to
necrotising and vomiting. She expired after shock and cardiac arrest on 08-Feb-
2008. The cause of death was fasciitis. During the hospital stay, the patient was
treated with ""promethezone"", ""NS"" and ""zolprclam"". The adverse events were
classified as type A (pharmacological) reaction. Naranjo's Algorithm for
Determination of Probability was used to assess the adverse drug reaction, and
scored a 2 which indicated that they were a possible reaction to the Mumpsvax II
(Jeryl Lynn). The adverse event appeared after administration of the vaccine. The
vaccine was not detected in the blood or other fluids in concentrations known to be
toxic. It was not known if the patient had a similar reaction to Mumpsvax II
(Jeryl Lynn) or similar vaccines. According to Schumocks Criteria for
Preventability, it was not considered preventable. The Mumpsvax II (Jeryl Lynn)
was not inappropriate for the patient's condition. The dose, route, and frequency
of administration was not inappropriate for the patient's age, weight, or disease
state. There was no required therapeutic drug monitoring necessary or lab tests
required. There was no reported drug interaction. A toxic serum of the drug
concentration was not documented and there was no poor compliance involved. No
product quality complaint was involved. The reporter considered the adverse events
to be an other important medical event and life threatening. A lot check has been
initiated. Additional information has been requested. 02/25/2008 Autopsy Report
received with the following findings: 1) Abscess, Left Upper Lobe of Lung. 2)
Apparent Cellulitis, Right Upper Extremity. 3) Congestion and Edema, bilateral
Lungs. 4) Pleural Effusion, Left side. 5) Congestion, Liver. 6) Mild Coronary
Artery Atherosclerosis. 7) Mild Atherosclerosis, Aorta. 2/27/2008 Tag2 received.
4/21/08 Initial report received from coroner. The deceased developed a high fever x
4 days s/p mumps vax for which pt did not seek treatment. On 2/8/08 pt developed
severe pain in arm and leg, and began spitting up blood and was brought to the ER.
Pt was admitted to the ICU at 930 am. At 1512 pt went into cardiac arrest and was
prounounced dead after CPR was unsuccessful. Attending MD stated victim most
likely died of sepsis or severe infection. 07/08/2008 Remainder of Autopsy report
received. Final COD Abscess, Left Upper Lobe of Lung (Days). Other significant
conditions: Mild Subcutaneous inflammation, skin of Right upper extremity.""
"Unknown. Tissue exam lungs (+) for abscess formation, tissue destruction,
necrosis and marked acute inflammation as well as adjacent lung tissue with acute
inflammation and accumulation of proteinaceous material in alveolar spaces and
marked congestion. Skin tissue exam of RUE (+) for edema, hemorrhage in subq fat
and inflammation. Bacterial clusters in deep dermis and subq tissue."
"305832-1" "305832-1" "Pt died within 24 hours of immunizations 3/28/08-
autopsy report received cause of death:sudden unexpected infant death. 3/28/08-
autopsy report received-COD: Sudden unexpected infant death." "No lab data for
this event."
"306238-1" "306238-1" ""Information has been received from a consumer
concerning her 17 week old grandson, who in July 2007, was vaccinated with
PedvaxHIB (Lot# ""VFIG4AA""). Concomitant suspect vaccination included Comvax.
Other concomitant therapies included ""five unspecified vaccinations and teething
pills."" The patient sought unspecified medical attention. Laboratory diagnostics
were performed, however the specific were unknown. On 19-SEP-2007 the patient died.
The cause of death was unspecified. No product quality complaint was involved.
Additional information has been requested. 5/13 Autopsy report state COD as anoxic
encephalopathy due to interrupted SIDS. Report states patient found pulseless &
apneic followed by successful parental CPR; hospitalized 9/16-9/19/2007
w/supportive care & developed seizures & condition deteriorated; diffuse anoxic
encephalopathy; scene & circumstances c/w interrupted SIDS."" "diagnostic
laboratory specifics unknown"
"306283-1" "306283-1" "Pt died in her sleep 48 hrs after receiving
vaccinations. I do not think related but close time frame with vaccination. We
just wanted to inform you (and family). Autopsy pending. Final COD: Mitral Valve
Disease. (no autopsy done)." "No lab data for this event."
"306563-1" "306563-1" ""Initial report received on 03 March 2008 from
another manufacturer, report number MCN54683. The initial reporter to this
manufacturer was a health care professional. ""This spontaneous case was received
via a company representative, reported by a physician and concerns a 46 year old
male patient who had an unexplained death after taking Peg-Interferon Alfa 2A
(Pegasys), Ribavirin (manufacturer unknown) for hepatitis C and tetanus vaccine as
a prophylaxis. On an unknown date, the patient commenced treatment with Peg-
Interferon Alfa 2A and Ribavirin. About a week back, the patient cut himself and
went to the hospital. He was administered a tetanus vaccine. The patient died
shortly after that due to unknown reason. No further information was available.
"""" "Relevant diagnostic testing was unknown."
"306817-1" "306817-1" "On 2/23/08 child received MMR and Varicella
vaccinations during routine one year check up. No adverse events reported to
physician prior to death on 2/27/08. 6/25/2008 Postmortem examination report
received. COD-Acute Febrile Illness. DX based on exam: Pale doughy lungs. Bite
marks on lower lip. Febrile illness by history. Acute inflammatory cells in walls
of bronchi in peribronchial alveoli." "None Performed. Labs: Microscopic exam
(+) for foci of neutrophils and eosinophils in walls of bronchi and scattered
neutrophils in peribronchiolar alveoli; congestion. Otherwise NPC. Blood cx (+) for
Enterobacter aerogenes, Enterobacter cloacae, Staph aureus, and Virididans
streptococcus group. Blood glucose 132. Creatinine 0.0. K+ 16.0. Cl- 116"
"306894-1" "306894-1" "Information regarding Prevnar was received from a
Physician regarding a female patient who experienced pneumococcal disease. The
patient received a dose on an unspecified date. The patient's concurrent illness
includes cochlea implant (had not received Pneumovax). Concomitant medications were
not reported. On an unspecified date, the patient experienced pneumococcal disease
and died. The cause of death was reported as pneumococcal infection. CSF culture
(results: Streptococcal pneumoniae serotype 19A) was done on an unspecified date.
No additional information was available at the time of this report." "CSF culture
streptococcal pneumoniae serotype 19A; Reported Cause of Death Pneumococcal
infection, pneumococcal disease"
"307009-1" "307009-1" "Patient received Hepatitis A and Varicella vaccines
2 days prior to presenting to the ED with respiratory distress and mental status
changes. The patient died 3 days later from influenza B. There is no indication
that the vaccines this patient received or any other vaccine could have had any
relationship to the outcome, or is there any reason to believe from the history
that anything other than the influenza and the patients underlying medical
condition (Congential Heart Disease, Asplenia, CP) were related to the death.
However, we report all incidents of patients with a serious adverse event
temporarily related to vaccine administration, whether or not there is a
relationship. 6/2/08 Reviewed hospital discharge/death summary for 2/29-3/2/2008,
FINAL DX: overwhelming influenza B sepsis & encephalopathy Records reveal patient
experienced labored breathing, altered mental status x 1 day; coughing, rhinorrhea
& fever x 2 days. Seen by PCP & dx w/viral illness. Conditioned worsened & became
unresponsive at home. Taken to ER by EMT with oxygen saturation 70's (baseline high
80's). In ER, noted to have frothy sputum. Tx w/CPAP & nebs. Improved & became
responsive. Then after another episode of bradycardia & hypotension, became
unreponsive again. Felt to be having sub-clinical seizures. Admitted to PICU,
intubated & coded several times. On multiple pressors w/fixed & dilated pupils.
Family requested no further resuscitation efforts. ME declined case & family
declined autopsy. 6/3/08 Reviewed medical records for 2006 & additional medical
records for 2008. Records for 2/15-3/2/2008 reveal patient in usual state of
health on day of vaccination. Seen by PCP 2/29 w/fever 103.3 for 1-2 days; had not
received flu shot due to prior facial swelling w/flu vaccine in 2006. Dx w/viral
illness. Seen in ER later same day for cough, rhinorrhea & fever x 2 days &
increased respiratory effort becoming unresponsive. Admitted to PICU w/influenza
w/pneumonia; respiratory failure; & congenital heart disease. Neuro & cardio
consults done." "Viral studies and Chest xray showed left lower lobe pneumonia
LABS: rapid test for influenza B (+). Initial WBC 3,000 & chemistry WNL. CT of
brain w/severe cerebral edema & transtentorial herniation. LABS: CXR LLL
pneumonia."
"307156-1" "307156-1" "On 2/25/08 infant breastfed well at 3 AM. At
approximately 6 AM 2/25/08 infant was found with blood in nose, apneic and
pulseless; 911 called, fail resuscitation attempted. Infant was declared dead at
hospital ED after failed attempt to revive her. She was a former 32 week preemie
who slept in same bed with parents. 4/18/08-autopsy report received: Cause of
Death:Sudden unexplained infant death in infancy." ""Medical Examiner autopsy -
report pending - by verbal report - ""petechial hemorrhages"" and blood in nose""
"307157-1" "307157-1" "Infant reported in paper as deceased. No contact
with parents. PHN who gave vaccine had remembered that infant died and had received
immunizations from local health unit on 010308. This was triggered by report of
another infant in same county who dies at 3 mo. of age and was given same vaccines
but with different lot #s of some vaccines." "None available. Autopsy pending."
"307158-1" "307158-1" ""1st series of vaccines given 022008. T. Call from
mother 022608 states in faint having ""projectile vomiting and severe diarrhea.""
PHN called CDNS who rec. infant see private MD STAT and report to nurse outcome.
022708 call from infant's mother states ""her pediatrician told her that""vomiting
not due to Rotavirus."" That it is OK to give at 4 months old. 031308 Mom called to
say baby dies lat PM. Mom states ""she was just fussy the past few days.""""
"Deceased - unknown"
"307188-1" "307188-1" "Patient was given the following vaccines: Hep B,
HIB, Rotateq, DT/DTAP, IPV, Pneumococcal Conj. on Monday March 3rd, 2008 around
1:45pm. He was fussy after and was given Tylenol at the dr's instructions and
slept most of Monday evening other than waking to eat. Tuesday he was still taking
deap breaths as if he just finished crying and was very quiet. Although I still
was able to have him coo with me he was very calm and relaxed. Monday morning I
got him ready for daycare and dropped him off around 7:30 along with his sister and
received a phone call at 4:45 that my baby was lot breathing. Daycare performed
CPR until the EMS arrived, then the EMS took over and transferred him to the
hospital. At the hospital they tried to revive him for an hour and had to
pronounce him dead. 3/31/08-records received from ED for DOS 3/5/08-Presented in
cardiopulmonary arrest. Found nonresponsive at daycare. Intubated. No blood
pressure, no pulse, asystolic pulse. Patient expired. DX: Cardiopulmonary arrest."
"An autopsy is currently being done to find out the cause of death. 6/3/08-
records received: cause of death-Sudden Infant Death Syndrome. Natural causes."
"308149-1" "308149-1" "Our office was informed 3/14/08 of patients demise -
no side effects in office. 5/15/08-records received-Cause of death:Sudden Infant
Death Syndrome (SIDS). Manner of death:natural." "State exam - pending"
"308577-1" "308577-1" "It was reported in a published article that a
patient was vaccinated with a dose of VARIVAX (Oka/Merck). After vaccination, the
patient died after receiving a diagnosis of familial hemophagocytic
lymphohistiocytosis. It was reported that the patient's younger sibling died after
vaccination with VARIVAX (Oka/Merck) (WAES # 0803USA04454). The article also
discussed the experience of two other patients while on therapy with VARIVAX
(Oka/Merck) (WAES numbers 0803USA03578 and 0803USA04453). Additional information
has been requested. A copy of the published article is attached as further
documentation of the patient's experience." "unknown"
"308661-1" "308661-1" "We received on 12 FEB 2008 from a healthcare
professional the following information: A 7-year-old male patient, born on 21 JUN
2000 was vaccinated with FLUVIRIN (batch no. unknown) on 19 NOV 2007. The patient
was killed in an automobile traffic accident on 01 FEB 2008. The subject had
participated in a clinical trial sponsored by MedImmune. FLUVIRIN was used in that
trial as a control, and Novartis Vaccine & Diagnostics (NVD) has donated the
FLUVIRIN, but other than that has not been involved. Although the event did not
occur during the duration of the trial, and the investigator did not see any causal
relationship to the vaccination with FLUVIRIN, he reported the event to the IRB and
NVD because the child had died." "No lab data for this event."
"308662-1" "308662-1" "Information has been received from a literature
article regarding an adult with diabetes, who was admitted for varicella-related
pneumonitis and died of respiratory failure after 11 days in an ICU. In the opinion
of the author, the data demonstrated the sizeable and continuing reduction in
severe varicella-related morbidity with the use of the varicella vaccine since
1995. It was also noted that the data highlighted the fact that the majority of
hospitalizations that occurred during this time period were preventable through
implementation of existing vaccination-policy recommendations. The author noted
that varicella incidence and varicella-related hospitalizations (VRHs) and deaths
have decreased substantially since the implementation of the varicella vaccination
program. A copy of this published article is attached as further documentation of
the patient's experience." "Unknown"
"308717-1" "308717-1" "(Less than 1 week after vaccines ) Death 3/23/08 -
found dead in crib 3/23/08 AM by mother. Pronounced dead at the scene. Autopsy
pending. Unknown if related to vaccines. 6/20/08-records received-final cause of
death:Sudden Infant Death Syndrome. 6/20/08-autopsy report:findings included
intrathoracic petechiae, umbilical hernia, tibial subperiosteal new bone formation
and right hydrocele." "No lab data for this event."
"308774-1" "308774-1" "Patient found cyanotic in crib and dead on 3/25/08
7/10/08-autopsy report received-COD: positional asphyxia. Accident, prone face down
positiong on soft bedding in crib." "No lab data for this event."
"308828-1" "308828-1" "Information has been received from a consumer
concerning her neighbor's son who on an unspecified date was vaccinated with a dose
of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3). On an unspecified date,
post vaccination, the patient developed autism and eventually jumped in a lake and
died. A product quality complaint was not involved. The adverse event autism was
considered an Other Medically Important Event (OME). Additional information has
been requested. 4/4/08 Received via email from FDA & manufacturer: The reporter is
a consumer who reported on a neighbor's child. The reporter refused to provide
information beyond what was on the VAERS form . The reporter refused to provide
the name and telephone number of the actual parents of the child. This is
unevaluable." "Unknown"
"309085-1" "309085-1" "Patient was a term infant who had had an uneventful
delivery. He did develop a fever in the first 24 hours of life, was treated with
IV antibiotics but blood culture was negative so IV abx were stopped after 48
hours. He was monitored for several days and did well. He was scheduled for
discharge and received HepB vaccine 24 hour prior to scheduled discharge. 12 hours
after immunization, parents report his fevers returned and he developed a skin
rash. He also had difficulty breathing requiring supplemental oxygen by nasal
cannula. A few days later, he deteriorated dramatically, required endotracheal
intubation and started having seizures. He then became encephalopathic and had
cardiopulmonary collapse as well as multi-system organ failure. An EXTENSIVE work
up was done. No infectious, endocrinologic, hematologic or neurologic cause was
found. He developed massive ascites, hepatosplenomagaly and renal failure
requiring peritoneal dialysis. He had skin biopsies, liver biopsies, bone marrow
biopsies in addition to an exhaustive amount of blood work for common and rare
disorders-all were negative. Patient eventually died at 6 weeks of age from
Pseudomonal sepsis. Lab studies showed on DOL #2 showed a normal CBC and
differential. <24 hours after the vaccine, showed severe thrombocytopenia which
remained low throughout his hospital course despite twice daily platelet
transfusions, etc. 4/11/2008 Autopsy report and Case Summary received for DOD
8/10/2007. Term infant developed fever (T=103'F), respiratory distress and
irritability at 4 hrs of age. Txd with Acyclovir for presumed viral infection,
viral cultures (-). Pt later developed macular rash which resolved. Pt developed
fever and increasing respiratory distress ultimately requiring intubation on
7/8/07. Infant became edematous and developed thrombocytopenia and seizures.
Transfered to higher level of care. Upon admission pt exibited temperature
elevations, twitching, rash, throbocytopenia. Sepsis w/u (-). Pt dx: Bone marrow
failure with gram-negative sepsis and renal failure. Deeply purpuric rash noted
after admission. 6 wk hospital course was dominated by diffuse edema, respiratory
distress, thrombocytopenia and renal failure. ID consult suspect Neonatal Onset
Multisystem Inflammatory Disease (NOMID). Autopsy revealed anasarca, Pseudomonas
pneumonia, multiple hemorrhagic infarcts of the spleen, hypoplastic bone marrow,
cholestatic hepatopathy, and marked thymic involution. Presumed COD: Overwhemling
sepsis. Contributing COD: Pancytopenia." "Lab studies showed on DOL #2 showed a
normal CBC and differential. <24 hours after the vaccine, showed severe
thrombocytopenia which remained low throughout his hospital course despite twice
daily platelet transfusions, etc. Labs and Diagnostics: WBCs 21.5. Platelets 9000
on DOL#3 and remained low. HCT and Hgb low. Chemistry abnormal. BUN 75. LFTs
abnormal. Hearing test failed. US of head (-) for intracranial hemorrhage. Abd US
(+) for enlarged kidneys with increased echo texture, moderate ascites. EEG
abnormal. ECG sinus tach. Chromosomal analysis WNL. Urine organic acids (+)."
"309233-1" "309233-1" ""Information has been received from a consumer
concerning her 12 year old daughter with a history of seizures and heart
arrhythmias, who on 25-JAN-2007 was vaccinated with a first dose of Gardasil. On
27-APRIL-2007 the patient was vaccinated with a second dose of Gardasil.
Concomitant therapy included LAMICTAL, vitamins (unspecified) and KEPPRA.
Subsequently, the patient began to have seizures, developed a rash on her arm, and
was complaining about headaches. On 22-JUN-2007 the patient experienced a heart
arrhythmia and was hospitalized. Due to the arrhythmia the patient was placed on
life support and died on 29-JUN-2007. The patient's mother reported that the
patient had an electrocardiogram (EKG) about 5 years ago to test for prolonged QT
syndrome. The test came back normal. It was reported that at that time the patient
was in and out of the emergency room due to having seizures periodically. The
patient had been seeing a neurologist and had not had any seizures for about two
years until she received the second dose of Gardasil. The patient's mother reported
after her daughter's death and burial she had received copies of her daughter's
medical records. Throughout the reports it showed that for the past five years the
patient had prolonged QT syndrome, and proguda syndrome ""which causes seizures and
heart arrythmias."" The patient's cause of death was prolonged QT syndrome, brain
death, and proguda syndrome. No product quality complaint was involved. The
seizures, rash, headaches, heart arrythmias, prolonged QT syndrome, brain death,
and proguda syndrome were considered to be other important medical events.
Additional information is not available."" "electrocardiogram"
"309426-1" "309426-1" "Unexplained death/SIDS 6/12/2008 Autopsy received
with COD Sudden Infant Death Syndrome. Manner of Death: Natural. Neuropathology
report DX: Gliosis of the Medullary Nuclei." "All viral PCR tests (-). Drug
screen (-). Mass spec shows no underlying metabolic disorder"
"310076-1" "310076-1" "My son died 5 days after being vaccinated from an
intussusception. 5/13/08 Autopsy report states COD as complications of
intussusception. Report states patient had clinical history of abdominal
distension & vomiting; IS w/5 in telescoping of ascending into transverse colon
beginning at the ileocecal valve;partially reducible telescoping w/colonic
infarction & prominent lymph nodes at leading colonic edge; dilated abdomen
w/increased abdominal distention; BRB per rectum on autopsy & history of currant
jelly stool at home; sepsis w/E.coli cultures from heart blood, spleen & lung'
interstitial pneumonitis w/positive RSV antigen from nasopharynx swab." "No
lab data for this event."
"310262-1" "310262-1" "Information has been received from a physician
concerning a 20 year old female with no medical history reported, who on 01-APR-
2008 was vaccinated with a dose of Gardasil. On 05-APR-2008, the patient died four
days after receiving Gardasil. The patient sought unspecified medical attention.
An autopsy was performed which ruled out suicide and anything suspicious. The
cause of death is currently unknown and they are performing toxicology tests to try
to determine the cause. No product quality complaint was involved. The reportable
physician considered death to be immediately life-threatening and disabling.
Additional information has been requested.7/14/08-autopsy report received-
COD:Undetermined. Died unexpectedly while working as a health aid. Postmortem
examination reveals focal nodular hyperplasia in liver; this finding though
significant, cannot accoutn for sudden death. There is no evidence of pregnancy.
Toxicology analysis negative. Based on history, autopys, and toxicological
examination, cause of death is undetermined." "autopsy, 04/??/08, ruled out
suicide or anything suspicious; diagnostic laboratory, 04/??/08, toxicology results
unknown. 7/16/09 Pathology report received Receipt 02/23/09 Sign-out 07/06/09.
Single focus of mononuclear inflammation of the epicardium. No molecular evidence
of infection with enteroviruses or adenoviruses. Liver shows focal nodular
hyperplasia. Lung is congested. Enterovirus group RT-PCR (-) Adenovirus group PCR
(-)."
"310806-1" "310806-1" """"a bit of a fever after vaccines 8/13/2007 but
cleared up and pt felt fine and ate well day before he died."" 12/10/08 Death
certificate states COD as SIDS."" "May have had done at ER unknown"
"310807-1" "310807-1" "Possible SIDS 4/25/08-COD Sudden Infant Death
Syndrome" "Autopsy Pending"
"310808-1" "310808-1" "Parents found infant blue, face down in crib around
1145 on 8/12/07. Per Coroner Possibly SIDS. CPR Attempted. Infant Pronounced Dead
at 1:30 on 8/12/07. 5/27/08-records received:Cause of death-Sudden Infant Death
Syndrome. Manner of death-natural" "Failed car seat test x3 (lot 9 days of life);
O2 De sats when sitting up"
"310946-1" "310946-1" "Sudden loss of consciousness several hours after
vaccination. EMT could not revive him. Physical and EKG were normal just 3 days
prior at annual exam. 4/29 Autopsy report states COD as atherosclerotic coronary
vascular disease. Manner of death is natural. 4/29 Autopsy states patient found
unresponsive & cyanotic at bottom of ladder with a drill (no malfunction). ASCVD
findings: LAD & circumflex arteries to pinpoint lumen; RCA 80% narrowing; aorta
w/ulcerated plaque partly occluding left coronary ostium; previous MI, extensive
involving lateral LV w/aneurysmal thinning of ventricular wall." "No lab data for
this event."
"311452-1" "311452-1" ""Information regarding Prevnar was received from a
healthcare professional regarding a female patient who received the fourth dose on
22-Jan-2007 at 12 months of age and died from Streptococcus pneumoniae meningitis
at the age of 26 months. The patient's concurrent illnesses included
nasopharyngitis or viral infection. Concomitant medications were not reported. On
an unspecified date in 2008, the patient developed Streptococcus pneumoniae
meningitis. On 17-Apr-2008, the patient died. The autopsy cause of death was
meningitis pneumococcal. A serotype was not provided. The reporter noted that the
patient had ""something going on in her system, such as possibly a cold or another
type of viral infection, that weakened her immune system."" Bacterial culture
(results: negative for Haemophilus infection, Group B strep, Neisseria
meningitides, and Escherichia coli) and bacterial culture (results: Streptococcus
pneumoniae) were done in 2008. No additional information was available at the time
of this report. 6/27/08 Autopsy report states COD as bacterial meningitis &
streptococcus pneumoniae. States acute bacterial meningitis: purulent exudate of
subarachnoid space & meninges; c/s (+) for alpha hemolytic streptococcus; PCR for
herpes simplex & enterovirus (-). 7/8/08 Reviewed hospital medical records of
4/16/2008. FINAL DX: Admitted for viral gastroenteritis. Final Dx: bacteremia.
Records reveal patient seen by PCP w/fever, nausea & vomiting x 3 days; diarrhea x
1 day; no oral intake; no further BMs; decreased UO; tired; irritable; excessive
sleepiness; minimal nasal congestion. Tx w/IVF. Began to become more alert then
found unresponsive, cyanotic & no pulse/respirations later in evening.
Resuscitation unsuccessful."" "Bacterial culture, 00/00/2008, Streptococcus
pneumoniae; 00/00/2008, negative for Haemophilus influenzae, Group B strep, N.
meningitides, and E. coli; Autopsy Results, Meningitis pneumococcal; Streptococcus
pneumoniae meningitis LABS: CBC abnormal, WBC 27.2(H), lymphs 7% (L), monos 2(L),
grans 85 (H). Chemistry, UA, CXR all WNL. Rapid strep & MRSA c/s (-). Blood c/s
(+) for streptococcus pneumoniae."
"311791-1" "311791-1" "Information has been received from a nurse
practitioner concerning an 83 year old female consumer who on 14-FEB-2008 was
vaccinated SQ with a 0.65ml of ZOSTAVAX. Concomitant therapy included acyclovir
(ZOVIRAX) and clorazepate dipotassium. Subsequently, on 20-FEB-2008, the patient
developed shingles. Unspecified medical attention was sought. It was unspecified
if lab studies were performed. It was reported that the patient was treated for
shingles (treatment regimen not reported) and made a full recovery. It was also
reported that the patient went on vacation and when she returned from vacation she
developed pneumonia and died on 12-APR-2008. There was no product quality
complaint involved. The cause of death was pneumonia. The nurse practitioner
considered the event to be disabling. Additional information has been requested."
"Unknown"
"311987-1" "311987-1" "information is a verbal report from spouse, onset of
illness 32 days after vaccination, treated by primary care MD, thought he had a
virus, became blind by 11/21/07, continued deterioration to death. Autospy
preformed: found patient had a demylinating process as cause of death. 05/27/08
Autopsy report reviewed which states COD as presumed acute pneumonia (autopsy
limited to examination of brain). Report also states clinical hx of acute
respiratory failure, febrile illness & staph aureus & e.coli dx on bronchoalveolar
lavage 1/14/08. Other contributing conditions included: acute aggressive
multifocal demyelinating disease w/white matter lesions multiple areas of the brain
including previous biopsy sites & cervical spinal cord; cerebral atrophy & edema.
9/26/08 Reviewed hospital medical records of 1/3-/-19/2008. FINAL DX: multiple CNS
lesions w/gadolinium-enhancing CNS lesions; myalgia; hypoxic respiratory failure;
dysphagia; poor oral intake; nutrition; possible pneumonia; prophylaxis. Records
reveal patient experienced re-admission for brain biopsy which revealed acute
demyelinating process. Failed high dose steroids & plasma exchange. Tx
w/mitoxantrone treatment & second course of high dose steroids in ICU. Mental &
respiratory status deteriorated, significant muscle spasms & pain. Mechanical
ventilation. Brain lesions continued to grow & new lesions appeared. Developed
decerebrate posturing. Comfort care only decided & transferred to hospital closer
to family home. 5/23/08 Reviewed initial eye clinic records of 11/29-11/30/2007
FINAL DX: probable retrobulbar ischemic ACON. Records reveal patient experienced HA
x 3 days & blurred vision x 1 day. Patient had viral infection w/fever approx 10
days prior & still has sore eyes & stiff neck. Referred to neuro-ophthal. 6/6/08
Reviewed neuro-optho medical records for 11/30-12/2/2007. FINAL DX: bilateral optic
neuritis Records reveal patient seen in clinic 11/30 emergently & admitted to
hospital same day. Had used Cialis & noted difficulty reading next AM w/HA. Then
developed blurry vision, decreased vision & pain over 3 days. Exam revealed visual
acuity hand motion in right eye & 4/200 left eye, IOP WNL, no ptosis, slit lamp
WNL, fundus w/1(+) edema of right optic nerve & trace edema left optic nerve.
Admitted for stat MRI & IV steroids. No improvement & D/C to home on continued
tapering steroids. 7/4/08 Reviewed hospital medical records of 11/30-12/02/2007
which were previously included in clinic records. FINAL DX: bilateral optic
neuritis" "unknown LABS: MRI of orbits revealed bilateral optic nerve
enhancement (prechiasmal). Sed rate, CRP, ANA & CBC WNL."
"312063-1" "312063-1" "Information has been received regarding a case in
litigation concerning a patient who was vaccinated with a dose of Recombivax HB
(manufacturer unknown), DTaP, poliovirus vaccine, PedvaxHIB (manufacturer unknown).
Subsequently, the patient experienced alleged injuries and died. The cause of death
was unknown. No additional information is available." "Unknown"
"313132-1" "313132-1" ""This case was received from a consumer in the
United Stated on 13 May 2008. A consumer reported that his 92-year-old mother
received an injection of Influenza Vaccine (manufacturer and lot number not
reported) on 29 November 2007. At the time of vaccination, the subject had high
blood pressure. Two days after vaccination, on 01 December 2007, the patient began
experiencing dizziness, nausea, and vomiting. She was diagnosed with pneumonia, and
admitted to the hospital for 14 days. She later developed shingles on her forehead.
She died on 12 January 2008; cause of death on the death certificate was ""heart
attack"" according to the patient's son. No autopsy was performed. 6/16/08-records
received for 12/03/07-presented obtunded and unresponsive. Felt weak and limp,
gurgling and wheezing, falling towards left side. Appeared to improved but had
sudden listless and fever, delirious and gurgling. ED assessment:CHF exacerbation.
Assessment viral versus bacterial community acquired pneumonia. 7/18/08-records
received for DOS 12/4-12/7/07-DC DX: Community-acquired pneumonia. Pulmonary edema.
Presented to ED less responsive than baseline. PE:rales. 9/24/08-records
receivedOD-cardiac arrest. Probable myocardial infarction. Possible aspiration.""
"6/18/08-records received-Sodium 130, BNP 2460. Troponin 0.04. CXR no acute
finidng. Echocardiogram normal. blood culture negative."
"314113-1" "314113-1" "Patient had immunizations on 5-19-08 and was found
in bed on back today. 7/18/2008 Autopsy report received with COD: Sudden
Unexplained Infant Death. Report states infant had some chest congestion x 2 days
for which no medication used for tx. Infant had been acting normally with no other
recent c/o. Infant had fed at 1 am and at 4 am parent noted infant was not
breathing." "No lab data for this event."
"314292-1" "314292-1" ""Information regarding PREVNAR was received from a
physician regarding a female patient who received the fourth dose on 05-May-2008 at
12 months of age and experienced neurogenic septic shock, neurogenic respiratory
failure, brain dead, pneumococcal bacteria in blood, vaccine failure and
pneumococcal meningitis at 13 months of age. On 11-May-2008, the patient was
admitted to the intensive care unit brain dead and in neurogenic respiratory
failure. Laboratory results revealed pneumococcal bacteria in blood and a large
amount of pneumococcal bacteria that grew in less than eight hours in CSF culture,
which led to the additional diagnosis of pneumococcal meningitis. Serotype testing
was not performed. An antimicrobial susceptibility test was unremarkable. The
physician felt ""like this is a vaccine failure"". The patient also developed
neurogenic septic shock. Treatment included ROCEPHIN and VANCOMYCIN. On 12-May-
2008, the patient died. The cause of death were reported as meningitis
pneumococcal, respiratory failure, septic shock, vaccination failure, brain death
and pneumococcal sepsis. No additional information was available at the time of
this report. 6/3/08-records received for DOS 5/11-5/13/08-Date of Death 5/13/08.
Final DX: Meningitis secondary to Streptococcus pneumoniae. Gram-positive coccal
bacteremia. Admission neurologic examination consistent with brain death,
subsequently confirmed. Brain death confirmed by repeat examination and
confirmatory tests through course of hospitalization. Admitted via emergency room
previously well child until 3/10/08, warm to touch temperature 101, listless and
febrile with temperature as high as 104.4. Vomited. Became limp, feet cold, apneic.
CPR initiated at home. Cyanotic. Pupils dilated and nonreactive. GCS 3. Heart rate
170 but not palpable pulses. No spontaneous respirations. Intubation, mechanical
ventilation."" "Antimicrobial susceptibility test (results: unremarkable) was
done in May-2008. On 11-May-2008 test results were: culture urine (results:
pneumococcal bacteria); CSF culture (results: grew large amount of pneumococcal
bacteria in less than eight hours); and blood culture (results: pneumococcal
bacteria). 6/3/08-records received-NM brain-no scintigraphic evidence of
intracranial flow. CSF milky appearance. Gram stain many gram-positive
coccobacilli. Protein 1020. WBC 73 and RBC 103. C-reactive protein 13.9.
Hypothermic, hypocalcemia, hypokalemia and hyperglycemia. Metabolic acidosis. EEG:
compatible with electrocerebral silence, no evidence of cortical activity. Blood
culture positive for gram positive cocci."
"314404-1" "314404-1" "DIAGNOSED WITH CIDP/GUILLIAN BARRE SYNDROME IN MAY
2003 HE RECEIVED THE MENINGITS VACCINE IN NOVEMBER 2002. Confirmed with parent and
vax record concurs Flu vaccine given 12/8/2003, not meningococcal. Onset of sx
January 2004, not 2003 as originally reported. 7/14/2008 Death Cert received with
Immediate COD listed as Chronic Inflammatory Demyelinating Polyneuropathy.
06/03/2008 MR received for DOS 1/23-28/2008 with D/C DX: Neuropathy. 2' DX:
Tachycardia. Respiratory Distress. Pt most recently presented to another facility
in December 2007 with GI issues and increasing lower extremity weakness. Pt was
discharged and was transferred for further evaluation due to progressive upper
extremity weakness and dyspnea, as well as new onset urinary and fecal
incontinence, orthostasis, decreased hearing and L hand pain. Pt had initially
developed limb weakness and paresthesias 4 years ago. Testing showed widespread
sensory motor polyneuropathy. DX: Presumed Chronic Inflammatory Demyelinating
Polyneuropathy. Course has been slowly progressing over the years and has had
multiple hospitalizations and rehabs. PE (+) for tachycardia, use of accessory
muscles for breathing, tachypnea and decreased breath sounds. Bowel sounds
decreased. Motor exam showed decreased bulk, tone and strength. Sensation decreased
with no proprioception below the elbow. Pt txd with plasmapheresis IVIG over the
years without response. Pt now with autonomic dysfunction. BIPAP improved overall
energy level. Pt unable to return to rehab facility given questionable prognosis so
pt was D/C to home. Per mother pt died at home on 2/17/2008. PMH since 2003: (CIDP
dx 2004 with depression, anxiety, osteoporosis. Sural nerve bx, OSA on CPAP,
Recent Gastroenteritis.)" "Labs and Diagnostics: EMG/NCS 1/24/08 showed
widespread sensory motor neuropathy significantly worsened since 2004. Swallow
study shows mild/moderate aspiration risk. Genetic testing showed several sequence
variations of unknown significance. CSF culture (-). CSF glucose 61. CSF protein
47. CSF lactic Acid 1.5. (N). CSF Pyruvic Acid 0.18 (N). ESR 22. Thymidine
phosphorylase activity normal."
"315005-1" "315005-1" "Subject in pneumococcal vaccine trial, with severe
COPD died of respiratory arrest on the way to the hospital. According to the
physician, relationship to treatment is 'None'. We would be happy to forward the
Study's SAE Report Form upon request." "No lab data for this event."
"316231-1" "316231-1" "Ex 29-week premature infant presented for routinue
post NICU follow-up on 6/5/08 for 2mo. Relatively nml Pexam (hx of RDS,Apnea, R/o
spesis, anemia, hyperbilirubinemia, cholestatic jaundice, murmur, bilat inguinal
hernia) Of note only jaundice and murmur were present at time of discharge.
Patient recieved 4 vaccines on 6/5/08. Patient presented with URI symptoms on
6/9/08 diagnoses with URI and sent home. The baby reportedly had a cardiac arrest
later that evening and did not survive. ****please note submission of similar
patient of similar event with ALTE diagnosis and hospitalization (survived).
6/27/08 Link w/317530 per direction of FDA. 9/24/08 ER record received for DOD
6/10/08. DX: Sudden Death. CPR unsuccessful. Infant last seen alive at 1800.
EMS on scene at 22:35. Pt found cold, stiff and puple in color. CPR attempted but
unsuccessful. Pt in rigor upon arrival in ED and prounounced. PMH: 28 wk premie. In
NICU from DOB 3/29/08 until 4/29/08 with DX: Respiratory Distress syndrome. Apnea
of Prematurity. R/O Sepsis x3. R/O NEC. Jaundice. Nutritional support. R/O IVH
and PVL. Temperature Support. Infant on CPAP and NC O2. Had apnea, bradycardia and
O2 desats. 3 episodes of sepsis w/u. Had physiologic jaundice requiring
phototherapy. On parenteral feeds with intermittant enteral feeds. D/C on O2 and
monitoring./pc 9/29/08 ME's report received. Probable COD Acute Bronchopneumonia.
DX: Acute bronchopnemonia, moderate. Cholestasis. Microscopic exam of the lungs
reveals moderate acute bronchopneumonia present w/in the major and minor bronchi
and alveolar spaces. Focal atelectasis. Liver shows diffuse cholestasis with bile
plugs present. Slight chronic inflammation. Severe autolysis. 10/30/08 PCP
records received which include d/c summary for 2+month NICU stay with D/C 6/4/08.
Seen in f/u 6/5/08-cholestatic jaundice, anemia, ROP and scrotal masses
(hydroceles) noted. Otherwise normal premie exam. Vax given. Seen again 6/9/08 for
cough and congestion with Impression URI. RR 60. P ox 95%. Wet cough, wheeze and
rhonchi noted (clear A/P/L). Nasal saline and suction as sympromatic care. To f/u
in 1-2 days or to ER PRN." "Labs and Diagnostics: CBC 6/9/08 WBC 5.6. Lymphs
75.3% Hgb 8.9, Hct 27.4"
"316983-1" "316983-1" "Death 9/9/08 Death certificate states COD as
idiopathic seizure disorder. 8/5/08 Reviewed ER medical records of 6/12/2008.
Records reveal patient found unresponsive, prone on her bed when parent went to
awake for school. Last seen at bedtime. Pupils fixed & dilated, cyanotic & pale,
incontinent of urine, developed pulmonary edema during resuscitation. Unable to
resuscitate." "No lab data for this event."
"317407-1" "317407-1" "See box 19 for information. Baby alive at 5:30 AM &
died approx. 6:00 AM. 7/7/08-autopsy report received-COD:Sudden Unexplained Infant
Death. Complications of Prematurity." "No lab data for this event."
"317757-1" "317757-1" "Death -coroner says enlarged heart & enlarge spleen
7/4/08 Reviewed PCP medical records of 1999-6/2008 which included vax record. In
8/2007, c/o of tiredness & loss of appetite. Monospot (-). On day of vax, patient
was well, weight noted as 237, otherwise no complaints. 7/8/08 Autopsy report
states COD as arrhythmia due to cardiomyopathy.States anatomic findings of obesity,
pulmonary edema, mild & left ventricular hypertrophy w/myocardial nuclear
enlargement. Patient had been found non-responsive by family. EMS found patient
cyanotic w/rigor & no further resuscitation was performed. Family reported patient
had been well earlier in the evening. Albuterol inhaler was found at scene but no
suspicious features at scene." "toxicology and other test came back negative
expect trace amount of nicotine (father heavy smoker)"
"317877-1" "317877-1" "Father called 6/25 to cancel appts for August/08 and
states baby died of SIDS. 8/29/09 Autopsy report also states: apparently found
unresponsive at home in car seat which had been placed in crib;no evidence of acute
traumatic injury; post mortem studies all negative. 8/29 Autopsy states COD: no
anatomic cause./" "Dwarfism, Premature at 37 wks"
"318491-1" "318491-1" ""Information has been received from a physician who
was told by a patient's mother that a female patient with a sulfa allergy who on an
unspecified date was vaccinated with a first dose of GARDASIL (lot number,
injection site and route not reported), which was well tolerated. On an unspecified
date, the patient was vaccinated with a second dose of GARDASIL (lot number,
injection site and route not reported). Subsequently the patient died. The cause of
death was reported as allergic reaction to GARDASIL. The physician stated that the
patient who died was not her patient and she knew no further details. Follow-up
information was received from the physician who reported that a other of one of her
patients had said to her, that she ""thought"" she read this report on the
internet. The physician asked the patient's mother to find out where she read the
report. The patient's mother could not find the report and did not know where to
locate the source information. Additional information has been requested.""
"Unknown"
 "318702-1" "318702-1" "Information has been received from an office worker
concerning a 4 month old patient who was vaccinated with oral ROTATEQ (lot #
660548/0501X), (therapy date and dose not reported). The baby died the same day
ROTATEQ was given to the patient. Per office worker, they had a memo in their
office not to give any further vaccines to patients because one 4 month old baby
died after receiving ROTATEQ. The office is currently waiting for the autopsy
report before they can resume giving vaccines in their office. Per office worker,
the patient is not a patient in their office. The Director of Pharmacy from the
pharmacy who dispensed ROTATEQ provided the name of the patient's physician and lot
# 0501X. Additional information was received from a pharmacist, indicating that
this patient also received second dose of ACTHIB, PREVNAR and PEDIARIX on the same
day that a second dose of ROTATEQ was given. It was reported that the patient
sought unspecified medical attention, physician. The event was considered life
threatening and disabling. A lot check has been requested. Additional information
has been requested." "autopsy, results not yet available"
"318749-1" "318749-1" "This male subject was enrolled in the prophylactic
open study 110870 (MenACWY-TT-057). On 4 April 2008, he received the 1st dose of
HIB-MENCY-TT (IM L thigh) and of PEDIARIX (IM R thigh). The subject received
concomitantly PREVNAR (IM) and ROTATEQ vaccines (po). Medical conditions at the
time of the event included apnea and seizure. Concomitant medications included
PREVACID and KEPPRA. On 02 July 2008, 89 days after the 1st dose of PEDIARIX, 89
days after the 1st dose of HIB-MENCY-TT, this five-month-old subject died. The
event was disabling, life-threatening, clinically significant (or requiring
intervention). The subject died on 02 July 2008, cause of death is unknown. An
autopsy was performed. The investigator considered that there was a reasonable
possibility that the death nos may have been caused by PEDIARIX and HIB-MENCY-TT.
Investigator Comments: Site was Notified of report of death on 07-03-2008, records
have been requested. All data pending. 07-07-2008. After PI review, cannot
completely rule out vaccine related causality, but not probable. Subject on
anticonvulsants and has underwent metabolic/neurologic work-up with no significant
findings. Possibility of Munchausen by Proxy, but waiting on pending results of
physician and ER notes, apnea monitor results and autopsy and toxicology report.
8/22/08 Autopsy states COD as sudden unexpected infant death. Report also states
Anatomical diagnosis: same as COD & aspiration of vomitus, terminal/subterminal
focal bilateral. Comments: infant had complicated history of seizures, aspiration
& apnea which could not be substantiated during multiple hospitalizations & ER
visits & Munchausen by proxy was questioned. Autopsy showed only relatively mild
terminal aspiration of vomitus. 8/5/08 Reviewed ER medical records of 7/2/2008
submitted by FDA from manufacturer. Records reveal patient well known w/history of
recurrent episodes of life-threatening events of possible apnea vs seizure over the
prior 2 months w/cyanosis, choking & gagging. Was on apnea/bradycardia monitor at
home. Found by parent vomiting & poorly responsive. Started CPR & ACLS by EMS.
Arrived in ER in full arrest & unable to resuscitate." "UNK"
"319501-1" "319501-1" "Reported to office patient deceased. 9/22/08-autopsy
report received-COD sudden unexpected infant death associated with inappropriate
sleeping environment. Found dead while sleeping on an adult mattress on floor with
pillows and blankets. Anatomical diagnosis:Thymic petechiae. Pulmonary edema.
Cerebral edema. Medical intervention. Facial abrasions, mild and tongue contusion."
"No lab data for this event."
"319533-1" "319533-1" "Pt received her 3rd and final dose of HPV vaccine on
6/3/08. Per mother patient was found dead, in bed on 6/22/08, in her dorm room at
an out-of-state college. According to the autopsy the patient had been dead for
about 48 hours. According to mother autopsy was negative except for splenic
inflammation. 8/22/08 Autopsy report also states Final Diagnoses: Cardiac arrest,
cause undetermined w/recent history of PAC w/otherwise normal EKG; normal
echocardiogram 2/08; no evidence of myocarditis; acute pulmonary edema; slight
splenomegaly; cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver
(+) for acetaldehyde (incidental finding). 3/5/09-records received for DOS 8/22/07-
seen for routine visit and first annual pap test..PE normal. First HPV vaccine
administered. 2/4/09-records received for DOS 11/20/07-C/O chronic PAC and
irregular heart beat." "None - apparently healthy young woman 8/22/08-records
received-cardiac blood neg for ethanol; urine (+) for ethanol=16 mg/dl; liver (+)
for acetaldehyde (incidental finding). 3/5/09-records received-pap smear normal.
2/4/09-records received-CBC WNL, chemistry WNL. 2/12/08 ECG abnormal mild tricuspid
regurgitation, 2D Doppler frequent premature ventricular contractions. 4/30/09-
records received-lung specimen showed diffuse edema and intraalveolar hemorrhages.
Staphylococcus aureus negative."
"319809-1" "319809-1" "Information has been received from a medical
assistant concerning a 22 year old female with no known medical history and no
known allergies who was vaccinated with GARDASIL. Subsequently the patient
experienced an unexplainable death. The mother of the patient found her daughter
unresponsive and dead in her bed. It was noted that this death was reported to
VAERS and the death was not caused by GARDASIL. It is unknown if medical attention
was sought. The medical assistant considered the death to be disabling and life-
threatening. No further information is available." "Unknown"
"319810-1" "319810-1" ""Information has been received from a certified
medical assistant concerning a 14 year old female who was vaccinated with a first
dose of GARDASIL and experienced syncope. She was taken to an emergency room and
released. The patient was vaccinated with a second dose of GARDASIL (unspecified
time). Subsequently, the patient experienced her first seizure (unspecified time)
and was taken to the emergency room (no further details provided). The patient was
vaccinated with a third dose of GARDASIL at 15 years old. Approximately 27-JUN-
2008, two weeks after the third dose, the patient developed a complication. She
was taken to the hospital by ambulance but passed away during the transport from an
unknown cause. The physician has asked the mother for the autopsy report. The
reporting medical assistant considered the syncope, seizure and ""a complication""
were considered to be immediately life-threatening and disabling. Additional
information has been requested. 2/13/09 Autopsy report received. COD: Seizure
Disorder. Summary Diagnoses: Clinical history of seizure disorder. Pulmonary
congestion and edema. Passive visceral congestion. 2/20/2009 ER received from
CDC. Pt presented to ER via EMS following witnessed seizure activity with fall from
standing. Upon EMS arrival pt had agonal respirations and was pulseless in V-fib at
650. Upon arrival in ER unresponsive, pupils fixed and dilated, no cardiac
activity. Resuscitation unsuccessful and pt expired."" "Unknown. Labs and
Diagnostics: Tox screen (-)."
"320129-1" "320129-1" "This case was reported by a healthcare professional
and described the occurrence of enlarged liver in a female subject (the aunt of the
reporter) aged between 50 and 59 years old who was vaccinated with HEPATITIS B,
manufacturer unspecified. Concurrent medications included Thyroid replacement. In
2004 the subject received unspecified dose of HEPATITIS B (unknown). At an
unspecified time after vaccination with HEPATITIS B, the subject complained that
she was not feeling well or not feeling right (unspecified). She was awakening
with horrible dreams and she was distressed. It was observed that the subject was
confused. She was in the bathroom saying things that made no sense and stumbling.
This was considered to be a systemic reaction. A friend took her to the doctor and
the doctor sent her to the hospital. The hospital did a work-up. The subject
failed the neuro exams and she was hospitalized. The events were also considered
to be life threatening and clinically significant (or requiring intervention). The
subject died in the hospital an unknown amount of time later. Initially in the
hospital, the subject was thought to have Lyme disease or an inflammatory reaction,
possibly an allergic reaction. An autopsy revealed an enlarged liver and brain
swelling. Specific events of not feeling well or not feeling right, awakened with
horrible nightmares and distress were said to have resolved and were considered
probably related to vaccination with HEPATITIS B. This case, A0738694A, is linked
to two other cases from the same reporter. The master case is A0738675A. The
other linked case is A0738681A. Cases A0738675A and A0738681A are sibling cases."
"The subject failed unspecified neuro exams."
"320329-1" "320329-1" "Pt found 5-15-08 @ 2110 by mother unresponsive, not
breathing. He had been fed 4 oz and given TYLENOL for temp at 2040 hrs, then put in
his crib, on abdomen with face turned to side, at 2100 she rushed him to ER at
local hospital where CPR was performed and pt transferred via helicopter to another
hospital. Pt on life support until 5-18-08 when it was stopped and he expired.
8/1/08-records received for DOS 5/16/08-5/18/08-presented in cardiopulmonary
arrest, resuscitative efforts included CPR, intubation, mechanical ventilation.
Hypothermic on presentation with rectal temperature of 91.6, hypoglycemia with
blood sugar 16, metabolic acidosis. Prior to event C/O fussy all day running low
grade fever, placed in crib on abdomen, found white, lump with face buried in
cover. Drove child to hospital. PE: agonal respirations not compatible with life.
Pupils nonreactive to light, fixed. No spontaneous movement of extremities. Deep
tendon reflexes absent. 8/11/08-records received-Findings:Myocarditis.
Inflammation and necrosis, myocardium. Interstitial edema, epiglottis.
Tracheobronchitis, chronic. The inflammatory lesions observed in heart are
consistent with either acute viral infection or post-viral syndrome." "Autopsy
reports myocarditis as cause of death 8/6/08-records received-EEG:abnormal organic
encephalopathy. CT brain-question of diffuse cerebral edema."
"320407-1" "320407-1" "Patient presented to the ED on 7/16/08 with seizure
activity that was difficult to contol after starting to have seizures at home. She
was finally stabilized then transferred to the PICU at hospital. After being here
she had again started to have uncontrolled seizures. She was started on multiple
seizure medications (Phenobarbital, Fosphenytoin, Pyridoxine) but still not
controlled so placed into a Pentobarbital coma. This was initially weaned with a
recurrence of seizures, so placed back into a Pentobarbital coma and Keppra was
added. This was again weaned with the recurrence of seizures. Parents then decided
that with the amount of brain damage noted on imaging that they would like to
withdraw support. The patient then passed a few hours after support was withdrawn.
7/29/08-pending. no significant trauma, no gross natural disease, brain and spinal
cord retained for neuropathology exam. 8/11/08-records received for DOS 7/16-
7/23/08-presented to ED after seizure, had low grade fever since Monday of last
week 2 days after immunizations. Intubation. Bulging pulsating fontanelle,
DX:seizure activity with cerebral edema." "Final MRI results: marked abnormal loss
of gray-white differentiation and edema in the frontal and parietaloccipital areas
8/11/08-records received- MRI brain acute anoxic ischememic injury within the
bilateral basal ganglia and bilateral occipital lobes, suggests two separate
etiologies one would be diffuse hypoxia and the other posterior circulation
infarcts from low/slow flow in left vertebral artery. Mild degree of brachycephaly.
Marked loss of gray white differentiation with edema involving the frontal and
parietoccipital regions."
"320559-1" "320559-1" "Initial and follow up information has been received
from a physician, who was told by one of his patients, that the mother of a
consumer was told by a neurologist that there were 4,400 kids who have died
following vaccination with GARDASIL. No product quality complaint was involved.
Attempts are being made to verify the existence of patients. Additional information
has been requested." "Unknown"
"320862-1" "320862-1" ""Brother states patient developed ""Transverse
myelitis"" from the MMR vaccine then the patient ""Fell down and died"". Developed
paralysis in legs one week after shot. 8/11/08-records received for DOS 12/12/07-
1/6/08- DX: Paraparesis secondary to transverse myelitis. Death secondary to
pulmonary embolism. Admitted for evaluation of lower extremity weakness for 2-3
weeks, with shooting pain in feet on 12/14/07-balance difficulties noted, tingling
in left upper extremity prior to hospitalization Upgoing plantar reflex noted on
right side, lower extremity reflex loss at ankles and left patella. Autopsy
refused by family."" "Lung cancer 2 years with chemotherapy 8/11/08-records
received- NCV abnormal evidence of primary muscle disorder. Glucose elevated, AST
and ALT elevation of 144 and 177. MRI normal. CSF leukocytosis. Culture negative.
on 1/6/08 began hypotensive with oxygen saturation 82%."
"320885-1" "320885-1" "Pt deceased on 07/26/08. Currently case remains open
at Medical Examiners office. Pt had no positive signs of illness at time of exam,
normal PE. 10/20/2008 Autopsy received. COD Sudden Infant Death Syndrome. Infant
found by parent cold and unresponsive. Resuscitation efforts were unsuccessful. No
significant anatomic, circumstantial or toxicologic findings on Autopsy." "Check
with Medical Examiner. Labs and Diagnostics: CBC with increased WBCs. Blood
glucose and K+ were high upon arrival in ED"
"320909-1" "320909-1" ""Information has been received from a physician
concerning a 22 year old female who on an unspecified date was vaccinated with her
third dose of GARDASIL. Subsequently the patient experienced soreness at the
injection site and fatigue. The outcome of soreness at the injection site and
fatigue was not reported. Two months after receiving her third dose of GARDASIL,
the patient died. The cause of death was ""viral insult to the heart"". Unspecified
medical attention was sought. Follow-up information was received via telephone call
from the physician. The patient was a family member. She did not have the
vaccination dates or lot numbers since she did not give them. The physician
reported that the patient's mother thought that the patient died related to
GARDASIL. She did not have the cause of death. The physician refused to provide
patient information, information was gave to the coroner. The physician considered
""viral insult to the heart"" to be immediately life-threatening and disabling.
Additional information has been requested."" "Unknown"
"320910-1" "320910-1" "Information has been received from a physician
concerning his patient's daughter who on an unspecified date was vaccinated with a
dose of GARDASIL. The patient's mother told to the physician that her daughter died
in her dorm room 4 days after receiving the dose. The physician did not have much
information because he did not administer the vaccine and the patient's daughter
was not his patient. The reporter did not know the name of the physician who
administered the vaccine. The physician considered the event to be life
threatening. Additional information has been requested." "Unknown"
"321696-1" "321696-1" "To Whom It May Concern: My daughter went to our
nurse practitioner at Health Care Center on March 31, 2008 for a sore throat. She
complained of her throat for about two days prior. Pt would get pharyngitis and
strep about twice a year since she was 13. She received a shot of ROCEPHIN in the
office on March 31st as well she was given a prescription for ZITHROMAX (Z-PAK) at
the same time. I'm not sure exactly what time her appointment was it was around
11:00 am. that day. She dropped off her prescription at the pharmacy and I picked
up on my way home. She took her first dose of ZITHROMAX on the 31st. She stayed
home from school the next two days. She slept late both days which is not abnormal
for her. In the evenings we played rummy, she was congested and coughing a little.
She complained of a headache the next night and I gave her some ibuprofen. On
Wednesday April 3rd she went to school, (school gets out at 3:05 p.m.) after school
she went to tract practice. Her tract practice was a short one, I know she ran but
I'm not sure how much. She stopped at a convenience store on the way home from
school and got a Red Bull. She went home and changed clothes for work. She called
me between 4:30 and 5:00 p.m. on her way to work to tell me about the road being
blocked due to rain where we live. She parked her car and was walking the short
distance into where she works she collapsed and started seizing. A lady in the
drive through told the owner that she had fallen and he went out immediately. He
said she was shaking, the employees inside called 911 and then me. The owner told
me she stopped shaking and took a few strained breaths and then went limp. The
police officer arrive within three minutes, he was a first responder. He did not
check for a pulse or attempt CPR (I am in the process of getting a police report as
well). Just as I got there an off duty paramedic arrived and started CPR. It took
quite awhile before the ambulance arrived; she had been down too long. I later
learned that they did not get her heart started until just before the ambulance
arrived at the hospital. Pt officially died on April 7th, the decision was made on
April 6th that she become an organ donor. My daughter was a very healthy, vibrant,
and beautiful person! Any other information you need I will do my best to provide.
I STILL have not received the autopsy report. I did talk to them Friday and they
said it would be within the next two weeks. Sincerely, pt's mother 9/19/08 Autopsy
report states COD as apparent cardiac rhythm disturbance of undetermined etiology.
Report states pathologic findings of: hx of sudden fall & cardiac arrest; subgaleal
hemorrhage, fontoparietal scalp; tongue abrasions c/w tooth marks; hx of recent
illness; agonal seizures; bilateral cerebral edema; catecholamine induced
myotoxicity; bilatreral lobar pneumonia; organ & tissue harvesting." "lab work,
Cat scans, X-rays"
"322250-1" "322250-1" "Information has been received from a registered
nurse (R.N.) concerning a 22 year old female (a relative of another employee) who
was vaccinated with a third dose of GARDASIL. Subsequently the patient died. The
cause of death was unknown. Additional information has been requested."
"Unknown"
"323037-1" "323037-1" "Child developed mutism, deafness, developmental
delay and diluted cardiomyopathy possibly following vaccination several years
before death. 10/3/08 Autopsy states COD as idiopathic dilated cardiomyopathy &
contributing condition of chronic sequelae of encephalomyelitis. 9/26/08 Reviewed
hospital medical records of 11/20-12/05/2008. FINAL DX: dilated cardiomyopathy,
pulmonary edema, cardiac arrest. Records reveal patient experienced cough, DOE,
weakness, extreme fatigue, excessive sleeping, rhinorrhea, sore throat & 1 day of
diarrhea x 1 week w/newly dx cardiomegaly on CXR at outlying hospital. Weight loss
over 1 month noted by family. Exam showed holosystolic heart murmur. Felt to have
had dilated cardiomyopathy worsened by or caused by myocarditis. Tx w/IVIG
empiracally for viral myocarditis. During intubation attempt in cardiac cath lab,
had cardiac arrest & expired despite attempted resuscitation." "Autopsy: Coroners
case no. 2007-08810 Hospital LABS: ESR 95 (H), Hep A (+), blood culture (-). ANA
(-). Urine c/s (+). Echocardiogram abnormal w/ejection fraction 35%, severe
mitral regurgitation & tricuspid regurgitation, dilated cardiomyopathy. EKG
w/conduction abnormalities."
"323493-1" "323493-1" ""Subject in pneumococcal vaccine trial, with severe
COPD, died on 7/10/2008 in home due to myocardial infarction and high cholesterol.
Vaccination took place on 4/9/07. According to the physician, the relationship to
treatment is 'None"". We would be happy to forward the Study's SAE Report Form upon
request."" "No lab data for this event."
"323974-1" "323974-1" "8/7/08 received phone call from patient's mother
that he had stopped breathing. She called EMS and he was taken to hospital and he
was pronounced dead." "No lab data for this event."
"324830-1" "324830-1" "April 2008, started experiencing symptoms of muscle
weakness in arms and neck, they progressed to her throat and breathing muscles.
She died 08-21-08." "No lab data for this event."
"324934-1" "324934-1" "Information regarding PREVNAR was received from a
pediatrician regarding a 15-week-old male patient who experienced Pneumococcal
meningitis. At 15 weeks of age, the patient received the first dose on 15-Jul-2008.
He also received the first doses of HIB (manufacturer unknown), Poliomyelitis
Vaccine Inactivated (manufacturer unknown), DTaP and ROTATEQ (Merck & Co Inc) on
15-Jul-2008. Relevant medical history was not provided. Concomitant therapy
included Hepatitis B Vaccine, HIB, ROTATEQ, DTaP and Poliomyelitis Vaccine
Inactivated. On 25-Aug-2008, the patient presented with nystagmus, irritability and
fever. He was hospitalized and diagnostic tests were performed (see test results),
however serotyping was not performed. The blood culture and cerebral spinal fluid
culture were positive for Pneumococcus. The patient was diagnosed as having
Pneumococcal meningitis drug ineffective on 25-Aug-2008. Treatments were not
reported. The patient died on 28-Aug-2008. The physician considered PREVNAR to be
ineffective in preventing Pneumococcal meningitis, but stated that she realized
that only receiving one dose in the series did not confer immunity to the disease.
No further information was available at the time of this report. The cause of death
was reported as meningitis Pneumococcal. On 25-Aug-2008 test results were: blood
culture (results: positive for Pneumococcus); body temperature (results: fever);
CSF culture (results: positive for Pneumococcus). 9/16/08-office notes received-
8/12/08-well visit normal exam. C/O fussy and will not take bottle. Daycare
provider was ill day prior to office visit. 8/25/08-fever and seizure. 9/25/08-
records received-urgent care center visit 8/12/08-C/O irritability and vomiting
without fever. Sent to ED. Presented to ED with vomiting and screaming. Large
projectile emesis times 3, decreased oral intake. Admitted overnight. Returned to
ED on 8/25/08-fever began day prior of 103.3. In ED pulse oximeter decreased to mid
80's. Transferred to another facility. 10/16/08-records received for DOS 8/25-
8/28/08-Expired 8/28/08 06:35. Fever, eyes deviating from neutral position. Right
pupil dilated, right side of face droopy. Symptoms began on 8/24/08 with
temperature of 100.6. Respiratory difficulty and perioral cyanosis. Irritable,
agitated. 11/06/08-records received-Cause of death:meningitis due to pneumoccal
meningitis." "Blood culture, 08/25/2008, positive for Pneumococcus; Body
temperature, 08/25/2008, fever; CSF culture, 08/25/2008, positive for Pneumococcus;
Reported cause of death, Meningitis pneumococcal, pneumococcal meningitis. 9/25/08-
records received-Urine turbid with RBC present. Blood culture positive
streptococcus pneumoniae. Urine culture no growth. Abdominal x-ray mildly abnormal
nonspecific bowel gas pattern. Lymph percentage increased 51.8. 10/16/08-records
received-CSF cloudy 150 red blood cells, 99 white blood cells, 91% neutrophils,
protein 257.9, CSF gram positive cocci in pairs. WBC 3.1, platelets 700,000,
fibrinogen 950, potassium 6.9, CT normal. MRI brain abnormal consistent with
leptomeningeal infiltration and meningitis secondary complications of compromise of
vasculature. EEG abnormal, seizure activity."
"325063-1" "325063-1" "Information has been received from a physician
concerning a 17 year old female with acne who on 24-JUL-2008 was vaccinated with
the first dose of GARDASIL. Concomitant therapy included erythromycin, solution,
topical. On 04-AUG-2008, the patient experienced abdominal pain, chest pain and
aching everywhere and was hospitalized. On 05-AUG-2008, the patient experienced
myocarditis and died. Diagnosis was myocarditis but the doctor said it was not
related to GARDASIL. The last time she was seen in this office was 2005. No
additional information at this time. Additional information has been requested.
10/01/08 Death certificate states COD as myocarditis & CHF as contributing factor.
9/22/08 Reviewed PCP medical records. Reveals patient experienced abdominal pain,
chest pain & aching everywhere. Expired 8/5/08 w/viral infection of the heart.
Concomitant med was erythomycin topical solution for acne. Patient noted to be in
good health on day of vaccination. 4/2/09 Received hospital medical records for
8/3-8/4/2008. FINAL DX: deceased secondary to severe nonischemic cardiomyopathy
secondary to viral myocarditis Records reveal patient experienced fever, chills,
feeling unwell x 2-4 days. Presented to ER w/abdominal & chest pain, weakness,
dizziness, hypotensive, tachycardia, SOB, respiratory distress w/hypoxemia,
azotemia, shocklike symptoms. EKG w/diffuse ST changes & ST elevations. Dx
w/acute anteroseptal MI Emergent cardiac cath revealed EF 23% & balloon pump
placed. Intensive care, deteriorated, V-tach, decompensation, extensive
resuscitation efforts failed." "Unknown LABS: WBC 10.3(H). Troponin greater
than 100(H) & CPK 5492(H), CKMB 313.1(H) c/w infectious myocarditis, possibly
viral. TSH 0.09(L). CRP 38.3(H). BNP 533(H). ANA neg. ASO 200(+). CXR
abnormal w/water bottle appearing heart. Sodium 132(L), potassium 3.7(L), bicard
18(L), BUN 29(H), creatinine 1.3(H). AST 832(H), ALT 211(H). Urine drug screen
neg. Blood c/s neg. MRSA screen neg."
"325385-1" "325385-1" "No adverse effects at the time of injection. But
patient died of Sudden infant death syndrome at a later date 07/29/2008 9/22/08-
autopsy report received;COD-Asphyxia due to overlay due to co-sleeping with older
sibling and parents in same bed. Petechiae of eyes." "No lab data for this event."
"325648-1" "325648-1" "None. Pt sch for autopsy 1/12/09 Autopsy report
states COD as: dTGA s/p arterial switch 7/8/08; ventricular hypertrophy; extensive
pericardial adhesions; mineralized foreign body w/giant cell reaction; para aortic
nodule w/suture; trachea & distal mainstem bronchi discoloration w/frothy exudates.
Report also states patient had history of transposition of great vessels comlicated
by single intramural coronary arter. Autopsy revealed nodule located anterior to
ascending aorta & posterior to right pulmonary artery. Histology revealed
fragments of mineralized foreign body w/marked inflammatory response of
corresponding foreign body giant cell reaction of uncertain significance. 12/23/08
Reviewed hospital medical records of 7/2-7/21/3008. FINAL DX: transposition of
great vessels; maternal hx of herpes on Valtrex; PROM; arterial switch procedure
7/8/08; relative adrenal insufficiency resolved; suspected left clavicle fracture;
s/p delayed sternal closure; relative lymphopenia resolved." "No lab data for
this event."
"325794-1" "325794-1" ""This case was reported by a lawyer and described
the occurrence of rheumatological symptoms in a male subject of unspecified age who
was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care
professional has not verified this report. On an unspecified date the subject
received unspecified dose of LYMERIX (unknown). According to the statement of
injuries, at an unspecified time after vaccination with LYMERIX the subject
experienced ""joint pain, flu-like symptoms, fatigue, rashes, tingling in
extremities, headaches, memory loss, cognitive dysfunction, muscle pain, numbness,
imbalance, weight loss, and decreased activities of daily life"". The statement of
injuries also alleged that the subject experienced ""rheumatologic, neurologic,
and/or cognitive impairment of an autoimmune, immune-mediated, or other mechanism
all caused by vaccination with LYMERIX including but not limited to those set forth
above."" At the time of reporting the outcome of the events was unspecified. Follow
up information was received on 08 September 2008 via medical records. On an
unspecified date during or prior to 2004, the subject was diagnosed with dementia.
On 09 January 2004 and 09 February 2004, the subject reported increasing joint
problems/joint pain. On 30 March 2005, he reported decreased memory. In August
2006, the subject underwent ambulatory electroencephalogram monitoring due to
hypersomnolence, memory loss, agitation, joint pain and Lyme disease. The subject
was diagnosed with dementia on an unspecified date. On 10 January 2007, the
subject's wife contacted his health care provider to inform that the subject was
hospitalized and ""they stated he doesn't have Lyme"". In January 2007, the subject
was experiencing end-stage dementia and was going into a nursing home. On 22
January 2007, the subject's internist was consulted and it was noted that the
physician had been managing the subject's ""chronic Lyme disease"" and was
reportedly ""unaware of the wife's concern that this is demyelinating
polyneuropathy secondary to the Lyme vaccine"". The internist noted that the
subject had been ambulating a few months prior to the date of evaluation ""and that
this rapid deterioration could not be secondary to dementia alone"". A trial of
ROCEPHIN was recommended. He was admitted to a nursing home for end stage dementia.
On 01 February 2007 he was noted during a neurology examination of have a history
of Lyme disease ""with tick bite and bull's eye rash in the late 1990's. He was
reportedly ""given vaccine"" two years later and developed symptoms including
dizziness, ataxia, back pain, poor vision, stiff neck, and weight loss. He was
noted to have ""dementia with Lewy Bodies"", with gradual memory and cognitive
decline. The subject was hospitalized on 04 February 2007 due to progressive
lethargy, dehydration, and sepsis. He was obtunded upon admission and remained so
throughout admission. He was admitted to the intensive care unit due to hypoxemia,
aspiration risk, and ""feeling that he was heading toward worsening and respiratory
failure:"" Initially he was ""a full code as it was his wife's feeling that this
was all secondary to Lyme disease and not Lewy body dementia"". Treatment included
intravenous fluids and antibiotics without change, and he was moved to a medical
floor and the family made the decision to ""do not resuscitate"" (DNR). He
progressed in a downward fashion until he expired under comfort care measures on 15
February 2007. The specific cause of death was not provided. Diagnoses were 1) end
state Lewy body dementia, 2) chronic failure to thrive, 3) history of Lyme disease,
4) aspiration pneumonia, 5) dehydration, 6) protein malnutrition. 9/24/08-death
certificate received-COD-Sepsis. Lewy Body Dementia"" "Antinuclear antibody,
11Sep2003, negative; Diagnostic tests: 03 June 2003: Lyme IgG and IgM Western Blot
positive. B. microti IgM less than 1:20 titer. B. microti IgG 1:160 titer. Human
monocytic IgM and IgG both less than 1:40 titer. Human granulocytic IgM and IgG
both less than 1:40 titer. 11 September 2003: Epstein Barr virus (EBV) VCA IgM
negative, EBV early antigen Ab IgG positive (99, positive), EBV nuclear antigen Ab
IgG negative. Bartonella species panel by PCR negative; Mycoplasma general by
qualitative PCR positive. Lyme IgM Western Blot positive. Lyme IgG Western Blot
equivocal. B. microti IgM and IgG both less than 1:20 titer. Human monocytic IgM
and IgG both less than 1:40 titer. Human granulocytic IgM and IgG both less than
1:40 titer. 11 February 2004: Chest x-ray showed hypertrophic degenerative changes
present in the dorsal spine. 16 May 2004: Magnetic resonance imaging of brain
without contrast due to clinical history of dementia showed 1) no acute
intracranial abnormality, 2) cortical atrop"
"325998-1" "325998-1" ""44 y/o male with a history of Tobacco abuse and
Hypercholesterolemia, developed dyspnea and progressed to a cardiac arrest on the
morning of 5 Sept 08 towards the end of a several mile run and after performing a
wind sprint. Member unsuccessfully given CPR and ACLS (at the scene and EMS/ED) and
declared deceased at Emergency Department. Subject 2/5 cardiac risk factors:
tobacco use and hyperlipidemia; autopsy results support severe atherosclerotic
disease with final cardiac examination for myocarditis pending at this time. Member
was seen in ED on 25 Aug 2008 (per wife) for a reported ""allergic skin rash"".
Wife reported the SM had the rash as a result of the Smallpox vaccination he had
received earlier. Symptoms: Dyspnea (shortness of breath), Cardiac Arrest, Rash,
pruritic. 1/30/09-records received-sudden death while performing PT. Previously
lived in foreign country until 8/4/08. Received small pox vaccine on 7/31/08.
Presented to clinice on 8/25/08 with C/O pruritic skin rash, pimples on legs and
stomach and C/O itching, treated with Keflex, hydrocortisone cream and Benadryl. On
9/4/08 C/O feeling tired. During PT collapsed, difficulty breathing. No C/O chest
pain. Stopped breathing. 4/6/09-Medical examiner report received-Probable cause of
death:Ischemic heart disease. Contributing conditions:hypertension.
hypercholesterolemia."" "See summary"
"326811-1" "326811-1" "Information regarding PREVNAR was received from a
pediatrician regarding a 16-month-old female patient who experienced Invasive
Pneumococcal Disease - drug ineffective, pneumococcal bacteremia and sepsis. The
patient died. The patient received the fourth dose on 16-Apr-2008. No significant
medical history. Concomitant medications were not reported. The patient was seen at
the doctor's office on 17-Aug-2008. She was fussy and clingy and had a temperature.
The child returned to the office on 19-Aug-2008, at which time, she was afebrile
and tachypnic. The physician sent her to the ER for diagnostic tests (see test
results) and treatment. The child died in the ER. It was determined that the
patient experienced Invasive Pneumococcal Disease - drug ineffective on 17-Aug-
2008, pneumococcal bacteremia, and sepsis on 19-Aug-2008. The physician stated that
IPD was due to serotype 33F, which was not covered by PREVNAR. An autopsy was
performed, however results were not available. No additional information was
available at the time of this report. The cause of death was reported as sepsis and
pneumococcal infection and the autopsy cause of death was not reported. Body
temperature (results: fever) was done on 17-Aug-2008. On 19-Aug-2008 test results
were: body temperature (results: afebrile); chest x-ray (results: revealed
pneumonia); and blood culture (results: revealed S. pneumoniae; Serotype 33F).
10/17/08 Autopsy report states COD as acute lobar pneumonia complicating CHF
following viral myocarditis. 10/17/08 Reviewed autopsy report, death certificate &
extensive hospital & PCP medical records received for coroner. Records reveal
patient experienced fever & difficulty breathing x 2 days. Seen by PCP & sent for
admission. Tx w/IV antibiotics. Became tachypneic, tachycardic & intubated for
impending respiratory failure. Developed bradycardia. CPR & transcutaneous pacing
initiated. Transported to higher level of care for PICU. Upon arrival, had blood
in ETT & was acidotic & despite continued resuscitative efforts expired. FINDINGS
at Autopsy: severe viral myocarditis w/marked patchy myofibrillar nectosis; chronic
lymphocytic bronchitis; acute bilateral pan-lobar pneumonia; acute passive visceral
congestion; pleural & pericardial effusions; ascites; mild focal lymphocytic
meningeal infiltrates; early neuronal anoxic changes; acute splenitis." "Blood
culture, 08/19/2008, revealed S. pneumoniae; Serotype 33F; Body temperature,
08/17/2008, fever, 08/19/2008 afebrile; Chest X-ray, 08/19/2008, revealed
pneumonia; Autopsy results not reported; Reported cause of death, Sepsis,
Pneumococcal infection, Invasive Pneumococcal Disease; Sepsis"
"326958-1" "326958-1" "Infant found unresponsive at home on 9/26/08,
pronounced dead in ER. Patient had been seen on 9/25/08 in our practice, normal
exam, no issues other than mother Hep B (+). Received Hep B dose #2 on 9/25/08 at
our practice." "Newborn screen NYSDOH negative 9/4/08"
"327331-1" "327331-1" "Pt found unresponsive & not breathing after nap.
Resuscitated by EMS & in ER, never regained consciousness & later died in PICU at
hospital. Intracranial bleed on head CT. 10/9/2008 Forensic Autopsy Summary Sheet
received, COD pending further studies. Infant found unresponsive and transported
to ER & dx with subdural hematoma. Transferred to higher level of care. Despite
resuscitation efforts, infant pronounced dead. Autopsy findings of 2 small abraded
contusions to L side of head, subdural hematoma overlying the L temporal lobe.
Marked brain edema and pulmonary edema. Otherwise unremarkable" "Intracranial
bleed on head CT"
"328396-1" "328396-1" "Information has been received from a physician
concerning a patient younger than 6 months who was vaccinated with a dose of oral
ROTATEQ. There was no concomitant medication. Subsequently, the patient died
after receiving a dose of ROTATEQ. The cause of death has not been reported.
Unspecified medical attention was sought. No product quality complaint involved.
Additional information has been requested. 10/30/08-records received for DOS 10/2-
10/3/08-presented with fever 103 and lethargy, developed abdominal distention and
occult blood positive stool. Decreased urine output. Exploratory laparotomy,
drainage of peritoneal fluid, omentectomy, appendectomy. Intubation and
ventilation and resuscitation. Profound metabolic acidosis. Right pleural effusion.
Necrotic omentum. Acute renal failure. 12/1/08-provisional autopsy report received-
Provisional clinical diagnosis: suspected abdominal compartment syndrome. Emergency
laparotomy with appendectomy, omentectomy and placement of peritoneal drain.
Postoperatively developed severe thrombocytopenia and prolong APTT and INR.
Hypotensive secondary to suspected ventricular fibrillation. Resuscitation
unsuccessful. Pathologic examination of appendix revealed suppurative acute
appendicitis with focal transmural necrosis and extensive periappendicitis.
4/6/09-final autopsy report received. Clinical Diagnosis:fever and lethargy.
Abdominal distention and hem positive stool with currant jelly appearance. Acute
passive hepatic congestion. Congestive splenomegaly. Bilateral renal medullary
congestion. Hypotension due to suspected ventricular fibrillation. Postoperative
severe thrombocytopenia and abnormal coagulation profile. krk" "Unknown 10/30/08-
records received-Pathology report acute abdomen, abdominal compartment syndrome.
Omental tissue with foci of acute inflammation and fibrinous exudate. CAT scan no
evidence of intussusception."
"328577-1" "328577-1" "Patient was vaccinated on 10/13/2008 in the AM. He
ate lunch then went to Physical Therapy for rehabilitation following knee
replacement surgery. He died during his PT appointment. 5/5/09-death certificate
received-Final COD cardio pulmonary arrest." "No lab data for this event."
"329267-1" "329267-1" "We received the following information from the above
mentioned literature article on 06 OCT 2008: During the 2004-2007 influenza
seasons, influenza-associated pediatric deaths were analysed. Of 90 children who
were recommended for influenza vaccination, only 5 (6%) were fully vaccinated. 18
children were at least partially vaccinated more than or equal 14 days before
illness onset per season, respectively. One child who was partially vaccinated did
not have either an age related or ACIP defined high-risk condition recommended for
vaccination. The reason for death was not reported for individual cases. Influenza-
associated pediatric mortality and/or bacterial coinfection were suspected. The
author will be contacted for details. Children with high risk condition (asthma,
seizure disorder, neuro/vesicular disorder). One child without any risk conditions.
Causality not related. Causes of death for individual cases not identifiable,
complications of influenza and bacterial coinfections were mentioned. Expectedness
assessment according to product information: Partial vaccination is unexpected.
Vaccination failure is expected. Bacterial coinfections and influenza
complications are unexpected after vaccination with FLUVIRIN, BEGRIVAC, FLUAD and
AGRIPPAL. On a case level, the case is considered unexpected. No change in
benefit-risk-ratio. No measures necessary." "No lab data for this event."
 "330032-1" "330032-1" "Friday 10/10/2008: Patient was in good shape when I
took him to MD - for a review of his blood test results. He was advised to get a
flu shot. They were available in the lobby with a paper from the Dr. He got the
flu vaccines shot. Saturday 10/11/2008: He sounds as if he has a hard time
breathing. -7 P.M. - Saturday 10/11/2008: Patient goes to hospital via ambulance.
911. Sunday 10/12/2008: Patient called me to advise me that he is in the hospital.
Monday 10/13/2008: I visit patient in hospital and he is non-responsive and barely
alive. Monday 10/13/2008: Patient died from pneumonia. Prior to the flu vaccine
he was in good health. I believe the vaccine should not have been advised as it
killed him. 10/28/08 Death certificate states COD as respiratory failure
w/pneumonia & myelodysplasia as contributing causes. 10/28/08 Reviewed hospital
medical records of 10/12-10/13/2008. FINAL DX: CHF; A-fib w/RVR; acute respiratory
failure; acute exacerbation of COPD; acute exacerbation of chronic renal
insufficiency & failure; malnutrition. Records reveal patient experienced SOB,
bilateral leg edema, atrial fibrillation w/rapid ventricular response.
Cardioverted & admitted to ICU. Developed acute respiratory failure, agitation,
confusion worsened & placed on BiPAP. Tx w/IV antibiotics. Pt was DNR, no
intubation. 11/25/08 Reviewed PCP medical records Office record of 8/20/08
reveals pt disoriented s/p ER visit for visual disturbance, HA & temporal
arteritis. Had been started on steroids. RTC 9/19/08 s/p ER visit after fall w/o
sequelae. RTC 9/29 w/fatigue. RTC 10/10 stating felt better. No record of flu
shot, was given by unknown company in lobby of physician office building." "LABS:
ESR peak 137 down to 51 on 10/10. CT chest revealed ground glass opacification.
Echocardiogram revealed bicuspid aortic valve, mitral aortic insufficiency, LVH &
normal ejection fraction. ABG: pO2 62(L), pCO2 38, pH 7.35. ECG abnormal. WBC
8.8, H/H 8.7/26(L), plts 86K. Sodium 132(L), BUN/creatinine 30/2.2. Troponin
0.12."
"330148-1" "330148-1" "Patient received Fluzone on Monday 10.21.08, and
died on Tuesday pm on 10.22.08 12/18/08 Autopsy report states COD as sudden
unexplained infant death. Manner of death is undetermined. Report also states
patient getting over cold w/runny nose & cough, no fever, on day of vaccination.
Had been put to sleep on back & found on stomach in crib." "Per pathologist unsure
of cause of death at this time, lab work being done ? SIDs, also noted no erythemia
or swelling at injection site."
"330245-1" "330245-1" ""Information has been received from an investigator
during a study concerning a 71 year old male with hypothyroidism (since 2006),
hypertension (since 2006), chronic obstructive pulmonary disease (2001),
prediabetes (2007), ex-smoker and occasional drinker who did not use recreational
or street drugs, who on 31-JAN-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot #
652936/0981F) at routine healthcare visit, including blood pressure and routine
testing. Patient did not have concomitant vaccines. No complaints or concerns at
this visit. Vitals on exam were within normal limits and on general exam patient
was a well-developed, elderly, male, in no apparent distress, comfortable.
Concomitant therapy included atenolol 50mg/d, therapy unspecified ""LT4"" 0.025mg/d
and vardenafil 20mg/prn. On 25-FEB-2007 the patient presented at a facility and was
noted as having a CVA and cardiac arrest. At this facility the patient had an EKG
which was T-abnormal. The EKG impression included: QRS interval 89, QT interval
298, QT corrected 417, frontal axis initial -81, frontal axis mean QRS -77, frontal
axis terminal -77, frontal axis ST 90, frontal axis T 85, left axis deviation, QRS
axis -31 to -90; ventricular tachycardia, rate 118; since 2/4/05 VT now present. At
the same day, the patient died. The cause of death was reported as cerebrovascular
accident. At this time, relationship of CVA and cardiac arrest to study therapy is
unknown. Upon internal review, cardiac arrest was determined to be an other
important medical event. A lot check has been requested. This is one of several
reports from the same source. Additional has been requested. 11/5/2008 Note
received from FDA. Pt presented 2/25/07 and DX'd with CVA and cardiac arrest.
1/9/09-death certificate received-COD-Cardiac arrest.Ischemia of heart.
Hypertension."" "electrocardiogram, 02/25/07, left axis deviation, QRS axis -31
to -90, VT, rate 118, since 2/4/05 VT now present; physical examination, well-
developed, elderly, male, in no apparent distress, comfortable; peak expiratory
flow, 210; electrocardiogram, 02/25/07, frontal axis: mean QRS -77, frontal axis:
terminal - 77, frontal axis: ST 90, frontal axis: T 85; electrocardiogram,
02/25/07, severity: T abnormal ECG; electrocardiogram, 02/25/07, QRS interval 89,
QT interval 298, QT corrected 417, frontal axis: initial -81; vital sign, within
normal limits Labs and Diagnostics: EKG abnormal."
"330246-1" "330246-1" "11/5/08 Death Summary received from FDA. Pt had
been admitted 5/2/08 with severe pancreatitis-epigastric abdominal pain and N&V.
Tachycardic on admission. PE (+) for abd tenderness and lower extremity edema. Pt
became hypoxic eventually requiring intubation and acute renal failure. Pt also
developed Atrial Fibrillation and anemia requiring 4 units of PRBCs. Family
consented to comfort care and pt was extubated 5/15/07 and expired. Dx at TOD:
Severe pancreatitis with probable necrotizing pancreatitis of unclear etiology.
Septic shock due to gram (-) rod bacteremia, Acute renal failure on hemodialysis,
Respiratory Failure, DM, HTN, Hyperlipidemia, hx of chronic back pain, hx of
osteopenia. Labs and Diagnostics: BUN 28. Creatinene 1.2. WBCs 24K. CT scan abd (+)
for pancreatitis, possibly hemorrhagic. Stools guaiac (+)./Information has been
received from an agency concerning a 70 year old female with diabetes mellitus,
hypertension, hyperlipidaemia, chronic back pain and osteopenia who on 17-APR-2007
was vaccinated with ZOSTAVAX (Oka/Merck) (lot # 656861/0329U). This report was
part of a study. Concomitant therapy included Td vaccine. The patient presented
to the emergency room with complaint of abdominal pain on the evening prior to
admission, occurring 30-45 minutes after dinner. In the emergency room, she was
afebrile with a blood pressure or 142/51, heart rate 88 and respiratory rate 19.
Her abdominal exam was significant for some moderate tenderness to palpation in the
epigastric region as well as the right lower quadrant region. She had trace lower
extremity edema. Her initial labs showed normal liver function tests and normal
urinalysis. Her chemistry panel was remarkable for BUN 28 and elevated creatinine
of 1.2 from her prior baseline. White blood count was 24,000. A CT scan of the
abdomen at the time of admission showed pancreatitis, possibly hemorrhagic with an
enlarged pancreatic head and peripancreatic right anterior pararenal space and
right paracolic gutter effusions of high density were also noted. On 02-MAY-2007,
She was admitted to the medical surgical floor with the diagnosis of pancreatitis.
The patient was kept NPO for severe pancreatitis; however, in the morning, her
electrolytes showed her bicarbonate decrease from initial 23 to 16 with an anion
gap of 22, BUN was elevated at 33 and her creatinine was 1.3. White blood cell
count initially had been 24,000 and was 20,000. STAT lactate level was obtained,
which was 4, and patient's status was subsequently changed from medical/surgical to
intensive care unit. She was treated with empiric imipenem. Her calcium level was
noted to be low, and she subsequently was repleted. On 03-MAY-2007, patient became
increasingly hypoxic and was subsequently intubated, developing respiratory
failure. She required LEVOPHED for blood pressure support. Chest x-rays revealed
significant pleural effusions, most likely from the aggressive IV fluid hydration.
She was intubated as indicated above and ventilation was managed by the
intensivist. Patient developed acute renal failure, which was most likely due to
ATN. Patient's creatinine on May 2nd was 1.3 when it had previously been 1. After
some aggressive IV fluid hydration the following day on May 3rd it was 0.8.
However, it continued to increase, most likely due to hypoperfusion to the kidneys,
as she did become hypotensive and required LEVOPHED. Nephrology was consulted on
May 3rd, and the nephrologist continue to follow. She was started on hemodialysis
after failing a LASIX trial and hemodialysis continued. On 05-MAY-2007 the patient
was noted to have an episode of atrial fibrillation. She was started on an
AMIDARON drip and converted back into sinus rhythm where she remained during her
hospital course. The patient was placed on intensive insulin drip for diabetes
mellitus, which was titrated off, and for the rest of her course was on a sliding
scale insulin with close monitoring of her blood sugars. The patient developed
hypocalcemia which was due to severe pancreatitis. This was monitored closely and
repleted. As of 15-MAY-2007, the pancreatitis appeared to be significantly worse
overnight. She had required increased LEVOPHED support and her lactate on the
morning of 15-MAY-2007 increased to 9.4. The patient was also requiring increased
ventilator support with 15 of PEEP, which had increased overnight, as well as the
fact that she remained in atrial fibrillation at a heart rate of 130s despite being
on an AMIODARONE drip. After conversation with the intensivist, who had been
following the patient, it was decided to have a family meeting regarding the
patient's poor prognosis, and it was decided at that time to focus on comfort care.
Pressor support was withdrawn, the patient was extubated, and she expired shortly
after on 15-MAY-2007. The cause of death was reported as sepsis and pancreatitis.
A lot check has been requested. This is one of several reports from the same
source. Additional information has been requested. 11/5/08 Death Summary received
from FDA. Pt had been admitted 5/2/08 with severe pancreatitis-epigastric
abdominal pain and N&V. Tachycardic on admission. PE (+) for abd tenderness and
lower extremity edema. Pt became hypoxic eventually requiring intubation and acute
renal failure. Pt also developed Atrial Fibrillation and anemia requiring 4 units
of PRBCs. Family consented to comfort care and pt was extubated 5/15/07 and
expired. Dx at TOD: Severe pancreatitis with probable necrotizing pancreatitis of
unclear etiology. Septic shock due to gram (-) rod bacteremia, Acute renal failure
on hemodialysis, Respiratory Failure, DM, HTN, Hyperlipidemia, 1/9/09-COD-
Necrotizing pancreatitis, etiology unknonw." "blood pressure, 142/5; physical
examination, significant for some moderate tenderness to palpation in the
epigastric region as well as the right; abdominal computed, 05/02/07, pancreatitis,
possibly hemorrhagic w/ enlarged pancreatic head; chest X-ray, significant pleural
effusions; abdominal computed, 05/02/07, peripancreatic R anterior pararenal space
& R paracolic gutter effusions of high density; total heartbeat count, 88;
urinalysis, normal; arterial blood HCO(3), 05/02/07, decreased from initial 23 to
16 with anion gap of 22; serum creatinine, 05/02/07, 1.3; serum L-lactate test,
05/02/07, 4; total heartbeat count, 130s; serum L-lactate test, 05/15/07, 9.4;
serum creatinine, previously had been 1; serum creatinine, continued to increase;
serum creatinine, 05/03/07, 0.8; serum calcium, 05/02/07, low; WBC count, 05/02/07,
initially had been 24,000 and was 20,000; serum blood urea, 05/02/07, 33, elevated;
serum creatinine, 1.2; WBC count, 24,00; serum blood urea, 28; hepatic function
tests, normal; respira"
"330247-1" "330247-1" "Information has been received from an investigator
concerning a 77 year old male with chronic obstructive pulmonary disease,
Alzheimer's dementia, hypertension, congestive heart failure, peripheral vascular
disease, hyperlipidaemia, glaucoma, gastrooesophageal reflux disease, shingles,
chronic renal insufficiency and cigarette addiction and previous surgeries of
appendicectomy, total hip arthroplasty, cataract surgery, bowel obstruction and
right endarterectomy in July 1995 who on 18-JUN-2008 was vaccinated with ZOSTAVAX
(Oka/Merck) (lot # 656412/1476F). This report was part of a study. The patient was
hospitalized in May of 2008. On 12-JUN-2008, he was referred for Hospice care. On
10-JUL2008, he as admitted to a skilled nursing facility for Hospice care and died
34 days after vaccination, on 22-JUL-2008. The cause of death was COPD, HTN, PVD
and CHF. A lot check has been requested. This is one of several reports received
from the same source. Additional information has been requested. 1/9/09-death
certificate received- COD-cardiopulmonary arrest. chronic obstructive pulmonary
disease." "Unknown"
"330248-1" "330248-1" "Information has been received from an investigator
during a study concerning a 64 year old female with a history of osteoporosis,
elevated blood pressure, hyperlipidemia, atrial fibrillation in the past and
recurrent dyspnea of uncertain etiology who on 25-JAN-2007, was vaccinated with
ZOSTAVAX (Oka/Merck) (Lot# 652936/0981F). The patient did not have concomitant
vaccines. The patient had sustained a recent lower back injury at work and was
being seen by occupational medicine. She was not anticoagulated. She was last
seen by her medical provider on 25-JAN-2007, the day of vaccination, and was doing
well. The patient suddenly expired on 04-MAR-2007. Her death certificate gives
cause of death as cardiac arrest and cardiogenic shock. A lot check has been
requested. This is one of several reports received from the same source.
Additional information has been request. 11/5/2008 Death Cert and note received
from FDA. Pt expired suddenly on 3/04/2007. COD Cardiac Arrest and Cardiogenic
Shock." "Unknown"
"330249-1" "330249-1" "Information has been received from an investigator
concerning a 71 year old male with benign prostatic hypertrophy and chronic kidney
disease stage 2 who on 14-FEB-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (lot#:
656608/0032U). This report was part of a study. The patient was admitted on 25-FEB-
2007 for slurred speech and found to have an ischemic bilateral lacunar
cerebrovascular accident, and transferred to the Intensive Care Unit secondary to a
second cerebrovascular accident involving the right mid brain, pons and with
extension to the right thalamus. On the second hospital day, he was found to be
unresponsive. A repeat head CT demonstrated an acute infarct of the right pons and
thalamus without extension, intracranial hemorrhage or dissection. There was
atherosclerosis of the vertebral and aortic arch. The right vertebral artery was
found to be smaller than the left and there was also age-related cortical atrophy.
Atherosclerosis of the vertebral artery was thought to be the likely embolic source
for this second event. A CT angiogram demonstrated occlusion of the right proximal
posterior cerebral artery along the P1 segment although the distal right cerebral
artery was patent secondary to communicating arteries. Because of this, he was
started on anticoagulation with heparin. Carotid ultrasound was obtained which
demonstrated no significant stenosis of the internal carotid arteries on either
side, and there was bilateral antegrade vertebral flow. The NIH stroke scale was 15
on admission upon evaluation by the neurologist. He was given permissive
hypertension and oxygen initially. He was also continued on full dose aspirin which
was started upon admission to the hospital since he was not taking that at home. In
addition, he was given lovastatin 40 mg p.o. daily. The patient had no significant
changes in his neurological examination after admission to ICU. He was hemiplegic
on the left side with significant sensory deficit and weakness. He was able to move
his right upper and right lower extremities spontaneously against gravity and
withdrew to noxious stimuli in all four extremities. However, he had no gag reflex
and was very somnolent on examination, at times difficult to arouse. His pupils
were bilaterally unequal with the right pupil approximately 4 mm and the left pupil
approximately 2 mm, sluggishly reactive bilaterally as well. In addition, on
2/27/2007 he was found to have apneic episodes with Cheyne-Stokes breathing
pattern, worrisome for central apnea. The patient was ruled out for myocardial
infarction with negative enzymes per protocol, in addition to negative
electrocardiogram. Echocardiogram on 2/26/2007 demonstrated an ejection fraction of
50-65% with normal LV function and no cardioembolic source. There was some aortic
sclerosis without stenosis. He was given aspirin as above in addition to the statin
as above. The patient had no history of diabetes but did have elevated fasting
glucose on admission so he was given an insulin sliding scale and his fingerstick
glucose was checked. He was also given D5 normal saline since he was not eating.
Because his fingersticks remained stable, the insulin sliding scale and fingerstick
checks were later discontinued. The patient had a baseline glomerular filtration
rate of approximately 78 consistent with chronic kidney disease Stage 2. His
creatinine remained stable during hospitalization and electrolytes were repleted as
needed. He was given aggressive intravenous hydration given that multiple doses of
contrast were given. The patient had no active issues and his temperature and white
blood cell count were monitored without any significant signs of infection. The
patient was made NPO and a nasogastric tube was initially placed to low
intermittent suction. This was later changed to CORPAK in order to initiate tube
feeding. He was given GI prophylaxis with famitodine (MSD). Patient was placed on
heparin drip secondary to the thrombus as above. His hematocrit was assessed as
stable. He was continued on SCD for prophylaxis and also given aspirin as above.
The patient was diagnosed with status post bilateral lacuna cerebrovascular
accident, status post right mid brain pontine thalamic cerebrovascular accident and
chronic kidney disease, Stage 2. The patient died on 01-MAR-2007 at 20:50. The
cause of death was haemorrhagic intracranial with likely herniation secondary to
left mid-brain pontine and possibly thalamic stroke. Additional information has
been requested. 11/5/08 Death Summary received from FDA. Pt admitted 2/25/07
for slurred speech and found to have an Ischemic bilateral lacunar CVA. Found
unresponsive on hospital day#2 and dx with acute CVA. Pt hemiplegic with
significant sensory defecits and weakness. Apneic episode with Cheyne-Stokes
breathing worrisome for central apnea. Gag reflex absent-place on aspiration
precautions. NG tube placed for feeds. Place on comfort care only. Pt expired
3/1/07 with COD Intracranial hemorrhage with likely herniation 2' to left midbrain
pontine and possibly thalamic stroke. 1/9/09-death certificate received-COD
intercerebral hemorrhage,non-traumatic. acute ischemic stroke.posterior cerebral
artery occulsion, etiology unknown." "head computed axial, an acute infarct of
the right pons and thalamus w/o extension, intracranial hemorrhage or dissection;
carotid artery, no significant stenosis of the internal carotid arteries on either
side; neurological, no significant changes; electrocardiogram, negative;
angiography, distal R cerebral artery patent secondary to communicating arteries;
echocardiography, 02/26/07, there was some aortic sclerosis without stenosis;
carotid artery, bilateral antegrade vertebral flow; angiography, occlusion of R
proximal post. cerebral artery along P1 segment; diagnostic laboratory, 02/25/07,
NIH stroke scale was 15 on admission; echocardiography, 02/26/07, an ejection
fraction of 50-65% with normal LV function and no cardioembolic source; cardiac
enzyme panel, negative; hematocrit, stable; glomerular filtration, approximately 78
consistent with chronic kidney disease; serum creatinine, remained stable; fasting
blood glucose, elevated. Labs and Diagnostics: Head CT (+) for acute infarct of
the R pons and t"
"330396-1" "330396-1" "Subject in pneumococcal vaccine trial, with severe
COPD, died at patient's fathers home on 9/13/28. Vaccination took place on 9/19/07
and death took place on 9/13/08. According to the physician, the relationship to
treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon
request Subject ID A100099. 6/1/09 Death certificate states COD as acute
respiratory failure & severe COPD & hyperlipidemia as contributing factors.
11/4/08 Reviewed SAE form which reveals patient experienced multiple exacerbations
of COPD during study participation making death most likely COPD related. No
autopsy was done & there was no hospitalization. Patient died at home." "No
lab data for this event."
"331191-1" "331191-1" "Information has been received from a study conducted
concerning a patient (age and gender not reported) who was vaccinated with a dose
of MMR II (date, dose, route and lot #'s not reported). Concomitant suspect vaccine
therapy included a dose of VARIVAX (date, dose, route and lot #'s not reported). It
was reported that the patient died within 30 days of receiving the vaccines (date
and cause of death not reported). This is one of several reports from the same
source. No further information is available." "Unknown"
"331192-1" "331192-1" "Information has been received from a study conducted
concerning a patient (age and gender not reported) who was vaccinated with a dose
of MMR II (date, dose, route and lot #'s not reported). Concomitant suspect vaccine
therapy included a dose of VARIVAX (date, dose, route and lot #'s not reported). It
was reported that the patient died within 30 days of receiving the vaccines (date
and cause of death not reported). This is one of several reports from the same
source. No further information is available." "Unknown"
"331193-1" "331193-1" "Information has been received from a study conducted
concerning a patient (age and gender not reported) who was vaccinated with a dose
of MMR II (date, dose, route and lot #'s not reported). Concomitant suspect vaccine
therapy included a dose of VARIVAX (date, dose, route and lot #'s not reported). It
was reported that the patient died within 30 days of receiving the vaccines (date
and cause of death not reported). This is one of several reports from the same
source. No further information is available." "Unknown"
"331194-1" "331194-1" "Information has been received from a study conducted
concerning a patient (age and gender not reported) who was vaccinated with a dose
of PROQUAD (date, dose, route and lot #'s not reported). It was reported that the
patient died within 90 days of receiving the vaccine (date and cause of death not
reported). This is one of several reports from the same source. No further
information is available." "Unknown"
 "331195-1" "331195-1" "Information has been received from a study
concerning a patient (age and gender not reported) who was vaccinated with a dose
of PROQUAD (date, dose, route not reported). It was reported that the patient died
due to drowning (date not reported). This is one of several reports from the same
source. Additional information has been requested." "Unknown"
"331589-1" "331589-1" "Pt. was found dead in the crib at daycare the
following afternoon. 2/18/09-autopsy report received-COD Sudden Infant Death
Syndrome." "Autopsy (P)"
"331645-1" "331645-1" "Course of illness prior to death unknown. Aware she
did have URI and could not attend school. 1/27/09 Autopsy report states COD as
acute bronchopneumonia due to acute intoxication by hydrocodone. Also states
additional anatomic dx: mod hepatocellular fatty metamorphosis & early postmortem
decomposition. 11/11/08 Reviewed PCP medical records of 10/27/2008. FINAL DX:COPD,
cough, acute rhinitis, chronic sinusitis Records reveal patient experienced cough &
body pain, no fever. Dx w/COPD & acute bronchitis. Tx w/antibiotics & cough med."
"No lab data for this event."
"332724-1" "332724-1" "she presneted 10/23 for a blood pressure check up
and in the course of that we did an annual flu shot for her. See the flu shot note:
10/23/08 The following questions were answered by the patient: Are you currently
ill with a moderate or severe illness? No Temperature: __ Are you allergic to eggs
or egg products? No Have you ever been paralyzed by Guillain Barre Syndrome? No
Have you ever had a severe allergic reaction after getting the flu vaccine?
(difficulty breathing, aiway swelling, hives, etc.) No Patient was given the
opportunity to ask questions prior to immunization and have them answered to their
satisfaction: _Yes Manufacturer: Aventis Lot #: U2805AA Expiration Date: 06/30/2009
Preservative Free _No Vaccine information sheet given: Yes VIS Pub. Date: 07/24/08
Dose: 0.5 ml Site: left deltoid She then reproted on 10/31 with swelling in hands
and feet and rash. It looked like allergic reaction. she was not ill so we treated
her as an out patient. she called a few days later and was getting worse. I had her
admitted to hospital. I have not received a formal report. One of the diagnosis
that was on the top of the list was influenza vaccine vasculitis. she was not
getting better. The Dr. that was caring for her reported that her dau, a hospice
nurse talked to her about what was going on and patient decieded to not have any
more needle pokes or evaluation. She was sent to nursing home and died the next
day. 12/29/08-records received for DOS 11/3-11/12/08-DC DX: likely vasculitis.
acute renal failure, resolving. Presented with C/O weakness, seen 3 days prior with
swelling in fingertips and lower extremities. Hyperkalemic. Dehydrated.
Hyponatremia. Purpura of feet and lower extremities. 11/21/08 Death certificate
states COD as acute renal failure with vasculitis & immunologic reaction as
contributing factors." "No lab data for this event."
"333759-1" "333759-1" "5 days after vaccines administered pt was found
face-down in crib not breathing. Resuscitation not successful. No other signs of
illness. Presumed SIDS vs suffocation. 3/9/09-autopsy report received-COD Sudden
Infant Death Syndrome." "None"
"334041-1" "334041-1" "Additional information was received that provided
patient details, medical history, concomitant therapy, laboratory results, event
details including updated and additional events, and a fatal outcome. Information
regarding PREVENAR was received from a healthcare professional regarding a 6-month-
old female patient who received a third dose on 02-OCT-2008 along with a third dose
of ACT-HIB (Aventis), a third dose of TRIPEDIA (Aventis), and third dose of ROTATEQ
(Merck & Co Inc) and experienced pneumocococcal bacteremia, Streptococcus
pneumoniae meningitis, apnea requiring intubation, multiple infarcts of brain,
bradycardia and fluid collection around the brain. The patient has a past history
of being a premature baby (36 weeks) (delivered by cesarean section, was in the
neonatal intensive care for 2 days). Has a twin. Concomitant therapy included ACT-
HIB, TRIPEDIA, ROTATEQ and Zantac. On 20-OCT-2008, the patient was hospitalized
after a brief history of several days with respiratory symptoms, low grade fever
and decreased appetite and was diagnosed with meningitis pneumococcal and
pneumococcal bacteraemia. A blood and cerebrospinal fluid culture was performed
showing Streptococcus pneumoniae (serotype not reported). Treatment included
KEFLEX, dexamethasone, vancomycin, rifampin, ceftriaxone, Cefotaxime and mannitol.
During the course of hospitalization, additional laboratory tests and brain scans
were performed which showed multi-focal infarcts with bilateral subdural fluid
collections. Initially, the patient's clinical condition stabilized but then was
complicated by seizures, apnea requiring intubation, multiple cerebral infarction
with subdural effusion and bradycardia. As of 05-Nov-2008, a hospital record
indicated the patient's pupils were fixed and dilated. On 14-NOV-2008, it was
reported that the patient died. The cause of death was reported as meningitis
pneumococcal. Physical examination (results: Weight-17 lb, 6-1/2 inches, height-27-
3/4 inches, head circumference 47.5 cm, language/speech, emotional/social,
fine/gross motor skills, cognitive thinking, physical growth, developmental
milestones - all normal range was done on 02-Oct-2008. On 27-Oct-2008 test results
were: chest X-ray (results: Normal chest); red blood cell sedimentation rate
(results:72); body temperature (results: 101.8 deg. F.); and culture urine
(results: no organisms). On 28-Oct-2008 test results were neutrophil percentage
(results: 64%); Band neutrophil percentage (results: 6%); blood culture (results:
Strep pneumo); white blood count (results: 5.8); CSF culture (results: pneumococcus
(Gram stain stain many G+ cocci in chains)); monocyte percentage (results: 4%); and
lymphocyte percentage (results: 26%). White blood cell count (results: 21.9) and
scan brain (results: stable extra-axial fluid collections) were done on 31-Oct-
2008. Scan brain (results: stable mild diffuse ventriculomegaly, bilateral subdural
collections with the left larger than the right, and signal abnormality within the
brain as above, compared to MRI performed two days ago) was done on 03-Nov-2008. On
05-Nov-2008 test results were: body temperature (results: 97.9 deg. F.); scan brain
(results: multi-focal infarcts, mild ventriculomegaly, and bilateral subdural fluid
collections - stable in comparison to a 03-Nov-2008 scan.); white blood cell count
(results: 10.0); antibody test (results: Anti - T antibodies - positive); and
culture (results: fluid from subdural effusions - negative). No additional
information was available at the time of this report." "Antibody test,
11/05/2008, Anti-T antibodies - positive; Band neutrophil percentage, 10/28/2008,
6%; Blood culture, 10/28/2008, Strep pneumo; Body temperature, 10/27/2008, 101.8
deg. F, 11/05/2008, 97.9 deg. F; CSF culture, 10/28/2008, pneumococcus (Gram stain
many G+ cocci in chains); Chest X-ray, 10/27/2008, Normal chest; Culture,
11/05/2008, fluid from subdural effusions - negative; Culture urine, 10/27/2008, no
organisms; Lymphocyte percentage, 10/28/2008, 26%; Monocyte percentage, 10/28/2008,
4%; Neutrophil percentage, 10/28/2008, 64%; Physical examination, 10/02/2008,
Weight - 17 lb, 6-1/2 inches.; height - 27-3/4 inches; head circumference, 47.5 cm;
language/speech, emotional/social, fine/gross motor skills, cognitive thinking,
physical growth, developmental milestones - all normal range; Red blood cell
sedimentation rate, 10/27/2008, 72; Scan brain, 11/03/2008, stable mild diffuse
ventriculomegaly, bilateral subdural collections with the left larger than right,
and signal abnormality within the brains"
"334606-1" "334606-1" "Patient is a 77-year-old male with a history of
factor V Leiden, hyperlipidemia, prior history of DVTs, and diabetes mellitus type
2, who presented to the hospital on 11/21/2008 complaining of 2 days of fever,
nausea, and generalized weakness and malaise. Pt had Yellow Fever vaccination on
11/14/08 prior to his planned trip abroad. Pt has been otherwise in good health
prior to admission. Influenza vaccine was given on 10/30/08. HOSPITAL COURSE: The
patient quickly progressed to hemodynamic instability and sepsis syndrome exhibited
by tachypnea, tachycardia, hypotension and confusion. Therefore, he was
transferred to the MICU on 11/22/2008. The patient was intubated for airway
protection at that time and increased work of breathing. The patient required
vasopressor support for his blood pressure and was started on broad-spectrum
antibiotics. The patient subsequently developed multiorgan system failure,
including respiratory failure requiring ventilator support, and oliguric renal
failure requiring hemodialysis support. Multiple cultures were sent to try and
determine the etiology of the patient's symptoms and reason for septic shock. It
was noted the patient was on broad-spectrum antibiotic, antiviral and antifungal
coverage. No specific infection inciting these symptoms was ever identified. The
only cultures that were positive were drawn from the patient's access lines, which
grew out Candida albicans. Infectious Disease was following along with the patient
the entire time of his stay in the MICU. Over the ensuing days, the patient failed
to progress and actually worsened from 12/02 and 12/03 as exhibited by increased
tachypnea and work of breathing, hypotension with continued pressor support, and
oozing from some of his lines and orifices. At this time, the patient's family
requested that the patient be made DNR and that supportive measures be withdrawn.
Therefore, these steps were undertaken on the afternoon of 12/03/2008. The patient
passed away officially at 1425 on 12/03/2008. Physical exam was performed to
confirm the patient's death. The family was offered autopsy and declined. 2/3/09-
records received for DOS 11/21-12/03/08-C/O Presented to ED with C/O malaise,
weakness, nausea, fever and fatigue. Mechanical ventilation. Sepsis. Metabolic
acidosis. Septic encephalopathy. 3/30/09-COD multi-organ failure. Septic shock."
"Yellow fever serum RT PCR: negative,LEPTOSPIRA ANTIBOD. neg, HSV 1/2
QUALITATIVE, PCR- neg,CMV DNA- neg, ehrlichia- neg, Blood cultures neg, CT head,
abd, pelvis, brain - negative 2/3/09-records received-MRI brain no evidence of
acute intracranial lesions. MRI spine multi level degenerative disease. 2/11/09-
laboratory reports received-YF IgM antigen positive. YF arboviral nucloic acid
negative."
"334611-1" "334611-1" ""Patient, a previously healthy 19 year-old female
college freshman died suddenly yesterday, approximately 10 days after receiving
Gardasil & menningococcal vaccines. Vaccines were administered by a medical
provider in her hometown while she was home for the Thanksgiving holiday, sometime
around 11-28-08. She had a medical appointment pending for 12-8-08 (the day of her
death) with the Student Health Service; medical clerk had entered ""possible
seizure"" as the reason for making the appointment. Patient had no history of
epilepsy. She complained of a headache and not feeling well in the 24 hours prior
to her death. She went to bed at 10:30 PM on 12-7-08, in her dorm room with a
roomate. She appeared to still be sleeping the next morning when her roomate left
for class. Her body was discovered still in bed around 5 PM that day (12-8-08) with
rigor mortis. No history of substance abuse, alcohol intake, or depression or other
mental health issues. She was a happy, achieving student. This report is filed by a
friend of patient's parents, who is a physician (board certified internal medicine
& geriatrics). Report also filed online today with the FDA. Patient's mother can be
reached at home for additional details. Memorial service & funeral 12-12-08 and 12-
13-08. Only known past medical history requiring physician attention was facial
acne. 12/10/2008 Recived records from health center via CDC. Seen 11/3/08 with c/o
sore throat, cough, muscle aches and nasal d/c. PE (+) for pharyngeal erythema,
purulent nasal drainage, nasal turbinate changes, and lymphadenopathy. Assessment:
Probable viral URI with ? sinusitis. Tx: Biaxin. Received from CDC via email: The
patient had no previous health problems. She was a freshman and was seen at the
college health clinic only once on 11/3/08 for sinusitis. She was on Yaz birth
control pills and a topical acne medication. After the death, police questioned her
roommate who said that the pt did go out on the evening of 12/6/08 and had a few
alcoholic drinks, but not an excessive amount. She had a HA the next day and
thought it was from the alcohol. She had a PCN allergy and was a non smoker.
12/11/2008 Records received from PCP. HPV#1 1/18/2008. HPV#2 3/28/2008. Vaccines
deferred 7/29/2008 2' to oral prednisone usage for acne (with Bactrim). Seen
8/15/08 for sore throat, runny nose. DX: Pharyngitis s/p steroid tx. Returned for
vaccines 11/26/2008 in good health with normal exam. Additional record also
received from health center for scheduled appt on 12/8/08. Pt reported 2 episodes
(one 1 month ago and one on the day of death) of waking up in a cold sweat, having
urinated in the bed, feeling the urge to vomit, dizzy with trouble reading. Appt
made for ? seizure. Pt did not arrive for appt. 3/3/09 Autopsy report received.
COD: Unable to ascertain after autopsy, microscopic, toxicologic and chemical
evaluation."" "Autopsy performed 12-9-08 was unrevealing per family verbal
report to me; no signs of intracranial bleed, meningitis, cardiomyopathy, trauma.
Toxicology report still pending at this time. Post-mortem tox screen (-)."
 "334930-1" "334930-1" "Stopped breathing/death. Blood(redness ) in both
eyes, (began 12/15). 2/18/09 Death certificate states COD as hypoxic-ischemic
encephalopathy due to whiplash shaking injuries of head & spinal cord."
"Vitamin deficiency; Liver disease; blood coagulation disorder"
"335226-1" "335226-1" "I would like some help to find out if my daughters
death was caused by a Vaccine Induced Reaction. This all started on November 13
2008. This is the day the i took my daughter to the clinic. She was supposed to be
seen for her 2 month well child exam which she was was not. The primary doctor had
only seen her once and this was on her 2 week well child exam. When we went in for
her 2 month checkup we had seen a nurse practitioner. The doctor never came into
see her not even once on this day nor did the nurse weigh her do any of the
measurements of check to make sure that everything was growing normally. She had me
sign for 2 vaccines when after all this i found out that she was given for 2 that i
didn't know about. We were sent home right after the vaccines were given and told
to come back in 4 weeks for more and to expect drowsiness, fussiness, low appetite,
not sleeping, irritability, that's what had happened Thursday night. She slept most
that afternoon and evening with very little to eat. Friday morning she was a little
fussier then usual. Later on into the day we had noticed her to be warm to the
touch but i had checked and it was normal a few more hours into the night. She
developed a fairly high pitched cry and it seemed like she had a belly ache but yet
eating very much. She was up about every 30 min during that Friday night and she
usually was a really good sleeper through the night. On saturday morning i had
gotten up to feed her i made a 6 oz bottle she still had about 2 oz left. When she
was finished i burped her changed her she was still really fussy so i laid her down
on a u shaped pillow and put her on her belly and i laid down beside her and patted
her on her bottom and i fell back asleep next to her and was woke up by her father
that had just gotten out of bed and told me to make sure the baby is breathing. I
grabbed her and her body was limp but still warm to touch. I held her close to my
body and ran across the street to the police station where the ambulance had
responded and took us to the hospital. They were able to resuscitate her but she
could not breath on her own nor did she have any brain function. They then air
lifted us to the hospital. After being there for 24 hours the doctor had told us
that our baby was not going to live and they see retinal hemorrhaging in the back
of the eyes and the only 2 ways were a car wreck or some body had to of shaken her.
Well i know that that is not what happened and i have research about these vaccines
and all the signs start the day she was vaccinated. Thank you for your time.
01/08/2009 MR received for DOS 11/15-16/2008. Pt presented to ER following parent
finding infant unresponsive and not breathing. CPR and intubation initiated at
local fire station. Upon arrival, infant was pulseless, pink, hypoxic and
hyperthermic. Epi administered with return of pulse but BP fluctuations. Pt
acidotic with dilated, unresponsive pupils, asymmetric lung sounds, fungal diaper
rash. Trasfered to higher level of care s/p cardiorespiratory arrest, now acidotic
and hyperthermic with epi dependent BP. Upon arrival infant was hypothermic with
T=35 with shivering, unresponsive to stimulation. Pupils non-reative, (+) retinal
hemorrhages, areflexia, flaccid tone. (+) respiratory and metabolic acidosis.
Assessment: hypoxic brain injury. Prognosis poor. No brain activity. Ventilator
support withdrawn. Pt expired. . 1/14/09 Autopsy report received with COD Anoxic
Encephalopathy of unknown etiology. Bilateral Retinal Hemorrhages. Metabolic panel
(+) for elevated 17 hydroxyprogesterone. No evidence of physical injury. Manner of
death undetermined." "none at this time allegations are retinal hemorrhage she
had passed away on Sunday November 16 2008 in hospital. Labs and Diagnostics: CBC
with 19.3 WBCs-24% lymphs, 24% bands, 1 metamyelocyte. K+ 7.7. Head CT (+) for
cerebral edema and diffuse loss of gray-white differentiation-no intracranial
hemoorhage or skull fx. Bone scan (+) for sutural diastasis. No fractures.
Arterial gases abnormal. APTT 52. Fibrinogen 225 (L). D dimer >20. Thrombin time
21. UC (+) for Enterobacter and E. coli. Blood cx (-). Metabolic panel (+) for
elevated 17 hydroxyprogesterone"
"335284-1" "335284-1" "Pt with a history of menigitis at 10 yrs old.
Vaccinated with MENOMUNE prior to college entrance. Contracted meningitis and
passed away at age 19 on 11/20/08. MD stated he will fill out VAERS himself and fax
to agency. No further info provided. 1/27/09 Death certificate states COD as
disseminated intravascular coagulation w/meningococcemia as contributing factor.
DOD corrected to 11/17/2008. 12/31/08 Reviewed hospital medical records of 11/13-
11/14/2008. FINAL DX: septic shock w/multiorgan failure, DIC, respiratory failure,
acute renal failure, lactic acidosis, metabolic acidosis & suspected
meningococcemia Records reveal patient experienced myalgia, malaise, generalized
aching, nausea, vomiting, diarrhea, fever, petechial rash, sweating, photophobia,
neck stiffness, SOB, abdominal pain, back pain. Taken to hospital. Intubated in
ER & admitted to ICU in isolation. Exam revealed tachycardia, hypotension(on
pressors), anasarca, fever, thrombocytopenia, coagulopathy. Renal, ID, pulmonary
consults done. Tx w/IV antibiotics, pressors, steroids, blood product transfusions
& hemodialysis. Transferred to higher level of care. 01/14/09 Reviewed hospital
medical records of 11/14-11/17/2008. FINAL DX: meningococcemia; purpura fulminans;
multiorgan system failure. Records reveal patient experienced purpura fulminans.
Had been transferred from outlying hospital. Noted to have had HA in addition to
other presenting symptoms as noted in prior records. Tx w/CVVHD, antibiotics &
pressors. Developed atrial fib/flutter & was cardioverted. Developed ARDS, acites
& anasarca." "LABS: Blood c/s (+) for Neisseria meningitidis serogroup Y. CXR
c/w ARDS. EEG abnormal c/w severe diffuse encephalopathy. Creatinine 4.34(H),
potassium 5.9, CO2 14(L), anion gap 21(H), calcium 6.3(L), phosphorous 7.7(H),
protein 3.2(L), albumin 1.7(L), bilirubin 3.3(H), alk phosphatase 182(H), AST
8881(H), ALT 5540(H), cpk 2204(H), CKMB 25(H), troponin 1 0.73(H), BNP 892(H),
lactic acid 13.2(H), D-Dimer .20000(H), PT/PTT/INR (H). CBC: RBC 2.40, H/H
7.4/20.6, plts 11(all low), WBC 19.2(H). LABS: TEE revealed increased right atrial
pressure. Head CT c/w diffuse cerebral edema w/acute hemorrhage & possible septic
emboli, IVH, hydrocephalus. Cerebral perfusion scan c/w brain death."
"335622-1" "335622-1" "Pt initally presented to hospital on 10/20-10/26/08
with gait instability, garbled speech and Left sided weakness. Pt was re-admitted
to hospital on 11/20-11/23/08 with worsening weakness, increasingly garbled speech
and severe gait instability. Pt. transferred to hospital on 11/23/08 for a brain
biopsy. Brain Biopsy revealed demyelination consistent with progresive multifocal
Leukoencephalopathy. Pt's neurological status deteriorated until pt expired on
12/11/08. 11/22/2008 MR received for multiple admissions beginning ~10/20/2008.
Pt expired 12/11/08 with COD Progressive Multifocal Leukoencephalopathy. Pt
presented to local hospital 10/20-26/08 with respiratory distress and admitted for
COPD exacerbation and CHF. Also having sx of L sided weakness attributed to
possible TIA. Pt d/c but developed increasing L-sided weakness and hemineglect and
readmitted 11/10/08 with D/C DX: Immunogenic encephalitis s/p vaccination, Diabetes
with hyperglycemia on steroids, COPD. Pt was acting confused with abnormal behavior
c/w encephalitis. Started on antiviral and steroids w/o improvement. Pt continued
to progress with worsening psychomotor retardation. Pt transferred to rehab for
several days and admitted agian 11/19/08 for brain biopsy. D/C DX: Infiltrative
bilateral frontal lobe process, extending into the brain stem, possible
postvaccinal encephalomyelitis. COPD, Dyslipidemia. Basilar artery stenosis, HTN,
DM, DVT risk, morbid obesity. Brain bx (+) for JC virus which lead to dx of PML. Pt
with decreasing LOC. Transferred to hospice care. Pt expired 12/11/2008. 2/5/09
Death Cert received. COD: Progressive Multifocal Leukoencephalopathy."
"11/10/08 MRI: Acute Inflamatory process in both frontal lobes crossing the
Corpus Callosum, consistent with encephalitis. On 11/24/08, open brain biopsy
showed demyelination consistent with progressive multifocal leukoencephalopathy.
On 12/08/08, testing showed the presence of JC Virus. Labs and Diagnostics: MRI
brain (+) for possible subacute R frontal stroke, later determined to be acute
inflammatory process. Repeat showed progression. MRA (+) for severe focal stenosis.
LP showed no sign of infection. Myelin basic protein elevated. Neuron specific
enolase (+). EEG (+) for background slowing. PCR and viral tests for HSV, CMV,
HZV, West Nile, enterovirus, EBV, Lyme all (-). CXR (+) for atelectasis and
possible pleural effusion. Brain bx (+) for JC virus."
"335762-1" "335762-1" "Patient vaccinated on 5/1/06 with Menactra (lot
U2004AA). Culture confirmed meningococcal disease on 6/5/08. Blood culture was
positive for Neisseria meningitidis serogroup C. 3/4/09-death certificate received-
COD Sepsis. Acute Meningococcemia. 3/8/09-office note received for DOS 5/1/06-well
visit-mild scoliosis. 3/19/09-records received for DOS 6/3/08-life flight
tranferred in hypotensive state intubated. Lifting weights day before, developed
diffuse abdominal painlast evening worsened overnight, this morning developed fever
and sweats with vomiting. Mottled, hypotensive and tachycardic. PE: cold,
tachycardic febrile and mottled. Bleeding from both eyes. Unresponsive. Purpura,
petechiae in eyes. At receiving facility in cardiac arrest resuscitation efforts
failed. Pronounced dead." "Blood culture was positive for Neisseria
meningitidis serogroup C on 6/5/08"
"335764-1" "335764-1" "Patient vaccinated with Menactra on 6/25/07 (lot
U2236AA). Culture confirmed meningococcal disease on 9/26/07. Blood culture was
positive for Neisseria meningitidis serogroup C. 1/6/09-records received-on
9/26/08-Three day history of fatigue, fever, tachycardia, altered mental status,
blurry vision and headache. Developed diffuse rash, renal failure, coagulopathy and
repiratory failure. 1/6/09-autopsy report received-Neisseria Sepsis. Antemortem
blood culture positive for neisseria meningitidis, serogroup C. Bilateral
hemorrhagic adrenal necrosis (Waterhouse-Friderichsen syndrome). Diffuse confluent
petechial purpuric rash. petechial hemorrhages of left conjunctivia, gingivae,
scalp and subgaleal tissue. Small vessel fibrin thromboemboli identified clinically
disseminated intravascular coagulopathy (DIC). Neutrophilic pulmonary airspace
infiltration consistent with terminal ventilator dependence. Bilateral pleural
effusions." "Blood culture positive for Neisseria meningitis serogroup C on
9/26/07."
"336129-1" "336129-1" "Death - Mom discovered infant's head wedged between
pillow and bed Thursday morning. 1/2/09-autopsy report received-COD 1. Compressive
asphyxia. Compressive markings of skin of chest, shoulders and sides of face.
Pulmonary atelectasis. Dilated heart, hypoxic myocardium. Congested cyanotic brain
and viscera. Petechiae in epicardium, pleurae and thymus glad. Aspiration of
gastric contents. Bilateral enlarged renal pelves, stenotic ureteropelvic
junctions, right more than left." "Autopsy - report showed accidental suffocation
as COD."
"336403-1" "336403-1" "Chest tightness, shortness of breath, and rapid
demise to death within 4 hours of receiving vaccine. 1/7/09-records received for ED
DOS 9/29/08-presented to ED with C/O chest pain, while enroute to ED became
diaphoretic, SOB required cardioconversion, intubation. V fib. DX and COD-Pulmonary
embolus. Expired 9/29/08. 2/9/09-COD-pulmonary embolism." "1/7/09-records
received-Chest x-ray infiltrate at left lung base and possible infiltrate right
upper lobe."
"336473-1" "336473-1" "Onset increased muscle pain, fatigue, weakness,
dysphagia, weight loss. Pt requiring Prednisone IVIG every q monthly. Methotrexate
headache, muscle atrophy. 2/6/09 Received PCP medical records of 11/11/08-1/20/09.
FINAL DX: polymyositis, likely MCV4 vaccine related; osteomalacia; neuropathy;
pernicious anemia; tachycardia; ataxia; Budd-Chiari syndrome; dermatomyositis.
Records reveal patient experienced muscle weakness, paresthesias, leg pain.
Referred to Neuro & Rheum. Tx w/PT & meds including methotrexate, imuran,
steroids, enbrel, bicillin, IVGG. Had to drop out of college due to illness.
04/6/2010 Patient's condition never improved and she died on 3/23/2009."
"muscle biopsy; MRI separate. Dx clinical myositis"
"336654-1" "336654-1" "Pt developed decreased PO intake and increased
frequency of stools with mucus on the night of 12/29/08 < 12 hours after
immunizations. Next day continued to have poor intake and increased stool and
became weak/lethargic. Pt came to evening clinic and was in state of shock and
hypothermia. He died at about 10pm. 2/13/09 Autopsy report received with COD
Dilated and hypertrophic cardiomyopathy. DX: Left ventricular myocardial
hypertrophy and dilitation, marked. Fatty alteration of the liver, moderate to
marked. Bilateral hydroceles, R>L. Pt seen 12/27/08 with c/o spitting up blood and
sneezing. Dx with thrush and tx with Diflucan. Returned to PCP 12/29/08, impetigo
noted and vax given. Returned 12/30/08 with c/o poor feeding, multiple watery,
stringy stools, weakness and pallor. PE notable for grunting, poor color and
decreased activity. Transported via EMS to hospital with concern for sepsis.
T=96.8'F. HR=170's. Severly dehydrated on arrival. Infant coded and expired."
"State examiner case pending."
"336777-1" "336777-1" ""Initial report was received 05 January 2008 from
another manufacturer, document number 455211201. The initial reporter to this
manufacturer had been a consumer, who is the patient's sister. According to the
reporter, her brother received a ""DTAP"" vaccination (manufacturer unknown, lot
number not reported) on an unspecified date and an unspecified amount of time
later, ""he developed severe seizures and he ended up with severe brain damage"".
Due to complications, he passed away. No cause of death was reported and no
additional information was provided at the time of the report. Documents held by
sender: None."" "Not reported"
"336785-1" "336785-1" "Patient seen on 12/18/08, received immunizations,
had low grade fever next day and then was brought to ER lifeless. 2/17/09-records
received COB bacterial sepsis. Other significant conditions contributing to death
but not related to terminal conditions:sickle cell anemia trait. krk" "No lab data
for this event."
"336841-1" "336841-1" "Patient found unresponsive in crib by parents. No
symptoms prior - autopsy revealed intussusception. Pronounced dead at ER. 1/23/09
Autopsy report states COD as complications of intussusception. Also states: six
areas of IS of small intestine; changes of distant intestine present; early
pneumonia; inflammation of lung tissue & small airways. Patient had been found
unresponsive in crib after recent history of cold like symptoms with fever." "No
lab data for this event."
"337033-1" "337033-1" ""Information has been received from a case in
litigation via a case report concerning a baby who on an unspecified date was
vaccinated with a dose of HEPTAVAX (manufacturer unknown). The patient had an upper
respiratory infection at the time of vaccination. Subsequently, the patient
experienced a very high fever and death. A special Master cited that ""each of the
two factors (the vaccine and the infection) were a substantial factor in causing
the patient's very high fever and death and, but for the presence of each of these
two factors, the baby would not have had the high fever and would not have died.""
No further information is available."" "body temp, high fever"
"337243-1" "337243-1" "Patient developed hemorrhagic shock w/
encephalopathy syndrome 5 days after vaccine administration and died. 1/27/2009 MR
received for DOS 12/16-18/2008 which was the Date of death. Principal DX:
Multisystem organ failure 2' to Hemorrhagic Shock and Encephalopathy Syndrome
(HSES). Pt initially presented with new onset seizures and diarrhea. Pt in usual
state of good health a.m. of 1/16/09 except for some recent mild congestion. Later
noted to be sweaty and did not respond while parent was changing clothes. Later
noted to be eye rolling and making unusual movements. In status epilepticus and
metabolic acidosis on arrivial in local ED. Intubated and medicated for seizures
and transferred to higher level of care. Cool and mottled on arrival. LFTs
elevated. Issues with hypoglycemia, abnormal coags and electrolyte fluctuations
with little response to tx. Parents elected to withdraw life support follwing
notification of fatal status of illness. 2/12/09 Death Cert received. COD-
Multiorgan Failure. Hemorrhagic Shock and Encephalopathy Syndrome." "See
attached. Labs and Diagnostics: CBC with 43K WBCs with 20% atypical lymphs. CT
brain scan (+) cerebral edema and probable ischemic infarcts. CSF (+) for few PMNs,
CSF glucose 105, CSF protein 62. CSF cx (-). EEG abnormal. Rotavirus (+), likely
due to shedding. ALT 938-9,480. AST 1,974-12,822. Blood cx (-). UC (-). Hgb 9.2.
Platelets WNL on admission down to 105K. Lactate 5.3 on adm up to 10.2. PT 36.3-
49.5. INR 3.54-5.22. PTT 42-56. Fibrinogen dropped from 153-137. D-dimer > 20. CXR
(+) for atelectasis. K+ 6.1. CO2 12. Cl- 110. Glucose 55."
"337323-1" "337323-1" "Provider notified on 1/2/09 that patient was
admitted to Hospital (different institution) and prognosis is grim. She died of
Bacterial Meningitis later that day. Upon record review, it was noted that she did
receive Menactra in January of 2006. Contacted the VAERS number and she indicated I
should submit information. 1/21/09-records received for DOS 1/1-1/2/09-Brain death
from increased intracranial pressure with transtentorial herniation secondary to
meningococcal meningitis. Sudden onset of headache and altered mental status
changes. Developed severe hypertension with signs of increased intracranial
pressure. Received as a transfer with fixed and dilated pupils and no evidence of
any cortical or brain stem fucntion. EEG electrocerebral silence. Intubated.
Mechanical ventilator. 3/11/09-probable cause of death-neisseria menengitis."
"We do not have data. She died at Hosptial. According to the State health
dept, the case was meningitis serogroup B. 1/21/09-records received-CT scan
catastrophic brain injury, diffuses brain edema with non-visualization of 4th
ventricle and basilar cisterns. CSF protein 290, WBC 175, gram negative diplococci.
Urine Klebsiella pneumoniae. WBC 29.0, ABS neutrophile 27.6. CKMB 5.1, myoglobin
88. 1/27/09-additional diagnostic reports received-CSF culture Neisseria
meningitidis Serotype B., toxicology screen negatove. CT head normal."
"337669-1" "337669-1" ""Pt given HIB #4; PREVNAR #4; Hepatitis A #1; MMR
#1; Varicella #1 and Influenza #1 on 11-17-08. Pt presented one week later ""barely
breathing""; flacid and unresponsive to verbal-painful stimuli at 1755-transferred-
died at local hospital a couple of hours later. 2/12/09 PCP and hospital records
received from FDA. Pt with mild fever 11/24/08 put down to nap. Ptfound to be
diaphoretic, limp, minimally breathing and non-interactive in crib. Upon arrival of
EMS pt noted to be unresponsive to stim, satring with no blink response, pulse 160,
RR 32 with rhonchi bilaterally R>L. Dx with severe croup at local hospital with
transport planned to higher level of care. In ER unresponsive in severe respiratory
distress, skin mottled, O2 sats 80s-90s on pale toes. Arrived to transfer hospital
unresposive to pain, lethargic, initially flaccid then posturing, (+) cervical
lymphadenopathy, resp distress with stridor and rhonchi- intubated. Impression-
Respiratory Failure. Cardiac arrest. CPR unsuccesful. 3/25/09 Autopsy report
received with COD: Community Acquired Pneumonia. Manner of Death: natural. Final
DX: 1) Acute hemorrhage pneumonia, multifocal, community acquired- a) Diffusely
firm, edematous and hemorrhagic lungs, bilaterally. b) Histologic exam confirms
purulent multifocal pneumonia. 2) Moderate Cerebral Edema. 3) Serous Pleural
and Peritoneal Effusions."" "Labs and Diagnostics: CXR (+) for R pneumpthorax,
pneumomediastinum, and probable L pneumothorax."
"337671-1" "337671-1" "Pt was administered vaccines on 013109. Pt was
found deceased on 011409. 10/28/09 Autopsy report received. DOD 11/14/09 Cause of
Death: Sudden Unexplained Infant Death. Additional information extracted: Suddent
Infant Death Syndrome." "No lab data for this event."
"339027-1" "339027-1" "Patient had fever within 24 hours of vaccine
administration. Patient was found unresponsive the next morning. Patient had a
history of febrile seizures. 2/17/09-records received-COD died from complications
of a seizure disorder. Seizure disorder, clinical history of febrile seizures.
Asthma Clinical history of mild asthma. histologic changes in large airways
consistent with mild asthma." "Autopsy found no other cause of death."
"339724-1" "339724-1" "He had a high fever 4 days after getting the
vaccines on 11/26/2008. He was not as alert as he usually was, he had diarrhea,
acted as though he didn't know how to suck a bottle, swelled, 1 week before he died
I took him to the hospital on 12/20/2008 for wheezing, hard time breathing, fever,
coughing severely. They said it was a respiratory infection. I had taken him to
the hospital and doctors office for the same reasons numerous times prior to that
last visit. They kept telling me there was nothing wrong with him, but I knew there
was. He died 12/27/2008. 7/14/09-autopsy report received-COD-positional asphyxia."
"No lab data for this event."
"340167-1" "340167-1" "None stated. 7/20/09 Autopsy report received. COD:
Undetermined. Manner of Death: Undertermined. Final dx: Developmentally normal
male infant" "No lab data for this event."
"340285-1" "340285-1" "02/09/09, mother of Pt said that 02/22/09 Pt was
taken to ED of medical center for respiratory illness by his father. Pt was
arrested in ED and after resuscitation, transferred to a different medical center.
Pt passed away 01/24/09. 3/11/09 Autopsy report received with the following DX:
Large right pleural empyema-collapse of R lung with no evidence of pneumonia-small
R pneumothorax-Gram (+) cocci present in fibrinopurulent coagulum from R pleural
space. Multi-focal acute bronchopneumonia of L lung (early?). Focal hemorrhage,
base of L lung. Left pleural effusion. Tri-lobed left lung (with normal bronchial
branching pattern). Mild cardiomegaly with dilated tricuspid valve. Moderate
congestive hepatosplenomegaly. Findings c/w acute physiologic stress: Moderate to
marked thymic involution, moderate lipid depletion of adrenal cortex, moderate
arrest of rib growth plate. Small pericardial and peritoneal effusions. Small
fragment of apparent old blood clot in bladder. Myeloid hyperplasia of bone
marrow, with left shift 4/6/09 Coroner's report received with COD: Acute
Respiratory Insufficiency due to Empyema, Sepsis and presumed pneumonia" "No
lab data for this event."
"340558-1" "340558-1" "Received first set of baby shots, left the
pediatrician's office and went to store. Became very fussy. Then in the car on the
way home became more fussy before falling asleep. When arrived home, the baby's
skin looked off white and the lips were cold and dark colored and the baby was not
arousable. Parents took the baby to the ER where they were unable to revive him and
he was pronounced dead after about 45 minutes. The baby had previously been to the
ER on 12/18/08 for small size and for congestion. Was put on weight gaining formula
and given Albuterol breathing treatment and sent home. Autopsy was done and showed
3 healing rib fractures that were old and the pathologist stated the baby had
chronic bronchitis, but the cause of death was undetermined. 2/25/09 Autopsy
report state COD as sudden unexplaineed death in infant & manner of death as
undetermined. 2/25/09 Received ER records of 12/18/2008. FINAL DX: URI
w/tachypnea Records reveal patient experienced SOB, nasal congestion, loose stool x
2 days. Seen in PCP office x 2 for same & sent to ER for eval. Resp rate in ER
64, pulse ox 98%. Remainder of exam WNL. Tx w/nebs & resp rate returned to WNL.
2/27/09 Received vaccine records & PCP office records which reveal patient in good
health on 1/12/2009. 3/9/09 Received ER medical records of 1/12/2009. FINAL DX:
DOA Records reveal patient brought to ER by parent. Patient gray, limp w/no pulse
or respirations after having found unresponsive. Resuscitation attempts failed"
"Autopsy done - LABS: 12/18/08: CBC, BMP, CXR WNL. 1/12/09: LABS: WBC 30.3,
segs 9.97% lymphs 16.9%."
"340925-1" "340925-1" "Patient died of influenza A on 2/10/09. 3/16/09-
preliminary anatomic diagnoses received-Influenza A infection with Staphylococcus
aureus superinfection and septic shock. Bilateral hemorrhagic bronchopneumonia.
Staphylococcus aureus isolated on postmortem lung culture;antibiotic sensitivity
pending. Influenza A virus identified by PCR testing on antemortem tracheal
aspirate. Bilateral adrenal hemorrhage Waterhouse-Friderichsen syndrome).
Coagulopathy widespread glomerular microthrombi. Congestive organomegaly, lungs,
liver, kidneys and spleen. Admitted 2/10/09." "No lab data for this event."
"340971-1" "340971-1" "Initial report received on 20 February 2009 from a
newspaper source. Two children, 2 years and younger, had one of the two doses of
vaccine recommended for young children (manufacturer and lot number not reported)
and have died of influenza. No further information was provided. List of Documents
held by Sender: None." "None."
"341467-1" "341467-1" "Subject in pneumococcal vaccine trial, with severe
COPD, died on 10/31/2008 of multiple drug intoxication. Vaccination took place on
3/13/2008. According to the physician, the relationship is 'None'. We would be
happy to forward the Study's SAE reporting form upon request 3/12/09 Death
certificate states COD as multiple drug intoxication. SAE & ER medical records
from study center reveal patient found asystolic w/o signs of trauma. Patient was
not on any know medications." "No lab data for this event."
"341562-1" "341562-1" "Death 7 days later 4/20/-09-autopsy report received-
Final diagnoses:straw colored pericardial effusion and ascites. No antemortem
trauma." "No lab data for this event."
"341593-1" "341593-1" "Patient died 1-11-09. Had received vaccines in our
office 1-5-09. Coroner determined cause of death as SIDS after autopsy completed.
3/16/09-autopsy report received-COS Sudden Infant Death Syndrome (SIDS). Manner of
death natural. Moderate thymic and pleural petechiae. Pulmonary and visceral
congestion." "No lab data for this event."
"341874-1" "341874-1" ""Information has been received from a published
article, concerning ""a patient who was vaccinated with two doses of ATTENUVAX
(manufacturer unknown). In approximately 2004, the patient experienced measles
related death. The cause of death was measles."" The article also discussed the
experience of 1 other patient who died while on therapy with ATTENUVAX
(manufacturer unknown) (WAES# 0903USA01794). Additional information has been
requested. A copy of the published article is attached as further documentation of
the patient's experience."" "Unknown"
"341875-1" "341875-1" ""Information has been received from a published
article, concerning ""a patient who was vaccinated with one dose of ATTENUVAX
(manufacturer unknown). In approximately 2004, the patient experienced measles
related death. The cause of death was measles."" The article also discussed the
experience of 1 other patient who died while on therapy with ATTENUVAX
(manufacturer unknown) (WAES# 0903USA02000). Additional information has been
requested. A copy of the published article is attached as further documentation of
the patient's experience."" "Unknown"
"341877-1" "341877-1" ""Information has been received form a physician who
received a ""health alert"" from the health department concerning an 8 week old
patient who was vaccinated with unspecified HIB (manufacturer unknown) (Lot# not
reported). 5-6 days after receiving the unspecified HIB (manufacturer unknown), the
patient developed invasive HIB disease and died shortly afterward. The adverse
events were considered to be immediately life-threatening. It was not reported
whether the patient's sought medical attention. This is one of several reports
receive from the same resource. Additional information has been requested.""
"Unknown"
"341933-1" "341933-1" "She dies on 12/31/08 - clinicians list
hypersensitivity myocarditis of unk etiology - I autopsy case 1-14-09 - confirmed
an eosinophilic myocarditis, unk etiology but cannot exclude ZOSTAVAX vaccination
given around 12-4-08 - unk where, clinician indicate possible delayed
hypersensitivity reaction. (She presented --> to ER 12-20-08 with diaphoresis,
chest tightness, SOB). 4/27/09-records received-COD Eosinophilic myocarditis,
etiology not established." "See autopsy report opinion and clinical records from
clinic."
"342046-1" "342046-1" "Baby died 4 days after vaccines were given, death is
under investigation cause of death is still unknown 6/15/09 Autopsy report also
states patient had fever since receiving vaccinations. 6/15/09 Autopsy report
states COD as unknown./Had been given Tylenol & put down for nap. Found face down
between pillow & mesh of playpen. Attempted resuscitation but patient with rigor &
unsuccessful. Noted to have dried blood around nose. Skeletal survey, drug &
metabolic testing all WNL./" "none"
"342079-1" "342079-1" "Information has been received from a consumer
concerning a young baby who on an unknown date was vaccinated with a dose of MMR
II. Subsequently, the baby died locally. No further information is available."
"Unknown"
"342365-1" "342365-1" "Information has been received from a registered
nurse who reported what read an article. In the article was reported that a female
patient died because of the serious adverse event due to GARDASIL. The patient was
not the reporting nurse's patient and she did not have a copy of the article. This
is a unconfirmed report. Attempts are being made to verify the existence of an
identifiable patient. Additional information has been requested." "Unknown"
"342366-1" "342366-1" "Information has been received form a lawyer
regarding a case in litigation which was reported in a literature article
concerning a 47 year old female patient who on 20-MAY-1998 was vaccinated with a
second dose of RECOMBIVAX HB (manufacturer unknown). Concomitant medication was not
reported. The special master reported that there was a logical sequence of cause
and effect in patient's having received the vaccination and then experiencing optic
neuritis, the first symptom of her Devic's disease of variant of multiple sclerosis
(MS). It was reported that two months after getting the second dose of the vaccine
the patient noted retro-orbital pressure in her left eye followed by decreased
visual function. On July 27, 1998, she noted a curtain over the superior visual
field in her left eye. On 25-JAN-2009 she had an magnetic resonance imaging (MRI)
scan of brain which was negative, although there was an abnormal signal in the
upper cervical spinal cord. The physician diagnosed neurologic syndrome involving
her optic nerves and spinal cord. The medical records during the patient's final
hospitalization reflected that she died from demyelinating disease. It was reported
that patient had a vaccine injury and her death was also vaccine related. The
patient died in May (Year not reported) at age of 47. The reporter felt that
Devic's disease and demyelinating disease were related to the therapy with
RECOMBIVAX HB. No other information is available." "Magnetic resonance,
01/25/99, MRI of brain showed negative, abnormal signal in upper cervical spinal
cord"
"342393-1" "342393-1" "Possible vaccine failure. Child expired with Flu A
cultured. 5/20/09-autopsy report received-COD-cardiopulmonary arrest. Due to:
systemic infection with influenza type A/H1. Sudden onset of muscle and leg cramps
on 2/14/09, URI symptoms last day or so including sore throat. Suddenly developed
tachypnea fever and diaphoresis within 20n minutes of onset of leg cramps. In ED
fever of 107, tachycardia and dyspnea, developed flutter then bradycardia.
Intubated, v-tach, coded and expired." "Flu A cultured; IVP, brain, heart
5/20/09-records received-CXR negative."
"343528-1" "343528-1" ""Information has been received from a consumer's
niece concerning her uncle whose age was undetermined. The consumer reported that
her uncle was ""older than me."" The patient received a triple vaccine of MMR II.
The patient became brain damaged. The patient had been hospitalized. The patient
was reported to die from pneumonia ""about 4 years ago"" in approximately 2005. No
further information is available."" "Unknown"
"343777-1" "343777-1" "Information has been received from a physician
concerning an 11 year old patient who was vaccinated with GARDASIL (lot number,
route and site not reported). Subsequently the patient died. Additional information
has been requested." "Unknown"
"343822-1" "343822-1" "Subject in pneumococcal vaccine trial, with severe
COPD died on 1/30/09. Vaccination took place 4/17/2008. According to the physician,
the relationship to treatment is 'None'. We would be happy to forward the Study's
SAE Report Form upon request. 3/14/2009 SAE received from reporter. Pt experienced
L sided pain and increasing SOB on 1/22/09 x 2 days. Presented to ER where dx with
L Pneumothorax and Pneumonia. Unresponsive to tx. Pt died 1/30/09." "No lab data
for this event."
"343825-1" "343825-1" "developed fever and rash approx. 10 to 12 days after
mmr was giver on Jan. 1, 1998, after rash was gone they developed cough around Feb
11, 1998. Mother took patient to doctor on Feb 16. Dx w/ pharyngitis and told
increase heart rate due to infection. Sent home w/ antibiotic. On Feb 17, patient
vomiting, mother called doctor, MD orderde suppository over phone. Mother tried
suppository for vomiting, did not work. Patient appeared to be getting worse. By
3:00 am Feb 18 mother took patient to ER. Patient died by 4:ooam. Autopsy ordered.
4/17/09 Autopsy report states COD as acute viral myocarditis & manner of death as
natural. Report also states patient had been seen by PCP for cold symptoms on
2/16/1998, dx w/pharyngitis & tx w/antibiotics. Later that day, began vomiting,
called clinic & tx w/suppositories. Coughing & vomiting continued & developed fever
on 2/18. Presented to ER on 2/18/98 w/very labored respirations & fever. Shortly
after arrival, went into cardiopulmonary arrest, resuscitation unsuccessful."
"Autopsy was done"
"343839-1" "343839-1" "Started w/chest congestion/shortness of breath on
3/11/09 PM. Vomiting, weakness on 3/12/09 PM. Death occurred 11PM 3/12/09.
4/16/09 Death Cert received from reporter who stated pt died at home. No Autopsy
done. Cause of Death: Cardiac Arrest. Coronary Artery Disease. COPD" "Neg"
"344158-1" "344158-1" "It was reported in a newspaper article that a 3 year
old received one dose of PEDVAXHIB (manufacturer unknown), and had onset of
clinical syndrome of meningitis in February 2008, and died. No further information
was available." "Unknown"
"344159-1" "344159-1" "It was reported in a newspaper article that a child
in who had received the full primary series of PEDVAXHIB (manufacturer unknown)
(dates not reported) died of Hib disease, in 2008 a spokeswoman for the Health
Department reported. She was unable to provide more details. No further information
was available. 4/20/09 FDA spoke with the NJ health authority. The child
received 3 doses of HIBV (unknown brand) and died of a brain abscess. The official
did not know whether an autopsy had been performed, nor whether the abscess was
cultured.." "Unknown"
"344160-1" "344160-1" "Information has been received from a physician
concerning an 11 year old female who on 30-MAR-2009 (last week) was vaccinated with
the first dose of GARDASIL. Concomitant therapy included VAQTA, MENACTRA and DTAP
(unspecified) on the same day. Patient complained about sore throat a week prior to
vaccination. A week later some kind test was performed and it showed that a group A
strep in the blood was found. On approximately 30-MAR-2009, after getting the first
dose of GARDASIL the patient experienced fever and pain in the hip after getting
the vaccine. The patient died on 03-APR-2009. The patient sought unspecified
medical attention. Additional information has been requested. 4/24/09 ER record
received for DOS 4/1/09 with dx: Fever. Pediatric Viral syndrome. Pt presented
with L hip pain and fever. PE (+) for tenderness over L anterior thigh. Tx with
analgesic and d/c. 4/24/09 ER record received for DOS 4/3/09 with dx: Post-
vaccination reaction. Pt presented again to ER with fever of 102'F, body aches,
inability to walk 2' to leg pain, nausea, vomiting, rash and polymyagias. PE (+)
for extremity pain and swelling, rash, as well as not sleeping and acting
differently. Transferred to higher level of care. 4/24/09 MR received for DOS 4/3-
4/2009 with Final DX: Necrotizing fasciitis (gram (+) cocci with septic shock).
Pt expired 4/4/09. Pt admitted from local facility for eval of fever with
difficulty ambulating. Neuro/ortho consults on arrival with probable dx: infectious
myositis. Tx with IV abx however IV access was lost and pt became hypotensive and
with eveidence of septic shock with cardiovascular instability. Pt intubated and
despite extensive resuscitation efforts pt expired. 4/24/09 Autopsy report received
with COD: Necrotizing Fasciitis (Gram (+)) with septic shock." "diagnostic
laboratory, a group A strep in the blood was found. Labs 4/1/09: CBC with WBCs
11.1 73% segs, 13.1% lymphs, 12.6% monos. UA WNL Labs 4/3/09: CK 116. LDH 389.
Na+ 131. K 3.1. Cl 94. CO2 18.6. Anion gap 21.5. Glucose 170. Albumin 3.3. Globulin
4.2. AST 132. ALT 90. Aldolase 22.3. WBCs 8.4 with 16% bands, 12% lymphs. Abnormal
RBC morphology. Hgb 11.1. Hct 33.6. MCV 70.3. MCH 23.4 UA (+) for 100 Glucose,
urobilinogen 8.0, (+) reducing subst. UC (+). Blood cx (+) Strep pyogenes Group A.
CXR ? bronchitis or atypical pneumonia."
"344385-1" "344385-1" "Information has been received from an office manager
that the physician heard from the physician's colleague that a 16 year old female
colleague's patient was given an unspecified dose of GARDASIL (Lot not reported) on
a Friday and on Monday the patient passed away (specific dates were unknown). The
reporter considered the event as disabling and life threatening. Additional
information has been requested." "Unknown"
"344399-1" "344399-1" "A 64-year-old male patient was admitted to the
hospital after becoming unresponsive. The family reported a 2-day history of
bleeding from the patient's rectum prior to admission. He had no recent changes in
medical conditions or medication regimen, which included Warfarin for stroke
prophylaxis secondary to atrial fibrillation. The patient had received an
inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his
international normalized ratio (INR) was 2.0. During the 6 months prior to
presentation, no medications were changed and no significant changes in the
patient's health were noted. Upon admission, the patient's international normalized
ratio was greater than 15; INR values over the previous 6 months had been
relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the
head showed a large parenchymal hemorrhagic infarction involving the left temporal,
parietal, and occipital lobes. In the emergency department, the patient received a
nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160
mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin
K. Following a neurosurgery evaluation, it was determined that nothing meaningful
could be done to alter the patient's outcome positively, and he died approximately
17 hours after admission. The patient's significant INR elevation, after being
relatively stable for at least 6 months, was thought to be due to an interaction
between warfarin and the influenza vaccination. The Horn Drug Interaction
Probability Scale indicated a possible interaction between warfarin and the
influenza vaccination. The authors also stated that the possibility of an unknown
contributor to the INR elevation could not be totally excluded. Seriousness
criterion: death. Causality: possible. Causality cannot be excluded as the
pathomechanism remains unclear and therefore the temporal relationship cannot be
assessed. Expectedness assessment according to agency label: The reported symptoms
are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No
change in benefit-risk-ratio. No measures necessary. 4/21/09 Per FDA COD:
Intracranial hemorrhage./pc" "No lab data for this event."
"344816-1" "344816-1" "None stated. 6/22/09 Autopsy report received DOS
4/22/09. Cause of Death: Sudden Infant Death Syndrome (SIDS). Manner of Death:
Natural." "No lab data for this event."
"345053-1" "345053-1" "Patient (68 year old male) received a flu shot on
10/10/07. He died that night in his sleep of a massive heart attack, presumably
in the early morning hours of 10/11/07. Although previously diagnosed with mild
artherosclerosis, he had never had a prior heart attack. He had just visited his
doctor the previous day and been given a clean bill of health. 5/6/09 Autopsy
report states COD as artherosclerotic & hypertensive-type cardiovascular disease
w/obesity as contributing condition. Manner of death natural. Report also states
40-50% stenosis of LAD by calcified atherosclerotic plaque; atherosclerosis of
aorta; cardiomegaly; obesity, BMI 34; hx of hypercholesterolemia; mild pulmonary
edema/congestion; prostatic nodular hyperplasia; hx of seizure disorder."
"Coroner's report conludes he died as the result of artherosclerotic and
hypersensitive-type cardiovascular disease, with obesity as a contributory
condition."
"345318-1" "345318-1" "None. 10/5/09 Autopsy received. Cause of Death:
Sudden Infant Death Syndrome. Additional information abstracted: History of co-
sleeping with both parents. Lividity present in anterior and posterior body with
areas of blanching on left face and abdomen. Petechial hemorrhages of thymus and
lungs. Pulmonary congestion and edema." "No lab data for this event."
"345435-1" "345435-1" "Information has been received via the internet
concerning a 21 year old female who was vaccinated with GARDASIL. The patient died
4 days after vaccination. The cause of death was unknown. No further information
is available." "Unknown"
"346137-1" "346137-1" "Information has been received from a consumer who
stated that he or she knew someone that died soon after receiving the MMR II.
Attempts to verify the existence of an identifiable patient and reporter have been
unsuccessful. No further information is available." "Unknown"
"346673-1" "346673-1" ""Initial report received from an assistant coroner
on 11 May 2009, with additional information received 13 May 2009 from an emergency
room health care professional. A 38-year-old male patient had received at 10AM in
the hospital emergency room on 04 May 2009, a first intramuscular right deltoid
injection of IMOVAX Rabies, lot number 446011A (also reported as 446601A; both lot
numbers are invalid sanofi pasteur lot numbers, manufacturer was reported as
Novartis). He also received a first right deltoid injection of Imogam Rabies-HT,
lot number 26NC8X1 (invalid sanofi pasteur lot number, manufacturer was reported as
Talecris). The sites of administration for the IMOVAX Rabies and Imogam Rabies-HT
were also reported as ""multiple deltoid, thigh, and buttocks"". At the time of the
report, there was no record of additional series doses and no record of other lot
numbers. The patient had been bitten by a bat on their right index finger on the
evening of 03 May 2009 and it was reported that the bat appeared to have been sick.
It was unknown if the bat had been captured for testing. An unspecified amount of
time after receiving the above vaccinations, the patient developed ""continuous""
vomiting and was subsequently found deceased on 09 May 2009. No additional
information was provided at the time of the report. Documents held by sender: None.
8/28/09 Autopsy report. Cause of Death: Fatty liver. Other significant conditions:
Chronic alcoholism. Opinion: The decedent has fatty liver changes and Mallory Weiss
Syndrome both of which are consistent with chronic alcoholism. 9/1/09 ER records
received DOS 5/4/09. Assessment: Bat Bite, Rabies Prone. Presents at ER with two
puncture wounds on right index finger. Bitten by bat that looked sick. Imogram
Rabies and Imovax rabies vaccine administered."" "Not reported"
"347042-1" "347042-1" "Per Coroner mom was in bed with baby between pillow
and mother on bed. Sheet & blanket in bed. Baby was on side when found. Mom
attempted mouth to mouth then drove infant to ED." "No lab data for this event."
"347248-1" "347248-1" "None noted. Pt was not seen in our office after
vaccine administration. Death was reported to our practice on Tuesday AM 5/26/09.
7/10/09 Autopsy report states COD as idiopathic epilepsy. Report also states pt had
history of cardiac pacemaker & seizure disorder. Admitted to hospital on 5/23/09
for local reaction w/swelling at injection site, had seizure & cardiac arrest on
5/24/09." "Autopsy by Medical Examiners office"
"347446-1" "347446-1" "5/5/09 Pt was brought into ED by EMS. Pt was
pulseless and apneic. Pronounced dead in ED. History was that pt was put on sofa
for a nap at 7 AM. At 915, EMS was called because pt was not breathing. Pt in
foster care. Coroner's case. Possible SIDS. 9/4/09 Coroner's Investigative Report
DOS 5/5/09. Decedent found on stomach, not breathing by parent. Parent called 9-1-1
and started CPR." "No lab data for this event."
"348859-1" "348859-1" ""Client received Twinrix vaccination on 5-26-09.
Clt's wife called Health Department 6-9-09 inquiring about services she received
and mentioned in passing that her husband passed away on 5-28-09. ""No one knows
what happened"" was quoted by the wife. 7/7/09 Autopsy report received. Cause of
death is Diphenhydramine intoxication."" "No lab data for this event."
"349339-1" "349339-1" "Information has been received from a registered
nurse concerning a patient with a history of coronary artery bypass who on an
unspecified date was vaccinated with ZOSTAVAX (Merck) (lot number, route and site
not reported) after cardiac bypass surgery and then died. It was unknown if the
patient sought medical attention. The patient's death was considered to be
disabling. Additional information has been requested." "Unknown"
"349653-1" "349653-1" ""Information has been received from a physician
concerning an 82 year old female patient with renal insufficiency, hypertension,
coronary artery disease, a history of ""diabetes"", asthma, and a previous
myocardial infarction (MI) who on 09-DEC-2008 was vaccinated subcutaneously in the
right arm with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 662860/1617X, expiration
date 14-MAY-2010). The physician reported that the patient's husband had shingles
and the patient inquired about the vaccine. The physician confirmed that the
patient's husband was not vaccinated with ZOSTAVAX (Merck) prior to developing
shingles. Shortly after vaccination within 1 week to 1 month the patient developed
an illness. The patient experienced shingles after receiving ZOSTAVAX (Merck). The
patient was admitted to the hospital on 09-JAN-2009. She was in the ICU and then
transferred to the long term unit prior to passing away. The physician explained
that the hospital records mention varicella encephalitis, chickenpox complicated
with encephalitis. He indicated that shingles was mentioned in the chart once. The
physician did not provide a definitive diagnosis or cause of death. Shingles and
pass away due to complication from the shingles were considered to be disabling and
immediately life-threatening. Upon international review, the patient's varicella
encephalitis was considered to be other important medical event. A lot check has
been requested. Additional information has been requested."" "Unknown"
"349674-1" "349674-1" "THERE WERE NO ADVERSE EVENTS THAT WE ARE AWARE OF
THE PATIENT DIED 06/11/09 WITH MEDICAL RESULTS PENDING I WAS TOLD I NEEDED TO FILL
OUT REPORT REGARDLESS OF LACK OF PROOF THAT VACCINATION CONTRIBUTED WITH HIS DEATH.
8/31/09 Autopsy Report received. DOD 6/11/09 Cause of Death: Sudden Infant Death
Syndrome (SIDS). Manner of Death: Natural." "No lab data for this event."
"349847-1" "349847-1" "UNKNOWN 6/29/09-autopsy report received-COD-
Undetermined." "No lab data for this event."
"350132-1" "350132-1" "None known. 7/2/09 Medical Examiner report received.
COD - Sudden infant death syndrome (SIDS)." "No lab data for this event."
"350666-1" "350666-1" "Information has been received from a physician
concerning his/her daughter's co-worker's daughter who on an unknown date was
vaccinated with GARDASIL. It was reported that the patient died after receiving a
dose of GARDASIL. The cause of death was not reported. Attempts to verify the
existence of an identifiable patient and reporter have been unsuccessful. No
further information is available." "Unknown"
"350967-1" "350967-1" "It was reported from an article published on 29-JUN-
2009 that there were 27 deaths in 2008 said to be associated with GARDASIL. This is
one of several reports received from the same source. Attempts are being made to
obtain additional identifying information to distinguish the individual patients
mentioned in this report. Additional information will be provided if available."
"Unknown"
"351421-1" "351421-1" "Information has been received from a case in
litigation via a case report concerning a child patient who on 22-MAR-2006 was
vaccinated with a dose of MMR II (Lot number not reported) and concomitantly on the
same day with a dose of poliovirus vaccine inactivated (unspecified) and a dose of
DTaP (unspecified). On an unknown date, the patient died. The family member alleged
that as a result of the administration of the vaccines on 22-MAR-2006. No further
information is available." "Unknown"
"351889-1" "351889-1" "This case was reported by a consumer and described
the occurrence of stroke in a 70-year-old male subject who was vaccinated with
TWINRIX (GlaxoSmithKline). A physician or other health care professional has not
verified this report. Co-suspect medication included COREG. The subject's medical
history included cataract, hearing loss, pacemaker (atrial fibrillation), quadruple
heart bypass and vitrectomy. Previous and/or concurrent vaccination included live
attenuated oral poliomyelitis vaccine; manufacturer unspecified; oral given on an
unspecified date. Concurrent medications included COUMADIN, PRINIVIL, VITAMIN C and
TYSHINI (unknown medication). On an unknown date, the subject started CARVEDILOL
(oral) at 3.25 mg twice per day. On 23 July 2007 the subject received unspecified
dose of TWINRIX (unknown). On 28 July 2007, five days after vaccination with
TWINRIX and while on CARVEDILOL, the subject experienced stroke, subdural hematoma,
headache, chills and tiredness. The subject was hospitalised. On 08 August 2007,
the subject had Computed axial tomography (CAT) scan and was diagnosed subdural
hematoma of the brain. The subject died on 10 August 2007 from stroke. It was
unknown whether an autopsy was performed. Vaccine AE template documented during the
call, after the call I realized that the patient was also taking COREG at the time
of death. Customer stated that the patient received the TWINRIX vaccine on July 23,
2007 and on July 28, 2007 he developed a severe headache, chills, and tiredness
that continued to worsen over time. The patient consulted his healthcare provider
that recommended a CAT scan because the patient was taking COUMADIN. The CAT scan
was performed on 8/8/2007 and a diagnosis of subdural hematoma of the brain was
made, the patient was then prepped for surgery which was successful but died on
8/10/2007 due to a stroke. 7/28/09 Death certificate received. Final cause of
death: Intracerebral hemorrhage. 8/25/09 DC summary outpatient and hospital
records received. Service dates 6/28/07 to 08/10/07. Assessment: Subdural hematoma,
atrial fibrillation, hypertension, coronary artery disease, hyperlipidemia, status
post craniotomy for evaculation of subdural hematoma, status post right basal
ganglia hemmorhage / brain herniation. Patient was complaining of headache.
Hematoma evacuated. Brain herniation. Terminal extubation performed and patient
expired." "08 August 2007, Computed axial tomography (CAT) scan: diagnosis
subdural hematoma of the brain. 8/25/09 DC summary outpatient and hospital records
received. Service dates 6/28/07 to 08/10/07. LABS and DIAGNOSTICS: CT - Abnormal,
subdural hematoma. Echocardiogram - Abnormal."
"351934-1" "351934-1" "Per translator client died 2 to 3 hrs. after
receiving vaccines on 7/2/09. Autopsy is pending to determine cause of death. Due
to language barrier unable to get more information.7/21/09-Nancy with Med Exam
office called with preliminary COD: Coronary Artery Disease with no other
significant conditions contributing to death. 8/13/09 Cause of Death: Coronary
artery disease. Manner of death: Natural. Autopsy report summary of findings: I.
Atherosclerotic cardiovascular disease. A. Calcific coronary artery disease,
marked, involving three major vessels and left main. B. Aortic atherosclerosis,
mild to moderate. II. Nephrosclerosis. III. Right rib fractures consistent with
resuscitation efforts." "Unknown"
"351970-1" "351970-1" "Information has been received from an investigator
concerning a 37 year old female with HIV and a history of migraine headaches and
methamphetamine abuse for 20 years who entered a study. On 08-MAY-2009 the patient
was enrolled in A5240 and vaccinated IM with the first dose of GARDASIL, 0.5ml, in
deltoid. On 22-JUN-2009 the patient developed the following adverse events: altered
mental status grade 3 (dysarthria, anomia, confusion); headache grade 3 (presented
to HD 22-JUN-09 with AMS, HA). CT angle of head showed diffuse cerebral edema);
left hand numbness grade 2. On 02-JUL-2009 the patient developed decreased
neurological reflexes grade 4 (life threatening), pupils fixed and dilated
bilaterally grade 4 (life threatening), and death. The report was as follows: The
patient presented to emergency department on 22-JUN-2009 with migraine-like
headache, left hand numbness, dysarthria and anomia. CT read as normal, patient
discharged, the patient returned on 23-JUN-2009 with persistent headache, anomia.
At that time, she was not on treatment for HIV and her CD4 count was 263. She was
admitted to the neurology service and empirically treated with antibiotics for
bacterial and HSV meningitis. Lumbar puncture showed borderline low glucose,
elevated protein and a lymphocytic pleocytosis without red blood cells, CSF tests
for EBV, HSV, VZV, Cryptococcus, VDRL, AFB smear were negative as well as CSF
culture for bacteria, fungus and mycobacteria. CSF cytology was negative, flow
cytometry was not performed. JC virus PCR was ordered, but results not reported.
Toxoplasma IgG was negative. Blood cultures, coccidioidomycosis titers, serum
cryptococcal antigen, RPR were all negative. Prior quantiferon testing in 2004 was
positive without subsequent isoniazid treatment chest X ray during admission was
negative as were 2 sputum for AFB smear and culture. MRI showed diffuse cerebral
edema with leptomeningeal enhancement. Repeated lumbar puncture showed
normalization of glucose. During the hospitalization, her symptoms had improved.
Discharged to home 29-JUN-2009 with diagnosis of resolving viral meningitis vs. HIV
encephalopathy. Initial consideration had been made of TB meningitis but her
symptomatic improvement without TB treatment made this less likely. HIV treatment
was not started during the hospitalization but was planned pending reevaluation
after discharge and final review of all cultures and pending test. Re-presented
emergency department on 01-JUL-2009 complained of worsening headache, symptoms and
confusion; discharged as it was thought her symptoms were consistent with previous
status. Returned to emergency department that night with confusion and altered
mental status. At 5 AM on 02-JUL-2009, she acutely became unresponsive in the
emergency room, requiring intubation and was noted to have fixed, dilated pupils
bilaterally. Emergent head CT revealed diffuse cerebral edema and herniation.
Pronounced brain dead of unknown cause on 02-JUL-2009. Post mortem pending, would
take up to 8 weeks at this site before results were available. Relevant diagnostic
tests conducted at the time of death occurred were as follows: On 22-JUN-2009,
computerized tomography (CT, CT Scan, CAT Scan) of head: diffuse cerebral edema: 3
am left ICA aneurysm; bilat symm, optic nerve sheath distention. On 23-JUN-2009,
magnetic resonance imaging (MRI) of brain: with contrast, diffuse supratentorial
leptomeningeal enhancement, consistent with leptomeningitis. Diffuse sulcal
effacement. Vague non enhancing T2/FLAIR hyperintensity multiple sites suggestive
of infectious or toxic/metabolic etiology or PML. 02-JUL-2009, computerized
tomography (CT, CT Scan, CAT Scan) of brain, profound diffuse sulcal effacement
throughout cerebral hemispheres and posterior fossa. Severe downward tonsillar
herniation and severe upward transtentorial herniation with compression of
brainstem. The reporting investigator felt the event death was not related to study
therapy. Study therapy association for the other events was not reported. Follow up
information has been received from medical records. The patient had a past medical
history significant for migraine headaches and HIV (new diagnosis, not on
antiretrovirals, recent CD4 count 263 to 381), substance abuse, recent Bell's palsy
January 2009 and no known drug allergies. She was on no medications upon admission.
The patient's CD4 count on 24-JUN-2009 was 308 and a viral load on 12-JUN-2009 was
45310, diagnosed in March of 2009 and currently not on antiretroviral therapy. She
was currently living in a drug rehab facility. The patient also had a history of
past methamphetamine abuse and had been sober since March of 2009. The patient also
had a questionable psychiatric history with a potential diagnosis of anxiety,
borderline personality disorder, and depression. The patient also had a history of
migraine disorders. She presented with a headache typical of her migraines but with
additional features of left hand numbness, dysarthria, and anomia. The patient
underwent a CT scan which was negative in the ED, and was initially sent home, and
re-presented the next day with similar headache with anomia without hand numbness.
A lumbar puncture was performed in the ED, remarkable for lymphocytic pleocytosis
and decreased glucose, as well as elevated protein, and an MRI showed evidence for
meningoencephalitis. The patient was admitted to the neurology service for further
work up. The patient was hospitalized from 23-JUN-2009 to 28-JUN-2009. She was
initially placed on vancomycin, cefapime, acyclovir, and ampicillin for bacterial
meningitis treatment and HIV encephalitis treatment. When the results of the lumbar
puncture were obtained, the antibiotics were discontinued and the patient remained
on acyclovir until her PCR came back as negative. Infectious disease was consulted
and upon discussion with them, the most likely differential diagnosis of the
patient's encephalitis was HIV encephalitis. Initially, a diagnosis of possible TB
meningitis/encephalitis was entertained given the slightly low glucose. However,
given that the glucose normalized on repeat lumbar puncture, the improvement of the
patient's condition throughout the hospitalization, and relatively benign course of
the patient's encephalopathy, it was felt that TB was much less likely. Lymphoma
was still a possibility for the patient's symptoms, and cytology was pending,
although this was felt to be a much less likely diagnosis. The patient was
discharged back to her program, with plans for close followup: retroviral therapy
was to be initiated and she was to be followed up in neurology within 1 to 2 weeks.
The discharge diagnosis on 28-JUN-2009 was human immunodeficiency virus (HIV)
encephalopathy. Discharge medications included IMITREX, amlodipine, compazine (10
mg PO Q8H, PRN nausea/vomiting), ibuprofen (PRN headache). The patient was
hospitalized again on 02-JUL-2009 with acute mental status changes. She was brought
to the ED" "head computed axial tomography, 06/22/2009, see narrative; spinal tap,
06/23/2009, see narrative; spinal tap, 06/23/2009, normalization of glucose;
magnetic resonance imaging, 06/23/2009, brain: see narrative; head computed axial
tomography, 07/02/2009, brain: see narrative; magnetic resonance imaging, diffuse
cerebral edema with leptomeningeal enhancement; plasma HIV RNA quantification,
03/17/2009, HIV infected; plasma HIV RNA quantification, 06/12/2009, 45310
copies/ml; blood CD4 count, 06/23/2009, 263 cells/mm3; WBC count, 06/24/2009, 3.3
k/ul, low; blood CD4 count, 06/24/2009, 308 cells/mm3; hematocrit, 06/24/2009, 32.3
%, low; hemoglobin, 06/24/2009, 10.9 g/dl, low; WBC count, 06/25/2009, 2.6 k/ul,
low; absolute lymphocyte count, 06/25/2009, 0.9 k/ul, low; absolute neutrophil
count, 06/25/2009, low; hematocrit, 06/25/2009, low; hemoglobin, 06/25/2009, low;
monocyte count, 06/25/2009, high; red blood cell count, 06/25/2009, 3.65 million/u,
low; WBC count, 06/26/2009, 3.1 k/ul, low; hematocrit, 06/26/2009,"
"352162-1" "352162-1" "The baby died under suspicious conditions this
morning. 7/23/09 Medical records and DC summary received. Assessment: Multisystem
organ failure, severe traumatic brain injury, acute respiratory distress syndrome,
metabolic acidosis, rule out nonaccidental trauma. Patient presents with frontal
traumatic brain injury, bilateral pneumothoraces, decreased hemoglobin and
hematocrit. Pupils are 4 mm and fixed. Does not move face or extremities. GCS of
6T. Bruising to frontal scalp area, left knee. No corneal (reflex) no gag (reflex),
no movement to pain. Diffuse hypotonia. Preretinal hemorrhage. Corneal edema.
Anoxic encephalopathy. Depressed brain stem reflexes." "7/23/09 Medical records
and DC summary received. LABS and DIAGNOSTICS: CT Brain - Frontal hemorrhage. CBC -
WBC 2.28 (L) HGB 14.5 (H) HCT 40.3 (H) MCV 88 (H) MCHC 36.2 (H) PLT 76 (L) MONO
2.6% (L) EOS 0.0% (L) NEUT# 0.89 (L) LYMPH# 1.30 (L) MONO# 0.06 (L) EOS# 0.00 (L).
Coagulation - Protime 15.7 (H) INR 1.7 (H) PTT 140 (H) D-DIMER 35.20 (H). CHEM - CL
124 (H) Glucose 255 (H) Total Protein 4.5 (L) Albumin 3.2 (L) A/G ratio 2.5 (H)
Calcium 7.7 (L) SGOT/AST 162 (H) SGPT/ALT 319 (H) Total Alk Phos 579 (H) Total CK
688 (H) Lactate 9.7 (H). Urine Tox Screen - Benzodiazapines. Urinalysis - color
red, cloudy, glucose 100, blood large amt, protein 100, bacteria trace. Urine
culture - E. Coli. Tracheal culture - Strep agalactiae, Staph aureus. Blood culture
- no growth. Chest X-ray - abnormal, right pneumothorax."
"352293-1" "352293-1" "She was born August 22nd, 2008, perfectly healthy,
an easy, happy, delicate baby girl. She did not receive any Hep B vaccines.
However, at two and four months she received all other vaccines according to the
CDC's schedule. Looking back, I see the downward spiral, but did not know what to
look at the time. For this, I am extremely ashamed to admit, being that I have a
medical degree. Her 2 month vaccinations were given 10/22/08. She was initially
excessively sleepy, at 5 days she was irritable and refused to eat, within the
first week her tongue began involuntarily protruding, at 5-6 weeks I believe she
suffered a seizure which I did not recognize at the time as being that, she would
also have frequent episodes of high pitched screaming. After the 4 month vaccines
(12/23/08), similar things took place, however, there was not a seizure episode
that I can recall. But she continued to become less interactive (would not respond
to a loud blender 2 feet from her, sit quietly in bath chair for an hour, not react
to play with siblings), bloated, allergy and infectious symptoms (but never spiked
a high fever). I did give her tylenol the first two days after both sets of
vaccinations because of the high fevers both my boys spiked with their
vaccinations. Patient took a bottle at 6am, was awake til 945a, took another
bottle, fell asleep in her papazon swing supine, nothing over her head, she made no
sounds, picked her up to change her 45 ming later, and she was lifeless. Autopsy
found nothing, unknown/undetermined. I am looking to find the appropriate person to
review it and do further testing as indicated." "Autopsy unknow/undetermined, did
not fit SIDS. Planning further review of autopsy by private pathologist, hopedully
that specializes in autoimmune disorders."
"352836-1" "352836-1" ""Information has been received from a published
article that an overwhelming postsplenectomy infection (OPSI) is a low-incidence
entity with a high mortality rate despite aggressive therapy. Although initial
symptoms may be mild and nonspecific, it can progress rapidly to Waterhouse-
Friderichsen syndrome with full blown septic shock and disseminated intravascular
coagulation (DIC). Overwhelming postsplenectomy infection is known to occur at any
time after splenectomy, even in patients who have received pneumococcal
immunization and/or chemoprophylaxis. Although the term OPSI gives the impression
of a ""postsurgical"" complication, it has been seen in association with conditions
predisposing to functional hyposplenism and in children with congenital asplenia.
The physicians reported there had been no previously reported cases of OPSI in a
pneumococcal vaccinated adult with congenital asplenia. A 67 year old woman with
congenital asplenia presented to the emergency department complaining of chills,
fever, severe low back pain, and vomiting of 24 hours of duration. She had a recent
history of a treated urinary tract infection and a remote history of sepsis and
pneumonia, for which she was hospitalized and treated in other institutions. The
patient also had a diagnosis of lung fibrosis of uncertain etiology and was a
chronic alcohol user. The patient had received pneumococcal vaccination 1 year
prior. On physical examination, she was found to be alert and in no acute distress.
Her temperature was 38 degrees C orally; blood pressure, 100/42 mmHg; heart rate,
113/min; respiratory rate, 26/min; and oxygen saturation, 95% on room air. She had
mild tenderness to palpation in the right lower abdominal quadrant and positive
bowel sounds. Her initial blood workup showed an elevated white blood cell count of
15.5 x 10^3/mm^3 with 94% neutrophils. A chest x-ray revealed right lung haziness.
A computer tomographic scan of the abdomen and pelvis documented no acute
intraabdominal process. Blood and urine samples were obtained for cultures. Within
a few hours of presentation, the patient developed a diffuse purpuric rash with
severe hypotension. Cefepime and vancomycin were started. Additional laboratory
tests revealed disseminated intravascular coagulation (DIC) and metabolic acidosis.
Cortisol levels were within normal limits, although lower than expected considering
the patient's condition. Despite administration of vasopressors agents and
intravenous fluids, she developed shock and died in less than 24 hours after
presentation. At autopsy a diffuse purpuric rash was noted. There was massive
bilateral adrenocortical hemorrhagic necrosis. A recent subdural hemorrhage and
scattered focal hemorrhages in the heart and gastrointestinal tract were present.
The right lung was extensively fibrotic. Interstitial fibrosis and bronchiectasis
were seen bilaterally. There were focci of organizing pneumonia in the right upper
lobe and a focus of acute bronchitis in the right middle lobe. The liver showed
severe steatosis and findings consistent with chronic alcoholic liver disease.
Arterionephrosclerosis was seen in both kidneys. The bone marrow was hypercellular
with a few paratrabecular aggregates of monotonous appearing lymphocytes. Asplenia
was the only congenital abnormality. Premortem blood cultures reported after death
grew Streptococcus pneumoniae sensitive to penicillin and cefotaxime. The urine
culture had negative results. Although the patient provided a history of congenital
asplenia, the absence of alarming signs at presentation, in addition to an up-to-
date pneumococcal vaccination and noncritical initial physical examination and
laboratory studies, gave the false impression of a relatively stable patient who
could be worked up for a precise diagnosis and subsequent treatment. Prior
pneumococcal vaccination should not be reassuring as seen in this patient who in
vivo blood cultures grew Streptococcus pneumoniae. The protective role of
pneumococcal 23-valent vaccine for adults aged greater than 65 years remains
controversial because some older patient do not develop an immune response to the
most prevalent serotypes causing invasive disease. In addition, antibody
concentrations and response may be lower in elderly patients with comorbid
illnesses such as alcoholic cirrhosis, chronic obstructive pulmonary disease, and
lymphoproliferative disorders. The 67 year old patient had comorbid illnesses
including chronic alcoholic liver disease and severe lung fibrosis. Because OPSI Is
a virulent entity with a 50% to 80% case fatality ensuing in less than 48 hours,
diagnostic workup should never delay the initiation of empiric antibiotic therapy.
As seen in this case, when the initial clinical presentation is mild or
nonspecific, physicians may have a false sense of security and attempt to reach a
precise diagnosis instead of intervening early with empiric antibiotics.
Consequently, this may result in death, even when the delay is only of a few hours.
Overwhelming postsplenectomy infection can occur at any time after splenectomy and
as demonstrated by this patient should also be considered in adults with congenital
asplenia. Additional information is expected. A copy of the published article is
attached as further documentation of the patient's experience. 9/3/09 Per FDA
COD=Pneumococcal Sepsis."" "blood pressure, 100/42 mmHg; chest X-ray, revealed
right lung haziness; computed axial, abdomen and pelvis showed no acute
intraabdominal process; diagnostic laboratory, showed disseminated intravascular
coagulation (DIC) and metabolic acidosis; body temp, 38 degr; total heartbeat
count, 113 min; blood culture, showed streptococcus pneumoniae after death;
respiratory rate, 26 min; arterial blood O2, 95%, on room air; WBC count, 15.5
10^3; absolute neutrophil, 94%;"
"352838-1" "352838-1" "Information has been received from a consumer
concerning a fried of the physician's daughter, who on an unspecified date was
vaccinated with a dose of MMR II. Subsequently the patient died. The cause of death
was unknown. Attempts are being made to verify the existence of an identifiable
patient. This is one of two reports from the same source. No further information is
available." "Unknown"
"353395-1" "353395-1" "This case was reported by a healthcare professional,
via a GSK representative and described the occurrence of death nos in a 4-month-old
male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent
vaccination included Haemophilus influenza type b vaccine (non-gsk) (non-GSK
manufacturer) given on 15 July 2009; PEDIARIX (GlaxoSmithKline) given on 15 July
2009; PREVNAR (non-gsk) (non-GSK manufacturer) given on 15 July 2009. On 15 July
2009 the subject received unspecified dose of ROTARIX (details unknown). On 19 July
2009, 4 days after vaccination with ROTARIX, the subject experienced death nos. The
healthcare professional considered the event was possibly related to vaccination
with ROTARIX. The subject died on 19 July 2009; cause of death was not specified.
It was unknown whether an autopsy was performed. No further details were reported.
8/13/09 Received PCP medical records of 3/24/09- Records reveal patient seen in
office on 7/7/09 for wet cough, nasal congestion, rhinitis, eating difficulty. Dx
viral URI. Sick family member. RTC 7/9/09 w/vomiting, cough, decreased appetite x
3 days. Dx viral gastroenteritis. RTC 7/15, well child visit w/shots.
Immediately after shots had emesis x 1 then perioral cyanosis w/recovery in 5 min.
ER records of 7/18/09 included which reveal patient arrived in full arrest approx 9
hr after being put to bed w/Tylenol, in asystole & unable to intubate due to rigor.
10/5/09 ER records received for 7/18/09 which had been previously received." "UNK"
"354571-1" "354571-1" ""Information regarding PREVNAR was received from a
healthcare professional regarding a 12-month-old male patient who experienced
pneumococcal meningitis, pneumococcal sepsis, upper respiratory infection and
stroke. The patient received the fourth dose on 30-May-2009. The patient also
received the first dose of VAQTA (Merck) on 30-May-2009. During the winter of 2008-
2009 the patient experienced wheezing, treatment unknown. On 09-Jun-2009 the
patient was seen in the office with wheezing treated with ORAPRED in addition to
PULMICORT and Albuterol inhalation therapy. On 13-Jun-2009 follow-up showed the
wheezing resolved. On 20-Jun-2009 the patient presented to the physician with a two
day history of fever, fussiness and being uncomfortable per the parents. In the
office the child engaged with the staff and was playful. He was afebrile with no
cough noted and was diagnosed with an upper respiratory infection, treatment
unknown. On 21-Jun-2009 the parents telephoned the office and ""seemed nervous
which was not normal for them"". The physician examined the child and noticed a
drooping eye, side unknown, and was diagnosed with stroke. This event was
considered medically important. The child was admitted to the local hospital and on
an unknown date was transported to another hospital. On 23-Jun-2009 the child died.
The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis.
Serotype testing was not performed at the time of this report but is being
requested by the child's physician. No additional information was available at this
time of this report. 8/24/09 Hospital records received DOS 6/21/09 to 6/23/09.
Assessment: Fever. meningitis. Patient earlier this day presented at ED with fever.
Seen later for drooping and swelling of right eyelid and vomiting after Advil.
Moderate distressed, photophobia, fussiness. Not alert, moaning, hypotonic. 9/1/09-
records received for 6/23/09-COD-Pneumococcal meningitis, septic shock, acute
respiratory distress syndrome, multiorgan failure, left hemispheric infarct.
Transferred from another facility after presenting with febrile illness,
progressive lethargy and poor feeding and worsening respiratory distress. Developed
respiratory failure intubation and ventilator support, developed shock, multiorgan
failure."" "CSF culture (results: Positive for Streptococcus pneumoniae) and blood
culture (results: Positive for Streptococcus pneumoniae) were done in Jun-2009.
8/24/09 Hospital records received DOS 6/21/09 to 6/23/09. LABS and DIAGNOSTICS:
Urinalysis - Dark Yellow, Ketone 80, Protein 300, RBC Many /hpf, Bacteria Many
/hpf, Hyaline Cast 10-20 /hpf. Basic Metabolic Profile - CO2 19 mmol/L (L) Glucose
118 mg/dl (H) Phosphorus 2.5 mg/dl (L). CBC - RBC 3.93 /pL (L) HGB 10.6 g/dl (L)
HCT 32.3% (L) RDW CV 16% (H) Platelet 24 /nL (L) Monocytes 3.0% (L) Bands 20% (H)
Lymphocytes Abs 2.8 (L). Prothrombin Time 20.2 sec (H) Activated PTT 42.8 sec (H)
Fibrinogen 539 mg/dl (H). C-Reactive Protein 315.2 mg/L (H). Sed Rate 100 mm/hr
(H). Spinal Tap / CSF - Turbid, WBC 167 /UL (H), RBC 15 /UL (H) Lymphocytes 25%
(L), glucose <1 mg/dl (L), Total Protein 474 mg/dl (H), gram stain Gram positive
cocci, culture Strep pneumoniae. Blood culture - gram positive cocci, Strep
pneumoniae. Urine culture - no growth. Vancomycin Trough 57.7 ug/ml "
"355131-1" "355131-1" "Pt found dead in crib on 8/14/09. Preliminary
autopsy showed no cause of death. 12/29/2009 Autopsy report received. Cause of
Death: Sudden Unexplained Infant Death. Additional information abstracted: History
of prone sleep position, Intrathoracic petechia (pleural and thymus involvement).
Toxicology: acetaminophen (+), carbon monoxide <5 % Sat. Skeletal Survey -
Hypoventilatory chest." "No lab data for this event."
"355219-1" "355219-1" ""Decedent is a 7 day old neonate who was given the
hepatitis B immunization at birth (Energix B). Lot # AHBVB663AA. Decedent
discharged on March 27, 2009 without complications. On March 30, 2009 decedent was
taken to pediatrician mild jaundice. Labs taken and was told to come back in two
weeks. In the evening of March 31, 2009, the decedent was very fussy, vomiting, and
not taking formula. The mother tried comforting the baby all evening of March 31,
2009 and in the early morning hours of April 1, 2009. At approximately 6 AM, the
mother felt the baby to be cold (the mother was sleeping with the baby in a
possibly compromising position). The mother got up with the baby and walked her
around and then when she was going to bed again, she saw the neonate take two deep
breaths and become unresponsive. Autopsy revealed a normally developed female
neonate with extensive necrotizing eosinophilic myocarditis. I did a literature
search and found that hepatitis B vaccine maybe associated with this type of
myocarditis and that is why I am reporting it. The cause of death for the death
certificate reads ""necrotizing eosinophilic myocarditis."" I am not including the
vaccination because I do not believe there is a direct correlation, but I felt I
should report the case for potential correlation. The neonate was never given any
prescription medications that I am aware of. Not sure if mother gave anything.
8/26/09-autopsy report received-COD-Necrotizing eosinophilic myocarditis."" "none
besides the histology of the heart."
"355396-1" "355396-1" "On 10-01-08 he complained of soreness and unusual
weakness and numbness in legs (after physical therapy). Had to have help to & from
wheelchair and bed. Much worse Thur, Fri. By Sat. he could not move on his own
from chest down. Convinced him to go to ER on Sunday. Paralyzed by PM 10-05-08.
Transferred to hospital 10-05-08, put in ICU AM 10-06-08. Code blue (heart failure
10-10-08). See med. reports (Also I kept diary) too numerous. 9/11/09 Hospital
records received DOS 10/6/08 to 10/21/08. Assessment: Cardiorespiratory failure.
Advanced Guillain-Barre Syndrome. Chronic renal disease with initiation of
hemodialysis. Type 2 Diabetes Mellitus with increased rhabdomyolysis. Episode of
supraventricular tachycardia. Episode of cardiac arrhythmia. Probable sepsis.
Patient transfered to facility after noticing weakness in upper and lower
extremity. Plasmapheresus. Renal functioning worsened. Flaccid. Pneumonia.
Extubated per patient's desire. Quickly expired. 10/5/09 Death Cert received with
COD=Cardiorespiratory Failure due to End Stage Renal Disease due to Guillain-Barre
Syndrome" "See med. records - too numerous. 9/11/09 Hospital records received DOS
10/6/08 to 10/21/08. LABS and DIAGNOSTICS: CD4/CD8 Ratio - Normal. CSF Oligoclonal
Bands (IEF) - Total Protein 133 mg/dL (H) IgG 11.20 mg/dL (H) Albumin 77.7 mg/dL
(H) Synthesis Rate 11.3 (H). Serum - IgG 558 mg/dL (L) Albumin 2200 mg/dL (L). No
evidence of IgG bands in CSF or serum. CSF - Glucose 94 mg/dL (H) Sodium 146 mmol/L
(H) Potassium 5.1 mmol/L (H). CHEM - Potassium 7.5 mmol/L (H) Chloride 113 mmol/L
(H) BUN 104 mg/dL (H) Creatinine 3.84 mg/dL (H) Glucose 247 mg/dL (H) ALKPHOS 525
U/L (H) ALT 901 U/L (H) AST 3348 U/L (H) Amylase 191 U/L (H) Bilirubin Direct 1.0
mg/dL (H) LDH 560 U/L (H) Phos 14.1 mg/dL (H) SGGT 189 U/L (H) Uric Acid 9.5 mg/dL
(H) CK 73311 U/L (H) CKMB 172.4 ng/mL (H) Troponin 6.38 ng/mL (H). CRP 24.27 mg d/L
(H). D-DMR >1000 ng/mL (H). PT 23.6 drc (H). Parathroid PTH 426.2 pg/mL (H).
Thyroid Profile abnormal. HGB A1C 8.2% (H). CBC - HGB 7.4 g/dL (L) HCT 22.5% (L)
RBC 2.51 M/mm3 (L) RDW 18.5% (H) Platelets 143 Thou"
"355624-1" "355624-1" "Information has been received from a consumer who
reported a female child died after the second dose of MMR II (route and lot number
not reported). Attempts to verify the existence of an identifiable patient and
reporter have been unsuccessful." "Unknown"
"356473-1" "356473-1" "Death. 9/11/09 Autopsy received DOD 07/09/2009.
Sudden Unexplained Death in Infancy (SUIDI or SIDS). The manner of death is
natural. Additional information abstracted: Infant was found dead in crib,
positioned supine. No evidence of injury." "Autopsy was performed. 9/11/09
Autopsy received DOD 07/09/2009. LABS and DIAGNOSTICS: Negative Radiographic
Skeletal Survey. Toxicology Blood - Ethanol (-) No Drugs Detected."
"356603-1" "356603-1" "Shortness of breath, initially with exertion.
Progressive to dyspnea at rest, pulmonary emboli, right heart failure."
"Cardiolyte stress test; chest CT scan; pulmonary function testing; heart
catheterization; open lung biopsy."
"356666-1" "356666-1" "This case was reported by a physician and described
the occurrence of abnormal liver function tests in an infant subject of unspecified
gender who was vaccinated with ENGERIX B (GlaxoSmithKline). There was no
information available regarding concomitant vaccinations, medications or medical
history. On an unspecified date the subject received 1st dose of ENGERIX B (details
unknown) at birth. Less than one week after vaccination with ENGERIX B, the subject
experienced abnormal liver function tests and fever. Blood levels were checked 6
days after vaccination with ENGERIX B and abnormal liver function tests were noted,
along with fever. This case was assessed as medically serious by GSK. At the time
of reporting the outcome of the events was unspecified. No additional information
was available. Follow-up information received on 03 September 2009 indicated that
the events of abnormal liver function tests were likely secondary to herpes simplex
virus type II infection and not ENGERIX B. It was reported that the subject died
with cause of death reported as herpes simplex virus type II. An autopsy was
performed, however, results were not provided." "Liver function test, abnormal"
"356938-1" "356938-1" "Headache, Nausea, dizziness, chilling, tiredness,
shortness of breath, complained of chest plain, severe cramps. 9/14/09 Received
vaccine & PCP medical records which reveal patient seen 12/5/07 & 2/27/08 with sore
throat, fever, chills, fatigue, body aches, productive cough w/yellow sputum & HA.
Dx both times w/acute bronchitis & tx w/antibiotics & cough syrup. 9/25/09 Autopsy
report received DOD 09/12/2008. Acute Cardiac Arrhythmia of Unknown Etiology.
Addtional information abstracted: Heart with focal microscopic ischemic changes,
pulmonary congestion and edema. Rare petechiae: conjunctival, periorbital and
laryngeal. Resuscitation related sternal fracture." "None. I do have copies of
all medical history from 01/08/2004 to the time of her death that I can provide if
needed. The Medical Examiners office will have tissue samples until 4/2010."
"357588-1" "357588-1" "NICU graduate (24 5/7 wks) gestation) Brought to
office apneic 9/08/09 CPR unsuccessful. Chron. age about 6 mos DOB 3/17/09." "None"
"358002-1" "358002-1" "Death of patient. 11/09/09 Medical records received
for DOS 9/19. Police dept summary and autopsy report. Final DX: Fibroelastosis,
natural death Infant stopped breathing. Father gave CPR until medics arrived.
Intubated. Transported. Reintubated in ED. ED not able to resuscitate. Bil retinal
hemorrhages. Infant had cold sx and fussiness since vaccine. Got worse. Not
sleeping or eating well. Labored breathing. Vomited 3-4x that morning. PMD had
wanted recheck for floppy baby syndrome. Autopsy revealed markedly enlarged heart."
"Labs & Diags: Brain bx: Focal neuronal ischemic changes, acute, R frontal
lobe. No evidence of traumatic brain injury"
"358388-1" "358388-1" "Subject in pneumococcal vaccine trial, with severe
COPD, died due to respiratory failure secondary to COPD. Vaccination took place
9/19/2007. According to the physician the relationship is 'None'. We would be happy
to forward the Study's SAE reporting form upon request. 10/1/09 PSCC Report DOS
6/2/09 Assessment: Death Due to COPD. Subject died in hospital from respiratory
failure secondary to COPD. 10/06/09 Death certificate states COD as COPD w/diabetes
mellitus, atril flutter, hypertension & CVA as contributing factors ICD-9 Code:
491.20 10/6/09 Death certificate received. Cause of death: COPD" "No lab data for
this event."
"358921-1" "358921-1" "Information has been received from a registered
nurse concerning her 84 year old father with multiple medical problems who in 1995
was vaccinated with a dose of PNEUMOVAX 23 (lot, route and site of administration
not reported). The nurse reported that her father may have had aspiration pneumonia
when he died on 27-JUL-2000. Her father was a hospice patient at the time of his
death. The registered nurse felt that her father's death and aspiration pneumonia
were not related to therapy with PNEUMOVAX 23. No further information is available.
11/16/09 Certificate of Death received. DOD 7/27/2000. Cause of Death: Alzheimers
Disease." "Unknown"
"359035-1" "359035-1" "Information has been received from a group of
physicians at an inservice meeting concerning a male patient who on an unspecified
date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not
reported). The group of physician's indicated that they had heard of a patient who
developed necrotizing lesions after getting ZOSTAVAX (Merck) and died. The
physicians didn't know if it was from the ZOSTAVAX (Merck) but they believed that
it was. Necrotizing lesions was considered to be disabling and immediately life-
threatening by the reporters. Attempts are being made to clarify the existence of
an identifiable patient. Additional information has been requested." "Unknown"
"359066-1" "359066-1" "Anaphylaxis shock. Angioedema. Death." "Blood sugar
- Accucheck 444/424"
"359358-1" "359358-1" "Received Varicella vaccine around 11:40-12:00 noon.
Left here to go to grandmother's house. They were leaving & child said I think I am
having a seizure to her mom. She came out of the seizure & screamed, stopped
breathing. Mom started CPR until ambulance got there & took over shocked her. Took
to hospital where they told her nothing else they could do for her. 10/23/2009
received hospital records for ED visit 7/20/2009. Patient presents with sx of a
seizure which resulted in cessation of breathing. Per ambulance to ED , patient
unresponsive, pupils fixed and dilated despite resuscitation efforts. Final DX:
Cardiac Arrest 12/8/09 Death Certificate received. DOD 7/20/09. Final cause of
death: Cardiac Arrest, Seizure Disorder." "Labs: CBC: Lymphocytes 88 H CMP: Glucose
394 H, SGOT 59 H Total protein 4.5, Albumin 2.5, Calcium 7.9, CO2 17 all Low
values Blood gases abnormal, Allen Test positive DX studies/Xrays: CXR abnormal,
noting in both lungs diffuse ground glass opacities"
"359582-1" "359582-1" "Flu like symptoms: Fever, SOB. Was admitted to the
hospital on 9/25/09 and was diagnosed with H1N1 and deteriorated; was placed on a
ventilator and expired on 10/5/09 at approxitmately 1800 hours. 10/9/09 Prelim
autopsy report received with the following findings: Multilobar pneumonia (all
lobes severely involved). Post mortem bacterial, fungal, acid fast and viral
cultures pending. H1N1 (-). Renal failure probably 2' to acute tubular necrosis.
10/21/2009 hospital records for date 10/1- 10/5/ 2009, patient with 1 week hx of
fever, malaise. nausea, vomiting, and chest discomfort. Saw PCP 9/26/2009 and
thought to be viral, sx progressed, cough worsened and patient became dyspneic. To
hospital 10/1/2009 in respiratory failure. TX: placed on continuous ventilation
with nitrous oxide and pressors, IV ABX Zyvox, Clindamycin, Levaquin, Aztreonam,
Cleocin, Xigris, Serum Bicarbonate. DC DX's: Severe Multilobar Pneumonia,
Respiratory failure, Renal failure, Metabolic Acidosis. 12/29/09 Autopsy report
received. DOD 10/5/2009. Cause of Death: Multilobar pneumonia secondary to
Legionella, non-pneumophilia species. Additional information abstracted: Patient
developed community-acquired bilateral pneumonia causing severe hypoxia and
multiorgan system failure." "Labs and Diagnostics: H1N1 (-). Labs: Admission:
CBC norm, CMP: Na 127, K-3.2, Albumin-1.9 all Low, Creatinine 2.4, BUN-36, AST-158,
ALT-81 all HIgh Viral respiratory panel neg, MRSA screening negative, Urine strep
pneumonia antigen negative, Mycoplasma IgM AB negative, Urine Legionella antigen
negative, Blood and Urine cultures negative Dx studies/Xrays: CXR multilobar
pneumonia , Echocardiogram pericardial effusion"
"359853-1" "359853-1" "Information has been received from a consumer
concerning his approximately 78 year old wife with lymphoma diagnosed in February
2007. The patient was underwent chemotherapy and radiation. In December 2007 she
experienced a recurrent lymphoma and was prescribed oral chemotherapy from January
2008 to May 2008. In October 2008 she was vaccinated with a dose of ZOSTAVAX
(Merck) (lot # not reported). Several weeks later, she was diagnosed with leukemia
and experienced recurrence of lymphoma. On an unspecified date she was
hospitalized. She received unspecified treatment which was unsuccessful. The
patient died on 01-JAN-2009. The cause of death were Lymphoma and leukemia. No
further information is available. 10/13/09 Hospital records and DC summary
received for dates 12/11/08 to 12/23/08. DC DX: Lower back pain-resolved, fever-
resolved, UTI-resolved, dental abscess, malnutrition. Presenting SX: pt c/o pain in
back and both hips. Assessment: Pt found to have fever. Pt treated for current
medical conditions and acute conditions and DC to rehab facility. 10/15/09
Medical records received for date of service 10/9/08. Shingles (Zostavax) vaccine
administered on 10/9/08. Physician reports that pt. did not call office to report
an adverse reaction. 10/21/09 Death Certificate DOD 1/1/2009. Myelodysplastic
syndrome. Acute myelogenous leukemia. Anemia." "Unknown 10/13/09 Hospital records
and DC summary received for dates 12/11/08 to 12/23/08. Diagnostics/Labs: CT
abdomen and pelvis�RUQ mass, bilateral pleural effusion. CXR-decreased inspiration
w/ basilar effusion/atelectasis. US RUQ - cholecystitis. EKG WNL. Platelet 13(L),
HGB 9.8(L), HCT 30.8(L), BUN 28(H), urine culture(+) E-coli.10/15/09 Medical
records received for date of service 10/9/08. Diagnostics and Labs: None."
"360397-1" "360397-1" ""Patient to PMD for physical. Was feeling well and
received flu vaccine. Upon arriving home minutes later told wife ""I don't feel
well"" and collapsed. Brought to ED in full cardiac arrest. Unable to resuscitate.
10/19/09 ER records received service date 10/2/09. Assessment: Cardiac Arrest.
Patient arrived unresponsive, intubated with CPR in progress. Asystole on monitor
with no spontaneous respirations. External trauma to eyes. ICD-9 code 427.5
cardiac arrest. 12/16/09 Death Certificate received. DOD 10/02/09. Cause of Death
- Hypertensive and arteriosclerotic heart disease."" "None performed"
"360527-1" "360527-1" "None stated. 11/30/09 Death Certificate Received.
DOD 10/03/2009. Final Cause of Death: Acute Methadone Toxicity. Additional
Information - Underlying conditions: Constrictive Atherosclerotic Artery Disease."
"No lab data for this event."
"360706-1" "360706-1" "Pt. expired on 10/3/09. Attending MD did not believe
immunization was cause of death but reported because of dose temporal proximity.
(Pt. expired approx. 24 hrs after receiving the flu vaccine). 10/16/09 Death
Certificate: Cardiorespiratory arrest, Diabetes mellitus type 2, Hypertension."
"No lab data for this event."
"360751-1" "360751-1" "Patient was seen on 10/1/09. Death reported on
10/4/09. Pt has seizure disorder along with encephalocele. / DANDY WALKER Syndrome.
Had received vaccines on 10/1/09." "No lab data for this event."
"360985-1" "360985-1" "Patient with hx of DOWN Syndrome, VSD, CHF developed
loose stools and low grade fever within 12 hrs of receiving vaccines. Mom noted
increase fluid demand and gave child extra water. Noted wheezing 10/4/09.
Bradycardia alarm @ 0307 on 10/5/09. CPR no response." "None"
"361101-1" "361101-1" "Patient pulled out trach (witnessed by family
members), unable to replace trach, trach site began gushing blood, patient coded.
Temperature in ER was 36.9 at the time of arrival at 8:22 p.m. Pronounced dead at
8:47 p.m." "Autopsy pending"
"361215-1" "361215-1" "Temp 103.2 at 0240 AM, rapid respirations began
approx 12 hours later. 10/19/09 Death Certificate DOD 10/5/09 - Complications /
effects of Influenza Vaccine. 10/19/09 Nursing Home medical records received
service dates 10/1/09 to 10/5/09. Patient develops elevated temperature. Tylenol
given, blankets removed and cool cloths applied. Oxygen via face mask. Respiration
rate increased, mouth breathing. Appetite poor, not eating. Lethargic. Coughing.
Unable to swallow. Unresponsive to voice or painful stimuli. Unable to obtain BP or
radial pulse. Labored respirations. Stopped breathing. Death. Concurrent Illness:
Toe has red flat area." "Chest x-ray negative for active disease. 10/19/09 Nursing
Home medical records received service dates 10/1/09 to 10/5/09. LABS and
DIAGNOSTICS: Chest X-ray - cardiomegaly."
"361282-1" "361282-1" "Unknown. 11/6/09 Autopsy report received. DOD
10/12/09. Anatomic Diagnosis: 1. Coronary artery disease. 2. Cardiac rupture with
cardiac tamponade. 3. Pleural effusion. 4. Status post cholecystectomy and
appendectomy. 11/12/09 Coroner - Final Cause of Death: Severe coronary
atherosclerosis." "No lab data for this event."
"361353-1" "361353-1" "None Stated. On 10/19/09, the PCP stated that
coroner called him and told him that he found consolidation of the lungs on
autopsy. Autopsy report is not complete yet. 10/20/09 ER records received service
date 10/14/09. Assessment: Cardiac arrest. CPR initiated. Pupils fixed and dilated.
Apnea, pale. Rigor, lividity. 1022/09 PCP /Nursing medical records received,
service dates 11/11/03 to 10/14/09. Assessment: Death. Office staff unable to
contact patient's family, eventually visited patient's home. learnd that patient
was found dead at home and taken to ER. 11/3/09 Additional ER records received for
service date 10/14/09. Found supine on floor at home apneic and pulseless. Cardiac
arrest. CPR initiated. 12/8/09 Autopsy received. Pronounced dead on 10/13/2009
Final cause of death: Pneumococcal Pneumonia. Pandemic Influenza A. Additional
Information Abstracted: Other contributing conditions - Leukopenia, history of
leukemia, Down syndrome. Drug Screen Heart Blood: Dextromethorphan <0.10 ug/ml,
Promethazine 0.11 ug/ml. \ksk 12/28/09 Pathology report received. Receipt date
10/23/2009. Sign out date 12/21/2009. Diagnosis: Lung - Diffuse alveolar damage and
bronchopneumonia. Immunohistochemical and molecular evidence of novel influenza A
H1N1. Immunohistochemical and molecular evidence of Streptococcus pneumoniae.
Immunohistochemical evidence of Neisseria meningitidis without molecular
confirmation. No immunohistochemical evidence of Group A Streptococcus or
Haemophilus influenzae. All follow-up attempts have been completed per company
SOPs. No further information available." "CBC: 2.5, 7.5, 21.3, 207; Sed rate 125.
10/20/09 ER records received service date 10/14/09. LABS and Diagnostics: EEG -
Asystole. CHEM - Glucose 107 mg/dL (H) Calcium 3.5 mg/dL (L) Albumin 3.4 g/dL (L)
Alk Phos 170 U/L (L). CBC - WBC 2.5 Thou/uL (L) RBC 2.57 Mill/uL (L) HGB 7.5 g/dL
(L) HCT 27.3% (L) RDW 16.4% (H) Neut ABS 565 cells/uL (L) Mono ABS 33 cells/uL (L)
Eosin 3 cells/uL (L)"
"361579-1" "361579-1" "patient found dead in the morning by his son.
presumed cardiac cause of death, although flu vaccine given 10/12/09 seems unlikely
as a cause, it can not be excluded. Autopsy is not planned. 12/31/09 Death
Certificate received. DOD 10/15/09. Cause of Death: Unknown. Other conditions: End
Stage Kidney Failure. Cardiomyopathy." "No lab data for this event."
"361629-1" "361629-1" "Information has been received from an office manager
and a consumer who reported that she had seen reports of deaths following GARDASIL
on television. This is one of two cases from the same source. This is a hearsay
report in the absence of an identifiable patient. All telephone attempts to obtain
follow up information have been unsuccessful." "Unknown"
"361716-1" "361716-1" "Pt had no obvious reaction to the vaccine. 10/23/09
Death certificate received. DOD 9/20/09. Cardiogenic shock, Hypoxic encephalopathy.
Ventricular fibrillation. 11/17/09: Discharge Summary and Medical Records
received for date of service 9/20/09: Final Dx: Out of hospital cardiac arrest,
ventricular fibrillation, cardiogenic shock, severe hypoxic encephalopathy,
respiratory failure. Assessment: Experienced sudden onset severe chest pain at
home. Ambulance arrived and found pt. in ventricular fibrillation. Received 2
shocks en route to hospital and upon arrival was intubated with additional CPR and
defibrillations. Major vasopressors were administered for support of blood
pressure. CPK was 3000. Admitted to ICU and maintained on maximal support for 12
hours including ventilation, temporary pacemaker and major vasorpressors at high
doses. No urinary output. Pupils fixed and unresponsive. Pt. eventually
experienced cardiac arrest and died after DNR was signed." "11/17/09: Discharge
Summary and Medical Records received for date of service 9/20/09: Labs and
diagnostics: EKG-ventricular fibrillation. CPK 3000 (H). WBC 21,000 (H), Hct 54
(H), glucose 250 (H), BUN 21 (H), Sodium 149 (H). BNP 395 (H). CK 82 (H)."
"362090-1" "362090-1" "Infant was found dead." "No lab data for this
event."
"362178-1" "362178-1" "Information has been received from a physician
concerning a 60 year old female smoker with severe chronic obstructive pulmonary
disease (COPD), chronic pancreatitis who on 30-JUL-2009 was vaccinated with a dose
of ZOSTAVAX (Merck). Subsequently, on an unspecified date the patient experienced
septic shock and cardiac disease. The patient was admitted to the intensive care
unit (ICU). On 04-AUG-2009 the patient died eight hours after admission. The
physician did not think death was related to ZOSTAVAX (Merck). The physician felt
the patient died of cardiac reasons, but her documents said that the cause of death
was septic shock and pancreatitis. Additional information has been requested.
reported the following additional information: No other vaccines were administered
at the time of the ZOSTAVAX Hospital records not received by the office, but a
copy of a cardiac consult done on admission on 02-AUG-2009 showed renal
insufficiency and DIC (consumptive coagulopathy); patient was intubated due to
decreased mental status changes; consult also shows that patient went into cardiac
arrest on 03-AUG-2009; onset of AEs was within 48 hours of death Death certificate
showed the immediate cause of death as septic shock with the underlining cause of
death as pancreatitis; no autopsy was performed." "Unknown"
"362855-1" "362855-1" "Patient got sick with flu like symptoms on 10/24
around 1PM, went to hospital with trouble breathing around 9PM, was pronounced
deceased at 1AM on 10/25. 10/27/09 ER and hospital records received service date
10/25/09. Assessment: Death due to septic shock secondary to infection of unknown
source. Asplenia. Patient had nausea, vomiting, chills, stomach cramping, diarrhea,
tachypnea, hypotension, diaphoresis for one day. Limited oral intake. Became
cyanotic around lips, fingernails, and toenails. Presented to ER hypotensive,
hypoxic, no longer breathing. Tachycardia. Cardiac arrest presenting as pulseless
electrical activity (PEA). Hyperacidemia. Resusitation. Intubated and transported
to ICU. Bilateral infiltrates consistent with acute respiratory distress syndrome.
End-organ damage including kidneys and brain. Repeated PEA. No pulse. Mottling of
head and extremities. Overwhelming sepsis and septic shock. Patient expired.
11/02/09: Primary Care Records received for date of service 10/9/09. Seasonal flu
vaccine record received VAERS updated. Assessment: Presented with vaginal
bleeding x 3 weeks, had hx. of D&C in 08 2/2 heavy vaginal bleeding. Also
presented with a cold that started 5 days prior, afebrile at visit. Seasonal Flu
vaccine given. 11/05/09 Diagnostic/lab results received. IDPB Test results: Lung
section shows increased interstitial inflammatory infiltrates. Heart section shows
focal interstitial edema and extravasation. No evidence of myocarditis. Liver
section shows increased portal infiltrates and dilated sinusoids with Kupffer cell
hyperplasia. Special stains: Scattered gram-positive cocci in lung, heart and
liver. Immunohistochemical Assays: (+) Strep penumoniae in lung, heart and liver.
(-) for influenza virus. PCR Assays: Negative for 2009 pandemic H1N1 influenza A
virus. PCR for penumoniae pending. 12/14/09 Autopsy Records receivedI. DOD
10/25/09. Final Cause of Death: Streptococcus Pneumonia Sepsis. II. Hemolytic
Anemia with Splenectomy. Additional information abstracted: Arteriovenous
malformation of brain. Cholecystectomy remote. Blood cultures (+) for streptococcus
pneumonias." "/27/09 ER and hospital records received service date 10/25/09.
LABS and DIAGNOSTICS: ECG - Abnormal, sinus tachycardia, Nonspecific ST and T wave
abnormality. Arterial Blood gases: pCO2 50 mmHg (H) O2 Sat 83% (L) Bicarb 8.0
mmol/L (L) Base Excess -26.0 mEq/L (L) pH 6.8 (L). CHEM - Potassium 3.0 mmol/L (L)
Glucose 27 mg/dL (L) Creatinine 2.42 mg/dL (H) AST 121 IU/L (H) Bilirubin Total 1.6
mg/dL (H). GFR 28 mL/min/1.73 m2 (L). CBC - RDW 15.0% (H) PLT 91 10^9/L (L)
Neutrophils 20.0% (L) Bands 20% (H) Metamyelocytes 3% (H) Lymph 55.0% (H) Lymphs
Atyp 1% (H) Anisocytosis slight, Howell Jolly Body few, Vacuolated Polys moderate.
Blood culture (+) for Streptococcus pneumoniae. Chest X-ray - Abnormal. 10/29/09
Hospital lab report. Blood Culture Final Report Verified on 10/28/09 - (+) for
Streptococcus pneumoniae. 11/02/09: Primary Care Records received for date of
service 10/9/09. Labs and diagnostics: WBC 12.5 (H), Lymph # 7.9 x 10 (H), RBC
3.7 (L), HCT 33.0 (L), MCH 32.2 (H), MCHC 36.1 (H), RDW 15 (H), PLT"
"363458-1" "363458-1" "Client contacted Dr.'s office on 10/27/09
approximately equal to 0900 c/o feeling lightheaded and was not sure whether it was
due to low BP or having received an H1N1 injection the day prior (10/26/09).
Position: ESE Paraprofessional (worked with special needs children). An autopsy
will be performed. 10/29/09 PCP medical records received service dates 10/26/09 to
10/28/09 includes vaccine records. Assessment: URI, low blood pressure, fatigue.
On 10/27/09 Patient presents with low blood pressure and fatigue. Slight sore
throat and post nasal drainage. Weak, 'woozy'. Weight loss of 38 lbs since 2/08. On
10/28/09 notified that patient had expired. 12/28/09 Note from Medical Examiner.
DOD 10/28/09. Patient found unresponsive in bed at home. History of recurring deep
vein thrombosis. Autopsy results show saddle embolus resulting in death. Local
Health Department requested this office's assistance in regards to possible
infection with H1N1. 1/5/09 Autopsy Report received. DOD 10/28/09. Final Cause of
Death: Pulmonary Thromboembolism Due To Recurrent Lower Extremity Deep Vein
Thrombosis. Additional Information Abstracted: Contributing - Morbid Obesity,
Uterine Leiomyomata." "No lab data for this event."
"364511-1" "364511-1" "About 1wk. from vaccination, she began to have pain
& tingling in her feet. She stayed tired all the time. She had gout in her feet
before and thought it was gout. She went to the Dr. and he gave her QUININE for her
legs cramping. This helped a little but kept getting worse, went to hospital on 5-
25-09 Died 7-5-09. 11/5/09 Death Certificate received DOD 7/5/09 Cause of Death:
Respiratory Failure consistant with Adult Respiratory Distress Syndrome." "No
lab data for this event."
"365165-1" "365165-1" "UNKNOWN." "No lab data for this event."
"365381-1" "365381-1" "77 y/o with Afib and lung cancer given H1N1 (Sanofi)
on 11/3/09- Died. 11/5/09-prob. heart attack. 11/06/09 Medical records received.
DOS 08/21/08-03/24/09. PCP office notes. Visits note looked well, unremarkable
PEs with well healed surgical scars, clear bronchial to minimal wheeze, CBCs WNL
w/some low 02 sats (92% on R/A). Extrems trace PTE, until 03/24/09. DX bad cold w/
white mucus and cough. Nausea, low grade fever. Lung sounds benign. Mild
leukocytosis, possible infection. Tx Levaquin. 4/28/09 Congestion continued, thick
mucus, worse since pneumonia. Bronchial w/minimal wheezes. CBC WNL. EKG sinus
rhythm, systolic murmur. Subsequent visits showed 02 sat 91%, weight loss. 11/03
occasional SOB, H1N1 vaccine given. Labs & Diags EKG- normal, sinus mechanism,
bradycardia 48. 12/17/09 Death Certificate received. DOD 11/05/09. Cause of
Death. Myocardial infarction. Other information abstracted: Other medical
conditions - lung cancer, atrial fibrillation." "PT/INR, 2.1."
"365416-1" "365416-1" "Patient showed a marked decline in functioning
starting about 12 hours after the vaccine was administered. Pt was shaky, weak,
could not put words together. Pt's doctor was contacted on Sept 8, ruled out UTI.
Seen by doctor on Sept 24. Pt was unable to stand or use legs, so she was taken to
the hospital on Oct 8. Pt was admitted to hospital Oct 8 at Hospital, admitted to
hospice on Oct. 13, and passed away Oct 17. 11/9/09: Medical records and
discharge summary received for dates of service 10/8/09 to 10/13/09. Dx: End
stage Alzheimers Dimentia, dysphagia, HTN, arthritis, hypothyroidism, scoliosis,
and sundowners. Assessment: Presented unable to ambulate that morning, not able
to communicate. Pts. baseline is to ambulate using walker, toilet and converse but
over past 3-4 weeks she has steady decline and is no longer lucid and has no
insight. Urine, blood work and CXR all used to rule out infectious process.
Patient unable to improve in any way, palliative care discussed and hospice home
decided on by family for comfort care measures only." "11/9/09: Medical records
and discharge summary received for dates of service 10/8/09 to 10/13/09. Labs and
Diagnostics: Blood cultures, Urinalysis, urine culture, CXR- all normal."
"365428-1" "365428-1" "Patient was fussy on 11/04/2009, he was hard to calm
down in the morning at approx 4 am I awoke to sounds of him choking, I picked him
up and then he was fine, I took him to daycare that morning and received the phone
call at 4:30 pm that he was being rushed to the ER. 12/22/09 Death Certificate
Received, DOD 11/05/08, Cause of Death: Sudden Infant Death Syndrome (SIDS) at
daycare. 12/22/09 Autopsy received. Cause of Death: Sudden Infant Death Syndrome
(SIDS). Additional information abstracted: Had been fussy and more congested
lately. Chronic inflammation in the large airways likely due to viral infection."
"No lab data for this event."
"365786-1" "365786-1" "Patient Died." "No lab data for this event."
"365979-1" "365979-1" ""Information has been received from a registered
nurse concerning an elderly patient who on an unspecified date was vaccinated with
a second dose of PNEUMOVAX 23 (lot#, route and site of administration not
reported). The first and second doses were reported to be given ""approximately 6
months apart"". On an unspecified date, the patient died but many months after
receiving the second vaccination. The nurse stated that the patient was
administered PNEUMOVAX 23 vaccine prior to discharge from a local hospital. The
reporting nurse insisted that it had nothing to do with PNEUMOVAX 23 vaccine and
death was from old ""age"". This is one of several reports from the same source.
Additional information has been requested."" "Unknown"
"366004-1" "366004-1" "Patient given vaccine on 8/12/09. Hospitalized for
respiratory illness/pneumonia 8/27-9/1, given steroids during hospitalization. Rash
developed on 9/1/09, day of discharge. Saw patient on 9/2/09, started on oral
acyclovir. DOH and hospital notified. 11/13/09 Death Certificate received DOD
11/2/09 Cause of Death: Multisystem Organ Failure, Acute Respiratory Distress
Syndrome, Varicella Pneumonitis. 12/9/09 DC summary received for dates 8/27/09.
DX: respiratory difficulty, bronchospasms, hypotonia. Chief c/o respiratory
distress, URI x1day, fever, tachypnea, retractions. Caretaker reports pt having
difficulty breathing, fever, irritable. Assessment, (+)fever, grunting,
retractions, hypotonia, O2 sat 91% on 3LNC. Speech and swallow eval: oropharyngeal
dysphagia. Pt improved over 3 days, stable at dc. ER/hospital 9/5/09 to 10/29/09.
DX: muscular weakness disorder, viral pneumonitis, varicella. Resp distress, fever.
Parent states varicella vax 8/12/09. Varicella skin rash formed 8/31/09.EMS
presented pt. to ER. Assessment: stridor, rash, fever, mild distress. Pt admitted
and following day resp distress increased, grunting, increase in fever 103F, pt
found to be irritable, O2 sats 92% w/ O2 therapy. Tylenol given, within 30 min temp
104.5F. One hr later pt HR 220-240bpm. Pt later stabilized but prognosis guarded."
"DOH did evaluation; PCR (+) for vaccine strain (isolated from fluid from
skin lesions). 11/13/09 Death Certificate received DOD 11/2/09 Cause of Death:
Multisystem Organ Failure, Acute Respiratory Distress Syndrome, Varicella
Pneumonitis. 12/9/09 Received records. Diag/Labs: CBC abnormal, CXR(-), chemistry
abn, CRP 1(H), sed rate 35(H), blood cult(-), tracheal aspirate cult (+)gram neg
bacilli, pseudomonas aeruginosa 1/4/09 Additional diag/labs received from date
9/5/09 to 10/29/09. Diag/Labs: CBC w/ diff abnormal, blood culture(+)pseudomonas
aeruginosa, urine cult(+)candida albicans, Immune tests: abs T cells 223(L), abs
suppressor 46(L), abs helper 169(L), IGG subclass 1-4(L), CXR (+)rt side
pneumothorax, abdominal US(-), brain US(-)."
"366035-1" "366035-1" "Pt received her 1st PCV vaccine on 9/9/09 and passed
on 9/10/09. The circumstances surrounding her demise are unclear at moment. Dx as
SID. 12/18/09 Autopsy Received. DOD 9/20/09. Cause of Death: Sudden Explained
Infant Death. Additional Information Abstracted: Final Other Significant Conditions
- Bed Sharing With Adult." "None"
"366608-1" "366608-1" "General malaise, nausea, hypotension. 11/13/09:
Medical record for date of correspondence 11/13/09: Assessment: Received H1N1
vaccine 11/6/09 at a dialysis appointment and did not feel well, c/o nausea and
malaise on 11/7 & 11/8/09, according to pt's husband, she continued to feel unwell
on 11/10/09. On the morning of 11/11/09 the patient was found to have died in her
sleep. 11/13/09: Hospital discharge summary(hospitalizaton prior to vaccine),
hemodialysis clinic records and correspondence of case summary received. On
11/09/09, patient received out-patient dialysis. The patient had gained four pounds
since her previous dialysis appointment. 12/21/09 Death Certificate received. DOD
11/11/09. Cause of Death: Hypertensive cardiovascular disease." "No lab data for
this event."
"366680-1" "366680-1" ""Patient died in sleep. presumptive diagnosis is
""SIDS""."" "None"
"366686-1" "366686-1" "Pt lethargic, with non custodial parent out of town.
Febrile 11-8-09 -> 11-9-09. Found unresponsive. Died in AM 11-9-09. ? foul play."
"No lab data for this event."
"366976-1" "366976-1" "Pre dialysis on 10/30/09 complained of achiness
(generalized), feeling cold, difficulty breathing. Lungs were clear (oxygen
administered w/ ease of breathing), BP 129/41, HR 81 - regular temp 98.38. TYLENOL
given for pain #7/10 on pain scale. Patient 3.4 kg > EDW. Edema +2 pitting in right
leg. Reported patient condition to Nephrologist. Hemodialysis treatment initiated
and completed without complication. Patient refused to be evaluated at ER and
discharged home in stable condition. 11/13/09 Medical records received. Dialysis
records for DOS 10/28-10/30. C/o fainting x3 at home. Can't stay awake. Vaccine
given same day (10/28). Admits he had called 911 x2 looking for help that day.
Seen 2 days later and c/o coldness, hurting all over. Can't breath. Kept asking for
help. Staff offered to call 911. Refused. Afebrile. No flu like sx noted by staff
other than achy. Dialysis tx given. D/C to home. Follow-up call made. Pt OK. Went
to bed. 11/16/09 Two discharge summaries received, hospital records. Service dates
10/30/09 to 11/10/09. Assessment: Dehydration, swine flu reaction, Patient
presented with fevers, generalized aches, and pains. Very weak and sick. Headache.
Non-healing ulcer on right heel. While in hospital became lethargic and difficult
to arouse. Developed high fever (105.5), more confused and lethargic. Bradycardic,
patient intubated, lost peripheral pulses, resusitation not sucessful, pronounced
deceased. 0/04/2010 Death Certificate received. DOD 11/10/2009. Cause of Death:
Coronary artery disease, severe peripheral vascular disease, chronic obstructive
pulmonary disease, septicemia. Other significant conditions: Status post left below
knee amputation, depression, diabetes." "obtained at our medical center. LABS and
DIAGNOSTICS: Chest X-ray - Abnormal, nodule left lung. CBC - RBC 3.21 Mill/uL (L)
HGB 11.2 g/dL (L) HCT 32.2% (L) MCV 102.0 fL (H) MCH 35.0 pg (H) RDW 21.2% (H)
Platelets 67 Thou/uL (L). CHEM - Chloride 96 mmol/L (L) CO2 33 mmol/L (H)
Creatinine 3.6 mg/dL (H) BUN CREAT Ratio 9.3 (L) Glucose 138 mg/dL (H) eGFR 17
mL/min (L)."
"367270-1" "367270-1" "Arrived to ED at 1214 via EMS. In asystole and CPR
in progress. Intubated and defibrillated in field. Interosseous IV started in ED.
Epinephrine, bicarb, and glucose administered. Code stopped at 1236. 11/17/09 PCP
medical records and ED records received service date 11/5/09. Assessment:
Cardiopulmonary arrest. Child presented for H1N1 vaccination with nasal congestion
and oxygen via nasal cannula. No mention from mother of concerns, no noticeable
distress from child. Later at home grandmother heard O2 Oximeter beep, found child
unresponsive and not breathing. Mother performed CPR. EMS started ACLS, intubated,
and defibrillated. Interosseous IV. Pupils on admission Fixed and dilated. No
spontaneous respirations. No cardiac activity - asystole. No pulse. No blood
pressure. Skin cyanotic and cool. Code terminated. Deceased." "Autopsy report
pending. 11/17/09 PCP medical records and ED records received service date 11/5/09.
LABS and DIAGNOSTICS: ECG - Abnormal."
"367379-1" "367379-1" "Killed in a car accident while pulling out of the
street where the clinic was located. Was turning left onto a divided highway when
the driver's side door was hit by an oncoming vehicle. Died on impact." "No
lab data for this event."
"367469-1" "367469-1" "difficulty breathing, unable to talk, was taken to
hospital via ambulance, O2 sat 88% later died. 12/7/09 Death Certificate
recieved. DOD 11/9/09. Cause of Death: Chronic Obstructive Lung Disease. Additional
information abstracted - Other significant conditions: ASHD; GI bleed. 11/25 and
12/4 Medical records and discharge summary received. DOS 10/23/09 Final DX: Acute
on chronic congestive heart failure likely s/to a combination of diastolic
dysfunction, severe HTN and valvular heart disease. COPD, New onset of atrial
fibrillation, CAD s/p coronary artery bypass grafting 2006. PVD with h/o moderate
carotid disease, HTN, DM type 2, Valvular heart disease w/moderate to severe mitral
regurgitation and moderate pulmonary hypertension by echocardiogram. C/O fatigue,
SOB, dizziness, edema. Lethargy. Breathless. Bil carotid bruits. ICU. D/C. Poor
prognosis. DOS 11/02 Final DX: Acute renal failure, suspect patient was prerenal
azotemia w/eleveated blood urea nitrogen to creatanine ratio related to diuretics,
poor oral intake, and congestive heart failure. Hypokalemia related acute renal
failure in setting of medications which can increase potassium. Bradycardia likely
related to hypokalemia in addition to medication which can slow heart rate. Now
s/p pacemaker placement. Hypotension r/to symptomatic bradycardia, anemia,
underlying CHF w/ bil pleural effusions, respiratory failure w/adequate gas
exchange. Admit for malignant hypertension and COPD, improved and was D/C to home.
Prognosis poor. 5 days later c/o lethargy, hypotension, bradycardia, intubated.
BP 90/60. Decreased breath sounds bil. 3rd degree AV block, acute renal failure.
Hypokalemia. Multiorgan failure. Acute resp failure. UTI.""Labs & Diags: CXR-
mildly enlarge enlarged and congestive changes, bil pleural effusions. MRA abd
-atherosclerotic disease of aorta. EKG - aortic sclerosis w/mild aortic insuff,
moderate pulmonary htn. WBC 13.8 (H), RBC 2.7 (L), HGB 7.9 (L), HCT 24 (L), RDW
15.3 (H), NEUTR 90.7 (H). LYMPH 4 (L). K 5.7 (H), UREA N 113 (H). CREAT 2.5 (H),
ALB 2.5 (L), PHOSPHOROUS 4.9 (L), GLUC 228 (H), CHLORIDE 114 (H), ALK PHOS 229
(H), NA 134 (L), SPUTUM CX GRAM + COCCI. U/A LARGE LEUKS, STOOL OCCULT BLD +,
URINE PROT 11.0 (H)"
"367792-1" "367792-1" "Patient had sudden cardiac arrest and had CPR from
onset, was picked up by EMS and transported to hospital and pronounced dead at
approx 11:30 PM. 12/16/09 Report of death received for 11/03/09. Decedent fell on
the floor while in a social gathering. No pulse, CPR performed by school nurse for
10 mins until EMS came. Decedent had emesis while compressions were performed. EMS
started ACLS, intubation, 3 IV lines, 4 Epi, 3 Atropine and 1 amp Bicarb. Sinus
rhythm established 1 time, but lost. CPR unsuccessful. Decendent pronounced dead.
12/16/09 Autopsy results revealed no visible internal signs of trauma. All systems
autopsy: normal. Teeth in poor condition. Cardiovascular system: myocardium: focal
areas of fibrosis, atrial; bulges in atrial and ventricular muscular fee walls,
interventricular septum 3cm thick. Pathologist opinion: Hypertrophic cardiomyopathy
(790gr). Heart severely congested and lungs heavy with possible aspiration.
12/24/09 Toxicology report received. This report showed that no drugs were used.
01/04/09 Medical/dental record received for DOS 10/29/09. Debridement performed.
Anesthesia used. Moderate to heavy generalized bleeding. Tx: Chlorhexidine
gluconate oral rinse. DX: Gingivitis, periodontal disease.""OMI results not
available at this time however chest xray showed enlarged heart, no pulmonary
effusion"
"368647-1" "368647-1" ""Report received on 17-NOV-2009 from a daughter of a
patient regarding a claim in litigation. The female patient (date of birth unknown)
received the ""flu shot"" (manufacturer and lot # not provided) on an unspecified
date in 2009. On 07-SEP-2009, the patient died possibly due to the flu shot. No
further information was provided."" "No lab data for this event."
"368648-1" "368648-1" "Initial report received 09 November 2009 from a
literature citation which involves a case of misuse (i.e., inappropriate schedule
of drug administration). On 24 November 2008, the Centers for Disease Control and
Prevention was notified about suspected rabies in a 55-year-old male patient who
had been bitten by a bat four to six weeks prior to symptoms onset. Family members
reported that they saw a bat in the rafters of the front porch for several days
before it flew into the house. The patient caught the bat and allowed it to crawl
up his arm and neck and was bitten on the left ear. The patient did not report the
incident to public health authorities or seek medical evaluation. The patient left
the bat unrestrained in the house for two days, and when the bat appeared to be
well after that period, he released it outside. On 26 November 2008, infection with
rabies virus variant associated with silver-haired bats was confirmed and the
patient subsequently died on 30 November 2008. The following report summarizes the
patient's treatments and clinical course. A 55-year-old male patient developed
pruritus on 19 November 2008 on his left ear that spread to his left face and arm.
Two days later on 21 November 2008, he began experiencing mild chest pain and
reported to the emergency department. Testing included an electrocardiogram and
cardiac enzymes which were negative for acute myocardial infarction and the patient
was discharged with instructions to return if symptoms worsened. On 22 November
2008, the patient returned to the emergency department with panic attacks and
anxiety associated with swallowing water. At that time, the patient reported that
he had been bitten by a bat on the left ear lobe four to six weeks earlier. He
received corrective treatment with rabies post-exposure prophylaxis consisting of
15.4 mL of rabies immune globulin (manufacturer, lot number not reported) and 1 mL
of rabies human diploid vaccine (manufacturer and lot number not reported), and a
tetanus-diphtheria vaccine booster (manufacturer and lot number not reported), and
was released. The patient reported to a second emergency department on 23 November
2009 due to new numbness of the left ear and face, continuing chest pain and
difficulty swallowing water. The patient also reported a history of chronic neck
and back pain that occasionally featured numbness. He also informed the physician
about his prior bat exposure and the PEP treatment he received the previous day.
The physician explained that the PEP treatment the patient received was
appropriate, but explained that treatment might not be helpful if administered late
in the course of rabies disease. The patient was released from the emergency
department and advised to seek medical attention if his symptoms progressed. Later
that same day, the patient returned to the emergency department complaining of
dehydration and he became anxious when he tried to drink fluids. On 24 November
2008, the patient was transferred to a tertiary care facility. The differential
diagnosis on admission included rabies and other causes of infectious meningitis
and encephalitis. A lumbar puncture yielded cerebrospinal fluid (CSF) with glucose
78 mg/dL (normal 50-80 mg/dL), protein 39 mg dL (normal 15-45 mg/dL, six red blood
cells/mm3 (normal 0), and one white blood cell/mm3 (normal 0-3 cells/mm3);
differential showed lymphocytic predominance of 68%, 26% monocytes, and 6%
neutrophils. Complete blood cell count, metabolic panel drug screen, and
computerized tomography scan of the head were unremarkable. Serum CSF, nuchal skin
biopsy and saliva were collected and submitted to CDC on 24 November 2008, where a
rabies diagnosis was confirmed on 26 November 2008. Viral antigen and RNA were
detected by CDC in the skin biopsy by direct fluorescent antibody testing and
reverse transcription polymerase chain reaction (RT-PCR), respectively. Viral RNA
was also detected in the patient's saliva by RT-PCR. Serum was positive for
neutralizing antibodies against rabies by rapid fluorescent focus inhibition test
(RFFIT), and CSF negative by RFFIT and indirect fluorescent antibody. Rabies viral
RNA amplified by RT-PCR was typed as a variant common to silver haired bats
(Lasionycteris noctivagans). On 25 November 2008, the patient began rabies
treatment using protocol, which included coma induction and administration of
amantadine. The following day, the patient became bradycardic and hypotensive and
was administered atropine and dopamine. On 28 November 2008, dopamine was replaced
with norepinephrine and persistent hypotension and bradycardia. Diuretics were
administered because of signs of increased intracranial pressure. On 29 November
2008, hypotension worsened and the patient developed oliguric acute renal failure
with lactic acidosis and was placed on dialysis. When signs of increased
intracranial pressure herniation were detected on 30 November 2008, his family
elected to withdraw life support, and the patient died shortly thereafter. The
autopsy (report not provided) confirmed the suspected cerebellar tonsillar
herniation and moderate bilateral uncal herniation. On histological examination,
multiple neurons had eosinophilic cytoplasmic inclusion bodies, particularly in
specimens from hippocampi, nucleus basalis, and Purkinje cells. Documents held by
sender: None." "21/Nov/2008: Electrocardiogram and cardiac enzymes (negative for
myocardial infarction); 24/Nov/2008: Lumbar puncture (CSF) - glucose 78 mg/dL,
protein 39 mg dL, six red blood cells/mm3, and one white blood cell/mm3;
differential showed lymphocytic predominance of 68%, 26% monocytes, and 6%
neutrophils; Complete blood cell count; metabolic panel; drug screen; and
computerized tomography scan of the head were unremarkable; Serum CSF; nuchal skin
biopsy; and saliva were collected and submitted to CDC, where a rabies diagnosis
was confirmed on November 26th; Viral antigen nd RNA were detected by CDC in the
skin biopsy by direct fluorescent antibody testing and reverse transcription
polymerase chain reaction (RT-PCR), respectively; Viral RNA also was detected in
the patient's saliva by RT-PCR; Serum was positive for neutralizing antibodies
against rabies by rapid fluorescent focus inhibition test (RFFIT), and CSF was
negative by RFFIT and indirect fluorescent antibody; Rabies viral RNA amplified by
RT-PCR was typ"
"369139-1" "369139-1" "Death - cause of death not confirmed by medical
examiner." "No lab data for this event."
"369428-1" "369428-1" "10/22/09 fever, cough, SOB: healthy 14 yo sib with
clinical H1N1. TAMIFLU began 75 BID. 10/23/09 seen in office & at home resp
decompensation admitted to PICU: BiPAP. DNI order. Bilateral severe pneumonia died
approx. 1pm 10/25/09. 12/14/09 Death Certificate received. DOD 10/25/09. Cause of
death: Pneumonia. Additional information abstracted: Rett Syndrome. 12/14/09
Hospital records received, service dates 10/23/09 to 10/25/09. Assessment:
Medically frail with hypovolemia, respiratory distress, ABG concerning for ARDS,
likely due to H1N1 infection w/ bacterial superinfection. Patient presents with
increasing work of breathing, fever, and cough. O2 Tamiflu at home. Tachypnea.
Wheeze, shortness of breath. Crackles, rhonchi, flaring, retractions. Decreased
responsiveness. Admitted to ICU. Mechanical ventilation. Edema of feet. Expired.
12/17/09 Hospital records and discharge summary received. Service dates 10/23/09 to
10/25/09. Assessment: Pneumonia present on admission, respiratory distress present
on admission." "CXR severe bilateral pneumonia. LABS and DIAGNOSTICS: CBC - WBC
8.4 k/mm3 (L) Hgb 10.4 Gm/dL (L) Hct 30.3% (L). APTT 33.3 sec (H). CHEM - Sodium
120 mmol/L (L) Potassium 3.3 mmol/L (L) Chloride 83 mmol/L (L) Glucose 165 mg/dL
(H) Creatine-Blood 0.3 mg/dL (L) C-Reactive Protein 33.4 mg/dL (H). Chest X-ray -
Abnormal. 12/17/09 Hospital records and discharge summary received. Service dates
10/23/09 to 10/25/09. LABS and DIAGNOSTICS: RBC 3.31 M/MM3 (L) Neut 90.0% (H) PLT
147 K/MM3 (L) Neut 7.5 K/MM3 (H) Lymph 0.4 K/MM3 (L) Mono 0.0 K/MM3 (L). Arterial
Blood Gases - Abnormal. Prealbumin 8.0 MG/DL (L)."
"370052-1" "370052-1" "Admitted to hospital 11/13/09. Expired 11/23/09.
Doctor's note state pt received H1N1 and Seasonal flu vaccine 3 days prior to
admission. 11/25/09 Hospital records received service dates 11/13//09 to 11/22/09.
Assessment: Pneumonia, diphtheria Patient presents with cough and shortness of
breath. Body aches, yellow sputum, right-sided chest pain with deep inspiration.
Sore throat. Fever. Intubated and mechanically ventilated. 1/6/2010 Hospital
discharge summary received. Service dates 11/13/09 to 11/23/09. Assessment: Severe
bilateral pneumonia with adult respiratory distress syndrome. Respiratory failure
with hypoxemia, sepsis, diarrhea, acute renal failure, hypernatremia,
hypoalbuminemia. Patient seen at ED and diagnosed with pneumonia. Seen at PCP
office later that day and admitted to hospital. Intensive care, intubation,
ventilator. High fever, hypotension, resusitation. Patient expired." "11/25/09
Hospital records received service dates 11/13//09 to 11/22/09. LABS and
DIAGNOSTICS: Pulse Oximetry 79% O2. Chest x-ray - abnormal. Sputum Culture (+) for
gram-positive bacillus. Blood cultures (+) for gram-positive cocci, gram positive
bacillus. CHEM - Sodium 147 (H), Potassium 3.9 WNL, Chloride 109 (H), bicarbonate
37 (H), glucose 216 (H), BUN 53 (H), Creatinine 1.1 WNL, Albumin 2.3 (L). CBC - WBC
23. (H), Hemoglobin 9.2 (L), Hematocrit 36.5% (L). Urinalysis - RBCs >50 (H), WBC
3-4 (H). 1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to
11/23/09. LABS and DIAGNOSTICS: CT Angiogram Chest - Abnormal."
"370081-1" "370081-1" "Pt went to the gym and died from a heart
attack/stroke?? within 24hrs of obtaining H1N1 injection. 12/22/09 ED records
received. Service dates 11/23/09 to 11/24/09. Assessment: Cardiac arrest. EMS
called because of chest pain, arrested on route to ED. Intubation. Resusitation.
Ventricular Fibrillation. Patient presents in cardiac arrest. Radial pulses absent.
Pupils fixed and dilated. Skin mottled, clammy, temperature is cool. Pronounced
expired" "12/22/09 ED records received. Service dates 11/23/09 to 11/24/09. LABS
and DIAGNOSTICS: ECG - Abnormal."
"370216-1" "370216-1" "Family reports that he came into the house from
outdoors c/o chest pain and abdominal pain. 11/30/09 Coroner Report Received. DOD
11/12/09. Cause of Death: Probable Myocardial Infarction, due to seasonal flu, with
other significant conditions of Diabetes." "No lab data for this event."
"370257-1" "370257-1" "The patient received her H1N1 vaccine at her place
of work on October 16, 2009. On 11/3/2009 she died at home. The cause of death is
unknown. The autopsy results were unremarkable. Labs and frozen sections are
pending. She is alleged to have had a seizure disorder and neurologic records are
being subpoenaed by the Coroner." "Toxicology and frozen specimen results are
pending."
"370514-1" "370514-1" ""Patient reported to ER 1 day after receiving H1N1
vaccine with ""flu like symptoms"", ""hurting all over"". VS and lab stable -
treated for lower back pain. Sent home with instructions to report back if problems
continue. Patient reported to ER on 11-20-09. Report is not available. Sister
states pt. was treated and sent home. Boyfriend discovered pt. dead at home after
returning home from store. 12/2/2009 ED record for 11/19/2009 and 11/20/2009 and
dialysis records for 11/13, 11/16 and 11/18/2009. Patient presented to ED with
c/o's flu-like sx: ""aching and pain all over"", no other sx noted. PE was
negative. Tx: IM pain meds Morphine and Dilaudid, po Zofran. Dc'd with Rx for
Lortab On 11/20/2009 presented to another ED with c/o's ""hurting all over and with
c/o's nausea/vomiting. Tx: Demerol and Vistaril Dc''d with dx of chronic back pain.
Notes state that later on 11/20/2009 patient expired at home. 1/7/2010 Death
Certificate received. DOD 1120/09. Cause of Death: Acute Myocardial Infarction.
Additional information abstracted: Other Significant Conditions - Diabetes.""
"WBC, 12.7 bil/L 12/2/09 Medical records received w/Labs: CBC, Hgb, Hct,
Lymphs and Monos all low, WBC high, CMP noted Cl low and Creatinine and Glucose
high"
"370596-1" "370596-1" "Wife called home health and said pt wasn't feeling
well, was more drowsy than usual. HH Aide visited at 9:15 AM. He was afebrile and
respirations were 36. Skin was cold and clammy. Aide encouraged daughter to take
him to ER. Daughter stated she thought he might get to feeling better and that if
he didn't get better or if he seemed worse, she would take him. RN talked to wife
later in afternoon around 3:00 PM and wife reported he had eaten some and seemed to
be feeling a little better. When his wife went to wake him early Thursday AM , she
could not arouse him and she called 911. When they responded the coroner was
called. 12/3/09 Death Certificate received. DOD 11/26/09. Final Cause of Death:
Myocardial Infarction, NOS & Chronic Pulmonary Disease, Dementia, Stroke (CVA)."
"He was pronounced dead at his residence by the coroner and no post mortem
workup was done."
"370733-1" "370733-1" "respiratory distress resulting in death 12/04/09 MR
and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. DX: Cardiopulmonary
arrest. Pt presented with s/p cardiopulmonary arrest on 11/23/09 with MOF,
hypotensive, coarse bs. Kidneys not functioning, coagulopathy, metabolic acidosis.
tx: epinephrine, diuretics, vasopressors, bicarbonates, antibiotics. Pt condition
worsened despite ICU tx. Pt expired. 12/29/09 Death Certificate Received. DOD
11/24/09. Cause of Death: Methicillin-Resistant Staphylococcus Aureus Pneumonia."
"CXR AP view 10/2/09, Selenium, Magnesium, Phosphorous, Zinc, CMP, CBC, T4
free, TSH 3rd generation, Vitamin D, phenobarbital, prealbumin on 10/2/09; renal
function panel with EGFR, and CBC on 10/8/09; renal function panel with EGFR & CBC
on 10/15/09; CMP & CBC with diff on 10/29/09; phenobarital level on 11/6/09.
12/04/09 MR and DC summary for DOS received for DOS 08/29/08 - 11/11/24/09. Lab and
DX tests: HR 149-193, BP: 67-122/30-48; BUN/creatinine: 56/2.25; INR 2.3; Culture:
gram + cocci."
"371039-1" "371039-1" "On August 12, 2009, 11:39 AM, infant had four-month
checkup and was found to be well. At 12:00 PM, he was given five immunizations
(DTaP/DT, IPV, Hib, PCV7, Rotovirus). The following morning at 8:00 AM (20 hours
later), he was found unconscious by his parents. Cardiopulmonary resuscitation was
initiated. Emergency medical services found the infant in full code. He was
transported to the hospital where he was essentially dead on arrival. 12/10/09
Autopsy report received. Cause of Death: Undetermined. Manner of Death:
Undetermined. Additional infomation abstracted: Pathological Diagnosis - Well baby
by clinical history. Overlay cannot be excluded. 12/3/09 PCP, cardiology
consultation, and hospital records received. Service dates 4/1/09 to 8/13/09.
Assessment: Not breathing. Child was sleeping with parents, not breathing this AM.
EMS called." "None. 12/3/09 PCP, cardiology consultation, and hospital records
received. Service dates 4/1/09 to 8/13/09. LABS and DIAGNOSTICS: Postmortem
Skeletal Survey - No evidence of acute or healing fractures."
"371206-1" "371206-1" "Unexpected death. Patient was asymptomatic except
for skipping lunch. Took his usual afternoon nap but expired during sleep. Autopsy
today did not reveal a cause. 01/07/2010. Autopsy received. DOD 1201/2009. Cause
of Death: 1. Undetermined. Manner of Death: Undetermined. Additional Information
Abstracted: I. [History of Febrile Seizures]: Cerebral Edema and Congestion. II.
Pulmonary Edema and Congestion. II. Postmortem Toxicology Results: A. Blood: 1.
Atropine = 870 NG/ML. B. Vitreous Humor: 1. Sodium = 137 MEQ/L. 2. Potassium = 17.8
MEQ/L. 3. Chloride = Creatinine = 0.8 MG/DL. 5. Urea Nitrogen = 7 MG/DL. 6. Glucose
= <20 MG/DL." "Unsuccessful resuscitation by EMS and Vassar Hospital ER. Was
asystolic when EMS arrived."
"371498-1" "371498-1" "Unk. Pt. deceased unattended. 11/23/09 Sheriff
officer said her doctor ruled heart attack and diabetes as cause of death.
12/10/09 Coroner's report received. Pronounced dead 11/09/09. Died of Natural
Causes related to diabetes, irregular heart rate - had pacemaker, COPD - asthma,
high blood pressure, thyroid disease, reflux disease, arthritis. 12/16/09 Death
Certificate received. DOD 11/09/09. Cause of Death: Cardiopulmonary Arrest, Chronic
Obstructive Pulmonary Disease, Hypertension, Diabetes." "No lab data for this
event."
"371508-1" "371508-1" "The subject was a 3-year-old, HIV-infected enrolled
in a study on 03/04/2006. The subject reportedly expired and the date of death is
unknown. On 12/28/2005, the subject's HIV viral load was greater than 227,000
copies/mL. On 02/01/2006, the subject's CD4 cell count was 2,724 cells/mm^3. On
01/04/2006, 01/18/2006, and 02/28/2006, the subject received the study agent,
Pneumococcal 7-valent Conjugate Vaccine. The participant was last seen at the
clinic for the week 8 study visit on 02/28/2006. On 05/12/2006, telephonic contact
was attempted with the participant's mother on numerous occasions but none of these
attempts were successful and eventually the cell phone number was not in use any
longer. A formal letter requesting the participant to come to the clinic was sent
to the participant's home: however this also did not yield any response. On
03/18/2009, one of the study nurses telephonically contacted the subject's mother.
She was very rude and said the her child had died and that the site should never
attempted to contact her again. She then hung up the phone without providing any
further information regarding the cause or date of death. Please note that the
participant's death is considered unconfirmed as the mother did not come to the
clinic to provide further details. This death has also not been confirmed at the
Death Registry. The agency has been informed of this case and has allowed
Independent Committee to review it. Note that discovery of this case was the result
of a request of the study team to actively pursue these lost to follow-up. It is
not expected that further information on the cause will be found. The site
Principal investigator has assessed the event of presumed death, unconfirmed, as
probably not related to the study agent, Pneumococcal 7-valent Conjugated Vaccine.
The Medical Officer has assessed the event of presumed death, unconfirmed, as not
related to the study agent, Pneumococcal 7-valent Conjugated Vaccine." "12/28/2005:
HIV viral load: greater than 227,000 copies/mL. 02/01/2006: CD4 cell count: 2,724
cells/mm^3."
"372029-1" "372029-1" "Vaccine administered 11/20/09. Found deceased
unknown cause 11/21/09." "No lab data for this event."
"372134-1" "372134-1" "12/03/09 Temp. 98.9-Flu vaccine given (Influenza) on
7-3 shift. 8:45 PM 12/3/09 Temp. 102.9, pulse 145-Dr. notified-CIPRO 500 mg via GT
given as an order BID. Change to ROCEPHIN 1 gm IM x 7 days, TYLENOL given, cold
compresses. 12:20 AM 12/04/09 resident ceased to breathe. 12/9/2009 Death
certificate received. DOD 12/4/09. Cause of Death: Pneumonia. Traumatic
Encephalopathy." "10/7/09 CXR"
"372288-1" "372288-1" "Vaccine given 12/1 at 10:30 AM. Pt immediately
reacted with increased temp and SOB. BENADRYL given 25mg stat and q 8 hours. Pt
alert/oriented. 12/2 At 1:55 AM, pt temp 102.7, TYLENOL given. 12/3 Temp 99, pulse
110 at 1000 AM, oriented to self only. 12/4 At 0500 pt died. * Pt on hospice; dx:
Parkinson's. 12/9/09 Death certificate received. DOD 12/4/2009. Cause of death:
Respiratory Failure. Cardiac Failure. Parkinsons Disease." "No lab data for this
event."
"372790-1" "372790-1" "We received via agency, and Norvartis
Pharmaceuticals, from a healthcare professional the following information on 01 DEC
2009: A 34-year-old female patient, born on 01 SEP 1975, pregnant for the third
time in 27 weeks gestation, was vaccinated i.m. with seasonal FLUVIRIN, batch no.
unknown) on 18 NOV 2009. The patient was also vaccinated with pandemic FLUVIRIN
(batch no. unknown) on the same day (please see MA2009-5711 for reference). The
patient also had a medical history of blighted ovum. On 30 NOV 2009 the patient
collapsed and died on 30 NOV 2009. Autopsy was pending at time of report. A male
male infant was delivered by C-section. Agency Ref. no: NA09-008971. Norvartis
Pharmaceuticals ref. no.: S2009US27919. 12/30/09 ED records summary received.
Service date 11/30/09. Assessment: Collapsed, unresponsive, asystolic rhythm. EMS
found patient unresponsive, collapsed on floor, in asystolic rhythm. Presented at
ED unresponsive, no spontaneous respirations, asystolic rhythm. Cental cyanosis,
prior intubation, oxygen, epinephrine. Fixed dilated pupils, no corneal reflex.
Pale. No spontaneous cardiac sounds. Fetal heart tones noted. Emergency C-Section,
premature infant delivered and resusitated. 1/6/09 ED records received. Service
date 11/30/09. Assessment: Cardiac arrest, expired. Pregnant patient arrived in
full cardiac arrest. Asystole/Pulseless. Reflexes absent. Emergency low transverse
cesarean. Male fetus delivered." "12/30/09 ED records summary received. Service
date 11/30/09. LABS and DIAGNOSTICS: Ultrasound to abdomen. 1/6/09 ED records
received. Service date 11/30/09. LABS and DIAGNOSTICS: ECG - Abnormal."
"373122-1" "373122-1" "Notified by patient's co-worker that patient had
passed away. 12/15/09 Death Certificate received. DOD 12/08/2009. Cause of Death:
Myocardial Infaction. Atherosclerotic Coronary Vascular Disease." "Unknown"
"373189-1" "373189-1" "Initial case received from a health care
professional on 10 December 2009. An 11-year-old male patient developed chickenpox
and died after receiving ADACEL (lot not reported) and VARIVAX (Merck, lot number
0630X410). The patient, who was HIV positive, received VARIVAX on 20 August 2008
and developed chickenpox (start date reported as August 2008). On 16 September 2008
he received ADACEL, and developed chickenpox again. He was seen in his physician's
office on 28 November 2008 and was admitted to the hospital at that time. He later
died (date of death not reported). No additional information was reported.
Documents held by sender: None." "No lab data for this event."
"373314-1" "373314-1" "Information has been received from a consumer who
saw a report on the internet about a 23 year old patient who was vaccinated with 3
doses of GARDASIL. Subsequently the patient died, the cause of the death was
unknown. This is one of several reports received from the same source. Additional
information has been requested." "Unknown"
"373315-1" "373315-1" "Information has been received from a consumer who
saw a report on the internet concerning two patients (unspecified ages) who were
vaccinated with 3 doses of GARDASIL (dates were not reported). Subsequently the
patients died, the cause of death was unknown. This is one of several reports
received from the same source. This is a hearsay report, attempts are being made to
obtain identifying information to distinguish individual patients. Additional
information has been requested." "Unknown"
"373347-1" "373347-1" "This case was reported in a literature article and
described the occurrence of fatal exacerbation of glomerulonephritis in an adult
male subject who was vaccinated with influenza virus vaccine (manufacturer
unspecified). At the age of 12 years, the subject was diagnosed with PR3-ANCA-
associated glomerulonephritis due to Wegener's granulomatosis. He was treated with
CYCLOPHOSPHAMIDE, METHYLPREDNISONE and AZATHIOPRINE. During the follow-up from 1999
to 2004, the subject suffered from several relapses that were treated with
CYCLOPHOSPHAMIDE or METHOTREXATE in combination with CORTICOSTEROIDS. In 2004, the
subject developed a biopsy-proven renal relapse. DEOXYSPERIGUALIN, an
antiproliferative drug with effects on lymphocytes and macrophage function and
neutrophil production, was started in combination with high doses of steroids.
During the 1st three cycles, a partial remission was induced. Because hematuria and
proteinuria persisted, the kidney was re-biopsied and showed persistently active
glomerulonephritis with new necrotizing and and crescentic lesions. The 4th and 5th
cycles went uncomplicated. In the 6th cycle, the subject received unspecified dose
of Influenza virus vaccine (unknown route and injection site), lot number not
provided. Shortly after vaccination, a severe relapse occurred with purpura,
arthralgias, new nodular lung lesions and active glomerulonephritis.
DEOXYSPERGUALIN was stopped and MYCOPHENOLATE MOFETIL in combination with high-dose
CORTICOSTEROIDS and plasma exchange was given. Despite this therapy, the subject
developed a severe ulceration of the legs, abdominal pain with bloody diarrhea and
intercerebral haemorrhage due to cerebral vasculitis, resulting in death. The
vaccination was done while the subject had an active glomerulonephritis suggestion
that activation of the vasculitic process after influenza vaccination was caused by
so-called bystander activation in which the vaccination resulted in activation of
antigen presenting cells expressing the autoantigen proteinase 3. The author
considered the events were possibly related to vaccination with Influenza virus
vaccine. The subject died, cause of death is not specified. It was unknown whether
an autopsy was performed." "UNK"
"373484-1" "373484-1" "H1N1 injection administered on 10.23.09. Patient
became ill 5 days later with pneumonia. History of pulmonary hypertension. PICU."
"No lab data for this event."
"373547-1" "373547-1" ""Per co-workers, patient reported ""not feeling
well"" on 12/04/09. 12/29/09 Autopsy received. DOD 12/06/2009. Cause of Death:
Long-term Sequelae of Spina Bifida. Additional information abstracted: Contributory
- Associated Chronic and Acute Urinary Tract Infection. Summary of Autopsy
Findings: I. Spina bifida - A. Large puckered lower lumbar scar. B. Chronic lower
extremity atrophy with bilateral foot deformities. C. Indurated scars and large
scarring - buttock and legs. D. Chronic and acute urinary tract infections. E.
Posterior absence of corpus callosum. F. Ventriculoperitoneal shunt. G. Congested,
dusky leptomeninges with associated cerebral edema. II. Other findings - A.
Moderate atherosclerotic coronary artery disease. B. Minimal to moderate cardiac
hypertophy. C. Acute visceral adhesions. D. Old abdominal adhesions. E. Status-post
cholecystectomy."" "Autopsy performed. Cause of death pending results of
various labs sent out."
"373588-1" "373588-1" ""Information has been received from a female
consumer concerning her child who ""over 10 years ago"" was vaccinated with a dose
of MMR II. The patient died after being given the vaccine. No further information
is available."" "Unknown"
"373830-1" "373830-1" "Patient seen for well visit/immunized on 10/12/09.
No problems found. Child found unresponsive in crib on 10/17/09 & taken to ER. CPR
unsuccessful. 12/17/09 ED record received. Service date 10/17/09. Assessment: SIDS,
Suffocation. Mother fell asleep in bed with baby. Awoke to find baby unresponsive.
Patient presents unresponsive, no spontaneous respirations, no pulse. Vomitus,
blood, in airway. Purple color. Resusitation attempted, intubation." "Results of
autopsy not available. 12/17/09 ED record received. Service date 10/17/09. LABS and
DIAGNOSTICS: EKG - Abnormal, asystole."
"373905-1" "373905-1" "Pt. had c/o chest pain x 1 d. Approx. 4 pm on
11/18/09, pt collapsed in parking lot at MD office. Resuscitation attempted at
office, during EMS transport and hospital. Pt. died of MI. 12/21/09 Death
Certificate received. DOD 11/18/09. Cause of death: Myocardial infarct due to High
Cholesterol, Hypertension, Hypothyroidism. Additional information abstracted: Had
c/o of chest pain at doctor's office, nurse found in cardiac arrest. EMS upon
arrival found patient pulseless and apneic, CPR being performed. Resusitation
including IV meds and defibrillation. Transported to hospital. 12/21/09 ER
records received, service date 11/18/09. Assessment: Cardiopulmonary resusitation
unsuccessful. Patient had C/O of chest pain. Found unresponsive, no respirations,
no pulse, cyanotic, pupils fixed and dilated." "None. 12/21/09 ER records
received, service date 11/18/09. LABS and DIAGNOSTIS: ECG - Abnormal. CHEM -
Glucose 342 MG/DL (H) Creatinine 1.8 MG/DL (H) GFR 43.02 (L) Potassium 3.0 MMOL/L
(L) CO2 19.9 MMOL/L (L) AST 561 U/L (H) ALT 748 U/L (H) Total Protein 5.2 G/DL (L)
Albumin 2.7 G/DL (L). Prothrombin Time 16.1 sec (H). CBC - RBC 3.94 M/UL (L) HGB
12.6 G/DL (L) HCT 37.2% (L) MCH 32.1 (H) PLT Count 130 K/UL (L) Seg Neut 10% (L)
Lymph 75% (H) Basophil 1.0% (H) Bands 4% (H) Anisocytosis slight, Giant Platelets
present."
"374023-1" "374023-1" "Client admitted to hospital for respiratory
symptoms. Diagnosis - pneumonia - diagnosed with viral pneumonia. Cause or type
unknown at time of death. 12/23/09 Discharge summary, hospital records received.
Service dates 12/5/09 to 12/11/09. Assessment: Bilateral extensive pneumonia/acute
respiratory distress syndrome. Acute hypoxia, respiratory failure.
Anxiety/depression. Chronic anemia. Pulmonary hypertension. Right ventricular
dysfunction. Patient developed acute onset of fevers, chills, shortness of breath,
productive cough. Decreased breath sounds. Patient admitted to ICU. On ventilator.
Acute renal failure. Discharged to higher level facility. 12/23/09 Discharge
Summary, hospital records received. Service dates 12/11/2009. Assessment: ARDS,
multiorgan failure, thrombocytopenia, multiple arterial and deep venous clots right
upper and left upper extremities, right-sided pneumothorax, hemodynamic
instability, possible heparin-induced thrombocytopenia. Patient transferred from
another facility intubated with left lower lobe pneumonia. Small pupils,
nonreactive. Crackles left chest. Hypotension. Bladder infection. Developed shock
liver and acute renal failure with oliguria. Patient expired." "12/23/09
Discharge summary, hospital records received. Service dates 12/5/09 to 12/11/09.
LABS and DIAGNOSTICS: CAT Scan Chest - Abnormal. Chest X-ray - Abnormal.
Echocardiogram - Abnormal. CBC - WBC 19.4 K/UL (H) RBC 3.39 M/UL (L) HGB 10.9 G/DL
(L) HCT 32.2% (L) MCH 32.1 PG (H)Neutrophils 92.0% (H) Lymphs 6.3% (L) Monos 1.0%
(L). Creatine Kinase 136 U/L (H). CHEM - Glucose 119 MG/DL (H) BUN 22 MG/DL (H)
Protein Total 5.4 GM/DL (L) Albumin 1.8 GM/DL (L) ALP 131 U/L (H) AST 77 U/L (H)
Chlorine 113 MMOL/L (H). Complement C3 65 MG/DL (L). NT-PROBNP 3340 pgmL (H).
Arterial Blood Gases Abnormal. Urinalysis - Protein (1+) RBCs 2 (H) WBC 13 (H)
Squamous Epithelial Cells few (H). Urine Bacteria - E. coli. 12/23/09 Discharge
Summary, hospital records received. Service dates 12/11/2009. LABS and
DIAGNOSTICS:CBC - WBC 14.6 1000/uL (H) Platelets 142 100C/uL (L). Creatinine 2.1
mg/dL (H). Glucose 25 mg/dL (L). ALT 1222 U/L (H) AST 4210 (H). C-Reactive Protein
13.3 mg/dL (H). LDH 6637 IU/L (H). Magnesium 3.1 mg/dL (H) Ph"
"374073-1" "374073-1" "Nausea/vomiting became unresponsive went into
cardiopulmonary arrest and died - was unable to be resuscitated by emergency
department staff." "12/23/09 ED records and Hospital Record of Death received.
Service date 12/18/09. LABS and DIAGNOSTICS: EKG - Abnormal. CBC - WBC 15.4 K/mm3
(H) Neutrophils 23.7% (L) Lymphocytes 70.7% (H) Lymphocytes 10.9 k/mm3 (H). CHEM -
Glucose 450 mg/dl (H) Total Protein 4.4 g/dl (L) Albumin 2.4 g/dl (L) AST 165 IU/L
(H) ALT 160 IU/L (H). Brain Natriuretic 200 pg/ml (H)."
"374336-1" "374336-1" "Information has been received from a physician
concerning a patient who on an unspecified date was vaccinated with a dose of
VARIVAX (Merck) (route and lot # unknown). On an unspecified date the patient
developed varicella lesions after receiving the vaccine. The patient was
hospitalized in and on an unspecified date the patient died. This is one of several
reports from the same source. Additional information has been requested."
"Unknown"
"374643-1" "374643-1" "Death, SIDS" "No lab data for this event."
"374649-1" "374649-1" "12/16 2130. Presented to ED 12/16 with fever 104.8.
Treated with TYLENOL and discharged to home. Returned to ED on 12/17-0615 - altered
Mental Status, diarrhea, Rash, T 99.8 - Cardiac arrest - Intubation, code Meds,
ROCEPHIN, Vancomycin, acyclovir. Transferred. 12/30/09 Preliminary autopsy report.
DOD 12/17/09. Cause of Death: None provided. Additional information abstracted:
Cerebrospinal fluid positive for gram negative diplococci on gram stain. 12/30/09
Preliminary autopsy report. DOD 12/17/09. Cause of Death: None provided. Additional
information abstracted: Cerebrospinal fluid positive for gram negative diplococci
on gram stain. \ksk 12/31/09 ED consultation records received. Service date
12/17/09. Assessment: Thrombocytopenia, purpuric rash, cardiopulmonary respiratory
arrest, shock with septic and hypovolemic metabolic acidosis, hematemesis, screen
for meningococcemia. Child presented to the ED the previous evening with a
temperature of 104.8 F was medicated for fever and discharged. This AM presents
with a purpuric rash all extremities. Diarrhea, lethargic. Decreased level of
consciousness. Intubated and attempted to stabilize for air transport. Abdominal
distention. Blood-tinged mucus fluid from nose and mouth. Full CPR. Pulseless
electrical activity." "Rapid Strep Test - Negative; Blood Cultures - Neisseria
Meningitidis. 12/31/09 ED consultation records received. Service date 12/17/09.
LABS and DIAGNOSTICS: Blood Gases - Abnormal. Lactate 12.0 mmol/L (H). CHEM -
Creatinine 1.4 mg/dL (H) Postassium 3.4 mmol/L (L) Anion Gap 26 mmol/L (H) Glucose
133 mg/dL (H) Calcium 7.2 mg/dL (H). CBC - WBC 4.8 x10e/uL (L) HGB 10.4 g/dL (L)
HCT 31.7% (L) Platelets 12.0 x10e3/uL (L) Mono# 0.0 x10e3/uL (L) Anisocytosis
slight, Microcytosis slight. Chest X-ray - Abnormal. ECG Abnormal."
"374692-1" "374692-1" "Heart stop beating, past away." "None"
"375144-1" "375144-1" "Resident complained of being dizzy and not feeling
well, went unresponsive and passed away at 9:30 PM. Resident was a comfort care
only resident no medical attention was necessary. 01/12/2010 Death Certificate
received. DOD 12/27/09. Cause of Death: Congestive Heart Failure as a consequence
of CAD. Additional information abstracted: Contributing factors - Diabetes
mellitus." "No lab data for this event."
"375507-1" "375507-1" "Patient reported cold-like symptoms (congestion and
sneezing) and was seen for that and for blood in his semen. He was given H1N1
vaccine and was released. The next morning he was found dead of a suspected heart
attack." "No lab data for this event."
"376329-1" "376329-1" "Pt died of Hemorrhagic shock within minutes of non-
emergent c/section." "Autopsy performed"
"376388-1" "376388-1" ""Seen in clinic 10/21/09 with cough, congestion, and
""feels hot"". Prescribed TAMIFLU on 10/21/09 and given intranasal H1N1 vaccine on
10/21. Subsequently apparently had flu-like symptoms and tiredness for unspecified
period of time and apparently found unresponsive in home. Resuscitation
unsuccessful."" "No autopsy performed, apparently no recent influenza tests
performed."
"376499-1" "376499-1" "Unknown if symptoms occured following vaccination
but patient passed away 3 days later." "unknown."
"376710-1" "376710-1" "According to mother, mom called office stated that
she walked into baby room he was unresponsive, she called EMS and baby was taken to
local ER where he was pronounced dead. Have not spoken to mother, she called office
and spoke with nurse." "No lab data for this event."
"376969-1" "376969-1" "Suspect H1N1 caused interaction with
COUMADIN/coagulation." "Increased INR"
"376990-1" "376990-1" "unknown" "No lab data for this event."
"377459-1" "377459-1" "DEATH. (Toddler was napping in crib during day.
Parent found child in full arrest. (Unclear if he'd be seizing prior.) CPR/EMS
achieved pulse with full interventions but pt was brain dead and life-support was
withdrawn within 8 hours of resuscitation." "Prelim autopsy results
inconclusive for cause of death. Tentative dx is SUDEp. (Sudden Unexpected Death
of Epilepsy)."
"377577-1" "377577-1" "Parents report onset of diarrhea and abdominal pain
in AM on day following vaccination. He presented to the ED 3 days following
vaccination with acute gastroenteritis, renal failure, repiratory distress and
shock. He was admitted to the PICU from the ED with a diagnosis of acute
gastroenteritis +/- HUS. He died later that evening in the PICU." "Admission:
WBC 37.9, H/H15/39.5, platelets 65, Na 127, K 6.2, HCO3 17, BUN 35, Cr 1.2 In PICU:
LDH 1779, CRP 22.93PT 16.3, PTT 37. INR 1.43, UA 4+protein and 3+blood Blood
cultures negative, tracheal cultures positive for non-antracis bacillus(thought to
be contaminant by pathology), Flu and RSV PCR (NP swab) negative, stool culture
negative, stool c.diff negative. Autopsy significant for diffuse colitis wth
patchy necrosis, chronic inflammation"
"377750-1" "377750-1" "Death apparent heart attack 1/16/10. Pt. w/ CAD/
angioplasty 7/09 w/ stent placement. On multiple meds, smoker, denied symptoms
1/14/10." "scheduled CMP, Lipid panel - Not done"
"378186-1" "378186-1" "PT PRESENTED TO ER WITH NEUROPOTHY AND LEG
WEAKNESS.WEAKNESS WAS BILATERAL, SYMMETRICAL, AND DEEP TENDON REFLEXES WERE ABSENT.
FELT TO BE GUILLAIN-BARRE SYNDROME. PT WAS STARTED ON IVIG." "PT HAD AN LP
PERFORMED ON 10/31/09 AND SHOWED AN ELEVATED PROTEIN VALUE"
"378368-1" "378368-1" "upper respiratory complaints - admitted to ICU."
"diagnosis: meningitis."
"378423-1" "378423-1" "He had diarrhea many times throughout the night and
all day the next day. I live an hour and a half from him and he traveled home on
Tuesday having to stop to go to the bathroom twice. He got home and had diarrhea
all day on Tuesday 12/15/2009. He also told me all week that he was feeling very
weak. He was even having trouble walking. I had told him all week to go to the
emergency room and he kept telling me he would be ok. Finally on Friday 12/18/2009
he agreed to call the emergency squad after I told him I would meet him at the
Hospital. The emergency squad arrived and being a big man he decided to walk to
the squad. He went down the first of two steps and died. They tried to bring him
back but was unsuccessful." "No lab data for this event."
"378896-1" "378896-1" ""She Died. I was not informed of anything other than
her death. Hospital records are conflicting. Tried to obtain medical records of
shots given to my baby, but the doctor's office said ""They don't have it"".""
"Still do not Know the cause of her death. My baby was healthy before I
brought her in to get her routine vaccines including the administered oral vaccine
Rotavirus, given to her two days before her death by Dr."
"379004-1" "379004-1" "well child check 1-20-2010. Infant received
Hepatitis B vaccine on 1-20-2010. Aunt found infant ,on the morning of 1-21-2010,
dead in the bed with mother,who was asleep. suspect SIDS or accidental
suffocation." "No lab data for this event."
"379008-1" "379008-1" "Tingling in extremities followed by weakness and
inability to walk. Hospitalized and received plasmapheresis for GBS. D/c to
nursing home for rehab therapy." "Lumbar puncture and EMG both suggest GBS."
"379119-1" "379119-1" "None stated." "No lab data for this event."
"379398-1" "379398-1" "None stated." "No lab data for this event."
"379507-1" "379507-1" "Lethargic, stopped drinking, stopped eating on the
21st. On the 22nd his arms layed limp at his sides when previously they were rigid
and locked from the Parkinson's. He would not eat or drink on the 22nd." "No
lab data for this event."
"379514-1" "379514-1" "Patient unresponsive at home after being discharged
on 12/12/09 at 9:15pm. Patient arrested, brought to hospital and pronounced dead at
11:40 PM." "No lab data for this event."
"379725-1" "379725-1" "Child given PENTACEL, ROTATEQ, and ENGERIX on
1/8/09. Child with apparent SIDS 1/12/09. I am not sure what the final ME report
stated." "SIDS 1/12/09"
"380175-1" "380175-1" "Initial case retrieved via the scientific literature
on 01 February 2010. This involves a case of misuse (drug administration error).
Summary of article: On 27 March 2009, blood products were collected from 89 active
duty military donor/trainees during a blood drive. On 10 April 2009, a routine
record review in connection with a subsequent blood drive learned of breach in the
deferral protocol for blood products collected from 89 donor/trainees. Further
investigation revealed that the blood obtained from the donor/trainees was from
donor/trainees who had been vaccinated with yellow fever vaccine 4 days prior to
donating blood. All the blood products had already been processed and incorporated
into the inventory at the hospital blood bank. Additional investigation showed
that, between 31 March and 09 April 2009, 5 patients had received a total of 6
blood products (3 platelets, 2 fresh frozen plasma, and 1 packed red cell unit)
from 6 of the 89 donor/trainees. One of 5 blood recipients had underlying diffuse
large B cell lymphoma and prostate carcinoma, and died 20 days after receiving the
blood product. Of the other 4 surviving blood recipients, 3 had VFV-IgM antibodies
confirmed by plaque reduction neutralization test. This case contains information
for 1 of the 5 blood product recipients. Information regarding the other 4 blood
recipients is reported in cases 2010-00827, 00841, 00842, and 00843. Information
regarding the 6 blood donor/trainees is recorded in case 2010-00844. An 82-year-old
male patient was discharged to inpatient hospice for terminal prostate cancer and
end-stage, transfusion dependent, B-cell lymphoma, and received on an unspecified
date, 1 unit of irradiated platelets that was from blood products that had been
donated by one of the active duty military donor/trainees who had received yellow
fever vaccination 4 days prior to donating blood. The blood donor/trainee had no
previous history of vaccination or travel history consistent with exposure to wild-
type YFV. Testing for pre-transfusion serologic status of the patient could not be
performed because banked sera were not available. The patient died (death not
related) 20 days after receiving the blood transfusion of irradiated platelets. It
was noted the patient had previously been vaccinated with yellow fever vaccine in
1959 and again in 1965. No autopsy was performed on the patient; and cause of death
was not provided. No pre-mortem blood specimens were available for testing, and
residual blood products from the patients transfusion was discarded. Documents held
by sender: None." "Pre-mortem specimen not available for serologic evaluation
testing."
"380328-1" "380328-1" "Loss of appetite, confusion, lethargy, excessive
mucus. Patient did not want to be hospitalized. Jan 14 thru Jan 18, 4 AM."
"Negative"
"380740-1" "380740-1" "Patient received the HPV as well as the flu nasal
spray on Aug 25th. I first declined getting her the vaccination but her doctor
ensured me that it was safe. I had declined the same vaccination a year earlier at
the downtown public health center. Patient was getting ready for school and was
standing by her closet, and all of a sudden she fell, she lost total control of her
legs. She went to school and could not engage in any of the activities because of
the numbness in her legs and the swelling of her foot. She also, started to get a
really bad headache. Days later she woke up out of her sleep complaining of a
severe headache, which usually she gets if she has a seizure but she hadn't had a
seizure this night. She continued to say she had not feeling in her foot and
tingling feeling in her leg. After I examined her foot I noticed it was swollen.
The next morning I called her doctors office and made her doctors appointment for
Oct 23rd. During the month of October she had irregular periods. My daughter
never made it to Oct 23rd, which as also her birthday. She passed on Oct. 17th, I
found her cold unresponsive in her room at 7am, which I went in to wake her up to
take her morning pills." "No lab data for this event."
"381102-1" "381102-1" "Fell at home 10/21/2009. By weekend began paralysis
of arms and legs. Had trouble eating and swallowing. 10/24/2009 to ER Hospitalized
2-3 days. Discharged and returned to hospital for two additional visits, nursing
home placement for 3 weeks. Returned home mid December 2009 with nurses and hospice
care. MD told family he thought she had Guillain Barre but would not put it in
writing." "none."
"381178-1" "381178-1" ""28 month old (ex - 30 week preemie) male was seen
in pediatric clinic for outpatient evaluation of croup. Examining attending
physician described barking cough but no stridor at rest. Given dexamethasone 9 mg
and vaccines. Child put to bed ""fine"". Found dead next morning. Unsuccessful
resuscitation."" "No lab data for this event."
"381218-1" "381218-1" "2-19-2010 Notified by coroner that child had died
today requesting copy of immunization record. No other information available."
"No lab data for this event."
"381305-1" "381305-1" "Initial report received on 19 February 2010 from
health care professional. A 16 year old female patient with an unknown medical
history tested positive for Neisseria Meningitidis 2 years, 7 months, 18 days (963
days) after she received a first dose of MENACTRA (lot number U2324AA) on 26 June
2007 (route and site were unknown). The patient was seen by a physician on 12
February 2010 after an emergency room visit for a sprained ankle after playing in
the snow. On 13 February 2010 at 10:30 AM, the patient was found dead in her home.
On 14 February 2010 the patient had a real-time PCR assay of the brain for
detection of neisseria meningitidis performed which detected Neisseria Meningitidis
serogroup C DNA. A spinal tap was done during an autopsy which revealed gram
negative rods Meningitis Type C DNA. The physician stated that the patient did not
have any symptoms of meningitis. No further information was provided. List of
Documents held by Sender: lab results." "Autopsy spinal tap revealed gram
negative rods, meningococcal type C. 14/Feb/2010: Neisseria Meningitidis PCR and
Meningitidis Serogroup PCR of the brain : Neisseria Meningitidis serogroup C DNA
detected."
"381726-1" "381726-1" "Found dead at home per dad in phone call. No ER note
available yet." "No lab data for this event."
 "381778-1" "381778-1" "15 hours after vaccinated started feeling ill,
headache, nausea, vomiting. To hospital where diagnosed w/ meningitis. Died a few
days later." "At hospital."
"382341-1" "382341-1" "reported child developed a fever early this am with
possible febrile seizure. Child was placed down for afternoon nap mother went in
room to check on child realized something wrong/ not moving/responding turned child
over and discovered child was blue. Coroner did note child had had an emesis."
"none currently available at this time"
"382444-1" "382444-1" "He was put to bed but did not awaken at the usual
time (about 2 AM) for feeding. It was then that mother found him in his bed,child
was transported to the hospital." "No lab data for this event."
"383127-1" "383127-1" "He recieved the H1N1 vaccine around 9:00 am. At he
at 12:00 Complaining of chest pain. No Diagnosis, then released from hospital. He
Died at midnight (12:00 am) from a ruptured aorta." "His aorta ruptured after
being released from E.R causing his death at 12:00 am"
"383169-1" "383169-1" "Information has been received from an administrator
concerning her nephew who on 22-JAN-2010 was vaccinated with a dose of RECOMBIVAX
HB (lot# not reported). On 31-JAN-2010 the patient died. At the time of death, in
approximately 31-JAN-2010 the patient had a bloody nose. The cause of death was
unknown. Additional information has been requested." "Unknown"
"383175-1" "383175-1" "Information has been received from a consumer via an
internet newspaper concerning a patient who on an unspecified date was vaccinated
with a dose of GARDASIL. It was reported that a parent can be guilty because if he
had known about the side effects, then he might not have allowed the pediatrician
to vaccinate the child, which resulted in death (cause of death unspecified). It
was unknown if the patient sought medical attention. It was also reported that
polysorbato 80 or tween 80 that is a chemical that causes infertility in mice and
aluminum which is neurological toxin are in GARDASIL. This is one of several
reports from the same source. Additional information is not expected." "Unknown"
"383746-1" "383746-1" "Patient received H1N1virus shot late AM 11-20-2009.
On the way home she was tired, near lunch I gave her peaches & a little soup. Heart
rate high, dizzy, short of breath, paleness, weakness went in & laid down. Got up &
went to bathroom & died." "Taken that AM 11/20/09 Blood Test office. Also Hosp
11-18-09 11-19-09"
"384071-1" "384071-1" "No symptons,or signs prior to child not breathing.
Child taken to ER and CPR was implemented." "Autopsy"
"384848-1" "384848-1" "Patient found dead in crib." "No lab data for this
event."
"385142-1" "385142-1" "Patient had life threatening lissencephaly
aspiration (G Butter Fed) & mixed apnea known risk & partial no code." "received 3
vaccines < 1 hour prior to apnea/ bradycardia asystole."
"385210-1" "385210-1" "Patient asymptomatic on day of immunization.
Afebrile before and after immunization. Patient found dead next day with face down
on bed with lots of secretions." "Skeletal survey at medical center Emergency
Room"
"385303-1" "385303-1" ""Information has been received from a Nurse at the
physician's office who heard from another Nurse that a patient came in to the
office to receive the third dose of GARDASIL and the friend of the patient told her
not to get the third dose because she knew of another girl that received the third
dose of GARDASIL and died ""within the last month"" (cause of death not reported).
It was unknown if the patient sought medical attention. Attempts are being made to
verify the existence of an identifiable patient. Additional information has been
requested."" "Unknown"
"385430-1" "385430-1" "None stated." "No lab data for this event."
"385948-1" "385948-1" "Diarrhea 4/24/10. Fever 4/25/10." "Chest x-ray
4/23/10 & 4/25/10 No significant change from previous x-rays"
"386283-1" "386283-1" "My daughter was sick. She was complaining about pain
in her stomach, she was vomiting for previuos 4 days. So I decided to take her to
her pediatrician and check what is wrong with her. Instead she was given 5 vaccines
at her pediatrician office. He said that she is fine. She was given second dose of
H1N1, HIB, Hepatitis A, varicella and tuberculosis shot. Since this time she was
uncontrollable crying and she was being in constant pain. She could not keep the
food. She was throwing up. The next day she collapsed, she stop breathing, she was
unconscious. My wife call the ambulance. In a hospital doctors said that she had
bleeding on one side of her brain. They transfer her from one hospital to another.
She was still unconscious but moving her limbs. The next day morning doctors
decided to perform surgery on her brain because of the bleeding. She never came out
from that. The brain was dead. She was dead..." "No lab data for this event."
"386360-1" "386360-1" "Death - 13 hours after Influenza A administration.
Spouse had evidence of febrile event when found. spouse had been exposed to son
with H1N1 (swine) continuously for 5 days in preceding 8 days before death. It was
unknown at time that son had H1N1 and only became known to us 6 weeks after
patient's death." "Toxicology report showed high ethanol content (0.43%) except she
didn't drink. 8hrs forensic investigation did not turn up any alcohol/containers/
glasses etc."
"386490-1" "386490-1" "Initial report was received 22 April 2010 from a
press article. A 22-year-old male college student had received a meningococcal
vaccination before entering college (manufacturer, lot number, route, site and date
of administration not reported), and an unspecified amount of time later on 13
April 2010, the patient reported feeling ill. He was taken to the emergency room by
his friends at approximately 5:30pm and within hours (also reported as before
11:30pm), he died from meningococcal disease/bacterial meningitis. According to the
report, test results (not specified) were pending. No additional information was
provided at the time of the report. Documents held by sender: None." "Test
results (not specified) were pending."
"386690-1" "386690-1" "Initial report received from a physician via health
authority on 03 May 2010: This patient was vaccinated with S-OIV FLUVIRIN (batch
number 107522P1) on 29 Apr 2010. 24 hours after vaccination, the patient presented
with sudden respiratory failure on 30 Apr 2010 and two hours later, the patient
died. Medical history of the patient was unknown. Autopsy was performed and cause
of death was stated as bronchopneumonia." "Autopsy, Bronchopneumonia stated as
cause of death."
"386796-1" "386796-1" "At birth at Hospital patient began with Infamil
formula and when perinatal insurance cut me off I was forced to use Similac
Advanced, my son took ill with gastrointestinal diarrhea immediately. Health
professional & Doctor were fully aware of this. Health professional threatened me
she was fully aware of my C.P.S. history & would report me if patient wasn't
brought in by 2-18-09 for his shots." "No lab data for this event."
"386863-1" "386863-1" "Apparently had flu-like symptoms starting about 2
OCT 09. He had lab work & flu shot at the Health Clinic, on 6 OCT 09. He had a
respiratory arrest at home on 9 OCT 09. H1N1 influenza from lung cultures & Nl Swab
at autopsy." "Autopsy - Office of Med Invest - H1N1 by RT-PCR confirmed"
"386946-1" "386946-1" "Child had been in distress at cardiology office -
was transported to hospital. When intubated for transport child had vagal response
with bradycardia - unable to resuscitate and child expired at ER." "Unknown."
"387104-1" "387104-1" "Subject in pneumococcal vaccine trial, with severe
COPD died of unknown cause on 10/14/09. Vaccination took place 10/07/07. According
to physician the relationship is 'unlikely'." "No lab data for this event."
"387119-1" "387119-1" "Subject in pneumococcal vaccine trial, with severe
COPD died of autoimmune hepatitis on 9/17/09. Vaccination took place 5/14/2008.
According to physician the relationship is 'unlikely'." "No lab data for this
event."
"387143-1" "387143-1" "None stated." "No lab data for this event."
"387160-1" "387160-1" "Information has been received from a physician who
found out from another treating physician who was also the father of the patient,
concerning a 16 year old female patient who on an unknown date, was vaccinated with
a dose of GARDASIL. Subsequently the patient developed a severe headache. Then the
patient went to sleep that night and passed away. The autopsy was performed which
revealed no cause of death. It is unknown if the patient sought medical attention.
Severe headache was considered to be immediately life-threatening. Additional
information has been requested." "Unknown"
"387614-1" "387614-1" "According to parents the baby was found not
breathing in bed. Taken to ER. Died before reaching the ER." "Taken to ER.
Coroner aware. Details unknown."
"387625-1" "387625-1" "Child found dead one morning." "No lab data for
this event."
"387760-1" "387760-1" "Pt with combined immune deficiency was exposed to
OPV through daughter's vaccination in 1996. In December 2008 developed (L) calf
cramping which progressed to bilateral lower extremity weakness. (see attached
sheet)" "Stool culture on 3/3/09 positive for sabin poliovirus type 2"
"388096-1" "388096-1" "Information regarding PREVNAR was received from an
emergency room physician regarding a 3-month-old (114 day-old) female patient who
experienced pyuria, Streptococcus pneumoniae meningitis and Streptococcus
pneumoniae sepsis and died. The patient received a dose on 25-Jan-2010. On an
unknown date in Feb-2010, the patient experienced pyuria and was empirically placed
on an unknown antibiotic thought to be either KEFLEX or OMNICEF. On an unknown date
in Feb-2010 the urine culture was negative. On 25-Feb-2010 the child was
transported to the emergency room where she died due to Streptococcus pneumoniae
meningitis and Streptococcus pneumoniae sepsis. The patient was not hospitalized.
The cause of death was reported as meningitis pneumococcal and pneumococcal sepsis
and the autopsy cause of death was meningitis pneumococcal and pneumococcal sepsis.
The serotype of the pneumococcal bacteria was not identified. No additional
information was available at the time of this report." "Culture (results:
Streptococcus pneumoniae) and culture urine (results: negative) were done in Feb-
2010."
"388098-1" "388098-1" "CHIEF COMPLAINT: He presents here as a 12 month old
that was brought in by mother, carried in from triage to shock room 2, lethargic
and listless. HISTORY OF PRESENT ILLNESS: The patient, according to mother's
history, was exposed to several family members who have had URI symptoms over the
last 24 hours and this morning he slept more than usual, walking up around 10:30
this morning, and was found to be lethargic. The patient was carried into shock
room 2. Further history was not available. PAST MEDICAL HISTORY AND SURGICAL
HISTORY: Negative. ALLERGIES: Negative. MEDICATIONS: Currently negative. REVIEW
OF SYSTEMS: As per HPI; otherwise, all negative. PHYSICAL EXAMINATION: General:
The patient was lethargic, listless, and unremarkable. HEENT: His oropharynx was
clear. He did not have any tongue lacerations or abrasions. He had moist mucous
membranes. Neck: Supple. I did not appreciate any obvious lymphadenopathy or
meningeal signs. Lungs: Clear on auscultation. He had moderate accessory muscle
use with intercostal retractions. Abdomen: Soft. I did not appreciate any
distention or signs of trauma. Extremities: The lower extremity exam was cold to
touch. He had poor perfusion. He was mottled. Neurologic: The patient had
positive nystagmus and almost exhibited tonic-clonic-like activity. EMERGENCY
DEPARTMENT COURSE: Immediately, we decided to intubate this patient to maintain a
definitive airway. Using a 4.5 endotracheal tube that was uncuffed, I proceeded
with intubation. A peripheral IV was inserted immediately by our nurse. I used 15
mg of IV succinylcholine with a dosing determined using a weight based scale. We
believed the patient was anywhere from 10 to 12 kg. Once the patient was adequately
paralyzed, I was able to successfully intubate this patient. He had positive end-
tidal CO2 and condensation in the tube. He had blood work including a CBC, a blood
culture, and a BMET. I had the patient transferred immediately to head CT which
showed evidence of chronic maxillary sinusitis with no evidence of mass effect.
When the patient returned back to the emergency room into shock room 2, I proceeded
with spinal tap. Given the emergency situation, we did not have a chance to
consent mother who was not immediately available. We went ahead and proceeded with
the procedure. I was able to successfully perform a spinal tap using his pelvic
crests as my landmarks. The entire procedure was performed under sterile
conditions. The back was cleaned using iodine applied in circular fashion x3.
Using the pediatric LP tray, and the spinal needle that was within the tray, I used
the L3-L4 interspace to access the subarachnoid space. I was able to collect 3
tubes of CSF, at least 2 mL each, and these were sent for studies including HSV,
PCR. We went ahead and ordered antibiotics including Rocephin 100 mg per kg IV.
Laboratories returned with a white count 30.7, hemoglobin 14.0, platelet count 344.
Sodium 153, potassium 6.9, chloride 113, CO2 of 10, BUN 88, creatinine 1.15,
calcium 7.2. We are getting a BMET. I have ordered IV glucose, D25 2 mL/kg. A
urine culture, and urinalysis, and a blood culture were ordered and pending.
Postintubation chest x-ray showed left-air space disease. Right lung was clear.
Endotracheal tube appeared to be in satisfactory position. Head CT did show
evidence of chronic maxillary sinusitis. I spoke to Dr. from ICU and the patient
will be transferred there in critical but stable condition. He asked that we go
ahead and give him vancomycin 20 mg/kg IV as well as Acyclovir 20 mg per/kg IV, and
I will also order maintenance IV fluids after receiving initial 200-mL normal
saline bolus. We also gave him an ampule of calcium gluconate for his
hypocalcemia. IMPRESSION: 1. Mental status changes. 2. Acute meningitis. 3.
Sepsis syndrome. DISPOSITION: To ICU in critical but stable condition. CRITICAL
CARE TIME: Exclusive of all procedures which included endotracheal intubation as
well as spinal tape, greater than 60 minutes." ""Note: All result statuses are
Final unless otherwise noted. Tests: (1) BLOOD CULTURE (BLC) Order Note: !
SPECIMEN DESCRIPTION ""Result Below..."" *1 RESULT:
BLOOD(A) PERIPHERAL STICK ! SPECIAL REQUESTS ""Result Below...""
*2 RESULT: Peds bottle only received. ! CULTURE NO GROWTH 6 DAYS
*3 ! REPORT STATUS FINAL *4
05042010 Note: An exclamation mark (!) indicates a result that was not dispersed
into the flowsheet. Document Creation Date: 05/04/2010 8:21 AM CT HEAD WITHOUT
CONTRAST Indication: Mental status changes, cyanotic, unresponsive Comparison: None
Findings: The ventricles and CSF spaces are within normal limits. There is no acute
hemorrhage, abnormal fluid collection or midline shift seen. No acute infarction or
mass is seen. MRI may be helpful if symptoms persist. There are mild chronic
sinusitis changes in the maxillary sinuses. Impressio"
"388188-1" "388188-1" ""Received H1N1 & Pneumonia vaccine 12 March 2010.
Apparently developed fever that night & the following 2 days was ""achy, dizzy &
had nausea all day"". On 12 Mar, complained of neck pain & dizziness, developed
lethargy & then became unresponsive."" "Autopsy at office of the Medical
Investigator"
"388189-1" "388189-1" ""Shortly after H1N1 vaccine ""began having flu-like
symptoms"". 1 week prior to death had nausea, vomiting, fever & diarrhea.""
"Autopsy. OFC of Med Investigator"
"388916-1" "388916-1" "Pt. received vaccines on 1/7/10 and was found
unresponsive in crib on 1/28/10. Autopsy showed pt. died from Fibroelastosis of the
heart." "No lab data for this event."
"389121-1" "389121-1" "Patient came in for well child check on 4/19/10
received DTAP and HIB at the same visit. Clinic contacted by Medical Examiner that
patient died on 4/24/2010 of ruptured R atrium after T.V. fell on him. D. Cert
attached." "Per Death Certif. - death caused by chest injury from accident of T.V.
falling on top of toddler"
"389842-1" "389842-1" ""This case involves a fatal event was considered
medically important for the events of vomiting and fever. Information regarding
PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male
patient who experienced a positive bacterial culture, fever and vomiting and died
due to an overwhelming sepsis from Group A Streptococcus pyogenes. The patient
received the first dose on 26-Apr-2010 along with a second dose of PENTACEL
(Aventis-Pasteur) and the second dose of ROTATEQ (Merck & Co Inc). On 18-May-2010
the patient experienced fever and vomiting and was evaluated in the emergency room.
On an unspecified date in May-2010, a culture (reported as ""a very early culture
of unspecified origin) was performed that revealed Streptococcus pneumoniae,
however a blood culture on 18-May-2010 revealed Group A Streptococcus pyogenes. On
19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus
pyogenes. The cause of death was reported as streptococcal sepsis. The autopsy
cause of death was undetermined. No additional information was available at the
time of this report."" "In May-2010 test results were: culture (results: (site
unknown) growth of Streptococcal pneumoniae); CSF culture (results: pending); and
autopsy (results: pending). Blood culture (results: Group A Streptococcus pyogenes)
was done on 18-May-2010."
"390042-1" "390042-1" "Febrile seizure 3/22/10. Patient found dead on
morning of 4/2/10, per parents febrile to 102 t bedtime with URI but no other sx.
Autopsy and toxicology were negative." "negative autopsy and toxicology"
"390402-1" "390402-1" ""Initial case was retrieved from the scientific
literature on 31 May 2010. A 75-year-old male patient, with a medical history of a
recent hospital admission 6 weeks prior for lassitude, pallor, peripheral edema,
anemia (hemoglobin 6.6 g/dL), low serum iron, folate, and B12, diagnosed as
pernicious anemia, mild hepatosplenomegaly and slightly elevated bilirubin of 1.4
mg/dL, received an injection (route and site not provided) on 29 November 1973 of
Yellow Fever Vaccine (lot number and manufacturer unknown). ""Six days later he
developed flu-like symptoms, with fever, chills, myalgia, nausea, vomiting, mild
sore throat, and abdominal pain. He was seen by a physician who noted a temperature
of 100 degrees Fahrenheit and prescribed penicillin and an analgesic. The next day,
the patient became confused and did not take food or fluids. He was admitted the
following day (8 days after vaccination) to the hospital. On the day of the current
admission, the patient was found to be moderately obese, lethargic, acutely ill,
and complaining of abdominal pain. The temperature was 98.6 degrees Fahrenheit,
pulse 120 and blood pressure 84/48. The face appeared swollen, mucus membranes were
dry, the abdomen protuberant and generally tender, with liver and spleen palpable
on deep inspiration. Serum urea nitrogen (BUN) was 140 mg/dL, glucose 116 mg/dL,
total bilirubin 4.4 mg/dL, albumin 2.6 g/dL; alkaline phosphatase, calcium, and
phosphorus normal. On the day after admission, he was admitted to the intensive
care unit because of hypotension and deteriorating mental status. The blood
pressure was 60/40, temperature 102 degrees Fahrenheit, urine output minimal, and
sensorium obtunded. The BUN was 190 mg/dL, creatinine 7.8 mg/dL, bilirubin 5.5mg/dL
(4.2 direct), SGPT 102 U/L, alkaline phosphatase 93 U/L, hematocrit 46.7%,
platelets 46,000, white blood cell (WBC) count 13,800/mm3 with 66%
polymorphonuclear cells, 3 % bands, 31%lymphocytes. Urinalysis showed 12-15 WBC,
50-60 red blood cells, 3-4 renal epithelial cells, 2+ albumin. The patient was
thought to be in acute renal failure, dehydrated, and to have significant hepatic
dysfunction. His condition deteriorated, with progression from delirium to coma.
His temperature, BUN, creatinine, and WBC remained elevated. Bilirubin increased to
11.2 mg/dL (9.4 direct). He developed a consumption coagulopathy with
thrombocytopenia (40,000/mm3), prolonged prothrombin time (15.4 seconds, 11.4
seconds control) and partial thromboplastin (66.0 seconds, 31.9 control), and
positive fibrin split products, but did not develop overt bleeding. He was treated
with corticosteroids, mannitol, heparin, furosemide, and vasopressors. The
electrocardiogram (EKG) showed low voltage and peaked T waves in V1-V6. Chest x-ray
showed fluid in the right pleural space and congestion. The patient died 3 days
after admission (11 days after vaccination). On autopsy, gross anatomical findings
included diffuse, focal necrosis of the liver, atrophic gastritis of the stomach,
lipid depletion of the adrenal glands, and congestion of both lower lobes of the
lung. A number of experts evaluated the liver histopathology. The findings included
focal single cell necrosis, scattered acidophilic degeneration, marked areas of
hepatocellular unrest, marked Kupffer cell hypertrophy, cholestasis, and fatty
degeneration. The distribution of lesions was not mid-zonal, and for that reason
the changes were not considered caused by yellow fever. A fluorescent stain of the
frozen liver was negative for yellow fever antigen and fixed liver tissue was
examined by electron microscopy and found negative. Documents held by sender:
None."" "Day of admission: temperature 98.6 deg F, pulse 120, blood pressure
(BP) 84/48, BUN 140 mg/dL, glucose 116 mg/dL, total bilirubin 4.4 mg/dL, albumin
2.6 g/dL; alkaline phosphatase, calcium and phosphorus normal. Day after admission:
BP 60/40, temp 102 deg F, urine output minimal, BUN 190 mg/dL, creatinine 7.8
mg/dL, bilirubin 5.5 mg/dL (4.2 direct), SGPT 102 U/L, alkaline phosphatase 93 U/L,
hematocrit 46.7%, platelets 46,000, white blood cell (WBC) count 13,800/mm3 with
66% polymorphonuclear cells, 3 % bands, 31%lymphocytes. Urinalysis showed 12-15
WBC, 50-60 red blood cells, 3-4 renal epithelial cells, 2+ albumin. Bilirubin
increased to 11.2 mg/dL (9.4 direct), developed thrombocytopenia (40000/mm3),
prolonged prothrombin time (15.4 seconds, 11.4 seconds control), partial
thrombocytopenia (66.0 seconds, 31.9 control) and positive fibrin split products.
EKG showed low voltage and peaked T waves in V1-V6. Chest x-ray showed fluid in the
right pleural space congestion. Fluorescent stain of the frozen liver tis"
"390561-1" "390561-1" "Infant found unresponsive by parents on the
afternoon of 6/10/10." "None"
"390676-1" "390676-1" "Information has been received from an anonymous
nurse concerning a male patient who on an unspecified date, was vaccinated with a
first dose of ZOSTAVAX (Oka/Merck) (lot no. not reported) because it was a required
vaccine for citizenship. The vaccine was not given by a physician but someone else.
On an unspecified date, the patient passed away. An autopsy was being done at that
time. The patient passed away was considered to be immediately life-threatening and
disabling by the reporter. Additional information has been requested." "unknown"
"391439-1" "391439-1" "Information has been received from a Registered
Nurse concerning an 18 year old female patient with a history of seizures prior to
GARDASIL, who on an unspecified date was vaccinated with a dose of GARDASIL. The
nurse advised that the patient experienced seizure and subsequent death after
receiving GARDASIL. It was not advised which injection in the series caused the
adverse experience or how the injection was administered. The health care
professional was contacted by telephone and call would not supply the following
information: patient name, date of birth, dates of vaccination/therapy, dose
number, lot number and date of event. Seizure was considered to be disabling and
immediately life-threatening. Additional information has been requested."
"Unknown"
"391910-1" "391910-1" "None reported - pt. left office without incident -
Found 6/26/10 AM-died while sleeping." "None"
"392434-1" "392434-1" "Information has been received from a physician
concerning a 90 year old female who on 24-JUN-2010 was vaccinated with a dose of
ZOSTAVAX (Merck) (dose, route and lot number not reported). The physician reported
that on Saturday (26-JUN-2010), the patient complained to a neighbor that she was
not feeling well, had diarrhea and arm pain. The physician stated that the patient
was found deceased at home on Monday 28-JUN-2010. The cause of death was unknown.
The patient did not seek medical attention. Additional information has been
requested." "Unknown"
"392516-1" "392516-1" "Information has been received from a published
article, regarding a case in litigation concerning a female patient who in 2004 was
vaccinated with a dose of RECOMBIVAX HB (Manufacturer unknown). Secondary suspect
therapy included PNEUMOVAX 23 (Manufacturer unknown) and PEDVAXHIB (Manufacturer
unknown), IPV (Manufacturer unknown) and DTAP (Manufacturer unknown). The next day
the patient died of a table encephalopathy. The cause of death was encephalopathy.
No further information is available." "Unknown"
"392671-1" "392671-1" "On day of vaccination throat was closing up for
about 40 minutes after vaccine, then was dizzy for several days after. Stated she
didn't feel good. On 12/4/09 was diagnosed with heart valve damage both mitral and
tricuspid and dilated cardiomyopathy. Was admitted to CCU on 12/10/09 and died.
Had H1N1 vaccine on 10/23/09." "No lab data for this event."
"393036-1" "393036-1" "None stated" "No lab data for this event."
"393060-1" "393060-1" "Pt died. Autopsy revealed Giant cell myocarditis. Pt
received H1N1 vaccine 2 1/2 months prior. Unsure if related." "Autopsy as above"
"393137-1" "393137-1" "Patient with SIDS event after shots. Unsure if shots
related or if coincidence. Autopsy reportedly (-)." "None"
"393479-1" "393479-1" "Information has been received from a registered
nurse concerning a haemodialysis male patient who in approximately July 2005 was
vaccinated with the first dose of PNEUMOVAX 23. In March 2010 the patient received
the second dose of PNEUMOVAX 23 but may have possibly be given 1 ml dose instead of
0.5 ml intramuscularly. The nurse also reported that the patient was helping his
son move and was lifting heavy objects when he died at the end of June 2010 (Date
unknown). The registered nurse thought that the cause of death on the certificate
stated cardiac problems, but was unsure since she did not have the medical records
at the time of the report. Additional information has been requested." "Unknown"
"393620-1" "393620-1" "High pitch crying, frequently spitting up, direahea,
and eating pattern wasn't regular." "No lab data for this event."
"393893-1" "393893-1" "Patient diagnosed with meningococcemia, serogroup W-
135." "Neisseria meningitidis detected by hospital laboratory, confirmed and
serogrouped."
"393972-1" "393972-1" "Unexpected death after sudden cardiorespiratory
arrest." "unavailable/ME report pending"
"394031-1" "394031-1" "Information regarding PREVNAR was received from a
healthcare professional regarding a 17-month-old female patient who experienced
pneumococcal meningitis/drug ineffective. At 12 months of age, the patient received
the fourth dose on 08-Dec-2009. On 04-May-2010, the patient developed pneumococcal
meningitis. Treatment included (unspecified) intravenous antibiotics. On 07-May-
2010, the patient died. The cause of death was reported as meningitis pneumococcal.
No additional information was available at the time of this report." "No lab data
for this event."
"395175-1" "395175-1" "Pt had been on an outing to the city with family,
returned home, sat on couch, had a seizure, then respiratory arrest, pt turned
blue, husband administered cpr, but she died." "June 2010: WBC 13 H/H 12.5/37,
plat 436,000 creat 0.6, glu 83, magn 1.7, phosph 4.7 Alk phos 252, bili 0.8, AST 23
ALT 14, TSH 2.1, Albumin 3.7 March 2010: Chol 409 LDL 342, HDL 33, TG 168"
"395200-1" "395200-1" "Found dead in crib by mother." "No lab data for
this event."
"396820-1" "396820-1" "None" "No lab data for this event."
"396858-1" "396858-1" "Minor cold for about a week and a half. Then a fever
started on 9-19-08. Doctor visit/urgent care the next day on 9-20-08, doctor found
nothing wrong. Urgent care and ER on 9-21-09 after an episode of shaking and a
higher fever. Vomiting at urgent care. IV was inserted at urgent care. Diarrhea
started after IV. Ambulance to the ER. Extreme lethargy. Spinal tap. Doctors
weren't sure what was wrong. A CT scan around midnight (Sunday night) didn't find
anything wrong. Second CT scan on 9-22-08 found swelling on the brain. MRI later on
9-22-08 found a blood clot. Our daughter died on 9-23-08. We were told by two
specialists that it was vaccine-related, but they wouldn't tell us more."
"Plasminogen Activator Inhibitor was over 1000 (should be less than 25). This
was not a genetic blood clotting problem."
"397045-1" "397045-1" "June 15 and 16 weakness, unsteadiness - June 17
weakness, falling, fever, fast heartbeat, confusion - June 18 same as above and
difficulty breathing (on June 18 20:00 AM put in ICU in critical condition)."
"No lab data for this event."
"397437-1" "397437-1" ""Information has been received from a physician that
he heard from a parent of one of his patients who also heard from elsewhere
concerning a female who was vaccinated with a 0.5ml dose of GARDASIL, IM. ""Some
time passed, then she died"". The cause of death was not reported. The patient
received unspecified medical attention. Died was considered to be disabling and
immediately life-threatening. No further information is available."" "Unknown"
"397525-1" "397525-1" "Initial report was retrieved from scientific
literature on 31 August 2010; with additional information received on 02 September
2010 from online news report. According to the two literature citations previously
noted the objective was to report the occurrence and characteristics of Guillain-
Barre syndrome (GBS) after administration of H1N1 vaccine in 2009. The method used
the data from the Vaccine Adverse Event Reporting System supplemented by additional
data from the center for biologics and research under the Freedom of Information
Act. All data was reviewed by a neurologist certified in neuromuscular diseases to
confirm the diagnosis of GBS. The data excluded GBS cases that occurred within two
days after vaccination. The results were as follows: Thirty five cases (mean age
36.6 +/- 22.5 years; 14 were men) of GBS were reported after administration of H1N1
influenza vaccination, with an estimated occurrence of 3.5 per 10 million
vaccinations. All cases of GBS except one were reported within six weeks of
vaccination, with 23 cases reported within the first two weeks after vaccine
administration. Twenty three of the GBS cases (65.7%) were reported in the first
two weeks after vaccination with maximum occurrence in the second week. One report
of death and one of disability were reported in the 33 patients who were
hospitalized. In 2009, 57 patients were diagnosed with GBS after vaccination with
the seasonal influenza vaccine with an estimated occurrence of 7.3 per 10 million
vaccinations. The time period of occurrence was similar to that reported for GBS
cases after H1N1 influenza vaccination. Documents held by sender: None." "Not
reported"
"397858-1" "397858-1" "Acute Necrotizing Eosinophilic Myocarditis. Patient
died at home." "not known"
"398497-1" "398497-1" "This female subject was enrolled in the 2nd year of
prophylactic observer-blind study. On 01 October 2009, she received a 2nd dose of
preservative-free FLUARIX or FLU NG. The subject's past medical history included
osteoarthritis. On 01 July 2010, nine months after the 2nd dose of Blinded vaccine,
15 months after the 1st dose of MOBIC and an unspecified time after the 1st dose of
Goody powder, this 68-year-old subject developed upper gastrointestinal hemorrhage.
On 05 July 2010, she developed acute renal failure. On 09 July 2010, she developed
multisystem organ failure. The subject was hospitalised and the events were life-
threatening. The upper gastrointestinal hemorrhage resolved on 01 July 2010. The
subject died on 09 July 2010 due to multisystem organ failure. An autopsy was not
performed. The investigator considered that there was no reasonable possibility
that the multisystem organ failure, upper gastrointestinal hemorrhage and acute
renal failure may have been caused by investigational product and that the events
were possibly due to the concomitant medication, Goody powder and meloxicam and the
subject's medical history of osteoarthritis. Investigator Comments: RE: Goodys
Powders on Relevant Medication screen. This medication was not reported to the
subject's PCP as being taken so I have no start date, dosage, frequency or unit.
Subject was abusing Goodys Powders and developed a bleeding ulcer. Subject admitted
to the hospital. Subject was transfused 2 units of packed red blood cells.
Initially she was doing well but became confused and agitated and hypotensive. An
endoscopy was done which showed a massive bleeding from the pylorus. Subject was
taken to surgery and the bleeding stopped. Subject did well until post-op day 5
when she started to deteriorate. Subject went into renal failure, then into
multisystem organ failure. Subject succumed to death 09Jul2010. Medical history at
study start : Other autoimmune diseases of the skin or subcutaneous tissue, COPD,
Other respiratory system disorder, Other gastrointestinal and hepatobiliary system
disorder, Other genito-urinary system disorder, Osteoarthritis, Osteoporosis, Gout,
Other musculoskeletal system and connective tissue disorder, Other nervous system
disorder. ." "01Jul2010, Blood Platelet count, 15L/L; 01Jul2010, Blood
Hemoglobin, 6.6g/dL; 08Jul2010, Blood Platelet count, 33L/L; 08Jul2010, Blood
Hemoglobin, 9.3g/dL"
"398967-1" "398967-1" "Patient received combination Flu shot on 01-17-1- at
approx. 1PM. Had shot at doctor's office. Had blood drawn at hospital at 1:38PM.
After arriving home, deceased complained of being sick to stomach and hot. Began
vomiting and had black, runny diarrhea. Overnight patient condition deteriorated,
lung filled with fluid and had no pulse when EMS arrived at approx, 12:40 PM 9-18-
10. Patient pronounced dead at 1:07 PM on 9-18-10. On 9-18-10 AM before EMS arrived
patient vomiting brown bile and had runny, black diarrhea" "None at present"
"399572-1" "399572-1" "Was informed that patient died 2 days after flu
shot, no symptoms were reported by police office department." "No lab data for
this event."
"401548-1" "401548-1" "Wife reports after leaving the Health Department,
she and her husband completed some errands, the stopped approximately one hour
later to let their dogs exercise. After getting out of the truck for a few
minutes, he returned to the truck, then suddenly collapsed onto her lap. Was
transported to Hopital." "No lab data for this event."
"401842-1" "401842-1" ""Initial report was received 30 September 2010 from
a health care professional, who received the report from the patient's wife. A 74-
year-old male patient who had a history of asthma and allergies to weeds and molds,
had received a first dose of FLUZONE HIGH-DOSE (lot number, route and site of
administration unknown at the time of the report) and an unspecified allergy shot
on 21 September 2010. On 24 September 2010, three days post vaccination, the
patient developed a slight fever which resolved the following day. According to the
reporter, the patient went to bed on 26 September 2010 and the following day on 27
September 2010, six days post vaccination, the patient was found dead in bed. The
patient had no concurrent illness at the time of vaccination. The patient had been
taking EFFEXOR, FLOMAX, ""NEURONTIN"", Hydromorphone and
""guiafesen""concomitantly. The patient had also received allergy shots in the
past. At the time of the report, it was unknown if an autopsy had been performed.
No additional information was provided at the time of the report. Documents held by
sender: None."" "None"
"402154-1" "402154-1" "4/21 daytime - nausea, vomiting, diarrhea, fever &
neck pain. 4/21 10:29PM At hospital ED - febrile, appearing septic & hypotensive &
had tachycardia. 4/21 11:34 PM Intubated. 4/22 12:36AM Pronounced dead." "Blood
& CSF collected 4/21 were positive for N. meningitidis. Blood isolate was
identified as serogroup Y."
"402744-1" "402744-1" "Per police report, pt was found deceased in parents
bed, in prone position. Vaccines were given 4 days prior to death. No complications
occurred in Dr office on that day." "No lab data for this event."
"403696-1" "403696-1" "My father developed high fevers a day after the
forced Pneumonia vaccine was given to him. This was given to him without asking our
authorization or making us sign any kind of paper. He begun to go on himself
constantly and we were told he developed Colitis, which he did not have. He also
was given blood transfusions constantly because they told us he was weak and he
would have benefited from the transfusions. A week after receiving the Pneumonia
Vaccine he had a massive stroke. Nothing was done to diagnose and prevent it. The
doctors who kept on coming in said that he was very very sick and everyone was
shaking their heads. When we saw how badly he was doing we even asked what they did
to him? His personal physician said he was given a Pneumonia Vaccine which was
very, very good! This is what he told us and he quickly walked out of the room. On
July 27th he was moved to Meadowlands Hospital in Secaucus. After they moved him to
Meadowlands Hospital a doctor asked me, why they did not operate on his brain to
relieve the pressure and stop the stroke. We were told he did not have colitis, but
Sepsis. His blood stream had become completely poisoned. He died on August 14th,
two days after we pulled the breathing tube away from him because they told us he
was brain dead and there was no hope that he would ever come out of it." "No
lab data for this event."
"403759-1" "403759-1" "Mother called me on 9-17-10 afternoon that her son
is sick and feeling very weak. I recommended the mother to take him to nearest ER
as the patient was about 50 miles away and mother took him to ER where he was
transferred to another hospital." "Unknown"
"404173-1" "404173-1" "Pt. deceased 10/11/2010. Unknown cause at present
time; per mo-pt found in crib, prone, not breathing on morning of 10/11/2010. Past
history significant for spinal muscular atrophy Type II. Treated for pneumonia
9/20-9/22/2010." "None"
"404258-1" "404258-1" "Patient was found pulseless and apneic in her bed by
mom in the morning (0500). CPR performed and pt taken to ED. Unable to
resuscitate." "None"
"404478-1" "404478-1" ""A couple weeks after receiving the H1N1 Flumist,
client complained of being tired and felt tired ""all the time""."" "Medical
examiner said client died of myocarditis. Attributed to a recent viral infection.
Patient had not had any known infections prior."
"404792-1" "404792-1" ""Initial information received from a health care
professional on 15 October 2010. A 75-year-old male patient with a history of
severe cardiopulmonary issues (unspecified), cataracts, and who was ""crippled"",
received a dose of FLUZONE HIGH-DOSE No Preservative 2010-2011, lot number U3635AA,
on 13 October 2010 at 10:00 a.m. The route and site of vaccination were not
reported. Following vaccination, the patient experienced no adverse events or
reactions and was reported to be ""fine"" at 8:30p.m. that evening. The following
day, on 14 October 2010 at 11:00 a.m., he was found dead by his sister. Autopsy
status is unknown and no cause of death was reported. Per the reporter, the patient
had been very ill prior to vaccination and his quality of life was poor. Follow-up
information received on 18 October 2010 from a health care professional. The
reporter stated that it is unknown if an autopsy was planned for the patient, but
that if the patient had been seen by one of their physicians during the month prior
to the event it is unlikely an autopsy would be performed. In addition, the
reporter stated that the patient's past medical history of cardiopulmonary issues
(unspecified) were ""more cardiac rather than pulmonary"", but no specifics were
provided. List of documents held by sender: none"" "Not reported."
"405388-1" "405388-1" ""Information has been received from a physician and
a consumer's family concerning an 88 year old ""healthy"" female who on an
unspecified date was vaccinated with a dose of ZOSTAVAX (MSD) and a third dose of
PNEUMOVAX 23 (MSD). The consumer received ZOSTAVAX (MSD) and PNEUMOVAX 23 together
and ""almost immediately"" experienced swelling, pain and redness at the injection
site (unspecified site). The consumer then had difficulty breathing and was
hospitalized. The consumer developed a low grade fever. The consumer was then sent
home. About 9 hours later the consumer returned to the hospital and had low blood
pressure. The consumer arrested but was resuscitated and placed on a ventilator and
stabilized. about 6-8 hours later the consumer arrested again but could not be
resuscitated. The consumer died and the cause of death as reported by the physician
was ""probably a reaction from the vaccines"". It was reported that the consumer
died 2 days after receiving the vaccines. The consumer previously received
PNEUMOVAX 23 in 2008 and 2009. Please reference WAES # 1010USA02427 for the
patient's experiences on PNEUMOVAX 23. Additional information has been requested.""
"No lab data for this event."
"405821-1" "405821-1" ""Information has been received from a physician
concerning a 15 year old male with asthma and ""cardiac history"" (unspecified) who
on 30-AUG-2010 was vaccinated with GARDASIL (Lot number 665607/1333Y). Concomitant
therapy included LIPITOR. On 27-SEP-2010 the patient died while playing hockey. The
physician reported ""awaiting autopsy results"". At the time of report no further
information was available. The reporter considered death to be life-threatening. A
lot check has been initiated. Additional information has been requested.""
"Unknown"
"405951-1" "405951-1" "HEADACHE, Swolen painful arms" "No lab data for
this event."
"406234-1" "406234-1" "Information has been received from a pharmacist
concerning a patient who on an unspecified date was vaccinated with a dose of
PNEUMOVAX (Lot #664653/1337Y). Subsequently the patient died. The cause of death
was unknown. A priority lot check has been initiated. This is one of several
reports received from the same source. Additional information has been requested."
"Unknown"
"406577-1" "406577-1" "Approximately 3-4 weeks after flu shot began to have
tingling of face and arm. Symptoms progressed to lower extremities Experienced
sensory problems - unable to swallow/had feeding tube. 1) Hospitalized - family
states multiple tests were done. 2) Released and went to neurology clinic in
another state for second opinion. 3) Admitted to another hospital and then
transferred to a rehab facility in another state. 4) Family had him brought back to
original hospital." "No lab data for this event."
"406994-1" "406994-1" "Child was seen at County Health Center on 110310 for
initial immunizations. Child was alert without any problems noted or voiced."
"No lab data for this event."
"406995-1" "406995-1" "Initial report received from a health care
professional on 02 November 2010. A female patient (age not specified) received an
injection (route and site not provided) in 2006 of MENACTRA, lot number not
reported. On an unspecified date one and a half weeks ago, the patient died from
group C meningococcal disease. No further information was available. Documents held
by sender: None." "Not reported."
"407754-1" "407754-1" "Previously healthy baby taken to ER by EMS
unresponsive, with no pulse, no respirations. Details of what occurred prior to
EMS arrival to apartment are unknown. One report is that the baby was in the bath
with an older sibling, or mom was in the bathroom with another child, heard
something in another room and then went and found the baby unresponsive. Mom
started CPR, it took 5 - 10 minutes before the fire department arrived and
continued CPR, the EMS arrived and found the baby on the floor with vomitis in
hair, continued CPR, intubated, were unsuccessful in placing an IV line and
administered Epinephrine via the ET. Upon arrival to the ER the baby was
asystolic, IV started, 3 rounds of Epinephrine and Atropine administered via the IV
and one dose of Na Bicarb, the ET tube was removed and another one placed, NG tube
placed. All attempts were unsuccessful. The baby was pronounced at 10:48 PM.
Medical Examiner to handle case." "Blood sugar 137"
"407788-1" "407788-1" "On 10/26/10, Pt was given TDAP 12:30pm; no contra
indications to vaccine per health screening. Later that evening, pt experienced
palpitations and called a physician to schedule appointment. 10/27/10, 06:00 am, pt
collapsed at home after walking her dog. 911 called and EMS transported to ER. Pt
died at 0820. Coroner reports cause of death as cardiac arrhythmia due to mitral
valve prolapse and state pt had extensive cardiac problems. Death reportedly
unrelated to TDAP vaccine. Pt did not disclose cardiac condition." "No lab data
for this event."
"409289-1" "409289-1" "Received INFLUENZA vaccine approx 5 pm 11-15-10. Did
not awaken from sleep 11-16-10 ->EMS->pulseless electrical activity-> CPR ->
Emergency Dept. Multiple attempts at resuscitation failed. Pt expired 11-16-10."
"No lab data for this event."
"409766-1" "409766-1" ""Sudden onset of weakness (back and neck)progressed
to lower extremities described as ""gel legs"", difficulty standing DX with
Guillain-Barre Syndrome"" "Lumbar Puncture->Glucose=118, protein=44, wbc 0,
lyme dna pcr neg"
"409831-1" "409831-1" "Pt was a 31 week preemie with hx of NEC D/C from
NICU 3 weeks prior to event. He was on O2 NC; ostomy bag; NG feeds on AB monitor 24
hours after vaccination Pt became apneic at home and was pronounced dead at local
ER." "No lab data for this event."
"410080-1" "410080-1" "Hives, pucking, then DEATH" "No lab data for this
event."
"410265-1" "410265-1" ""Initial report retrieved from the scientific
literature on 15 November 2010. It is a case report taken from the following
source: The following is verbatim from the article: ""A 15-month with no
significant past medical history presented to the emergency department for 2 days
Tmax of 102 degrees F, lethargy and decrease oral intake and urine output. There
was vomiting the day before admission. He was seen by his physician who diagnosed
otitis media and referred him to the ED because of a concern for the level of
consciousness. Immunizations were up-to date (3 DTap and Hib vaccinations, with the
last being 9 months ago) except for VARIAVX which he did not receive secondary to a
manufacturer shortage. Family history included a 3-year-old brother with reactive
airways disease. Social history was notable for attendance at a church daycare
where many children were not immunized. On arrival to the ED, vital signs were as
follows: temperature, 36.5 degrees C; heart rate, 133 beats per minute; blood
pressure, 81/62 mm Hg; respiratory rate, 24 breaths per minutes; and pulse
oximetry, 97% on room air. Physical examination revealed a child with a weak cry
who did not maintain eye contact with the examiner. Stiffness of his neck was noted
with flexion and extension. The right tympanic membrane was erythematous and
bulging. Pulses and perfusion were normal. Leukocyte count was 3 x 10E9/L white
blood cells (0.23 segmented neutrophils and 0.55 bands) with Dohle bodies and
vacuolization noted on the smear. Two 20-mL/kg saline boluses were given with no
improvement in mental status. A blood culture was obtained before ceftriaxone 100
mg/kg was given intravenously. Soft tissue radiographs and computed tomographic
scans of the neck ruled out retropharyngeal abscess but revealed opacification of
both maxillary sinuses. Cloudy cerebrospinal fluid was obtained from lumbar
puncture. Immediately after the procedure and before laboratory results, vancomycin
was given. Cerebrospinal fluid had the following: white blood cell count, 3.45 x
10E9/L (0.59 neutrophils); red cell count, 1 x 10E9/L; glucose, 0.6612 mmol/L, and
protein, 2.98 g/L; CSF was also positive by Phadebact Haemophilus Co-Agglutination
test, manufactured by BOULE Diagnostics, Foreign. When the Gram stain showed gram-
negative rods, meropenem was added. The hospital microbiology laboratory serotyped
the organism as type b, which was confirmed by the state laboratory. The patient
was admitted to the pediatric intensive care unit with a diagnosis of meningitis
and sepsis. Mental status improved on day 2. Dexamethasone was started, and
antibiotics were switched to ceftriaxone alone when blood and CSF cultures returned
positive for Hib sensitive to ampicillin. Evaluation for the immunologic response
to Hib and immunodeficiency was initiated on day 3, but results were not available
during the hospital stay. The patient was transferred to the floor after results of
CT scan of the head were normal on day 4. A lumbar puncture was planned on day 7,
but the parents refused the procedure. Day 8 was the last day that fever (Tmax,
38.8 degrees) was present. Blood and urine cultures were sent; vancomycin was added
for a possible central venous line infection. Magnetic resonance imaging on day 9
demonstrated a thin dural hygroma over the left cerebral convexity that measured
approximately 4mm in thickness but normal spleen for age. On day 12 of
hospitalization, vancomycin was discontinued. The patient was discharged after 13
days of antibiotics with appointments scheduled with neurology and immunology. The
pediatrician was to arrange audiologic with appointments scheduled with neurology
and immunology. The pediatrician was to arrange audiologic evaluation and early
intervention; further immunologic evaluation was planned. The patient returned to
the ED 48 hours after discharge with focal seizure activity. On the day of
admission, the patient was afebrile and was more active than in previous days.
Parents described right side shaking that lasted several minutes. After the
seizure, he was noted to have decreased movement of the right upper and lower
extremities. Vital signs in the ED included the following: temperature, 37.9
degrees C; heart rate, 96 beats per minute; respiratory rate, 28 breaths per
minute; pulse oximetry, 99% on room air (no blood pressure was recorded). Physical
examination revealed an awake child in no immediate distress. Anterior fontanelle
was open and flat; pupils were equally round and reactive. No papilledema was
noted, and extraocular eye movements were intact. Neurological examination was
significant for flaccid right lower extremity and a weak right upper extremity with
normal reflexes and sensation. The remainder of the physical examination was
unremarkable. There was improvement of the right hemiparesis during his ED stay.
Workup in the ED included CT scan of the brain, which demonstrated a left-sided
hygroma without midline shift. He then underwent a lumbar puncture that obtained
clear fluid with opening pressure of 17 cm H20. Results of analysis were as
follows: white blood cells, 0.064 x 10E9L (o.11 neutrophils and 0.77 lymphocytes)l
red blood cells, 0.017 x 10E9/L; glucose, 3.94121 mmol/L; and protein, 1.14 g/L.
Gram stain demonstrated rare white blood cell count and no organisms. Bacterial
antigen panel was negative as was the final culture. White blood cell count was
24.7 x 10E9/L with 0.81 neutrophils, 0.11 lymphocytes, 0.06 monocytes, and 0.02
basophils. Electrolytes and liver profile were normal. Urine toxicology was
negative. Neurology and infectious disease consultations were obtained. Ceftriaxone
was given intramuscularly per recommendation of the infectious disease specialist
because intravenous access was not obtained immediately. Shortly after the lumbar
puncture was completed, the patient had generalized tonic-clonic seizure
characterized by lip smacking for which he received 1 mg of lorazepam and 15 mg/kg
of fosphenytoin intravenous with resolution. During transport to the PICU, he had
recurrence of seizure activity. On transfer to the PICU bed, he became apneic and
bradycardiac. At that time, his pupils were fixed and dilated. Cardiopulmonary
resuscitation was initiated, and his trachea emergently intubated. Mannitol was
given along with additional doses of lorazepam and resuscitation medications.
Hypertonic saline was infused for presumed cerebral edema. The pediatric
neurosurgeon performed a ventricular tap that produced 7 mL of purulent CSF. A
ventricular catheter as then placed and yielded 40 mL of CSF, but resuscitation was
unsuccessful. Autopsy demonstrated severe acute and chronic leptomenigitis
described as multilayer exudates with neutrophils, lymphocytes, and proliferating
capillaries. There was subdural empyema with organizing pachymeningitis of the left
frontal region and diffuse brain edema with acute neuronal injury. No evidence of
herniation was noted at autopsy. Immunologic workup f" "Immunologic workup from
the first hospitalization included quantitative immunoglobins with an IgG of 4.91
g/L (range 0.40-2.50 g/L) both at the lower end of normal for age. No significant
tetanus antitoxoid antibodies at 0.08 IU/mL (reference, 0.16 IU/mL) or Hib
antibodies at 0.13 mg/L (reference, 0.15 mg/L) were detected. Diphtheria antitoxoid
antibodies were present at 0.20 IU/ML (reference, 0.10 IU/mL). Varicella IgG was
also negative at 0.81 mg/L (reference, 0.90 mg/L) with vaccination occurring
approximately 3 weeks before assessment. There were only 2 increased pneumococcal
antibody IgG serotypes despite the receipt of his fourth PREVNAR 4 months before
presentation."
"410690-1" "410690-1" "Almost 6 weeks in ICU with paralysis, respiritory
arrest, death from Guillain Barre Syndrome" "spinal taps, blood tests, MRI
scans, etc"
"411487-1" "411487-1" "Dob 9-16-10 dod 11-15-10 received ENGERIX B
9/18/10." "No lab data for this event."
"412247-1" "412247-1" ""Information has been received from a physician via
a consumer who provided the physician with a link to a forum. The information was
received from the patient's mother, from the link, concerning her healthy 14 year
old daughter who in August 2007, January 2008, and June 2008, was vaccinated with a
first, second and third dose of GARDASIL (lot # not provided). It was reported that
the patient experienced several symptoms including numbness and tingling in her
fingers and toes, fatigue, a really hard time falling asleep, urinary tract
infections, ovarian cyst, moody, trouble getting out of bed and seizures. The
patient had had upwards of 150 seizures following her third shot in June 2008.
During her seizures she stopped breathing for periods of 30 to 40 seconds. The
patient was diagnosed with Neurocardiogenic syndrome and seizures. It was reported
that the patient died due to ovarian cyst. The reporter felt that the patient's
symptoms were related to vaccination with GARDASIL. Upon internal review, the
seizures were considered to be other important medical events ""seizures"" as an
other important medical event. No further information is available."" "Unknown"
"412768-1" "412768-1" "Patient started getting sick around 9 hours after
receiving the vaccine. Patient had never been sick before, not even a cold. Her
symptoms included fever, diarrhea, loss of appetite & not sleeping very well."
"No lab data for this event."
"413092-1" "413092-1" "respiratory and cardiac arrest resulting in death"
"No lab data for this event."
"413215-1" "413215-1" "On 12/6/10, developed fever & headache. Treated
with Advil until 12/9/10; went to PMD; patient vomiting, 12/10/10, vision loss,
adm. to E.R. 12/11/10, transferred to PICU. Expired 12/16/10." "No lab data for
this event."
"413591-1" "413591-1" "None stated." "None"
"413664-1" "413664-1" "After 2 weeks SP immunization Resid - Began to c/o
increased weakness & numbness. Sat -> MD. Apt with MD. Started on neurontin
11/20. Sat on floor. L/T increased weakness. 11/21 -> hosp with signs & sx of
CVA." "No record available."
"413868-1" "413868-1" "GUILLAIN BARRE Syndrome Dx 10/2010 by Dr. Tx at
hospital." "Au at hospital. Not available to me."
"413980-1" "413980-1" "Became fussy with feeds 24 hours after vaccines
given then went into cardiac arrest." "autopsy - grossly normal"
"414023-1" "414023-1" "Pt got birth dose of Hep B 7/31/10 SIDS baby." "No
lab data for this event."
"414074-1" "414074-1" "Death" "No lab data for this event."
"414096-1" "414096-1" "Details unknown. I was notified by agency that pt
expired 12/31/10." "Coroner performing autopsy 1/4/11"
"414136-1" "414136-1" "My mom received shingles vac. on 7/15/09. In May she
developed a very intense case of shingles & developed severe neuropathy in her left
leg & abdomen. She was hospitalized for about 6 weeks had to move to assisted
living, never fully recovered & died 10/26/10." "No lab data for this event."
"414262-1" "414262-1" "To ER. Deceased. Details unavailable. Coroners
case. Autopsy performed. Information from Coroner - preliminary shows no cause of
death." "Autopsy."
"414511-1" "414511-1" "ADEM secondary to agency from administration of live
virus flu vaccine to patient following interferon confusion, fever, coma, death.
Contact hospital doctor for details." "MRI & LP at Clinic and Hospital"
"414719-1" "414719-1" "Day after vaccines pt. sleepy, fussy. Two days after
vaccines pt died." "Not available"
"414753-1" "414753-1" "12/16/2010. Patient's wife called to report that he
developed nausea, headache, sweats, aching, cold two days ago (1 day after the flu
vaccine was administered). On 12/15/10 he had more difficulty breathing but didn't
mention this on 12/16/10 although he still had body aches. I recommended that he
receive ibuprofen 800 mg tid until the symptoms subsided. Go to ER for increased
difficulty breathing. 12/20/10. Hospital ED physician called to report that
patient was found by his wife in the morning to be difficult to arouse. His
abdomen was distended and he had nausea with increased secretions. 911 was called.
They found his pulse to be thready and while being transported to the ER went into
ventricular fibrillation and then asystole. A full code was done in the ER but
they were unable to resuscitate him and he died." "No lab data for this event."
"414974-1" "414974-1" "Per patients daughter, he developed Guillain Barre
Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away
on 1/6/2011." "No lab data for this event."
"415383-1" "415383-1" "NONE" "No lab data for this event."
"415725-1" "415725-1" "Pt. received vaccinations at at 10:00am on 1-13-11 -
no problems noted after receiving vaccinations. Infant found not breathing at 0930
on 1-16-11 by parents. Had been sleeping in car seat (not strapped in)- in living
room. Unable to resuscitate. Pronounced dead at hospital. Autopsy listed cause of
death SUIDS - Sudden Unexplained infant death. Awaiting toxicology
reports/results." "No lab data for this event."
"416107-1" "416107-1" "Non-specific symptoms began 1/12/2011, progressed to
rash, fever, numbness in arms/legs 1/13. Taken to Emergency Department, experienced
blood in tears, was intubated and crashed within 2 hours of arrival to hospital.
Cerebrospinal fluid was collected and showed Gram-negative diplococci. Culture
later tested positive for Neisseria meningitidis serogroup C." "Neisseria
meningitidis serogroup C confirmed by culture in cerebrospinal fluid sample. Cause
of death: meningococcemia and meningitis."
"416374-1" "416374-1" "Initial case received from a physician on 01
February 2011. A 17-year-old male patient received an intramuscular injection of
MENACTRA (lot number U2818AA) on 17 August 2009. On 21 January 2011 he presented to
the emergency room with fever, vomiting, and petechia, and was diagnosed with
meningococcal septicemia. He was transferred to the intensive care unit in critical
condition, and died on 23 January 2011. Per the reporter, the patient had undergone
blood cultures which were positive for meningococcal strain C. No medical history
or concomitant medications were reported; the patient was not ill at the time of
vaccination. Documents held by sender: None." "No lab data for this event."
"416893-1" "416893-1" "apparently found dead in bed by parent" "No lab data
for this event."
"416930-1" "416930-1" "seizure resulting in defribrilation resulting in
anoxic brain injury. treated at Hospital." "No lab data for this event."
"417137-1" "417137-1" "Patient deceased within 30 days of vaccine
administration." "No lab data for this event."
 "417195-1" "417195-1" "Baby was found apneic in bed with parents. She was
resuscitated, but died of complications of hypoxia." "Please refer to hospital
records."
"417625-1" "417625-1" "No known adverse event at tim eof the vaccination.
Pt died on 02/05/2011." "CSF tested by SC medical centers resulted as N.
meningitidis. Serotype Y."
"417899-1" "417899-1" "Threw up after a feed, then apnea monitor kept
alarming. To ED - found to have slow, shallow respirations. Became apneic/pulseless
- unable to resuscitate despite intubation/CPR. Time of death 4:31 PM." "No
lab data for this event."
"418006-1" "418006-1" "Pt. came into clinic for annual flu shot. Was non-
ill appearing. Wife received same flu shot at the same time with no adverse rxn.
Pt. then went home and later passed away in house (residence)." "No lab data for
this event."
"418081-1" "418081-1" ""Information has been received from a doctor of
pharmacy concerning a female patient in her 50's, who in October 2010, was
vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported).
Concomitant therapy included COUMADIN. The pharmacist reported that the patient
received a shot of the ZOSTAVAX (Merck) and then was rushed to the hospital with a
hematoma. After being admitted to the hospital the patient passed away, in October
2010, ""a week after her shot"". The pharmacist was not sure if it was due to the
ZOSTAVAX (Merck) or not, and she was also not sure of the length of time between
the patient getting the ZOSTAVAX (Merck) and being to the hospital. The pharmacist
considered that the hematoma and that the patient ""passed away"" to be life
threatening. Additional information has been requested."" "Unknown"
"418246-1" "418246-1" "Infant was immunized 1/19/11 DTaP, Hib, IPV, HepB,
PCV13, Rotavirus. Infant died ? SIDS." "No lab data for this event."
"418362-1" "418362-1" "A serious spontaneous report of INFLUENZA has been
received from a non-healthcare professional concerning a male, subsequent to
FLUMIST. Neither relevant medical history nor concomitant medications have been
reported for this patient. The patient was presumed to be an active employee. On an
unknown date, the patient received FLUMIST. Five weeks after receiving FLUMIST, the
patient developed symptoms of INFLUENZA. On an unknown date, the patient died. An
autopsy was performed. Endemic H1N1 was isolated from the bronchioles. The cause of
death was reported as INFLUENZA. The outcome of the event of INFLUENZA was fatal."
"Endemic H1N1 isolated from the bronchioles"
"418868-1" "418868-1" "Tdap vaccine was givin in the clinic. The patient
called on 2/15/2011 and reported that within 2-3 hours of the injection he was
feverish, chilled, nauseated, had body aches, and chest congestion and overall felt
very ill. Patient died on 2/20/2011 of an unusual strain of pneumonia." "No
lab data for this event."
"418984-1" "418984-1" "SIDS." "No lab data for this event."
"419371-1" "419371-1" "Arrived at hospital ER at 1:59AM pulseless, in
asystole." "No lab data for this event."
"419564-1" "419564-1" "DTaP/IPV and VARIVAX given at 14:30 on 2/7/11 as
health care maintenance. Patient found unresponsive with vomit in bed around 6 am
on 2/8/11. Pronounced deceased on arrival to the ED on 2/8/11. Presumed cause of
death is status epilepticus in this patient with known and worsening epilepsy.
Medical Examiner involved, and no autopsy performed." "Known left middle cerebral
artery infarct with right hemiplegia and epilepsy."
"420013-1" "420013-1" "This is a spontaneous report from a Pfizer sales
representative on behalf of a contactable physician. A 15-month-old male (at the
time of death) received the first dose of PREVNAR 13 on an unknown date in JUL2010
at 0.5ml, and the second dose on an unknown date in Oct2010, to prevent against
pneumococcal disease. Relevant medical history was unknown. The relevant
concomitant medications were unknown. The infant had only been administered two
doses of PREVNAR 13 instead of four doses. On 11MAR2011, he was taken to the
Emergency Room and diagnosed with neural infection. Treatment was not reported.
On 13MAR2011, the patient was taken to the Emergency Room again, but did not see
the doctor came back home. On 14MAR2011, the patient was taken to the physician's
office, where he presented with fever, vomiting, and neural infection, because of
which he was hospitalized. On 14MAR2011, while in the hospital, he had seizures.
An x-ray was performed which revealed an enlarged heart. The patient then had
cardiac arrest. On 14MAR2011, the patient was transferred to a hospital where they
have found viral myocarditis. Treatments in response to the events were not
reported. On 15MAR2011, the infant died. An autopsy was performed on brain tissue
culture on 15MAR2011, which showed that he died due to pneumococcal meningitis.
The clinical outcome of the reported event of pneumococcal meningitis (per autopsy
results) was fatal, and the outcome of the other events was unknown. Based on the
information provided in the case, this individual report would not seem to modify
the benefit/risk profile of PREVNAR 13." "X-ray (14-MAR-2011) results: showed he
had an enlarged heart; Autopsy - brain tissue culture (15Mar2011) revealed:
pneumococcal meningitis"
"420044-1" "420044-1" ""Initial report received on 28 September 2010 from
an investigator participating in a study under the reference number M5A11. An
infant male subject who born with an incarcerated inguinal hernia on 29 December
2009. The investigator reported that at 4 months of age the infant received the
following vaccines on 30 April 2010: first injection of DAPTACEL, lot number
C3139AA; first injection site of ACTHIB, lot number D0870 (UF739AA); first
injection of IPOL, lot number D0304; and first injection of pneumococcal vaccine
(PNCV7), Wyeth, lot number E15306; and died 15 days post-vaccination. According to
the autopsy report, the infant's medical history included premature birth (25 weeks
gestation) with intrauterine growth restriction (395 g birth weight) ascribed to
maternal chronic hypertension with super-imposed pre-eclampsia/atypical HELLP
syndrome. The infant had a prolonged hospital course with morbidity including
respiratory distress with apnea, retinopathy, patency of the ductus arteriosis with
attempted surgical closure, hepatic dysfunction and metabolic derangements, and
inguinal and umbilical hernias. The infant was discharged to home on 9 May 2010 at
a ""corrected"" gestational age of 42.5 weeks. Repair of his inguinal hernias was
planned for around 50 weeks corrected age. On 13 May 2010, the infant became
unresponsive following a period of inconsolable crying after a feeding. He could
not be resuscitated despite efforts by parents, EMS, and attendings in the ED. The
most striking finding in the ED and at autopsy was massive abdominal distension
that was not relieved by removal of copious milk from the stomach via NG tube. The
large volume of air in the highly distended intestine was sufficient to elevate the
diaphragm and increase the intra-abdominal pressure; thus predisposing the infant
to reduced cardiac output, increased renal and systemic vascular resistance,
decreased venous return to the heart, reduced visceral blood flow, and altered
respiratory dynamics. The origin of the intestinal air was most likely a
combination of vigorous crying and resuscitative efforts (which included 10 minutes
of bag-mask ventilation). Hypertrophy of the right ventricle and pulmonary arterial
changes further predisposed him to hypoxia and low cardiac output if venous return
were reduced. Obstruction of the terminal ileum in the hernia would be worsened by
the intra-abdominal pressure, which would prevent egress of intra-intestinal air.
Autopsy internal examination found right inguinal hernia contains 8 cm loop of
congested dilated edematous distal-most ileum, along with its hemorrhagic appearing
mesentery. There is egress of approximately 10 cc blood tinged clear fluid when the
right hernia is reduced (with difficulty). The left hernia contains 8 cm loop of
sigmoid colon, which is mildly edematous and mildly dusky and relatively easily
reduced. Death was considered multifactorial: acute incarceration of right inguinal
hernia, with crying, swallowing of air, and abdominal distension resulting in
cardiorespiratory compromise against a background of chronic lung disease with
pulmonary hypertension and right ventricular hypertrophy. According to the
investigator, the event was not related to the study vaccine. Follow-up information
was received on 14 October 2010 from a investigator participating in a trial under
the reference number M5A11. The start date of the SAE was changed to the probable
date of aggravation of congenital condition (incarceration of inguinal hernia). The
start date for the incarcerated inguinal hernia was changed to 13 May 2010
(previously reported as 29 December 2009). According to the investigator, the event
remained not related to the study vaccine. Documents held by sender: Autopsy
report."" "Not reported"
"420077-1" "420077-1" "Initial report received on 19 Aug 2010: This patient
was enrolled in study to evaluate the safety of Novartis MENACWY conjugate vaccine
when administered with routine infant vaccinations to healthy infants. Study
vaccination was commenced on 18 May 2009. The patient received the second dose on
20 Jul 2009, the third dose on 21 Sep 2009 and the fourth on 22 Mar 2010. On 18 Aug
2010, the patient died. No further information was available. In the absence of the
investigator causality, Novartis has processed the case as suspected for reporting
purposes. The case will be further reassessed upon receipt of follow-up
information. Follow up received on 20 Aug 2010: At the time of death, the child
(patient) was in the custody of a friend of the father. They were in a car and the
friend pulled over because the child did not look right. They then went to the
emergency department. The mother stated that the child was already deceased by the
time she got to the emergency department. The investigator assessed the event as
not suspected to be related to the study vaccine. Follow up received on 20 Aug
2010: On 13 Aug 2010, the patient was seen in the emergency department (ED) for
possible seizure with congestion and fever. The patient's eyes rolled up in his
head and had foaming at the mouth. The patient experienced generalized tonic-clonic
movements which lasted 30 seconds to a minute. The patient was diagnosed with upper
respiratory infection (URI) and fever. The patient received treatment with MOTRIN.
The patient was discharged after around 4 hours in good condition with an
impression of febrile seizure. On 18 Aug 2010, the patient was in the seat in a car
next to 'step mother' and experienced sudden syncope episode and cardiac arrest.
The report also stated the patient experienced sudden epistaxis. The patient was
intubated and given drugs (atropine and epinephrine). Cardiopulmonary resuscitation
(CPR) was performed en route to the ED. The patient died at 17:38. Follow up
received on 24 Aug 2010 prior to previous follow up circulation: The investigator
assessed all events as not suspected to be related to the study vaccine. Follow-up
received on 13 Dec 2010: The cause of death was not yet received by the
investigator. Follow-up received prior to circulation of previous follow-up on 14
Dec 2010: The patient was presented with upper respiratory tract infection on 09
Aug 2010 and was seen in ER. The patient was discharged in 4hrs after observation.
The patient developed febrile seizure on 13 Aug 2010 at 16:30 hrs. The investigator
did not suspect a relationship between the event and the study vaccine. Batch
review report (reference number 78559) received from quality assurance department
on 12 Jan 2011: Based on the document review, it was stated that the concerned
MENACWY batch number X79P45I1U was manufactured in accordance with approved
internal procedures and it was in compliance with the current good manufacturing
practices (cGMP) requirements. Follow up received on 24 Mar 2011: on 18 Aug 2010,
after resuscitation had started, the patient also had blood coming from his mouth.
The patient's diagnoses on the autopsy examination were as follows, focal deep
scalp hemorrhage, very focal, 2.5 cm area of organising subdural blood at left
parietal dura; left temporal lobe arachnoid cyst of approximately 2 cm; mild
laryngeotracheobronchitis with follicular hyperplasia of lymph nodes, Peyer's
patches and spelenic white pulp; perimortem laboratory studies during resuscitative
effort consistent with history of prolonged hypoxic-ischemic condition. No other
significant pre-existing disease or injury was identified. The autopsy examination
revealed a slightly asymmetric skull and an arachnoid cyst at the left temporal
lobe, small deep scalp hemorrhages and a very small focus of subdural blood. The
investigator stated that the arachnoid cyst is a congenital condition, which is
usually identified as an incidental finding rather than a lesion causing death; the
leptomeningeal thickening seen microscopically is related to the cyst and is not
related to the study vaccine. Furthermore the investigator stated that febrile
seizures are usual benign conditions, rarely the children of parents who have
experienced febrile seizures are found unresponsive after sleep. The circumstances
of this patient's death are different and no history of parental febrile seizures
in childhood are known. Microscopic findings were consistent with the history of
recent respiratory illness but were not sufficient to account for the history of
sudden unresponsiveness or death. The abnormal laboratory results obtained during
the resuscitative attempt were nonspecific and consistent with the prolonged
cardiovascular collapse documented in the medical records. The small organising
subdural blood and the small deep contusions were not sufficient to cause death,
how they occurred was unclear. Toxicologic examination revealed only the drug
atropine used in resuscitation. The investigator concluded that based on the scene
circumstances and autopsy findings, as well as review of medical records and law
enforcement investigation, the cause of death is undetermined. The Novartis medical
safety physician has assessed arachnoid cyst and bronchitis as non serious. In the
absence of causality assessment for hemorrhage, arachnoid cyst,
laryngeotracheobronchitis, follicular hyperplasia of lymph nodes, Peyer's patches
and spelenic white pulp, Novartis has processed the case as suspected for reporting
purposes." ""Activated partial thromboplastin time, 99.5 sec; Alanine
aminotransferase, 40 ul; Aspartate aminotransferase, 72 ul; Blood albumin, 1.8
g/dl; Blood alkaline phosphatase, 189 ul; Blood bicarbonate, 8 meq/L; Blood
bilirubin, <0.1 mg/dL; Blood chloride, 112 meq/L; Blood culture, unknown, anaerobic
blood culture had insufficient quantity; Blood glucose, 542 mg/dL, 337; Blood
lactic acid, 19.1 mg/dL; Blood potassium, 7.1 meq/L; Blood sodium, 146 meq/L; Blood
urea, 9 mg/dL; Haemoglobin, 6.7 g/dl; International normalised ratio, 2.7; Lipase,
252 ul; Microscopy, unknown; Microscopic comment: Summary of sections: 1. left
anterior descending coronary artery, anterior papillary muscle, ductus x 2; 2.
circumflex coronary artery, posterior papillary muscle, right atrium; 3. right
coronary artery, septal base of heart, horizontal segment of septum; 4. right lung
x 2; 5. right lung, larynx, edematous arytenoid cartilage; 6. liver x 2, spleen,
pancreas, pituitary; 7. thymus; 8. rectum, small bowel, cecum; 9. bladder, prosta"
"420242-1" "420242-1" "Patient received her shots on Feb 25, 2011. On
Thursday March 3rd patient seemed like she was coming down with a cold. We bathed
her and she ended up throwing up what little food she ate for dinner. On Friday
March 4th patient seemed OK during the day according to her daycare, but at home
that night she seemed lethargic and was running a 100.4 fever. Was given a little
infants ADVIL and was put to bed at 8:15pm, checked her at 10:15pm, and then at
3:15 am when she had already passed in her sleep." "No lab data for this event."
"420337-1" "420337-1" "4-1-2011 mother presents to clinic requesting child,
immunization record. Mother reports that her baby died 3-31-2011 at approximately
10:50 am. She reports the following: On 3-30-11 at 12:30pm she brought patient to
the CHD for a routine well baby visit and immunizations. The child was done with
the visit and receiving his shots by about 1pm. The rest of the day the child was
sleepy and ate about 2 oz of formula vs his normal 7 oz at a time. At 11:30 pm she
performed his routine diaper change and feeding. At that time he was moist to
touch, but not running a fever (she never took his temperature but he felt warm to
touch). 3-31-11 2AM; the baby accompanied the family to the ER for another child's
scraped knee. They returned at 4AM, in which the mother reports she fed the baby 2
oz and did a diaper change. 10:40 AM the mother woke up and checked the baby, the
baby was sleeping on his stomach. She reports that she does not believe in putting
the baby on his back, because she thinks the baby will choke, she admits that she
was trained by the provider, he should be on his back for sleeping. She then went
out to the garage to have a cigarette. She returned at 10:50 am to get the baby up.
The babies arm was flopped out and looked yellow, she checked the baby for
breathing, and he was not breathing, then called 911. I gave the mother a copy of
the child's immunization record. Offered Healthy Start bereavement services, she
declined, stating she has enough family support for that." "No lab data for this
event."
"420445-1" "420445-1" ""Information has been received from a physician
concerning a 75 year old male with ""chronic leukopenia"" who in April 2010, was
vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). Concomitant
therapy included hydrocortisone (manufacturer unknown). In May 2010, the patient
developed shingles spread to his face. In October 2010, the patient was admitted to
hospital with dissemination. Acyclovir IV was given for two weeks then Acyclovir
oral for 2 weeks for the treatment of the adverse event. In December 2010, the
patient was admitted again to the hospital and died three weeks later. On
unspecified date, lab study was performed on the ZOSTAVAX (Merck) which confirmed
it was the oka strain. Additional information has been requested."" "herpes
simplex virus, Confirmed it was the oka strain"
"420450-1" "420450-1" "This is a spontaneous report from a contactable
nurse via a Pfizer Sales Representative. A male patient received the fourth dose
of PREVNAR on an unknown date. Relevant medical history, drug history and
concomitant medications or vaccines were unknown. Vaccines taken within the last
four weeks were unknown. On an unspecified date, the patient developed
staphylococcal pneumonia disease. It was unknown if the patient was hospitalized.
In Nov2010, the patient died. The cause of death was staphylococcal pneumonia
disease. At the time of the report, it was unknown if an autopsy was performed.
Based on the information provided in the case, this individual report would not
seem to modify the benefit/risk profile of PREVNAR." "No lab data for this event."
"421094-1" "421094-1" "Mother had + HSV, gestational diabetes and protein
S deficiency." "No lab data for this event."
"421096-1" "421096-1" "None stated." "No lab data for this event."
"421121-1" "421121-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee On
Immunization Practices) criteria. This child was vaccinated with INFLUENZA
(manufacturer unknown, batch number: unknown) during 2007/2008 season. This child
was vaccinated completely as per schedule. This child presented with influenza
which later lead to death on unknown date. The causality was not reported. The
authors commented that influenza-associated mortality among children is a rare
event; however, healthcare providers should be mindful of the severe outcomes
associated with influenza in children, especially those with high-risk medical
condition. Critically ill children should be promptly treated with anti-viral
medications, unless contraindicated, upon influenza diagnosis or suspicion. Because
isolation of S. aureus potentially representing co-infection was identified in a
substantial proportion (19%) of children with influenza-associated mortality within
three days of hospital admission, healthcare providers should consider
administering antimicrobial agents active against locally circulating strains of S.
aureus when empirically treating children with influenza-like illness and severe
respiratory illness." "No lab data for this event."
"421122-1" "421122-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with INFLUENZA
(manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient
was partially vaccinated and did not complete vaccination schedule. The child
presented with influenza which later lead to death on unknown date. The causality
was not reported. The authors commented that influenza-associated mortality among
children is a rare event; however, healthcare providers should be mindful of the
severe outcomes associated with influenza in children, especially those with high-
risk medical condition. Critically ill children should be promptly treated with
anti-viral medications, unless contraindicated, upon influenza diagnosis or
suspicion. Because isolation of S. aureus potentially representing co-infection was
identified in a substantial proportion (19%) of children with influenza-associated
mortality within three days of hospital admission, healthcare providers should
consider administering antimicrobial agents active against locally circulating
strains of S. aureus when empirically treating children with influenza-like illness
and severe respiratory illness." "No lab data for this event."
"421123-1" "421123-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with INFLUENZA
(manufacturer unknown, batch number: unknown) during 2007/2008 season. The patient
was partially vaccinated and did not complete vaccination schedule. The child
presented with influenza which later lead to death on unknown date. The causality
was not reported. The authors commented that influenza-associated mortality among
children is a rare event; however, healthcare providers should be mindful of the
severe outcomes associated with influenza in children, especially those with high-
risk medical condition. Critically ill children should be promptly treated with
anti-viral medications, unless contraindicated, upon influenza diagnosis or
suspicion. Because isolation of S. aureus potentially representing co-infection was
identified in a substantial proportion (19%) of children with influenza-associated
mortality within three days of hospital admission, healthcare providers should
consider administering antimicrobial agents active against locally circulating
strains of S. aureus when empirically treating children with influenza-like illness
and severe respiratory illness." "No lab data for this event."
"421124-1" "421124-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with seasonal influenza
vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The
child presented with influenza which later lead to death on unknown date. The
causality was not reported. The authors commented that influenza-associated
mortality among children is a rare event; however, healthcare providers should be
mindful of the severe outcomes associated with influenza in children, especially
those with high-risk medical condition. Critically ill children should be promptly
treated with anti-viral medications, unless contraindicated, upon influenza
diagnosis or suspicion. Because isolation of S. aureus potentially representing co-
infection was identified in a substantial proportion (19%) of children with
influenza-associated mortality within three days of hospital admission, healthcare
providers should consider administering antimicrobial agents active against locally
circulating strains of S. aureus when empirically treating children with influenza-
like illness and severe respiratory illness." "No lab data for this event."
"421125-1" "421125-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with seasonal influenza
vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The
child presented with influenza which later lead to death on unknown date. The
causality was not reported. The authors commented that influenza-associated
mortality among children is a rare event; however, healthcare providers should be
mindful of the severe outcomes associated with influenza in children, especially
those with high-risk medical condition. Critically ill children should be promptly
treated with anti-viral medications, unless contraindicated, upon influenza
diagnosis or suspicion. Because isolation of S. aureus potentially representing co-
infection was identified in a substantial proportion (19%) of children with
influenza-associated mortality within three days of hospital admission, healthcare
providers should consider administering antimicrobial agents active against locally
circulating strains of S. aureus when empirically treating children with influenza-
like illness and severe respiratory illness." "No lab data for this event."
"421126-1" "421126-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with INFLUENZA
(manufacturer unknown, batch number: unknown) during 2007/2008 season. The child
presented with influenza which later lead to death on unknown date. The causality
was not reported. The authors commented that influenza-associated mortality among
children is a rare event; however, healthcare providers should be mindful of the
severe outcomes associated with influenza in children, especially those with high-
risk medical condition. Critically ill children should be promptly treated with
anti-viral medications, unless contraindicated, upon influenza diagnosis or
suspicion. Because isolation of S. aureus potentially representing co-infection
was identified in a substantial proportion (19%) of children with influenza-
associated mortality within three days of hospital admission, healthcare providers
should consider administering antimicrobial agents active against locally
circulating strains of S. aureus when empirically treating children with influenza-
like illness and severe respiratory illness." "No lab data for this event."
"421127-1" "421127-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with seasonal influenza
vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The
child presented with influenza which later lead to death on unknown date. The
causality was not reported. The authors commented that influenza-associated
mortality among children is a rare event; however, healthcare providers should be
mindful of the severe outcomes associated with influenza in children, especially
those with high-risk medical condition. Critically ill children should be promptly
treated with anti-viral medications, unless contraindicated, upon influenza
diagnosis or suspicion. Because isolation of S. aureus potentially representing co-
infection was identified in a substantial proportion (19%) of children with
influenza-associated mortality within three days of hospital admission, healthcare
providers should consider administering antimicrobial agents active against locally
circulating strains of S. aureus when empirically treating children with influenza-
like illness and severe respiratory illness." "No lab data for this event."
"421128-1" "421128-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with seasonal influenza
vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. The
child presented with influenza which later lead to death on unknown date. The
causality was not reported. The authors commented that influenza-associated
mortality among children is a rare event; however, healthcare providers should be
mindful of the severe outcomes associated with influenza in children, especially
those with high-risk medical condition. Critically ill children should be promptly
treated with anti-viral medications, unless contraindicated, upon influenza
diagnosis or suspicion. Because isolation of S. aureus potentially representing co-
infection was identified in a substantial proportion (19%) of children with
influenza-associated mortality within three days of hospital admission, healthcare
providers should consider administering antimicrobial agents active against locally
circulating strains of S. aureus when empirically treating children with influenza-
like illness and severe respiratory illness." "No lab data for this event."
"421129-1" "421129-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with INFLUENZA
(manufacturer unknown, batch number: unknown) during 2007/2008 season. It was
unknown if the patient was vaccinated completely as per schedule. The child
presented with influenza which later lead to death on unknown date. The causality
was not reported. The authors commented that influenza-associated mortality among
children is a rare event; however, healthcare providers should be mindful of the
severe outcomes associated with influenza in children, especially those with high-
risk medical condition. Critically ill children should be promptly treated with
anti-viral medications, unless contraindicated, upon influenza diagnosis or
suspicion. Because isolation of S. aureus potentially representing co-infection
was identified in a substantial proportion (19%) of children with influenza-
associated mortality within three days of hospital admission, healthcare providers
should consider administering antimicrobial agents active against locally
circulating strains of S. aureus when empirically treating children with influenza-
like illness and severe respiratory illness." "No lab data for this event."
"421130-1" "421130-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with INFLUENZA
(manufacturer unknown, batch number: unknown) during 2007/2008 season. It was
unknown if the patient was vaccinated completely as per schedule. The child
presented with influenza which later lead to death on unknown date. The causality
was not reported. The authors commented that influenza-associated mortality among
children is a rare event; however, healthcare providers should be mindful of the
severe outcomes associated with influenza in children, especially those with high-
risk medical condition. Critically ill children should be promptly treated with
anti-viral medications, unless contraindicated, upon influenza diagnosis or
suspicion. Because isolation of S. aureus potentially representing co-infection was
identified in a substantial proportion (19%) of children with influenza-associated
mortality within three days of hospital admission, healthcare providers should
consider administering antimicrobial agents active against locally circulating
strains of S. aureus when empirically treating children with influenza-like illness
and severe respiratory illness." "No lab data for this event."
"421131-1" "421131-1" "Initial literature report received on 03 Jan 2011:
This literature was about cases of pediatric influenza-associated deaths. To
further investigate the bacterial organisms that may have contributed to death, the
authors systematically collected information about bacterial cultures collected at
non-sterile sites and about the timing of Staphylococcus aureus specimen collection
relative to hospital admission. The authors performed a retrospective, descriptive
study of all reported influenza-associated pediatric deaths in 2007/2008 season.
This child was recommended for vaccination by 2007/2008 ACIP (Advisory Committee on
Immunization Practices) criteria. This child was vaccinated with seasonal influenza
vaccine (manufacturer unknown, batch number: unknown) during 2007/2008 season. It
was unknown if the patient was vaccinated completely as per schedule. The child
presented with influenza which later lead to death on unknown date. The causality
was not reported. The authors commented that influenza-associated mortality among
children is a rare event; however, healthcare providers should be mindful of the
severe outcomes associated with influenza in children, especially those with high-
risk medical condition. Critically ill children should be promptly treated with
anti-viral medications, unless contraindicated, upon influenza diagnosis or
suspicion. Because isolation of S. aureus potentially representing co-infection was
identified in a substantial proportion (19%) of children with influenza-associated
mortality within three days of hospital admission, healthcare providers should
consider administering antimicrobial agents active against locally circulating
strains of S. aureus when empirically treating children with influenza-like illness
and severe respiratory illness." "No lab data for this event."
"421334-1" "421334-1" "None stated." "No lab data for this event."
"421371-1" "421371-1" ""Initial report was received on 08 April 2011 from a
consumer and the following electronic lay press article. A 23 year-old male patient
(also reported as 21 year-old) with no reported past medical history had received
possibly in 2007 MENOMUNE A/C/Y/W-135 (lot number, route, site and date of
administration not reported) and ""on Friday"" (01 April 2011) developed a sore
throat, was achy and had flu-like symptoms that lasted through the weekend. He was
evaluated by his physician on Tuesday and it was thought ""it was just a regular
virus"". Later on Tuesday, the patient complained of being in the ""worse pain of
his life"", he appeared swollen and had ""bruise-like blotches"" on his body. The
patient was taken to the hospital and then transferred to another hospital. He was
diagnosed with N-Meningitis serogroup unknown. Relevant diagnostic tests/laboratory
data was reported as positive. Treatments were not reported. No further information
was available at the time of the report. The patient's outcome was fatal. The cause
of death was reported as bacterial meningitis on 06 April 2011 (also reported as 05
April 2011). Documents held by sender: none."" "Relevant diagnostic
tests/laboratory data was reported as positive."
"421495-1" "421495-1" "10-14-10 Merck 1483Y." "No lab data for this event."
"421582-1" "421582-1" ""Information has been received from a nurse
practitioner concerning a patient's nephew, a 17 year old male consumer who she
""thought"" was vaccinated with a dose of GARDASIL (lot number not provided) in
November 2010. The nurse practitioner stated that two weeks after the patient
received the dose of GARDASIL, approximately November 2010 (also reported as ""two
weeks ago"" on approximately 01-APR-2011), the patient died of sudden cardiac death
on the lacrosse field. Unspecified medical treatment was given. It was unspecified
if any lab diagnostic test were performed. The cause of death was sudden cardiac
death. Sudden cardiac death was considered to be immediately life-threatening and
disabling by the reporting nurse practitioner. Additional information has been
requested."" "Unknown"
 "422085-1" "422085-1" "Death." "Chest x-ray showed diffuse, hazy,
bilateral granular opacities throughout both lungs, worse on the right."
"422268-1" "422268-1" "He was administered the shot and by the next day
started having fevers & spitting up his food. His fever got worse and his appetite
also. He was sleeping & crying for the most part and his fever was being stabilized
by MOTRIN and TYLENOL." "No lab data for this event."
"422403-1" "422403-1" "Started complaining of not feeling well a few days
after the injection onto pin and needles effect in hands & feet. Bells palsy on one
side of face then onto the other side onto Severe weakness throughout entire body
to being on a ventilator severly paralyzed for over 6 months until death on
5/20/08" "Spinal Tap revealed Guillain Barre."
"422585-1" "422585-1" "Pt noted to be lifeless on awaking in morning.
Epistaxis reported by father." "Autopsy to be performed."
"422660-1" "422660-1" "Case number PHHO2011US07292, is an initial report
received on 26 Apr 2011, from a clinical study. This 70-year-old male subject was
enrolled in a study. The subject's medical history included hyperlipidemia and
cancer of left breast. Concomitant medications included Simvastatin. The subject
received the study vaccine on 03 Sep 2010 at 13:15. On 18 Apr 2011, the subject was
taken to the hospital for evaluation of dizziness and headaches. The same day, the
subject experienced botulism and quadriparesis. The subject was unsteady on their
feet and was weak in the upper extremities. The subject experienced progressive
weakness and quadriplegia. The subject was seen by a neurosurgeon and neurologist.
The subject underwent an MRI scan which showed spinal stenosis and multiple levels
of degenerative disk with diffuse bulging and osteophyte formation. The
investigator stated that per the neurosurgeon, did not cause the quadriparesis. An
MRI scan of the brain revealed moderate microvascular disease. A CT scan of the
head showed no evidence of acute cranial or intracranial abnormality. The subject
was treated with Aspirin and DECADRON and some improvement in status was noted. The
subject was placed on 'JV' for atypical presentation of Guillain-Barre syndrome.
The subject was started on Doxycycline. The subject had a CT myelogram, a lumbar
puncture and their antibody cultures were collected. The patient's protein was
normal. In the subject's CSF fluid it was noted that their glucose level was
increased (assessed as not clinically significant by the investigator). On 21 Apr
2011, the subject was transferred to ICU and signed a DNR (do not resuscitate). The
subject refused to be intubated and refused a N16 and foley catheter placement. The
subject's condition deteriorated with desaturation 100% and blood pressure dropped.
The subject was started on a dopamine drip, maximum dose. The subject experienced
respiratory muscle paralysis. On 21 Apr 2011, at 03:38am, the subject died. An
autopsy was performed, and results are pending. The seriousness for botulism as
life threatening and fatal, quadriparesis was disability and respiratory muscle
paralysis was fatal. The outcome of the quadriparesis was condition deteriorating.
The investigator suspected a relationship between the botulism, quadriparesis and
respiratory muscle paralysis and the study vaccine. Follow up received on 04 May
2011: Patient's sex corrected, lab tests updated, events updated, death details
updated, treatments provided, causalities updated." "04/18/2011, Blood pressure
dropped, abnormal; 04/18/2011, Computerised tomogram head showed no evidence of
acute cranial or intracranial abnormality, normal; 04/18/2011, CSF culture, glucose
level was increased, abnormal; 04/18/2011, Nuclear magnetic resonance imaging
showed spinal stenosis and multiple levels of degenerative disk with diffuse
bulging and osteophyte formation, abnormal.; 04/18/2011, Nuclear magnetic resonance
imaging brain revealed moderate microvascular disease, abnormal."
"423815-1" "423815-1" ""Information has been received from a physician
concerning a male patient who ""quite some time ago"", was vaccinated with a dose
of PNEUMOVAX 23 (route and lot number not reported). On an unknown date ""quite
some time ago"", the patient experienced cellulites like reaction around the
injection site after receiving the PNEUMOVAX 23, ""it got really red and swelled
up"". The physician reported that the patient had deceased and stated that it was
unrelated to the PNEUMOVAX 23 vaccine. It was unknown if the patient sought medical
attention. Outcome of cellulites like reaction around the injection site was
unknown. Additional information has been requested."" "Unknown"
"424063-1" "424063-1" "Initial report received from a consumer on 18 May
2011. This case is not medically confirmed. A 5-year-old male patient had received
a dose of DTP vaccine (trade name, manufacturer name and lot number unknown) on an
unspecified date and had a reaction and died 24 hours later. The reporter declined
to provide any further information regarding the event. She declined to provide any
other contact information for follow-up, and she did not wish to be contacted any
further. No further information is expected. The reporter for this case is the same
as for case 2011-02908. Documents held by sender: None." "Not reported"
"424300-1" "424300-1" "No known vaccine adverse reactions; parents report
father rolled over on infant found unresponsive per mother; preliminary autopsy:
asphyxiation per suffocation." "none"
"424958-1" "424958-1" "Baby was immunized 4/6/11. Baby was born
prematurely. Hep B refused." "No lab data for this event."
"425289-1" "425289-1" "unexplained death" "No lab data for this event."
"425334-1" "425334-1" "Baby had cold symptoms, cough, congestion, a little
vomiting. My son came home at 7:20 p.m. On 5/10 to babysitter advising baby was
napping from 6 p.m. Patient was face down on bed. My son laid next to him and put
his hand on his back and he noticed he wasn't breathing right. He lifted him and
turned him over and his one side of face and mouth was drooping and his right arm
and leg kept jolting. No left side movement at all. 911 was immeidately called. CT
scan showed bleeding on brain. Three hours later transferred by ambulance to
Hospital (not airlifted) was put on respirator at Medical Center. Got to another
hospital had another CT scan, bleed was worse underwent neurosurgery and brains was
hemorrhaging too bad. Neurosurgeons said bleed was too bad and injuries were
consistent with shaken baby syndrome. Patient had no brain activity or breathing
capacity at all. Passed away on 5/13 at 10:30 a.m. Initial Autopsy was
inconclusive. Undergoing more tests. Patient on 5/5 had PVC (Pneumococcal Vaccine
and Varicella Vaccine). It is being treated as a homicide by Prosecutor's office. A
local chiropractor told us about a link with vaccines and brain injuries similar to
shaken baby. We wanted to report this since he did get these two recent injections.
Awaiting second autopsy. They said brain and eyes were sent to specialist around
the country." "No lab data for this event."
"425476-1" "425476-1" ""This case was reported in a literature article and
described the occurrence of anaphylaxis in an adult male subject who was vaccinated
with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions
included allergic rhinitis, allergy to DAPSONE, asthma, coronary artery disease,
dermatitis and obesity. On an unspecified date, the subject received unspecified
dose of Hepatitis B vaccine (unknown route, unknown lot number). 15 minutes after
vaccination with Hepatitis B vaccine, the subject experienced anaphylaxis,
respiratory arrest, cardiovascular collapse, loss of consciousness, shortness of
breath and diaphoresis. The subject was treated with EPINEPHRINE and ATROPINE. The
subject died, cause of death is not specified. It was unknown whether an autopsy
was performed. The case could have been an acute coronary event. Initial case was
retrieved from the scientific literature on 08 June 2011. The National Vaccine
Injury Compensation Program (VICP) was established in 1986 in response to vaccine
safety concerns. A unique feature is a table of compensable injuries, the Vaccine
Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to
4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine
with the task of completing a comprehensive review of the medical literature
regarding adverse events related to vaccines so that the VIT could be updated.
Concurrent with the Institute of Medicine's review, we undertook a systematic
analysis of the VICP''s anaphylaxis case experience. The VICP administrative
database was queried for all cases submitted to the VICP alleging ""anaphylaxis or
anaphylactic shock"" for the 10-year period from January 1, 2000, through December
31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis,
and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton
Collaboration (BC) case definition and were further subdivided into 3 levels of
diagnostic certainty using major and minor criteria, with level 1 being the
greatest level of certainty. Possibly allergic cases were defined as those for
which there were signs and/or symptoms compatible with an allergic reaction
occurring within 4 hours of injection but that did not meet any of the BC case
definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic
certainty and, with an interval of 0 to 4 hours, are consistent with the current
VIT. This case was classified at level 1 of certainty. This review represented the
first systematic approach in analyzing the VICP experience with anaphylaxis and
will be useful when the VIT is updated. This was one of 9 cases reported in the
same article and represented 8 different vaccines containing at least 11 different
vaccine antigens."" "UNK"
"425513-1" "425513-1" "None known -suicidal ideation denied at visit 4/26 -
known chronic depression she elected to stop her medications when she turned 18.
Committed suicide 04/28/11. Hung herself." "None"
"425598-1" "425598-1" ""A consumer reported that he/she read an internet
concerning a female who on an unspecified date was vaccinated with a dose of
GARDASIL (lot # , dose and route not reported). On an unspecified date, the patient
died of ""clot blood"" eight hours after vaccination. This is one of several
reports from the same source. No further information is available."" "Unknown"
"425680-1" "425680-1" "A consumer reported that he/she obtained the
information from internet concerning a 17 years old woman who in June 2007 was
vaccinated the first dose of GARDASIL. In the afternoon of the same day, in June
2007, the patient was found unconscious (without signs of life) by her mother. The
doctor from the emergency crew attempted resuscitation, but without success. The
cause of death was unspecified. This is one of several reports received from the
same source. No further information is available." "Unknown"
"425817-1" "425817-1" ""Initial case was retrieved from the scientific
literature on 08 June 2011. ""The agency was established in 1986 in response to
vaccine safety concerns. A unique feature is a table of compensable injuries, the
Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval
of 0 to 4 hours for vaccines containing Td, DPT, DTaP, MMR II, IPV, and HBV. In
2009, the agency charged the Institute with the task of completing a comprehensive
review of the medical literature regarding adverse events related to vaccines so
that the VIT could be updated. Concurrent with the Institute's review, we undertook
a systematic analysis of the agencies anaphylaxis case experience. The agency
administrative database was queried for all cases submitted to the agency alleging
""anaphylaxis or anaphylactic shock"" for the 10-year period from January 1, 2000,
through December 31, 2009."" The patient captured in this case was one of 8 noted
in the above reference that experienced anaphylaxis after vaccination. A geriatric
male patient (age not reported) with a medical history of type 2 diabetes mellitus,
hypertension (HTN), coronary artery disease (CAD) after coronary artery bypass
graft, dementia, and dysrhythmia, received an injection (route and site not
reported) for Diphtheria and Tetanus Toxoids, lot number and manufacturer not
reported, on an unknown date. On an unknown date within 30 minutes after receiving
the vaccine, the patient developed anaphylaxis with symptoms of choking, shortness
of breath, and face/neck/whole body swelling. The Emergency Medical Service (EMS)
was unsuccessful in intubation. The patient became hypotensive and went into
respiratory arrest. The patient received epinephrine x 3, atropine x 3, and
remained an unsuccessful intubation. The patient died (date not reported). The
outcome was reported as fatal. The reporter in this case is the same as cases:
2011-03327, 2011-03328, 2011-03329, 2011-03330, 2011-03331, 2011-03332, and 2011-
03333. Documents held by sender: None."" "Not reported"
"425996-1" "425996-1" ""Initial report received on 18 May 2010 from an
investigator participating in the above-mentioned trial under the reference number
M5A11. A 3-month-old male subject died 28 days after he received a first dose
injection of PENTACEL, lot number C3385AA on 12 November 2009. The subject also
received the following vaccines on the same date: a first dose of PREVNAR (lot
number D74804), a second dose of RECOMBIVAX HB (lot number AHBVB761CA), and a first
dose of ROTATEQ (Lot number 0088Y). The subject was last seen on 12 November 2009
for normal well baby care which was unremarkable. The subject died on 10 December
2009. The reporter had no additional information pertaining to the cause or
description of death; therefore the ""Event Start Date (Date of onset of
symptoms)"" was reported as unknown. At the time of the report, the county
coroner's bureau confirmed the death but would not provide preliminary information.
The bureau did indicate that the manner of death was determined to be natural
causes and autopsy results would be available as soon as they were considered
final. According to the investigator, the event was not related to PENTACEL.""
"Not reported"
"425997-1" "425997-1" ""Initial report received on 18 May 2010 from an
investigator under the reference number M5A11. A 10-month-old female subject with a
history of cerebellar atypical teratoid rhabdoid tumor (ATRT) died due to disease
progression 153 days after receiving a third injection of PENTACEL (lot number
C3181AA). The subject also received the following vaccines on the same date: a
second dose of PREVNAR(lot number D46873), and a second dose of rotavirus vaccine
(lot number 1695X). The subject was born with a small pedunculated skin lesion on
the left side of the midline at about T3-T4 region. It was initially the size of a
pea, which gradually grew over the next 4-5 months, becoming a pedunculated,
multilobulated, cornified, epithelialized lump dangling on the peduncle against the
back. She also developed other lesions which were biopsied and described as
fibroblastic, myofibrotic, myoblastic lesions with mitotic figures. However,
pathology results did not lead to a diagnosis. She behaved normally during this
time with the exception of a slight head tilt. An MRI of the neck subsequently
indicated that the lesions were related to deeper structures, specifically a large
anterior fossa mass, and that the child had significant hydrocephalus. The subject
was diagnosed with ATRT on an unspecified date. She underwent a resection with
external ventricular drain placed on 30 September 2009. The drain was removed on 07
October 2009. Due to her extremely poor prognosis, the family decided against
chemotherapy at that time. She was at home doing well until 05 December 2009, when
she developed upper respiratory infection (URI) symptoms and vomiting. She was seen
by her primary care physician, diagnosed with otitis media, and treated with
amoxicillin. The following date she presented to the emergency department with
persistence distress, emesis, and a lack of wet diapers. She was diagnosed with
dehydration. Laboratory date included Na=134, K=4.4, CO2=18, CL=101, BCN=7, CR=0.3,
RBS=77 (all units unspecified). A CT scan showed enlarged ventricles that had
increased in size from her initial post-operative scan. An enlarged posterior fossa
fluid collection was noted, with no evidence of transependymal edema. Due to these
findings, as well as the dehydration, she was admitted to the hospital on 07
December 2009 for rehydration and possible neurosurgical treatment of
hydrocephalus. She had low blood pressure on admission (NBP-94/61), which improved
following administration of intravenous fluids (Bolus with normal saline 10 ml/kg,
D5NS at 40 ml/hr). In addition, ZOFRAN was prescribed for nausea and vomiting.
Diagnostic imaging showed that symptoms had progressed significantly, and the
family decided on palliative care only. On 09 December 2009 her code status was
changed to ""DNR"" (do not resuscitate, and she was started on morphine and a
transdermal fentanyl patch for pain control. The subject was discharged to home
hospice on 14 December 2009, and she expired the following day, on 15 December
2009. No autopsy was performed. According to the investigator, the event was not
related to the study vaccine. Documents held by sender: discharge summary,
medication records, physician consult."" "Fibroblastic, myofibrotic, myoblastic
lesions with mitotic figures: pathology results did not provide a diagnosis. 07
December 2009: Laboratory data included Na=134, K=4.4, CO2=18, CL=101, BUN=7,
CR=0.3, RBS=77 (units unspecified). A CT scan showed enlarged ventricles that had
increased in size from her initial post-operative scan. An enlarged posterior fossa
fluid collection was noted, with no evidence of transependymal edema. Low blood
pressure on admission (NBP=94/61)."
"427555-1" "427555-1" ""Initial case was retrieved from scientific
literature on 04 July 2011. A 44 year-old female with a history of common variable
immunodeficiency and was receiving intravenous immune globulin. The patient
experienced sudden paralysis of all four limbs and respiratory muscles, resulting
in death. The patient was found, to have Type 2 vaccine-derived poliovirus in her
stool. According to the report, the patient was probably infected 11.9 years prior
when her child had received the oral poliovirus vaccine. Verbatim from the report:
""In March 2009, the Department of Health investigated a case of acute flaccid
paralysis associated with a positive stool culture for enterovirus. Case report: In
December 2008, cough, purulent rhinorrhea, mild dyspnea, malaise, and a ""low-grade
fever"" developed in a 44-year-old woman with long-standing common variable
immunodeficiency; the symptoms, which she assumed were an exacerbation of her
chronic sinusitis, resolved after 4 days. Two days later, cramping developed in her
left calf and progressed over a period of 5 days to leg weakness, which was
associated with a fall and ankle sprain, and the patient was hospitalized. On
examination, she was afebrile and her cranial nerves were normal, without
meningismus. Upper-extremity muscle strength was normal, and reflexes were ""quite
brisk"". Measurements of lower-extremity muscle strength on the right and left
sides, respectively, were as follows: iliopsoas, 3/5 and 1/5; quadriceps, 3/5 and
1/5; dorsiflexors, 2/5 and 1/5; and plantar flexors, 4/5 and 3/5. A trace right-
ankle jerk was noted, but all other lower-extremity stretch reflexes were absent.
The plantar (Babinski) reflex was downward bilaterally. Sensory responses to a
light touch, temperature changes, and pinprick were intact, with severe pain noted
in both legs. Common variable immunodeficiency was diagnosed in 1991, with
subsequent diagnoses of chronic lymphoid interstitial pneumonia (on lung biopsy),
liver cirrhosis with esophageal varices of grade 1 to 2, and spruelike enteropathy
(on intestinal biopsy) with chronic diarrhea (which had worsened during the 2
months before the patient's hospitalization in 2008). She had undergone splenectomy
in 2006 owing to portal hypertension. B cells were absent on flow cytometry,
expression of Bruton's tyrosine kinase was normal, and she was heterozygous for an
R202H mutation in the transmembrane activator and calcium-modulator and
cyclophilin-ligand-interactor (TACI) protein. Frequent episodes of otitis media and
sinusitis were treated with antibiotics. She was being treated with prednisone, 20
mg daily, and two different brands of intravenous immune globulin every 3 weeks,
with multiple changes in the dose, before the onset of her neurologic symptoms. The
only travel of possible relevance was with her family 2 months earlier. By hospital
day 2, the weakness had progressed to involve both upper extremities. The patient
became constipated and remained afebrile. The cerebrospinal fluid contained 6 white
cells per cubic millimeter (51% lymphocytes) and glucose and protein levels were
normal. Initial magnetic resonance imaging showed increased T2-weighted signal in
the spinal-column parenchyma from T7 to the conus medullaris, without contrast
enhancement. When imaging was repeated on hospital day 6, new areas of
hyperintensity were noted in C3 through C7, findings that were consistent with
anterior horn-cell disease. The patient's upper-extremity muscle weakness
progressed (biceps strength, 3/5 on the right side and 2/5 on the left), and she
continued to have severe muscular limb pain. Electromyography and nerve-conduction
testing on hospital day 8 were consistent with acute motor axonal neuropathy or
motor neuronopathy (anterior horn-cell disease). On hospital days 8 through 38,
negative inspiratory force was reduced, and pulmonary infiltrates required
noninvasive, bilevel positive airway pressure and intermittent endotracheal
intubation. On hospital days 61 through 73, liver dysfunction worsened and
pneumonia and respiratory failure ensued. These problems continued, and given the
multiple coexisting illnesses and persistent neurologic deficits, the family chose
to withdraw support on hospital day 92, and the patient died. No autopsy was
performed. Although the initial viral cultures were negative, a stool sample
obtained on hospital day 74 was found to contain enterovirus and was sent to the
Department of Health for assessment of speciation. Investigators of reportable
diseases, including polio, under state statute are classified as public health
response, nonresearch by the Department of Health Institutional Review Board."" The
patient reportedly had received all recommended childhood vaccinations. The
patient's child had received the primary series of oral poliovirus vaccine at 13.0,
12.8 and 12.6 years before the patient's isolate was collected. The patient had the
first nonimported case of paralytic poliomyelitis and the second case of VDPV
infection reported since the ""discontinuation in 2000 of oral poliovirus
vaccinations"". The patient's history of receiving intravenous administration of
immune globulin did not ""prevent the acquisition of infection, stop the long-term
poliovirus infection or prevent the development of paralytic poliomyelitis.""
Diagnostic and Laboratory findings included: MRI of the Spinal cord on hospital day
2 revealed the signal was increased on T(2)-weighted images from the lumbar spine
to the seventh thoracic vertebra; on day six focal focal hyperintensity was seen on
T(2)-weighted images in the anterior horns bilaterally, extending from the third
through seventh cervical vertebra with mild enlargement of the spinal cord.
Cerebrospinal fluid white-cell count was 6 x10(-3)/mm(3) and myelin basic protein
on hospital day 1-30 was 17 ng/ml and on days 61-91 was 5.24. Blood white-cell
count on hospital days 1-30 was 17.8 x10(-3)/mm(3); on hospital days 31-60 was 22.3
x10(-3)/mm(3); and on hospital days 61-91 was 25.5 x10(-3)/mm(3). Neutrophils on
hospital days 1-30 were 17.1 x10(-3)/mm(3); on hospital days 31-60 was 18.7 x10(-
3)/mm(3); and on hospital days 61-91 was 23.7 x10(-3)/mm(3). Documents held by
sender: journal article."" "MRI of the Spinal cord on hospital day 2 revealed
the signal was increased on T(2)-weighted images from the lumbar spine to the
seventh thoracic vertebra; on day six focal hyperintensity was seen on T(2)-
weighted images in the anterior horns bilaterally, extending from the third through
seventh cervical vertebra with mild enlargement of the spinal cord. Cerebrospinal
fluid white-cell count was 6 x10(-3)/mm(3) and myelin basic protein on hospital day
1-30 was 17 ng/ml and on days 61-91 was 5.24. Blood white-cell count on hospital
days 1-30 was 17.8 x10(-3)/mm(3); on hospital days 31-60 was 22.3 x10(-3)/mm(3);
and on hospital days 61-91 was 25.5 x10(-3)/mm(3). Neutrophils on hospital days 1-
30 were 17.1 x10(-3)/mm(3); on hospital days 31-60 was 18.7 x10(-3)/mm(3); and on
hospital days 61-91 was 23.7 x10(-3)/mm(3)."
"427564-1" "427564-1" "None stated." "No lab data for this event."
"427623-1" "427623-1" "Nothing major just fussy, no temperature. She ate
somewhat normal, was a little fussy at the breast at times. Didn't want to be put
down." "Autopsy revealed Re-breathing/SIDS"
"428369-1" "428369-1" "Mom awoke in am to find baby unresponsive. EMS
initiated CPR. No response & pronounced in ED. Associated risk factors: bed-
sharing, maternal smoking. Autopsy pending." "No lab data for this event."
"428370-1" "428370-1" "Fever & fussy 6/20/11. Fever 6/21/11. Found
unresponsive after taking a nap." "No lab data for this event."
"428488-1" "428488-1" "Put down for nap and found by mother 1 hr later -
face down. Pale, cold & non-responsive. CPR initiated. 911. Perfusing rhythm re-
established in ED at 11:18. Never required any function. EEG - no electrical
activity x 2. CT scan - compatible with hypoxic injury. Removed from life support
on 7/31/11 at 14:40." "No lab data for this event."
"428554-1" "428554-1" "None stated." "No lab data for this event."
"429007-1" "429007-1" "Information has been received from a consumer
concerning her daughter who was vaccinated with GARDASIL. The consumer reported
that he had nothing to live for because GARDASIL killed his daughter. It was
unknown if the patient sought medical attention. No further information is
available." "Unknown"
"429045-1" "429045-1" "See autopsy report." "No lab data for this event."
"429366-1" "429366-1" ""Patient's legs immediately began to swell, much
larger than I had seen swell in his older sister. The nurse advised me to
administer ibuprofen when we got home. From the time of vaccination, patient
screamed a very high pitched scream from 2:00 PM 3/5/07 until midnight -- 10 hours
straight. He flinched at the slightest touch and pain was evident. I called my
doctor's office at approximately 3:30, and the nurse told me to administer more
ibuprofen and rub the sites where he received vaccination. I did not administer
more ibuprofen as I was uncomfortable with giving him another dose, but I did rub
his legs -- which proved to be completely excruciating for him to endure. I called
my doctor's office again at 5:00, but the office was closed so I called a ""Call A
Nurse"" from the hospital. She suggested a myriad of ridiculous suggestions from
teething to gas. I tried to nurse him several times but he would not nurse and his
screams of pain would turn into gasps for air if I touched him. At one point, I
laid him on the floor and leaned over the top of him to try and nurse him. He
suckled for under a minute and continued crying. He did not sleep or eat for 10
hours. At approximately midnight it seemed like he began to have trouble
breathing. Strangely enough, it seemed that this calmed him down, and within a
minute his breathing became regular and he fell asleep. I called the ""Ask A
Nurse"" again and talked to a gentleman that said I let him sleep if he's sleeping
and bring him in to the doctor again the following day. Patient slept for 15-30
minutes at a time during the night, waking up often screaming a scream I had never
heard from him before. In the morning, I called the doctor's office and talked to
the nurse. I told her what had happened since I talk to her last and she said
""That sort of reaction happens often. It might be the Pertussis part of the
vaccine because it often gives people trouble. We'll give him his next round of
shots in a couple months, and if this reaction happens again we'll consider taking
out the Pertussis."" Patient was not the same baby he was previously to 3/5/07.
He cried often and was inconsolable. He always seemed like he was in pain. I
discussed my concerns with my doctor and his nurse, and they both assured me it was
a normal reaction and that he was not injured or hurt long term. They both urged
me to continue vaccinating him. Patient's behavior for the next 14 months was...
odd. He was always ""touchy"" and cried often as if he was always in pain. I
found him many times standing in one spot, hitting his head with his hand. When he
was about 14 months, I found him hitting his head with his hand saying ""ow ow ow""
with every touch to his head. My little boy would have been a different person had
he not received those vaccinations. He passed away on 4/10/2008, unrelated to
vaccinations."" "No lab data for this event."
"429528-1" "429528-1" "Onset of fever on 8-6-11 up to 102 degrees. Playful
when afebrile. Seen in doctor's office on 8/8. Presented later to ER where resp.
arrest occurred during evaluation. CPR and defibrillation with aggressive IV
inotropes unsuccessful. (intermittent fever present 8/6-8/8)." "ABG at ER showed
acidosis. No other testing done at ER due to rapidity of clinical decline. Autopsy
inconclusive. Further testing of tissue samples being done by state lab. Results
pending."
"430641-1" "430641-1" "SIDS baby." "No lab data for this event."
"430780-1" "430780-1" "Found dead in bed in a.m. by family. Pathologist
stated cause of death as consistent with cardiac insufficiency, due to cardiac
arrhythmia, due to probable early cardiomyopathy. Child Death Review Team felt
this death was consistent with a diagnosis of sudden cardiac death." "Autopsy,
including microscopy slides. Heart blood culture showed alpha streptococcus (not
Strep. pneumoniae, not enterococcus sp., not Strep. bovis). Femoral blood and
vitreous humor samples showed no drugs on complete drug screen. Vitreous panel
(Glucose - 32 mg/dL, Sodium - 137 mmol/L, Potassium - 15.2 mmol/L, Chloride - 124
mmol/L, Urea Nitrogen 13 mg/dL and Creatinine - 1.3 mg/dL)"
"430811-1" "430811-1" "Sudden infant death. Patient received vaccine in the
morning. Found dead at around 9pm after he was put in bed at 7pm." "Autopsy all
organs normal except heart which was not seen by Medical Examiner because it was
harvested for valve donation"
"432081-1" "432081-1" "This literature report with sparse information
(initial receipt: 19-Aug-2011) concerns a male patient who died from Guillain-Barre
syndrome after receiving influenza vaccination. Of note, the patient's daughter
experienced a serious adverse event after receiving influenza vaccine (WAVES
2011029570)." "No lab data for this event."
"432209-1" "432209-1" "Pt. wife reports pt. died." "No lab data for this
event."
"432347-1" "432347-1" "This case was reported by a lawyer and described the
occurrence of death nos in a male subject of unspecified age who was vaccinated
with TWINRIX (GlaxoSmithKline). A physician or other health care professional has
not verified this report. On an unspecified date the subject received 2nd dose of
TWINRIX (details unknown). At an unspecified time after vaccination with TWINRIX,
the subject experienced death nos. The subject died due to unknown cause. It was
unknown whether an autopsy was performed." "UNK"
"432984-1" "432984-1" "EMPLOYEE RECEIVED HEP B ON 8/23/2011. DONOR PASSED
ON 9/1/2011. UNKNOWN IF SHOT ASSOCIATED WITH DEATH." "No lab data for this event."
"433101-1" "433101-1" "Swelling at site." "No lab data for this event."
"433733-1" "433733-1" ""Initial report was received 31 August 2011 from a
consumer who was a co-worker of the patient. A female patient (age and date of
birth not reported), who was fit and worked out, had received an injection of swine
INFLUENZA VACCINE during the 1970s and right before Christmas, she became ill. The
patient died two years later. According to the reporter, at first they thought it
was GBS (Guillain-Barre Syndrome), but it was found to be ""something else""
(unknown by the reporter). Per the reporter, she had no additional information to
provide regarding this event. The reporter further stated that the business where
they worked had been bought and sold several times and had since gone out of
business; therefore, there is no one to contact for follow-up. The reporter for
this case is the same as for case numbers 2011-08149 and 2011-08150."" "Not
reported"
"434287-1" "434287-1" "Shortly after the vaccine, he started feeling tired,
out of sorts, disconnected. In January 2010, he started having headaches, seeing
double, difficulty swallowing, eventually lost continence. Would fall and be unable
to get up. MRI on 1-29-10 dx 2cm tumor in ponds. Admitted to hospital. Died 2-14-
10." "MRI"
"434581-1" "434581-1" "ADACEL vaccine administered 7/29/10 Occ Health.
Fasiculations developed 2 weeks later. Diagnosed with ALS 11/10. Expired Sept
2011." "Abnormal EMG; Exam"
"435007-1" "435007-1" "His body was limp and pale rush to Hospital where
his body was posturing and Cat scan showed swelling of the brain. Organs started to
shut down and he died the next day." "No lab data for this event."
"435354-1" "435354-1" "At 12:30 PM patient laid down for a nap he offered
no co at that time, at 2 PM I (wife) found patient unresponsive no pulse no
respiratory effort. His skin was cold and moteled I dailed 911 and began chest
compressions as instructed by 911 operator. I never got a pulse first responders
and also worked on patient and transfered him to hospital he was pronounced dead at
2:08 pm on 09/07/2011." "I dont have results of postmortum as of today. Still
pending."
"435682-1" "435682-1" "Death." "No lab data for this event."
"435707-1" "435707-1" "Member was given the Flumist on 09/22/2011. On
09/25/2011, member was feeling chest pain and not feeling well after dinner and
going to the Club. Mamber was found down face in vomit by his friends. CPR was
started and 911 activated. Paramedics arrived and continued CPR en route to
Hospital where CPR was continued unsuccesfully. Member was pronounced dead at 0215
by Dr." "Autopsy has been ordered"
"435871-1" "435871-1" "Case number PHEH2011US04709 is an initial
spontaneous report received from a health care professional on 16 Sep 2011. This
report refers to a 24-year-old male patient. He was a soldier and he was bitten by
a stray dog on his hand while breaking up a dog fight and had a likely canine
exposure three months prior to redeployment on an unspecified date. It was reported
that the doctor who treated him stated that he would have given exposed soldier
expired rabies vaccine shots (manufacturer and batch number: unknown) on an
undetermined date. It was also noted that he received incomplete post exposure
schedule of vaccine. Three months after redeployment symptoms began making the
overall incubation period of nearly six months. He was admitted for suspected
rabies on 19 Aug 2011 and it was confirmed on 21 Aug 2011. Typing was consistent
with foreign canine rabies. He expired on 31 Aug 2011." "No lab data for this
event."
"436253-1" "436253-1" "Patient was found dead in bathroom after no obvious
reaction." "No lab data for this event."
"436542-1" "436542-1" "This literature report (initial receipt 19-Sep-2011)
concerns 17 children. This literature report summarises 115 cases of influenza-
associated pediatric mortality reported to CDC (Centre for Disease Control and
Prevention) that occurred from 01-Sep-2010 to 31-Aug-2011. A case was defined as a
death from a clinically compatible illness confirmed to be influenza by a
diagnostic test in a resident aged < 18 years, with no period of complete recovery
between illness and death. Confirmatory influenza testing methods include
commercial rapid diagnostic tests, viral culture, fluorescent antibody, enzyme
immunoassay, reverse transcription-polymerase chain reaction and
immunohistochemistry. Information about influenza vaccination was available for 74
children aged 6 months or greater; 17 received influenza vaccine in the appropriate
number of doses at least 14 days before illness onset. Of 39 vaccine-eligible
children with agency-defined high-risk medical conditions who had vaccination data
available, 12 had been vaccinated according to 2010 agency recommendations. Among
children who dies from influenza described in the report, 23% were vaccinated. 49%
of the children who died had no known agency-defined high-risk medical conditions,
57 children were reported with medical conditions recognised by agency that placed
them at increased risk for influenza-related complications and the medical history
of two children was unknown. Of the 57 children with at least one agency-defined
high-risk condition, 31 had a neurologic disorder, 17 had pulmonary disease, 14 had
a chromosomal abnormality or genetic disorder, 11 had congenital heart disease or
other cardiac disease, and 11 had asthma or reactive airway disease. Obesity was
reported in two of the 57 children. Other types of agency-defined high risk
conditions that were reported for children who died from influenza associated
illness include immunosuppressive disorder (9 children), endocrine disorder (5
children), mitochondrial disorder (3 children), renal disease (2 children) and
pregnancy (1 child). Of the 115 influenza-associated pediatric deaths reported, 72
occurred in males. The median age of patients was 6 years, and 53 cases were in
children aged < 5 years. 71 of these cases were associated with influenza A virus
infection; 30 cases were 2009 influenza A (H1N1), 21 cases were influenza A (H3N2)
and 20 cases were influenza A viruses for which the subtype was not determined. The
remaining 44 cases were associated with influenza B virus infections. Of 64
children who had specimens collected for bacterial culture from normally sterile
sites (including 58 blood cultures), 25 had positive cultures; staphylococcus
aureus was detected in nine patients (six with methicillin-resistant S. aureus, two
with methicillin-sensitive S. aureus, and one with unknown sensitivity).
streptococcus pneumoniae was detected in six patients, and Group A streptococcus
was detected in three. The most frequent complications reported were
radiographically confirmed pneumonia (62%), shock or sepsis (40%), and acute
respiratory distress syndrome (34%). Encephalopathy or encephalitis was reported in
12 children (14%). Other complications included seizures (13%), hemorrhagic
pneumonia/pneumonitis (6%), croup (5%), cardiomyopathy/myocarditis (4%) and
bronchiolitis (2%). Of the 47 children who received antiviral therapy, three died
in the emergency department and 44 died after being admitted to the hospital. All
three children who died in the emergency department received oseltamivir. Of the
children who died after being admitted to the hospital, 41 received oseltamivir
only, two received oseltamivir and zanamivir and one received zanamivir only."
"Group A streptococcus, positive; Staphylococcus aureus, positive;
Streptococcus pneumoniae, positive"
"436701-1" "436701-1" "Initial case retrieved from the scientific
literature on 22 September 2011. The authors evaluated clinical-pathological
features of 37 infants/children whose parents alleged a relationship between
vaccination and death or permanent central nervous system (CNS) damage, and sought
compensation through the National Vaccine Injury Compensation Program during the
years from 1990 through 1999. CNS tissue was available for evaluation by a
pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%)
ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-
three of the 37 patients were dead at the time the case was evaluated. Most
commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and
IPV/OPV (25 cases each). The authors concluded that there was no obvious
relationship between type of vaccine (or vaccines simultaneously administered) to
time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions
were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32
remaining cases, but pathogenesis of the majority was apparent and not considered a
complication of vaccination. Of the 37 patients described in the article, the
vaccines received by eight of these patients were specified. This case captures one
patient; and the other seven patients are captured in case numbers 2011-09243,
-09245, -09246, -09247, -09248, -09249 and 2011-09250. An unidentified patient
(infant/child, age not reported) had received a DTAP vaccine (manufacturer unknown;
lot number, route, site and date of administration not reported) and within three
days of vaccination, the patient died. Cause of death was pulmonary hemorrhage
(onset not reported) although pathogenesis of the hemorrhage remained undefined. No
CNS lesions were identified. Documents held by sender: None." "Pathogenesis of
the hemorrhage remained undefined. No CNS lesions were identified."
"436704-1" "436704-1" "Initial case retrieved from the scientific
literature on 22 September 2011.The authors evaluated clinical-pathological
features of 37 infants/children whose parents alleged a relationship between
vaccination and death or permanent central nervous system (CNS) damage, and sought
compensation through the National vaccine Injury Compensation Program during the
years from 1990 through 1999. CNS tissue was available for evaluation by a
pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%)
ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-
three of the 37 patients were dead at the time the case was evaluated. Most
commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and
IPV/OPV (25 cases each). The authors concluded that there was no obvious
relationship between type of vaccine (or vaccines simultaneously administered) to
time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions
were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32
remaining cases, but pathogenesis of the majority was apparent and not considered a
complication of vaccination. Of the 37 patients described in the article, the
vaccines received by eight of these patients were specified. This case captures one
patient; and the other seven patients are captured in case numbers 2011-09242,
-09243, -09246, -09247, -09248, -09249 and 2011-09250. A three-year-old female
patient (who was one of triplets) and who had a history of developmental delay,
microcephalic, and recurrent CNS infections by unidentified agents which were
thought to have been viral, had received an INFLUENZA VACCINE (manufacturer
unknown; lot number, route, site and date of administration not reported) when she
was 3 years 9 months old. Two weeks later, she presented with CNS symptoms similar
to those she had had unassociated with vaccination in the past, including fever.
The day following hospitalization, she had a seizure which proceeded to status
epilepticus and cardio-respiratory arrest. Respirator therapy was terminated on the
following day. Postmortem examination disclosed acute hypoxic-ischemic
encephalomyelopathy, noted to have been secondary to status epilepticus. Documents
held by sender: None." "Post mortem examination disclosed acute hypoxic-ischemic
encephalomyelopathy."
"436705-1" "436705-1" "Initial case retrieved from the scientific
literature on 22 September 2011. The authors evaluated clinical-pathological
features of 37 infants/children whose parents alleged a relationship between
vaccination and death or permanent central nervous system (CNS) damage, and sought
compensation through the National Vaccine Injury Compensation Program during the
years from 1990 through 1999. CNS tissue was available for evaluation by a
pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%)
ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-
three of the 37 patients were dead at the time of the case was evaluated. Most
commonly implicated vaccines were DTP or DTaP (33 cases), followed by MMR and
IPV/OPV (25 cases each). The authors concluded that there was no obvious
relationship between type of vaccine (or vaccines simultaneously administered) to
time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions
were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32
remaining cases, but pathogenesis of the majority was apparent and not considered a
complication of vaccination. Of the 37 patients described in the article, the
vaccines received by the eight of these patients were specified. This case captures
one patient; and the other seven patients are captured in case numbers 2011-09242,
-09243, -09245, -09246, -09247, - 09249 and 2011-09250. A 10-month-old male infant
had received DTAP, IPV, HIB (Manufacturers unknown) and Hep B (Other manufacturer)
lot numbers, routes, sites and dates of administration not reported. Seven to 10
days post vaccination, the patient developed a stiff neck and fever; he could not
sit, roll over or hold this head up, and was quadriparetic. He developed fever and
had a cough at 14 months of age, and died at 16 months. CNS lesions consisted of
subacute non-demyelinizing viral encephalitis, acute infarctions, and acute anoxic
encephalopathy. Pathological diagnosis was unknown. The authors further noted that
the two anti-viral vaccines he received, Hep B was a non-neurotropic virus and even
natural infection does not cause CNS inflammation. IPV is a killed vaccine (SALK)
and on the remote chance that some live virus remained, the CNS pathology was quite
different from that cause by polio virus. The authors further noted that the two
anti-viral vaccines he received, Hep B was a non-neurotropic virus and even natural
infection does not cause CNS inflammation. IPV is a killed vaccine (SALK) and on
the remote chance that some live virus remained, the CNS pathology was quite
different from that cause by polio virus. Documents held by sender: None." "CNS
lesions consisted of subacute non-demyelinizing viral encephalitis, acute
infarctions and acute anoxic encephalopathy."
"436735-1" "436735-1" "Case number PHHY2011CA86216 is an initial literature
report received on 27 Sep 2011. Authors presented a case of acute disseminated
encephalomyelitis (ADME) following influenza vaccination. This case refers to a 75-
year-old female patient. Her past medical history included non-insulin dependent
diabetes mellitus type 2, dyslipidemia, hypertension, hypothyroidism and a
seronegative arthropathy. She had no other recent illness, history of tuberculosis,
or travel history in the preceding 24 months. She had never previously received
influenza vaccination. She was vaccinated with an inactivated seasonal influenza
vaccine (manufacturer and batch number: Unknown) on an undetermined date in 2008.
She presented with a 20 day history of headache, malaise, fatigue, intractable
hiccups, nausea and vomiting in Nov 2008. It was reported that the symptoms began
evolving 2 days following receipt of vaccination. She developed left hemiparesis 20
days post-immunization (PI) and by 29 days PI had progressed to hemiplegia and
hemianesthesia of the left side. She then became encephalopathic and developed
brainstem involvement with a left abducens palsy, dysarthria, right hemiparesis,
and incontinence. Her neurological exam demonstrated bilateral spastic tone, brisk
reflexes and extensor plantar responses. Magnetic resonance imaging of the brain
and spine demonstrated a long segment of T2 hyperintensity extending from the
caudal medulla down the entire length of the cervical cord terminating at T6.
Spinal cord expansion was presented throughout this segment, maximal at C5/C6. Skip
lesions were also present through the rest of the spinal cord down into the conus
medullaris. Patchy enhancement was presented on postgadolinium sequences
throughout. The remainder of the brain MRI was within normal limits for her age
(non-specific white matter changes). Her cerebrospinal fluid demonstrated
lymphocytic pleocytosis (white blood cell count of 208/micro L), comprised 56%
neutrophils, 29% lymphocytes and 15% monocytes, and elevated protein of 911 mg/L. A
comprehensive parainfectious workup and rheumatologic panel were negative apart
from an elevated CRP of 37.4 mg/L. CSF pathology was negative for malignant cells.
Her clinical and radiologic findings fulfilled published criteria for ADEM
according to the Brighton Collaboration Encephalitis Working Group. Despite
treatment with broad-spectrum antibiotics, acyclovir, methylprednisolone and plasma
exchange therapy (7 treatments in 14 days), the patient continued to deteriorate to
quadriplegia and required intubation secondary to hypercapneic respiratory failure,
she developed pneumonia and passed away 70 days PI. Authors stated that seeing as
the patient passed away 70 days PI and did not attain the minimum 3 months follow-
up duration required to document a monophasic pattern of illness and fulfill a
level 1 of diagnostic certainty, her case meets a level 2 of diagnostic certainty
for ADEM. Although CSF findings are not included in the abovementioned diagnostic
definition of ADEM, the CSF pleocytosis and elevated protein in this patient are
useful indicators of central nervous system inflammation. Authors also stated that
brainstem dysfunction may serve as a poor prognostic indicator. When assessing
post-vaccination adverse events it is always difficult to separate causality from a
temporal coincidence, however, in accordance with the World Health Organization's
causality assessment criteria it is 'very likely' that in this case disease was
caused by the administration of vaccine." "C-reactive protein increased, high,
37.4mg/l; CSF lymphocyte count, significant, 29%; CSF monocyte count, significant,
15%; CSF neutrophil count, significant, 56%; CSF protein, significant, 911 mg/l;
CSF test abnormal, significant demonstrated lymphocytic pleocytosis, abnormal; CSF
white blood cell count, 208/micro L; Nuclear magnetic resonance imaging, brain,
significant, Magnetic resonance imaging (MRI) of the brain and the spine
demonstrated a long segment of T2 hyperintensy extending from the caudal medulla
down the entire length of the cervical cord terminating at T6. Spinal cord
expansion was present throughout this segment, maximal at C5/C6. Skip lesions were
also present through the rest of the spinal cord down into the conus medullaris.
Patchy enhancement was present on postgadolinium sequences throughout. Abnormal"
"436743-1" "436743-1" "Parents found patient blue and not breathing at
home. Code Blue to hospital." "No lab data for this event."
"436818-1" "436818-1" "Initial case retrieved from the scientific
literature on 22 September 2011. The authors evaluated clinical-pathological
features of 37 infants/children whose parents alleged a relationship between
vaccination and death or permanent central nervous system (CNS) damage, and sought
compensation through the National Vaccine Injury Compensation Program during the
years from 1990 through 1999. CNS tissue was available for evaluation by a
pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%)
ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of
the 37 patients were dead at the time the case was evaluated. Most commonly
implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25
cases each). The authors concluded that there was no obvious relationship between
type of vaccine (or vaccines simultaneously administered) to time of onset of
symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5
of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases,
but pathogenesis of the majority was apparent and not considered a complication of
vaccination. Of the 37 patients described in the article, the vaccines received by
eight of these patients were specified. This case captures one patient; and the
other seven patients are captured in case numbers 2011-09242, -09245, -09246,
-09247, -09248, -09249 and 2011-09250. A five-month-old female patient had received
a DTP vaccination (manufacturer unknown; lot number, route, site and date of
administration not reported) and within 24 hours developed onset of seizures, but
later manifested developmental delay. The patient died at seven years of age at
which time acute anoxic encephalopathy was found and was most likely a consequence
of terminal seizures. No lesions that may have accounted for the developmental
delay were found. Documents held by sender: None." "CNS tissue - No lesions that
might have accounted for the developmental delay were found."
"436838-1" "436838-1" ""Initial case retrieved from the scientific
literature on 22 September 2011. The authors evaluated clinical-pathological
features of 37 infants/children whose parents alleged a relationship between
vaccination and death or permanent central nervous system (CNS) damage, and sought
compensation through the National Vaccine Injury Compensation Program during the
years from 1990 through 1999. CNS tissue was available for evaluation by a
pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%)
ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of
the 37 patients were dead at the time the case was evaluated. Most commonly
implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25
cases each). The authors concluded that there was no obvious relationship between
type of vaccine (or vaccines simultaneously administered) to time of onset of
symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5
of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases,
but pathogenesis of the majority was apparent and not considered a complication of
vaccination. Of the 37 patients described in the article, the vaccines received by
eight of these patients were specified. This case captures one patient; and the
other seven patients are captured in case numbers 2011-09242, -09243, -09245,
-09246, -09247, -09248 and 2011-09249. A nine-month-old male infant had received a
DTP vaccine at six months of age (manufacturer unknown, lot number, route, site and
date of administration not reported) and at 9 months of age, developmental delay
was noted, along with seizures, complex neurologic dysfunction and eventually
microcephaly. The patient died when they were nine years three months of age. At
that time, brain lesions were those of classical perinatal hypoxic-ischemic injury,
consisting of periventricular leukomalacia and ""status marmoratus""; there was
associated atrophy. Documents held by sender: None."" ""Brain lesions were those of
classical perinatal hypoxic-ischemic injury, consisting of periventricular
leukomalacia and ""status marmoratus""; there was associated atrophy.""
"436852-1" "436852-1" "Initial case retrieved from the scientific
literature on 22 September 2011. The authors evaluated clinical-pathological
features of 37 infants/children whose parents alleged a relationship between
vaccination and death or permanent central nervous system (CNS) damage, and sought
compensation through the National Vaccine Injury Compensation Program during the
years from 1990 through 1999. CNS tissue was available for evaluation by a
pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%)
ranging in age from 1 month to 17 years at time of death or biopsy. Thirty-three of
the 37 patients were dead at the time the case was evaluated. Most commonly
implicated vaccines were DTP or DTaP (33 cases), followed by MMR and IPV/OPV (25
cases each). The authors concluded that there was no obvious relationship between
type of vaccine (or vaccines simultaneously administered) to time of onset of
symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5
of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases,
but pathogenesis of the majority was apparent and not considered a complication of
vaccination. Of the 37 patients described in the article, the vaccines received by
eight of these patients were specified. This case captures one patient; and the
other seven patients are captured in case numbers 2011-09242, -09243, -09245,
-09246, -09247, -09248 and 2011-09250. A five-month old female infant received a
DTP vaccine (manufacturer unknown, lot number, route, site and date of
administration not reported) and had onset of seizures within 24 hours post-
vaccination. After the seizures, the patient manifested developmental delay.
Multifocal infarctions were found when she died seven years later. Documents held
by sender: None." "Multifocal infarctions were found."
"437334-1" "437334-1" "Received shots (PENTACEL/PCV13/ROTATEQ) on 9-28-11.
H/o bronchiolitis 9-15-11 --> better 9-20-11. NL exam on 9-28-11." "No lab data
for this event."
"437391-1" "437391-1" "Police reported to us that patient was found dead in
her home the day after flu vaccine was administered. We had no communication w/ pt
after office visit 10/4." "No lab data for this event."
"437570-1" "437570-1" ""DATE OF EXAM: 10/07/2011 at 08:20. SUBJECTIVE: The
patient is an 80-year-old lady who was brought in to the Emergency Room last night
unconscious. I reviewed the reviewed the history in the system as well as reviewed
the history from the patient's family at bedside. The patient's daughter saw the
patient during lunchtime and had lunch with her. She was in her usual state of
health. She has not had any fever or chills. No productive cough, no chest pain,
no abdominal pain and no diarrhea. She was in her usual state of health without
any evidence of an infectious process. After lunch time, the patient was supposed
to get her flu shot and was on her way to get her flu shot. The patient's family
believes that she has gotten her flu shot. They were not told otherwise. It is
presumed that the patient has received her flu shot. We are at this time unsure of
the route it was given if indeed she received it. At around 6:00 after work, the
same daughter came to visit the patient to cook her dinner. She was noted to be
unconscious, sitting up in her electrical wheelchair. The patient does have
episodes of syncope and has had multiple episodes in the past. Normally this is
associated with ""bowel movement"" vasovagal syncope). At this time, the patient
was not on the toilet bowl. The patient's daughter did not smell or see any
evidence of bowel or bladder incontinence or any sign that she had tried to move
her bowels. The patient's daughter tried to pick her up, thinking that this was
one of her usual episodes of syncope. She asked the nursing staff to help her wake
the patient up, but when they could not wake up the patient, EMS was called. When
EMS arrived, the patient was noted to have low blood pressure. The patient's
daughter believes that she had taken all of her morning medications since her
medication dispenser for that day was empty. The only thing that they are not sure
of is whether or not the patient took her ""fibromyalgia pill"". The patient was
then brought to the emergency room. The patient remained unconscious and had to be
intubated to protect her airway. She was given IV fluid boluses without good
response and started on vasopressor initially with dopamine and subsequently
changed to Levophed. While the patient was in the emergency room, the patient was
noted to have a pulseless electrical activity. They were not sure how long the
patient had pulseless electrical activity and so CPR was performed. The patient
sustained some broken ribs as well as mild pneumothorax. I have counseled the
patient's family regarding this and they are aware. The patient remains
unresponsive on the vent. Occasionally, she tried to move her upper extremities.
She is noted to have some movements of the lower extremity, but is not necessarily
consistent with stimulation and not necessary purposeful. Occasionally, she will
bite down on her ET tube. She is also noted occasionally to be ""ruminating"". The
patient has guaiac positive stools, but there is no evidence of active bleeding or
GI bleed. Blood count remains stable despite aggressive IV fluid hydration. There
is some decrease in blood count, but mainly secondary to hemodilution. OBJECTIVE:
GENERAL: The patient is mainly unresponsive, intubated, on vent support and
vasopressor support. VITAL SIGNS: Most recent vital signs showed blood pressure
114/90, heart rate of 98, respirations of 15-22, temperature 35.4 degrees
centigrade. Temperature minimum was 34.7 degrees early this morning. HEENT:
Normocephalic and atraumatic. ET and OGT noted. Pupils were 4-5 mm bilaterally
and minimally reactive to 3-4 mm bilaterally. Doll's eyes were equivocal. There
is some eye movements, but not entirely consistent with doll's eye movement. Pink
conjunctivae, no icterus. I was unable to fully evaluate the patient's oral
mucosa. NECK: Supple. CHEST: Lungs are symmetrical with good chest expansion.
Diminished breath sounds at the bases with occasional scattered rhonchi noted,
otherwise no significant wheezing. CARDIOVASCULAR: Normal rate, regular rhythm,
S1, S2 noted. I do not appreciate any rubs or gallops. PMI is difficult to
palpate secondary to the patient's low blood pressure. No significant JVD noted.
GASTROINTESTINAL: The abdomen is globular very hypoactive bowel sounds, soft, no
grimace to palpation, no rebound tenderness. MUSCULOSKELETAL: There is no
significant edema of bilateral lower extremities. Pedis pulses are significantly
diminished. The patient's extremities are cold to touch and the left upper
extremity appears to be somewhat cyanotic. SKIN: Cool to touch as noted above. No
other rash or skin breakdown noted. I am not able to detect any injection site on
both of the patient's deltoid areas. NEUROLOGIC AND PSYCHIATRIC: Examination
severely limited secondary to the patient's mental status. Babinski are equivocal.
There are some occasional movements of both upper extremities and left lower
extremity as noted above. DIAGNOSTIC RESULTS: Laboratories obtained this morning
showed WBC 12.2, hemoglobin 12.5, hematocrit 36.5, MCV of 93, and platelet count
243. PT 11.6, INR 1.1. Sodium 151, potassium 3.6, chloride 113, CO2 18, BUN 47,
creatinine 2.2, calcium 7.3, magnesium 3.8, phosphorus 4.4. Lactic acid 4.6, alk
phos is 614, total bilirubin 1.6, AST 213, ALT of 84, total protein 5.3, albumin
2.8, glucose of 166. PH is 7.20, pCO2 42, pO2 of 109, CO2 17, oxygen saturation
95% at 60% FIO2. Stools for guaiac came back positive. Stools for Clostridium
difficile back negative x2. CT of the abdomen and pelvis obtained, preliminary
reading, showed multiple findings without definite evidence of bowel obstruction,
left-sided pneumothorax with left-sided rib refracture of the left transverse
process at L1-L2. Compression fracture of T12 of indeterminate age with marked
compression deformities in retropulsion noted. ASSESSMENT AND PLAN: * Hypotension
with mental status change presumed to be secondary to severe sepsis with septic
shock. Unclear source at this time. Urinalysis obtained did show some evidence of
possible infection; however, this was a contaminated urine with a lot of squamous
epithelial cells. So far there is really no other definitive infectious source.
We will continue vasopressor support. We will continue IV antibiotics with
vancomycin and Zosyn. We will need to ascertain whether the patient did receive a
flu vaccine and what route it was given. We might need to know the lot number. I
personally spoke with Dr. from Infectious Disease. I recommend continuing IV
antibiotics and this might need to be reported, especially once we are certain that
the patient did receive a flu vaccine. I will also order a rapid flu test. We
will follow the results of blood cultures and urine cultures. * Status post cardiac
arrest with pulseless electrical activity requiring chest compression. Initial
troponin did come back negative. I will not order further troponins since "
"10/6/11: WBC 21.4, Scr-1.8, BUN-39, LA-7.9, ABG-7.16, troponin-0.01 10/7/11:
Wbc-12.2, Neuts-71.1%, scr-2.2, BUN-47, LA-4.6, ABG-7.20, CRP-1.8, sed rate-
10mm/hr"
"437685-1" "437685-1" "Our office became aware of the infants death by an
acquaintance of the family. This person also states that cause of death was
determined to be S.I.D.S." "No lab data for this event."
"437735-1" "437735-1" "Relapse of ITP: 18 year-old female with immune
thrombocytopenic purpura, diagnosed in 1995 and in remission from 2004 to 2011
following treatment with Rituximab. Relapse in early April, 2011, followed
administration of Gardasil vaccine on 10-26-10 and 1-7-11. Relapse of ITP led
eventually to death from intracranial hemorrhage on 07/06/2011." "Petechiae and
ecchymoses noted by patient and family in early April (exact date not known). CBC
on 04/26/2011 included platelet count 5000; WBC 5.4 with normal differential, Hgb
12.8, Hct 37.2, MCV 87.9; normal RBC morphology."
"437999-1" "437999-1" "Information has been received from a physician
concerning an 18 year old male patient with acne and no drug allergy or reaction
who on 16-MAY-2011 was vaccinated with the first dose of GARDASIL (Lot number
668554/0306AA; Expired date: 10-MAY-2013) and a dose of VAQTA (Lot number:
670377/0126AA; Expired date: 07-DEC-2013, dose in series unknown). On 22-JUL-2011,
the patient received the second dose of GARDASIL (Lot number 668262/0841AA; Expired
date: 18-APR-2013). Concomitant therapy included SEPTRA. Follow up phone call from
the physician was received. The physician reported that the patient had no medical
history. The last time he saw the patient was on 22-JUL-2011, when the patient
received his second dose of GARDASIL. The physician also reported that there was no
indication from the patient that he was troubled. On 27-JUL-2011 the patient
committed suicide. The cause of death was asphyxiation by hanging. The death report
that the physician received was that the patient had a normal examination. The
Toxic screen indicated that there were no medications involved in the patient's
death. The patient's mother had asked the physician if GARDASIL could have caused
her son to commit suicide. The physician reported to the patient's mother that he
did not feel that GARDASIL was the cause of her son's suicide. The physician stated
that he was not aware of any reported deaths by suicide that were related to
GARDASIL. Lot checks have been initiated for 668554/0306AA, 668262/0841AA for
GARDASIL and 670377/0126AA for VAQTA. Additional information has been requested."
"diagnostic laboratory, ?/?/11, toxic screen indicated that there were no
medications involved in the patient's death."
"438031-1" "438031-1" "Case number PHEH2011US06146 is an initial
spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-
year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on
01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot
raised his blood sugar to a diabetic coma that he did not wake up. The patient
received care at hospital. The critical team worked on him for 12-hours and he
expired on 03 Oct 2011. No other information was provided.""No lab data for this
event."
"438050-1" "438050-1" "Case number PHHY2011US89577 is an initial literature
report received on 06 Oct 2011: The authors analyzed clinical-pathological features
of 37 infants/children whose parents alleged a relationship between vaccination and
death or permanent central nervous system (CNS) damage, and sought compensation
through the National Vaccine Injury Compensation Program. This report refers to a
female child. She was one of the triplet and her medical history included recurrent
CNS infections by unidentified agents, but which were thought to have been viral.
She was developmentally delayed and microcephalic. At the age of 3 years and 9
months, she was vaccinated with seasonal influenza vaccine (manufacturer and batch
number unknown) on an unspecified date. Two weeks later, she presented with CNS
symptoms similar to those she had unassociated with vaccination in the past,
including fever. The day following hospitalization, she had a seizure which
proceeded to status epilepticus and cardio-respiratory arrest. Respiratory therapy
was terminated on the following day. Postmortem examination disclosed acute
hypoxic-ischemic encephalomyelopathy. The authors concluded that provided evidences
were not supportive of direct relationship between a given vaccine and a specific
CNS complication. Pathogenesis of majority of the cases was apparent and not a
complication of vaccination." "No lab data for this event."
"438069-1" "438069-1" "Patient died in crib 48-hours after receiving the
series of vaccines identified in Box 13 below. Coroner listed the cause of death as
SIDS." "No lab data for this event."
"438416-1" "438416-1" "Sudden onset of decline. Audible, course crackles
upper airways. O2 sats 88% on 4L O2, BP 112/70, P90, R24, T98.6. Elevated HOB,
nebulizer given. MD immediately informed w/orders, if no improvement w/PRN neb tx
or worsening sx's, transfers to ER for eval. Guardian notified & in agreement w/MD
orders. During neb tx, O2 sats decreased to 84% w/audible course crackles, BP
102/78, P89, R34. Ambulance called, arrived & during assessment per ambulance crew,
rt. expired at 2145. Ambulance crew informed Co. Sheriff of death. No concerns re:
death. Guardian & MD informed of rt.'s passing. Funeral home notified." "No
lab data for this event."
"438770-1" "438770-1" "Pt. had emesis that she vomited on the floor, she
then tried getting up & fell. Resident was confused, weak, & had pale color. Sent
to ER for evaluation. ER called at 1:22am & said she was admitted with A-fib,
dehydration, rapid ventricular response, & mental status changes." "No lab data
for this event."
"439082-1" "439082-1" "None stated." "No lab data for this event."
"439265-1" "439265-1" "Death." "No lab data for this event."
"439266-1" "439266-1" "Death." "No lab data for this event."
"439267-1" "439267-1" "Death." "No lab data for this event."
"439269-1" "439269-1" "Death." "No lab data for this event."
"439567-1" "439567-1" "Baby expired around 6AM on 10-21-11 as per the
grandmother's call to the office at 0900 (approx)." "None"
"440304-1" "440304-1" ""Per report received from hospital, Pt. was
pulseless, apneic, cyanotic unresponsive upon arrival. Father doing CPR upon EMS
arrival. Pt. pulseless per report. Grandmother reported child ""was fine"" at 1:00
AM."" "Autopsy results pending."
"440529-1" "440529-1" "Reported to us that patient received Flu shot on
10/17/2011 and went to ER. Admitted to ICU with septic shock and multiple organ
failure." "Unknown"
"441125-1" "441125-1" "Was seen for 15 mo well child visit 10/28/2011
received DTaP, HIB, PCV 13 and influenza vaccines approximately 5pm exam was
normal. Patient was at daycare 10/31/11 and found to be unresponsive after being
put down for a nap. Brought to ER, pronounced dead after unsuccessful resuscitation
attempt." "See medical examiner's report"
"441679-1" "441679-1" ""61 y/o stated he received injectable INFLUENZA
vaccine on 4 Oct 2011. States he has received the flu shot every year with no
problems as well as no adverse events with any other vaccinations in his career.
PMH includes ulcerative colitis for which he took ASACOL. He developed this
condition in the late '90's and it has been under good control with no active
symptoms. Took ASACOL up until the time of hospitalization but was not given it
after admitted. Pt was healthy and active, worked full time and ran 3-4 miles
5x/week and ran the 10 miler on Sunday 9 Oct'11. On Tues, 11 Oct he developed
chills in the evening. He went to work the next day but by evening ""wasnt feeling
right"". He stayed home from work on Thurs 13 Oct with chills, myalgias, headache,
abdominal bloating and weakness. Denied having chest pain, fever, cough, sob. He
got weighed and found he had gained 7 pounds. He continues to feel badly and went
into primary care on Fri, 14 Oct where exam was normal, was diagnosed with the flu
and was sent home with conservative tx. He went to the ER on Sat 15 Oct when he
continued to feel worse: WBC 18 Neutrophils Troponin 3.6 (continuing to rise to
current 8.24, BNP 38747, ALT 209, AST 147, CKMB 34.8. He was admitted to CCU with
diagnosis of myocarditis with cardiac failure. Labs as of 18 Oct at hospital:
creatinine 1.8, D-dimer 2.15, urine protein SSA positive, influenza A & B virus
antigen negative via nasopharyngeal swab. Pt was SOB, slightly jaundiced, c/o
bloating in abdomen and fatigued. P 94, 113/64 CXR shows enlarged
cardiacmediastinal silhouette with bilat pul, consolidations. CXR had evolved to
develop pleural effusion, clear evidence of pulmonary edema, and continued
cardiomegaly. INPT treatment: LOPRESSOR, NEXIUM, PLAVIX, TAMIFLU, LASIX, O2,
piperacillin/tazobactam. Transferred to another hospital on 18 Oct not only to
receive dialysis due to worsening renal function, but also due to potential need
for ECMO (extra-corporeal membrane oxygenation) as a bridge to LVAD (Left
ventricular assist device). Update 21 Oct: pt continued to worsen, on ECMO,
receiving steroids, unable to do heart biopsy due to worsening condition.
Biventricular assist device inserted on 25 Oct at hospital. Patient died on 27 Oct.
Titers/PCR pending on myocardial tissue. Path report returned yesterday showed
giant cell myocarditis, no eosinophils. Additional labs pending from hospital to
include parvo and coxackie abs."" "CRP, 25.92 (15 Oct); ESR, 79; 18 Oct labs:
WBC, 24.4/87 neuts; Troponin I 12.40; BNP, 55321; CKMB, 63.8; CK, 501; ALT/AST,
2587/3549; creatinine, 2.7; phosphate, 7.9; ABG pH/ PO2CO2, 7.48/63/16.1; Antibody
panels: Epstein-Barr virus nuclear Ab IgG serum, >5.00; Epstein -Barr virus capsid
Ab IgG serum, 2.7; Epstein-Barr virus capsid Ab IgM serum, <0.2; Epstein-Barr virus
nuclear Ab IgG, >8.0; Hepatitis B virus surface Ab serum Non reactive; Hepatitis B
virus surface Ag serum Non reactive; Hepatitis B virus Core Ab IgM serum Non
Reactive; Hepatitis C virus Ab serum Non reactive; nasopharyngeal swab 21 Oct: NO
INFLUENZAE A/B, PARAINFLUENZA 1-3, adenovirus, or RSV isolated; HIV negative;
Cytomegalovirus Ab IGG/IGM negative; Toxoplasma Ab IGG/IGM negative; Streptolysin O
Ab negative; Lyme disease total ab screen negative; ECHO 18 Oct, - overall left
ventricular systolic function severely reduced EF < 20%, - small circumferential
pericardial effusion present, -mild pulm hypertension w/PA systolic pressure
estimated"
"441707-1" "441707-1" "1/18/2010 red color in urine, 1/23/2010 out of
breath, 1/24/2010 medical diagnosis was hemolytic anemia, 1/25/2010 condition
became worse, 1/25/2010 admitted to hospital, surgery to take out spleen, 1/26-
2/1/2010 kidneys failed, heart attack with death on second heart attack." "No
lab data for this event."
"442054-1" "442054-1" "Death" "No lab data for this event."
"442306-1" "442306-1" ""Information has been received from a physician
concerning a ""little over 70 years old"" male patient with heart disease who
either in 2007 or 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot number,
dose and route not reported). The physician reported that either in 2007 or 2008
the patient developed shingles about 6 days after receiving the vaccine. The
patient had some heart issues and had been hospitalized before getting the vaccine.
Apparently the ZOSTAVAX (Merck) was given after the patient was released from the
hospital but the physician did not know how soon after. Later on an unspecified
date about 6 to 12 months after getting the vaccine the patient passed away. The
physician reported that he thought the cause of death was the heart disease but he
did not know for sure. Additional information has been requested."" "Unknown"
"442402-1" "442402-1" "Initial soreness and swelling. Death 10/20/2011."
"No lab data for this event."
"443115-1" "443115-1" "Diarrheal illness on 10/28/11 - transferred to
hospital on 10/31/11. Died on 11/2/11 - dx with E-coli 0157 Huhs. She was Trisomy
21 (Downs) & epilepsy, well controlled with med." "No lab data for this event."
 "443611-1" "443611-1" "This is a spontaneous report from a contactable
nurse communicated to a Pfizer sales representative. A 5-year-old patient (gender
unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history
and concomitant medications were not provided. On an unknown date, the patient
developed a Streptococcus pneumoniae infection and died. It is unknown if an
autopsy was performed. No further information was provided." "No lab data for
this event."
"443669-1" "443669-1" ""This case was retrieved via a search of scientific
literature on 11 November 2011. The reporter for this case is the same for case
numbers: 2011-11264, 2011-11267, 2011-11271, 2011-11272 and 2011-11371.
""Background: TDAP vaccine was not licensed for use in adults aged greater than or
equal to 65 years due to lack of sufficient efficacy and safety data. To
characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among
adults aged greater than equal to 65 years who received TDAP vaccine 'off label' to
assess for potential vaccine safety concerns. We searched VAERS for reports of
adverse events (AEs) in subjects aged greater than or equal to 65 years who
received TDAP vaccine from 9/1/2005 to 9/08/2010. Medical records were requested
for all reports cases as serious (death, hospitalization, prolonged
hospitalization, permanent disability, life-threatening illness). Proportional
reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs
after TDAP compared with Td reports in subjects aged greater than or equal to 65
years. VAERS received 243 reports following TDAP administered to persons aged
greater than or equal to 65 years. Eleven (4.5%) reports were serious, including
two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-
eight (32.1%) reports contained coding terms that denoted inappropriate
administration of vaccine. 'Cough' was the only term associated with
disproportionately higher reporting after TDAP compared with Td. Six of seven Tdap
reports containing the term 'cough' were non-serious. Clinical review of serious
reports identified no unusual patterns of AEs. Our VAERS review of the 'off label'
use of TDAP vaccine in adults greater than or equal to 65 years did not find any
safety concerns that warrant further study. These date will provide useful baseline
information to assist CDC and FDA with monitoring efforts as permissive
recommendations for TDAP in older persons are adopted."" A 66-year-old female had
received DTAP vaccine (manufacture, lot number, route site and date of
administration not reported) and two days after vaccination, presented with
shortness of breath, which worsened in the following six weeks. The patient died
two months after vaccination; the cause of death was indicated to be pulmonary
hypertension due to acute interstitial lung disease. Documents held by sender:
None."" "Not reported"
"443738-1" "443738-1" "Died of apparent SIDS." "No lab data for this
event."
"443774-1" "443774-1" "Case number PHHY2011US100194 is an initial
literature report received on 14 Nov 2011: The authors reported the first case of
central diabetes insipidus associated with hemophagocytic lympho-histocytosis
following vaccination with H1N1 vaccine. This report refers to a 75-year-old female
patient. Her past medical history was significant for osteoporosis treated with
risedronate for one year, then alendronate for one year, after which she received
two infusions of zoledronic acid, her last one in Oct 2009. She had a history of
gastric ulcer at age 60, a possible transient ischemic attack in Jul 2009, and
hypertension. Computed tomography of the brain without contrast in Jul 2009
revealed small vessel ischemia. Her only medications were vitamin D, 50,000 IU once
a month, and lorazepam, 0.5 mg, for anxiety. She was vaccinated with H1N1 vaccine
(batch number and manufacturer: unknown) on an undetermined date in 2010. One month
after vaccination she presented with flu-like illness in Mar 2010 and was treated
with oseltamivir phosphate. However, within several days of developing this flu-
like illness, she began to have polyuria associated with polydipsia and loss of
appetite. A urine culture was negative. She was asked to record her urinary volume
over a 24-hour period. On two successive days, her 24-hour urinary volumes were 3,
990 mL and 2, 550 mL respectively. An overnight dehydration test was performed, and
her morning urine sodium concentration was 22 mEq/L, urine osmolarity was 145
mOsm/kg, serum sodium concentration was 147 mEq/L, and serum osmolarity was 314
mOsm/kg. She continued to complain of generalized weakness, loss of appetite, loss
of taste for salt, excessive thirst, and frequent urination. She was found to have
iron-deficiency anemia with an elevated erythrocyte sedimentation rate of 42
mm/hour (normal, less than 20 mm/hour). Her fasting serum gastric level was 44
pg/mL (normal, less than 200 pg/mL), serum prolactin level was 16.7 ng/mL
(reference range, 1.9 to 25 ng/mL), and serum protein electrophoresis revealed a
polyclonal gamma increase. Her follicle-stimulating hormone level was 24.2 mlU/mL
(normal postmenopausal, more than 25) and luteinizing hormone level was 11.2 mlU/mL
(normal postmenopausal , more than 20 mlU/mL). Thyroid and liver function tests
were normal. Magnetic resonance imaging (MRI) of the pituitary revealed a 4-mm
nodular lesion within the left lobe of the pituitary gland, consistent with a
possible pituitary micro adenoma. In May 2010, she was started on intranasal 1-
deamino-8-D-arginine vasopressin (DDAP) supplementation, one puff at bedtime, with
marked improvement of her polyuria. A few days later she developed gastrointestinal
bleeding and was hospitalized. She was found to have three non bleeding polyps on
colonoscopy and had a negative capsule endoscopy. Her polyuria remained improved on
DDAVP. In Aug 2010, she was readmitted with intermittent daily fevers that reached
39.5 degree Celsius, a white blood cell (WBC) count of 20, 000/L (reference range,
3, 500 to 9,000/L) with 65% neutrophils, 15% lymphocytes, 17% monocytes, and 3%
band forms indicating leukocytosis, and a urinary tract infection (indicated by the
presence of 3+ leukocyte esterase, no nitrites, and 31 WBCs on urinalysis). She had
progressive fatigue and anorexia and had lost 3.6 kg in the past few months (from
49.5 to 45.9 kg). She appeared cachectic on examination. She was not orthostatic,
acromegalic, or Cushingoid and demonstrated full visual fields. Her thyroid was not
enlarged. There was a diffuse, maculopapular rash confluent on her torso and
abdomen and palpable hepatosplenomegaly. Aside from leukocytosis, admission
laboratory results were also notable for normocytic anemia (hemoglobin, 9.1 g/dL
(reference range, 12 to 15.8 g/dL); mean corpuscular volume, 79.5 fl (reference
range, 79 to 93 fL); red blood cell distribution width, 15.1% (normal, less than
14.5%), with absence of reticulocyte response (1.5%), mild thrombocytopenia
(platelet count was 134 x 103/uL, reference rang 165 to 415 x103/uL), an elevated
international normalized ratio of 1.39 (reference range, 0.86 to 1.16), and a
partial thromboplastin time of 43.4 seconds (reference range, 24.4 to 37.9
seconds). Electrolytes and hepatic function tests were essentially normal with the
exception of mildly reduced total protein 6.5 g/dL (reference range, 6.7 to 8.6
g/dL). Results of a fasting lipid panel were as follows: high-density lipoprotein,
3 mg/dL; low-density lipoprotein, 46 mg/dL; and triglycerides, 118 mg/dL.
Assessment of the hypothalamic-pituitary-adrenal axis demonstrated a robust 8 am
serum cortisol of 22.3 ug/dL (reference range, 5 to 21 ug/dL), normal thyroid
function tests thyrotropin, as 2.43 mlU/L (reference range, 0.32 to 4.05 mlU/L) and
free thyroxine as 1.09 ng/dL (reference range, 0.7 to 1.24 ng/dL), mildly
suppressed gonadotropins for a postmenopausal woman (follicle-stimulating hormone,
10.4 mlU/mL and luteinizing hormone, 6.9 m;U/mL), and a normal prolactin level
(22.5 ng/mL). Two MRIs of the brain with focused imaging of the sella region were
performed at 1.5 Tesia before and after administration of contrast material. The
overall appearance of the brain was unremarkable for a 75-year-old woman with
history of mild hypertension. Specifically, no parenchymal brain mass and no
abnormal parenchymal or meningeal enhance, enhancement affected the cerebrum,
brainstem, or cerebellum. The ventricular size was normal. There was focal
thickening of the pituitary infundibulum extending to its insertion into the
hypothalamus. This finding was most obvious as plaque like contrast enhancement
surrounding the infundibulum. The pituitary gland was of normal size. The posterior
pituitary signal intensity was a bit lower and more heterogeneous than normal. The
pituitary gland enhanced somewhat heterogeneously post contrast administration, but
there was no clear evidence of microadenoma. The sella and the remainder of the
hypothalamus were entirely unremarkable. These findings were similar on both MRI
exams performed. The patient remained febrile despite the escalation of her
antibiotics to treatment with piperacillin and tazobactam. Polydipsia and polyuria
remained well-controlled on DDAVP. Dermatology was consulted and performed a skin
biopsy; the pathologic findings showed histiocyte collections within the epidermis
and papillary dermis that stained positive for CD43. Computed tomography of the
abdomen and pelvis showed hepatosplenomegaly with heterogeneous enhancement
suggestive of an infiltrative process. Her leukocytosis progressively increased to
a WBC count of 93, 800/uL with worsening anemia (hemoglobin, 6.1 g/dL) and
thrombocytopenia (platelet count, 12 x 103/uL) requiring transfusions. Oncology was
consulted and performed a bone marrow biopsy, which revealed a markedly
hypercellular marrow (nearly 100% cellularity) with trilinear hyperplasia. CD68
(PGM1) immunostaining demonstrated florid" "Biopsy bone marrow, significant,
revealed a markedly hypercellular marrow (near 100% cellularity) with trilinear
hyperplasia; biopsy skin, significant, the pathologic findings showed histiocyte
collections within the epidermis and papillary dermis that stained positive for
CD43; blood cortisol, 22,3 g/dL, high; blood follicle stimulating hormone,
decreased low, 44 pg/mL; blood follicle stimulating hormone, decreased, 24.2
mlU/mL; blood luteinising hormone decreased, low, 11.2 mlU/mL; colonoscopy,
significant, three non-bleeding polyps; computerised tomogram, significant,
computed tomography of the abdomen and pelvis showed hepatosplenomegaly with
heterogeneous enhancement suggestive of an infiltrative process; Epstein-Barr virus
antibody positive, positive, IgG antibodies to Epstein-Barr virus (EBV) were also
found at a low titer in our patient (EBV viral capsid antigen, 1:80; EBV early
antigen, 1:20; and Epstein-Barr nuclear antigen, 1:10); haemoglobin, low, 9.1 g/dl;
international normalised ratio, high, 1."
"444038-1" "444038-1" "ER VISIT C/O VOMITING NAUSEA ALSO REPORTING SIMILAR
SYMPTOMS INTERMITTENTLY OVER PAST THREE DAYS-DISCHARGED HOME AFTER UNEVENTFUL ER
WORK UP. RETURNED TO CLINIC FOR FOLLOW UP 11/14 AND REPORT OF INCREASING FATIGUE
AND SIMILAR SYMPTOMS OVER PREVIOUS THREE WEEKS. ADMITTED TO HOSPITAL. RAPID
DETERIORATION AND EMERGENCY XFER BY LIFE FLIGHT TO HIGHER LEVEL OF CARE> MULTIPLE
ORGAN FAILURE > LIFE SUPPORT > SUBSEQUENT DEMISE 11/29 AT OTHER HOSP." "EXTENSIVE
MULTIPLE SYSTEMIC WORKUP / MULTIPLE ORGAN FAILURE: CARDIOMYOPATHY, HEPATO-RENAL
FAILURE."
"444950-1" "444950-1" "Went for well child check 12/2 no issues flu
vaccination given. Next day developed flu like illness with fever 102.3, body
aches lethargy, treated with Tylenol and Motrin, symptoms waxed and waned got
significantly worse Tuesday 12/6/11 with dyspnea. Patient went unresponsive on way
to pediatrician emergent resuscitation and died 12/6/11." "Gross Autopsy negative.
Preliminary cultures negative Pending Microscopic examination"
"445775-1" "445775-1" "Patient received vaccines in office on 12/08/2011.
Patient's mother stated he ran a low-grade fever of 100-101 that evening and was
treated with Tylenol twice. No fever after that. Child passed away on 12/12/2011
of suspected SIDS." "No lab data for this event."
"446207-1" "446207-1" "This is an initial spontaneous report from a
contactable physician communicated to a Pfizer Sales Representative. A 4-year-old
patient (gender unknown) received a dose of PREVENAR on an unknown date for an
unknown indication (site and time of administration were also unknown). Relevant
medical history, concomitant medications, concomitant vaccines or vaccines given
within the last four weeks were unknown. On an unknown date, the patient
experienced invasive pneumococcal sepsis which resulted in death. Relevant
laboratory data was unknown and it was unknown if an autopsy was performed. The
cause of death was reported as invasive pneumococcal sepsis." "No lab data for
this event."
"446208-1" "446208-1" "This is an initial spontaneous report from a
contactable reporter. The reporter reported for a consumer (age, gender and race
unknown) who received a dose of PREVNAR on and unknown date for an unknown
indication. Relevant medical history and relevant concomitant medications were
unknown. The reporter mentioned that the child died on an unknown date due to
pneumococcal disease after taking PREVNAR. Therapeutic measures taken in response
to the events, if any were unknown. Relevant laboratory data was unknown and it was
unknown if an autopsy was performed. The reported cause of death was pneumococcal
infection." "No lab data for this event."
"446332-1" "446332-1" ""Initial report was received on 19 December 2011
from a consumer who is also the patient's parent and additional information was
received from a health care professional. A 43-year-old male patient received an
injection (route and site not reported) of INFLUENZA VACCINE, Sanofi Pasteur Inc.
lot not reported, on 17 November 2011 (also reported as 18 November 2011). The
patient had a medical history of increased blood pressure and ""Dbj"". It was
unknown if the patient had any illnesses at the time of vaccination, or had any
vaccinations within 4 weeks of the influenza vaccine. The patient's concomitant
medications were unknown. It was reported that the patient had no previous
influenza vaccines. The parent stated that the patient was seen by her on 18
November 2011 and he had been sick after receiving the influenza vaccine and was
having a severe headache and could not eat. The patient had called 911 on Sunday
and was taken to a hospital. The patient died on 21 November 2011. The outcome was
reported as fatal. Documents held by sender: None."" "Not reported"
"446850-1" "446850-1" "Infant developed very high fever (sepsis ruled out)
hours after vaccine. Despite maximal medical support, infant died. No explanation
for fever could be found." "All radiographic/laboratory data unable to explain
fever or death"
"447405-1" "447405-1" "This case was reported in a literature article and
described the occurrence of influenza A in a subject of unspecified age and gender
who was vaccinated with FLULAVAL (GlaxoSmithKline). This case corresponds to
patient A in the literature article. The subject's medical history included
aspiration pneumonia and history of abnormalities noted on chest radiography.
Concurrent medical conditions included inability to move, inability to speak,
cerebral palsy, intellectual disability and neurological impairment. Between
October and November 2010, the subject received an unspecified dose of FLULAVAL
(administration site and route unknown) which was incorrectly stored: the vaccine
refrigerator temperature was considerably below optimal temperature during the
investigation. On 19 February 2011, within months of vaccination with FLULAVAL, the
subject experienced fever (38.4 deg.C). His oxygen saturation was 88% on room air.
On illness day 2, the subject developed mild cough and wheezing. On day 3, he
became tachypneic and required increased respiratory suctioning. On day 5, the
subject was hospitalised with fever (38.5 deg.C) and respiratory rate of 24 bpm. On
day 6, he was tested positive for influenza A and developed both acute respiratory
distress syndrome requiring mechanical ventilation and sepsis with hypotension
requiring vasopressor support. On day 7, the chest radiography showed diffuse lung
opacities that progressed to complete opacity of both lungs. The subject was
treated with ciprofloxacin, Piperacillin, Tazobactam, vancomycin, Oseltamivir,
oxygen, mechanical ventilation and vasopressor. The subject died in February 2011
on day 8, the cause of death was not reported. It was unknown whether an autopsy
was performed. Summary of the literature article: Children with neurological and
neurodevelopmental conditions are at increased risk for severe outcomes from
influenza, including death. In April 2011, the state Department of Health and CDC
investigated an influenza outbreak that began in February 2011 in a residential
facility for 130 children and young adults with neurologic and neurodevelopmental
conditions. This report summarizes the characteristics and clinical courses of 13
severely ill residents with suspected or confirmed influenza; 10 were hospitalized,
and seven died. Diagnosis is challenging in this population, and clinicians should
consider influenza in patients with neurologic and neurodevelopmental conditions
who have respiratory illness or a decline in baseline medical status when influenza
is circulating in the community. The findings in this report are subject to at
least two limitations. First, a broad case definition was used to identify
suspected cases, and not all ill residents underwent diagnostic testing; thus,
respiratory pathogens other than influenza might have contributed to this outbreak.
Second, residents of this facility are considerably more medically fragile than
subjects with mild neurologic and neurodevelopmental conditions; therefore, this
report is not generalizable to all patients with neurologic and neurodevelopmental
conditions or all patients in residential-care centers. The authors' conclusion
stated that prompt testing, early and aggressive antiviral treatment, and antiviral
chemoprophylaxis are important for these subjects. When influenza is suspected,
antiviral treatment should be given as soon as possible after symptom onset,
ideally within 48 hours. Treatment should not wait for laboratory confirmation of
influenza. During outbreaks, antiviral chemoprophylaxis should be provided to all
residents of institutional facilities (e.g., nursing homes and long-term care
facilities), regardless of vaccination status. Residential facilities for subjects
with neurologic and neurodevelopmental conditions are encouraged to vaccinated all
eligible residents and staff members against influenza." "Body temperature,
19Feb2011, 38.4deg.C; Chest x-ray, 19Feb2011, lung opacities; Oxygen saturation,
Feb2011, 88%; Respiratory rate, Feb2011, 24bpm"
"447716-1" "447716-1" "Jan 20 2011 5 pm Call from hosp/med ctr. Mother
accompanied infant to ER. Resp difficulty infant had cardiac arrest. Expired.
Infant had been sleeping in parent bed with his father." "No lab data for this
event."
"448347-1" "448347-1" "Received report from hospital that patient had died
from SIDS." "No lab data for this event."
"448515-1" "448515-1" "Information has been received from a pharmacist
concerning a consumer's female friend, who on an unknown date, was vaccinated with
a dose of ZOSTAVAX (Merck) (dose, route and lot number not reported). It was
reported that the patient was diagnosed with an unspecified type of cancer on an
unspecified date shortly after the vaccination with ZOSTAVAX (Merck). It was also
reported that the patient died six months after she was diagnosed with cancer. It
was reported that the cancer was not a congenital anomaly. At the time of the
report, the cause of the patient's death is unknown. Additional information has
been requested." "Unknown"
"448544-1" "448544-1" "UNKNOWN- ADVERSE EVENT ONSET TIME IS UNKNOWN." "No
lab data for this event."
"448750-1" "448750-1" "None stated." "No lab data for this event."
"449283-1" "449283-1" "Patient was found down by significant other and
brought to ER in private vehicle. Enroute patient stopped breathing. On arrival to
ER patient was cold, mottled with no pulse. Code was called. After 30 minutes of
resuscitation, time of death was called." "10/11/2011, Na, 122 mmol/L L; K, 3.7
mmol/L; Cl, 62 mmol/L L; CO2, 20.0 mmol/L L; Glucose, 493 mg/dL H; BUN, 78 mg/dL H;
Creat, 7.3 mg/dL H; AST, 197 U/L H; ALT, 79 U/L H; ALP, 71 U/L; T. Bil, 1.0 mg/dL;
D Bili mg/dL; Alb, 2.5 G/dL L; Calcium, 6.9 mg/dL L; PO4, mg/dl; Mg, 0.9 mEq/L L;
Ani Gap, 40.0 mmol/L H; BUN/Cr, 10.7; Glob, 3.6 G/dL; T Prot, 6.1 G/dL; WBC, 19.3
K/cu mm H; RBC, 4.21 M/cu mm; Hgb, 14.9 g/dL; Hct, 40.8%; MCV, 96.9 fL; MCH, 35.4
pg H; MCHC, 36.5 g/dL, RDW, 14.4%; Plt, 134.0 K/cu mm L; MPV, 14.1 fL H; Lymph,
12.7% L; Mono, 5.9%; Gran, 64.5%; Eos, 0%; Baso, 0%; IM, 1.0%; Ly, 1.67 K/cu mm;
10/04/2011, Na, 134 mmol/L; K, 2.8 mmol/L L; Cl, 98 mmol/L; CO2, 22.2 mmol/L;
Glucose, 93 mg/dL; BUN, 4 mg/dL L; Creat, 0.5 mg/dL; AST, 133 U/L H; ALT, 79 U/L;
ALP, 71 U/L; T. Bil, 0.6 mg/dL; Alb, 3.2 G/dL; Calcium, 8.7 mg/dL; Ani Gap, 14.0
mmol/L; BUN/Cr, 7.5 L; Glob, 3.3 G/dL; T Prot, 6.5 G/dL; WBC, 8.0 K/cu mm; RBC,
3.61 M/cu mm L; Hgb, 12.7 g/dL; Hct, 38.0%; MCV, 105.3 fL H; MCH, 35.2 pg H; MCHC,
33.4 g/dL"
"449334-1" "449334-1" "Information has been received from a physician
concerning a 19 year old female who on an unspecified date was vaccinated with a
dose of GARDASIL (lot # not reported, dose number unknown). Approximately a year
and a half prior to developing the onset of rapidly progressive ALS (amyotrophic
lateral sclerosis). It was unknown if the patient was on any medications or had
concomitant vaccinations. Patient died within a year of symptom onset. Patient was
found to be positive for a genetic mutation (FUS) recently recognized as associated
with early-onset, rapidly progressive ALS. Her parents also had the mutation. It
was not reported if the patient had sought medical attention. This is one of
several reports received from the same source. Additional information has been
requested." "diagnostic laboratory, genetic mutation (FUS): positive"
"449429-1" "449429-1" "Within hours of vaccination (night of vaccination
day) infant became febrile. At approximately 2:00AM on 1/26/2012, he was taken to
hospital because of breathing difficulty. Infant was resuscitated at hospital but
expired on 1/27/2012." "Blood & urine cultures positive for both, hemolytic
Streptococcus. Preliminary autopsy report -> polymorphonuclear leukocyte
infiltration of lungs and other organs."
"449546-1" "449546-1" "Baby found dead by mother." "Autopsy results
pending"
"449871-1" "449871-1" "Case number PHHY2012US012947 is an initial
literature report received on 14 Feb 2012. The authors published the adverse events
following administration of H1N1 to pregnant women that were reported to Vaccine
Adverse Event Reporting System (VAERS). This case refers to a female patient (age
not specified). She was vaccinated with H1N1 (manufacturer and batch number:
unknown) between 01 Oct 2009 to 28 Feb 2010. She was pregnant at the time of
vaccination. On an unspecified date she had a cesarean section and she gave birth
to a live neonate. Following caesarean the patient experienced uterine atony which
led to hemorrhagic shock. The patient died due to hemorrhagic shock. The causality
of the case was not reported. The authors stated that the VAERS database search did
not reveal any clustering of spontaneous abortions, still births or congenital
anomalies. Authors concluded that the pregnant women who were vaccinated with H1N1
inactivated and live vaccines did not show unusual pattern of maternal or fetal
outcomes." "No lab data for this event."
"450086-1" "450086-1" "PATIENT PRESENTED WITH VOMITING AND DIARRHEA ON 8
FEB. AAS SHOWED PULM INFILTRATE. PT STARTED ON PO ABX. PT STARTED FEELING FEVERISH
ON THE EVENING OF 8 FEB. 9 FEB WOKE UP FEELING LIGHTHEADED AND DIZZY. TAKEN BY
AMBULANCE TO ED, WHERE SHE SUFFERED RESP ARREST. CODED 3 TIMES. ADMITTED TO ICU
ON VENT. DEVELOPED MULTI-ORGAN SYSTEM FAILURE. DIED ON 10 FEB." "SHE HAD A
POSITIVE RPR. ALL OF THE FOLLOWING WERE NEGATIVE: RESP - FLU A/B, H1N1, RSV, M
PNEUMONIA, SPUTUM CX; BLOOD - CX, MHA-TP, COLD AGGLUTININS; CSF - BACT AND VIRAL
CX, GRP B STREP, STREP PNEUMO, HIB, NEISSERIA MEN A/C/Y/W135, NEISSERIA MEN B/E
COLI K1-0 AGS; URINE - CX, LEGIONELLA AG, DRUG SCREEN"
"450410-1" "450410-1" "Information has been received from a pharmacist
concerning an unspecified patient who on an unspecified date was vaccinated with a
dose of ZOSTAVAX (Merck) (lot #, batch # and route not reported) for prevention of
shingles. The pharmacist stated that she heard from an unspecified pharmacist who
stated that he heard from another unspecified person that the patient died after
receiving ZOSTAVAX (Merck). Attempts are being made to verify the existence of an
identifiable patient. No further information is available.""Unknown"
"450453-1" "450453-1" "Patient found unresponsive by babysitter. EMS called
to scene. Patient transported to ER at Medical Center. Time of death noted to be
20:48 on 2/8/12 by ER." "No lab data for this event."
"450655-1" "450655-1" "None at time of service. Pt. expired 2-26-12." "No
lab data for this event."
"450832-1" "450832-1" "Patient started feeling flu-like symptoms (nausea,
diarrhea, extreme exhaustion) on 10/14/11 that lasted 2-3 days. Patient later
passed away while playing Squash/handball on 10/19/11." "Autopsy performed that
concluded pt had myocarditis in Rt ventricle/AV node."
"451286-1" "451286-1" "Patient received her 4 month vaccines (PENTACEL -
(DTaP-Hib-IPV), PREVNAR 13 (pneumococcal 13 Conj) and Rotavirus oral vaccine) on
1/12/12 around 12 noon. On 1/13/12 at 1022 our office received a call from Dad
stating patient stopped breathing at daycare, 911 called. At 1652 on 1/13/12 the
coroner called to report her death." "None"
"451373-1" "451373-1" "Unexplained crib death 7d after MMR + VARIVAX."
"Autopsy pending"
"451473-1" "451473-1" ""Information has been received from a Doctor of
microbiology and a licensed practical nurse (LPN) concerning a 45 year old female
with end stage renal disease (ESRD), lupus, a history of renal transplant that was
failing so patient was being considered for another one; who on an unspecified
date, may have been vaccinated or exposed to someone who was vaccinated with a dose
of VARIVAX (Merck) (manufacturer unknown) (lot number, dose and route not
reported). The LPN reported that after much investigation it could not be
determined if the patient had ever received a VARIVAX (Merck) (manufacturer
unknown) or if she was exposed to chicken pox, and stated that the office would not
have authorized or administered a live vaccine to a immunosuppressed patient. The
Doctor of Microbiology reported that on 10-FEB-2012, the patient was admitted to
the hospital with a diagnosis of cholecystitis. On 11-FEB-2012 a cholecystectomy
was performed. On 15-FEB-2012, rash and skin lesions appeared. On an unspecified
date, strain identification for samples was found to be varicella zoster virus
(VZV) positive in the lab. The patient experienced respiratory failure on 19-FEB-
2012 and died at 11:28 hours. The doctor of microbiology reported that there was
""disseminated varicella"" at time of death. The cause of death was respiratory
failure secondary to herpes zoster viremia. It was unknown if an autopsy was
performed (death certificate showed No for autopsy). Additional information has
been requested."" "Cholecystectomy, 02/11/12; Serum varicella zoster, VZV positive"
"451752-1" "451752-1" "Admitted 12/16/10 for cough x 3 days, and SOB. Found
to be in CHF. Hospitalized for approximately 8 days and released to hospice.
Patient expired 12/26/10. Patient had ZOSTAVAX 10 days prior to admission." "No
lab data for this event."
"452127-1" "452127-1" "Patient passed away the day after his well exam.
Vaccines were not indicated as a reason for death." "No lab data for this event."
"452383-1" "452383-1" "DEATH." "No lab data for this event."
"452453-1" "452453-1" "Baby died at home DOA at hosp." "None"
"453010-1" "453010-1" "Undetermined cause death occurred nine days after
2nd injection of Gardasil. 1st dose on 01/31/2012." "No lab data for this event."
"453048-1" "453048-1" "Information has been received from a physician,
author of a literature article, title as stated above, concerning a 13 year old
male patient who on an unspecified date, was vaccinated with a dose of MMR II
(dose, route and lot number not reported). Measles inclusion body encephalitis
(MIRE) was a disease of the immunocompromised host and typically occurred within 1
year of acute measles infection or vaccination. In addition to acute encephalitis
and subacute sclerosis panencephalitis in immunocompetent hosts, measles virus
could cause measles inclusion body encephalitis (MIBE) in immunocompromised hosts.
MIBE presented typically with focal and intractable seizures within 1 year of
initial measles infection. The mortality rate was high, and no effective treatment
existed. The patient was a 13-year-old boy who received a diagnosis of X-linked
chronic granulomatous disease (CGD) at 2 years of age after serratia lymphadenitis.
The patient traveled frequently to urban, most recently 4 years before this
illness. He received 1 documented MMR at one year of age, and had no history of a
measles-like illness or measles exposure at any time. A second MMR was not
documented. Despite prophylactic therapy for CGD with trimethoprim-sulfamethoxazole
and thrice-weekly y-interferon, he had multiple staphylococcal liver abscesses that
required extensive surgical drainage. Poor compliance with interferon was
documented. Because of the severity of his repeated infections, SCT was performed.
The conditioning regimen comprised fludarabine (180 mg/m2), busulfan (6.4 mg/kg),
and equine anti-thymocyte globulin (ATG). Because of fever and chills after equine
ATG, he received rabbit ATC for the last 3 days. On day -1, he began graft-verus-
host disease (GVHO) prophylaxis with cyclosporine (CsA) and on day 0 with
mycophenolate mofetil. He received anti-infective prophylaxis with oral acyclovir,
itraconazole, intravenous vancomycin, and weekly CMV-immune globulin. On SCT day
+10, he was admitted for fever and neutropenia and treated with broad-spectrum
antibiotics. On day +11, a pruritic, erythematous rash developed, and his CsA dose
was increased to treat presumed GVHD. Rash and low-grade fever persisted, and
conjunctivitis and photophobia developed. Skin biopsy was consistent with GVHD;
oral steroids were started with improvement in the rash. By day +19, he had
engrafted with 99% donor chimerism by variable N-terminal repeats. On day +23, he
presented with fever, headache, and eye pain. Head computed tomography scan and
ophthalmologic examination were normal. Lumbar puncture showed 13 white blood cells
(WBCs; 30% neutrophils, 52% lymphocytes, and 18% monocytes), glucose of 50 mg/dL,
and protein of 34 mg/dL. Bacterial fungal and viral cultures were negative;
cryptococcal antigen was negative. His symptoms improved, and he was discharged on
day +27. By day +33, he had worsening erythematous rash on his face, arms, and
trunk, and corticosteroids were increased to treat GVHD. On day +38, he was
admitted to Hospital with afebrile focal seizures involving his left hand.
Immunosuppressive medications on admission included CsA, mycophenolate mofetil, and
prednisone. CsA was stopped and tacrolimus was started for possible CsA-induced
seizures. The seizures progressed to involve his chin and tongue despite
anticonvulsant therapy with clonazepam and valproic acid. Electroencephalogram
showed focal status epilepticus (epilepsia partialis continua) involving the right
frontal cortex. No neurologic abnormalities were noted on brain magnetic resonance
imaging (MRI). He was transferred to the intensive care unit, where a continuous
infusion of midazolam followed by a phenobarbital coma were unsuccessful in
completely controlling seizures. Subclinical seizures persisted despite
phenobarbital levels >300 ug/mL. Lumbar puncture on day +43 was significant for
glucose of 43 mg/dL, protein of 77 mg/dL, 51 WBCs/mm3 (88% lymphocytes, 8%
monocytes, and 4% neutrophils), and 8 red blood cells/mm3. A repeat lumbar puncture
on day +49 showed less inflammation, with glucose 59 mg/dL, protein 54 mg/dL, 9
WBCs/mm3, and 294 red blood cells/mm3. Spinal fluid cultures for bacteria, fungi,
mycobacteria, and viruses were negative. Cryptococcal antigen was negative.
Polymerase chain reaction (PCR) for herpes simplex virus (HSV) -1 and 2, human
herpesvirus-6, enterovirus, Epstein-Barr virus, and arboviruses were negative. CMV
antigenemia was negative. No antibodies to measles, mumps, varicella, adenovirus,
HSV-1/2, or lymphocytic choriomeningitis virus were detected in the spinal fluid.
Brain MRI on day +45 showed bilateral patchy areas of cortical swelling and signal
abnormality, predominantly involving the frontal and temporal lobes, compatible
with meningoencephalitis. A right frontal lobe lesion showed restricted diffusion.
In retrospect, the initial MRI showed a small focus of signal abnormality in the
right frontal cortex. Subsequent brain MRIs on day +49 and day +55 showed
progressive involvement of the cerebral cortex and the basal ganglia. Treatment
dose intravenous acyclovir was started on day +44 and was changed to intravenous
gancyclovir on day +47. Brain biopsy on day +53 demonstrated numerous eosinophilic
intranuclear inclusion bodies and minimal perivascular inflammatory reaction.
Inclusions of varied sizes were seen in astrocytes, oligodendroglial cells, and
neurons. Electron microscopic examination showed that the inclusions were clusters
of relatively long, curved, tubular structures consistent with paramyxovirus
nucleocapsids. Extensive demyelination of axons was seen. Immunohistochemistry for
HSV-1/2, CMV, human immunodeficiency virus, adenovirus, and Epstein-Barr virus was
negative. Measles studies of the brain tissue performed at the Centers for Disease
Control and Prevention were positive by reverse transcriptase (RT)- PCR for wild-
type measles virus, genotype D3, and by immunohistochemistry for measles
nucleoprotein. Measles virus was isolated using the B95a marmoset lymphoblastoid
cell line, and genotype D3 was confirmed by nucleotide sequence analysis of RT-PCR
products. In addition, repeat skin biopsy on day +61 was consistent with GVHD.
After demonstration of intranuclear inclusion bodies, intravenous ribavirin was
initiated on day +57 (loading dose of 30 mg/kg, then 15 mg/kg every 6 hours for 16
doses, and then 7.5 mg/kg every 8 hours). Despite ribavirin and intensive
supportive therapy, the patient's neurologic status continued to deteriorate, and
brain death was determined on day +70. Ribavirin was discontinued. Life support was
stopped with the family's agreement on day +92, and the patient died. No postmortem
study was permitted. Immunohistochemistry and RT-PCR of the initial skin biopsy
(day +15) were negative for measles virus. RT-PCR performed on the donor stem cells
was negative for measles virus. MIBE occurred typically in immunocompromised
patients within 1 year of measles infection. Patients usu" "Electroencephalography,
Showed focal status epilepticus (epilepsia partialis continua) involving the right
frontal cortex; magnetic resonance, No neurologic abnormalities were noted on
brain; spinal tap, on day +43 was significant for glucose 43 mg/dL, protein 77
mg/dL, 51 WBCs/mm3 (88% lymphocytes, 8%; magnetic resonance, Brain MRI on day +45
showed bilateral patchy areas of cortical swelling and signal abnormality;
diagnostic laboratory, Measles studies of the brain tissue were positive by reverse
transcriptase-PCR for wild-type measle; brain biopsy, on day +53 demonstrated
numerous eosinophilic intranuclear inclusion bodies and minimal perivascular;
spinal tap, on day +49 showed less inflammation, with glucose 59 mg/dL, protein 54
mg/dL, 9 WBCs/mm3, and 294 re; cerebrospinal fluid, for bacteria, fungi,
mycobacteria, and viruses were negative. Cryptococcal antigen was negative;
enterovirus PCR, Negative; Epstein-Barr virus PCR, Negative; serum Herpes virus Ab,
Polymerase chain reaction was negative; serum H"
"453774-1" "453774-1" "Pt. received vaccines (MMR & Varicella) on 3/6/12.
On 3/25/12 was found dead in crib (still waiting for autopsy results)." "None"
"453833-1" "453833-1" "Information has been received from an office manager
(Bachelor of Science) from a physician's office concerning a 56 year old male
patient with hypertension, high cholesterol, metabolic syndrome, vitamin d
deficiency and impaired fasting glucose who on 25-JUL-2011 was vaccinated with a
dose of ZOSTAVAX (Merck), 0.65 mL, subcutaneous (lot # 670613/0657AA). It was
reported that the patient died on 26-JUL-2011 after receiving the ZOSTAVAX (Merck).
The office manager stated that on 25-JUL-2011, the patient received ZOSTAVAX
(Merck) and flew out of town and was found dead in a department store on 26-JUL-
2011. The reporter indicated that on 10-APR-2012, the patient's wife went to the
physician's office and showed them the death certificate. The cause of death was
unknown. The reporter considered the event to be disabling and immediately life-
threatening. A lot check has been initiated. Additional information has been
requested." "Unknown"
"453867-1" "453867-1" "Hx - child in NICU r/t drug withdrawal." "None"
"453949-1" "453949-1" "Information has been received from a published
article. Abstract: Introduction: Invasive Streptococcus pneumoniae disease (IPD)
carries a high risk of death, approximately 15% to 20% in pneumonia, 40% in
meningitis and 10% to 15% in septicemia. The occurrence of 2 or more IPD
(recurrent) in the same individual is uncommon. The authors investigated the
clinical features of patients with recurrent IPD to assess whether they possessed
risk factors that increased their likelihood of recurrent IPD. Methods: Between
1983 and 2010, the authors identified 27 patients with recurrent IPD during
inpatient surveillance of 889 patients with IPD in their city, by recovery of
pneumococci from otherwise sterile sites. Serotype/serogroup (ST/SG) was determined
by capsular swelling and the penicillin MIC by E-strip. Clinical data were
abstracted from hospital charts. Results: Sixteen (59%) of 27 patients were 65
years and older at first IPD, males predominated (67%), two-thirds had pneumonia
and 21 (78%) had the same clinical diagnosis at both IPD. Four (80%) of 5 patients
with the same ST experienced their second IPD 1 to 6 months apart, unlike most
patients with discordant ST/SGs (P = 0.047). Eighty-four percent of ST/SGs were
included in the PNEUMOVAX 23 and occurred as often during the first and second IPD.
Twenty (77%) of 26 adults suffered from comorbid diseases placing them at high risk
of IPD, including multiple myeloma, HIV/AIDS, neoplasia of hematological origin and
sickle cell disease. Conclusions: Recurrent IPD occurred uncommonly. Comorbid
conditions including multiple myeloma and immunosuppressive/immunodeficient
conditions, chronic alcoholism and splenectomy represented unique risk factors for
recurrent IPD but did not predict recurrences. Results: Continuous surveillance of
IPD among inpatients residing in the city, and environs from 1983 to 2010
identified 989 individuals with IPD, 813 adults and 176 children, and recurrent IPD
was detected in 26 adults (a total of 28 episodes) and 1 child, for recurrence
rates of 3.4% and 0.6%, respectively. Sixteen (61.5%) of 26 adults were 65 years or
older when they had their first IPD. Males accounted for 18 (66.7%) of the
patients. All 5 adults who died during their second IPD were 65 years or older when
they experienced their first IPD. However, the case fatality rate (CFR) of the age
group 65 years and older was not significantly different from the nil CFR of the
age group 30 to 64 years (P =0.12), likely due to the small Ns. Three females
(33.3%) and 2 males (13.3%) died, also not a significant difference (P=0.29). Of
the 5 patients who died, 3 had pneumonia at their second IPD, 1 had septicemia and
1 had meningitis, the second of 2 meningitis illnesses. Only 5 (19.2%) of 26 adults
received PPV23 before their second IPD and none of them died. Three of these
vaccinated adults suffered from multiple myeloma. The other adult with multiple
myeloma did not receive PPV23. Three adults received PPV23 during or after their
second IPD. No data were available on vaccine administration for the other 18
adults including 1 male with multiple myeloma. Although, no data were available on
vaccine administration for the only child with recurrent IPD, he was born after
routine immunization of infants and children with PCV7 was initiated and was aged 1
year at the first IPD and it seemed likely that he had received at least 1 dose of
PCV7. The time interval between consecutive episodes of IPD varied from 1 month to
15 years. Of 10 consecutive episodes that occurred 1 to 12 months apart, the second
IPD of 4 (80%) of 5 with the same ST/SG and 6 (28.6%) of 21 with different ST/SG
occurred within 12 months of the first IPD (P =0.055). Three patients did not have
the isolate from their second IPD available for serotyping. The occurrence of 3
consecutive IPD with the same ST/SG each more than 1 month apart suggests that
these recurrent IPD were reinfections, as opposed to relapses. Twenty-two (75.9%)
of 29 consecutive episodes of IPD showed the same diagnosis each episode. Recurrent
pneumonia/pneumonia episodes accounted for slightly more than one-half of
consecutive episodes and occurred across the spectrum of time intervals from 1
month to 15 years apart. By comparison, the few recurrent septicemia/septicemia
episodes occurred 1 to 12 months apart and the 2 meningitis/meningitis episodes
occurred 7 or more years apart. Overall, 45 (84.9%) of 53 ST/SGs recovered from
patients with recurrent IPD were included in PPV23, with about the same proportion
of vaccine ST/SGs in the first, second and third episodes, namely 85.2%, 83.3% and
100%, respectively (P=1.00). Only 5 ST/SGs not included in PPV23 were recovered,
totaling 8 isolates. Of the 50 isolates tested for penicillin susceptibility during
all recurrent IPD, 9 (18.0%) were intermediate, including 2 from non-PPV23 ST/SGs,
and 5 (10.0%) were resistant to penicillin. Three (33.3%) of 9 patients with
intermediate or resistant ST/SGs died during their second or third IPD compared
with 2 (11.8%) deaths among the 17 patients with penicillin-susceptible ST/SGs (P
=0.30). Immunosuppressive/immunodeficient comorbid diseases occurred in 21 (80.8%)
of 26 adults, 10 (100%) of 10 adults in the 30 to 64 year age group and 11 (68.8%)
of 16 adults in the 65 years and older age group (P =0.12). Four patients had
multiple myeloma, 6 had solid cancers, 5 had lymphoma/leukemia, 1 had HIV, 4 had
chronic renal disease and 5 had chronic alcoholism. Eight (80%) of 10 adults in the
30 to 64 years age group and 9 (56.3%) of 16 adults in the 65 years and older age
group had only 1 immunosuppressive/immunodeficient comorbid disease. Additionally,
only 2 adults had a splenectomy before their first IPD. One adult in the 30 to 64
years age group sustained a gunshot wound to the head before his first of 2
meningitis illnesses, about 8 years apart, and he survived. Of the 5 patients who
died, 3 had comorbid diseases that increased their risk of IPD, including 1 patient
had alcoholism and chronic obstructive pulmonary disease (COPD); 1 patient had
chronic renal failure, colon cancer, arteriosclerotic heart disease, COPD and
hypertension and 1 patient had colon cancer. Nineteen (73.0%) of 26 adults had
arteriosclerotic heart disease or COPD or hypertension, 14 (87.5%) of 16 adults in
the 65 years and older age group and 5 (50.0%) of 10 adults in the 30 to 64 years
old age group. Eight (50%) of 16 adults in the age group 65 years and older had 2
or all 3 of these comorbid diseases, as might be expected among a group of elderly
adults. This report concerns a female patient among the three adults who received
PNEUMOVAX 23 during or after their second IPD. The female patient was one of the 5
adults who died during their second IPD. She had experienced her first IPD when she
was 65 years or older. The reporter commented as follows: Five patients with 6
episodes of IPD in our study each of whom had been immunized with PPV23 before
their se" "No lab data for this event."
"454143-1" "454143-1" ""Information has been received from a registered
pharmacist concerning a 69 year old female patient with sulfa and amoxicillin
allergies who on 26-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose
and route not provided) (lot # 671144/1269AA, expiration date 05-NOV-2012). The
pharmacist informed that the patient died approximately on 02-APR-2012 ""around 1
week after receiving the ZOSTAVAX (Merck)"". The pharmacist indicated that no
adverse reaction was reported or any physical symptoms other than the death and
that the patient did not seek medical attention. The cause of death was not
provided. A lot check has been initiated. Additional information is not expected.""
"Unknown"
"454298-1" "454298-1" "Child was found dead on the morning of 04/14/2012."
"An autopsy is being performed."
"454494-1" "454494-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, pre-existing conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused out analyses on those patients from who S. aureus was isolated from a
specimen collected within three days of hospital admission. as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical
age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were
recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known
vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended
children received at least one dose of influenza vaccine in the 2007-2008 season at
least 14 days prior to illness onset. Of these 11 children, six were completely
vaccinated, one was partially vaccinated, and complete vaccination status could not
be determined in four. One child who received the vaccine in the 2007-2008 season
did not meet an age-related or ACIP-defined high-risk criteria for vaccination.
This case (2 0f 6) refers to 6 of 11 children who were completely vaccinated. S.
aureus continues to be the most common bacteria isolated from children with
influenza-associated mortality. S. aureus isolated were associated with older age
and lack of high-risk medical conditions. Healthcare providers should consider
influenza co-infections with S. aureus when empirically treating children with
influenza and severe respiratory illness." "No lab data for this event."
"454497-1" "454497-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, preexisting conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused our analyses on those patients from whom S. aureus was isolated from a
specimen collected within three days of hospital admission, as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC. Of the 88 children, 47 (53%) were boys and the median
age at death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age. Fifty-six (66%) of 85 children were recommended for
vaccination by 2007-2008 ACIP criteria, and of these 48 had a known vaccination
status for the 2007-2008 influenza season. Eleven (23%) of 48 recommended children
received at least one dose of influenza vaccine in the 2007-2008 season at least 14
days prior to illness onset. Of these 11 children, six were completely vaccinated,
one was partially vaccinated, and complete vaccination status could not be
determined in four. One child who received the vaccine in the 2007-2008 season did
not meet an age-related or ACIP-defined high-risk criteria for vaccination. This
case (1 of 6) relates to 6 of 11 children who were completely vaccinated. Authors
comment: S. aureus continues to be the most common bacteria isolated from children
with influenza-associated mortality. S. aureus isolates were associated with older
age and lack of high-risk medical conditions. Healthcare providers should consider
influenza co-infections with S. aureus when empirically treating children with
influenza and severe respiratory illness." "No lab data for this event."
"454503-1" "454503-1" "This literature report concerns a series of 10
fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7
adults and 1 elderly reported. This case (4 of 10) concerns a 38-year-old male
patient, who had a medical history of immunodeficiency. The patient died of
respiratory failure (under review), nineteen days after H1N1 vaccination (type:
monovalent inactivated, split-virus or subunit vaccine; manufacture: unknown).
Reporters comment: VAERS (Vaccine Adverse Event Reporting System) received 13
reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after
receipt of LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV
(monovalent inactivated, split-virus or subunit vaccines). In 9 of these deaths,
significant underlying illness (including illness that might be indication for
vaccination) was present; 1 death resulted from a motor vehicle crash, and the
remaining 3 deaths await review of final autopsy results or death certificates by
CDC (Centers for Disease Control)." "No lab data for this event."
"454522-1" "454522-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, preexisting conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
from all patients from whom S. aureus was isolated from one of the designated
sites. We focused our analyses on those patients from whom S. aureus was isolated
from a specimen collected within three days of hospital admission, as we were
attempting to identify patients in whom a bacterial co-infection may have
contributed to their severe presentation (as opposed to having been acquired during
hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-
associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were
boys and the median age at death was 5. Forty-two (47%) of the children were <5
years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of
85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of
these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven
(23%) of 48 recommended children received as least one dose of influenza vaccine in
the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children,
six were completely vaccinated, one was partially vaccinated, and complete
vaccination status could not be determined in four. One child who received the
vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-
risk criteria for vaccination. This case (case 1 of 4) relates to 4 of 11 children
whose vaccination status could not be determined, but they received at least one
dose of vaccine. Authors comment: S. aureus continues to be the most common
bacteria isolated from children with influenza-associated mortality. S. aureus
isolates were associated with older age and lack of high-risk medical conditions.
Healthcare providers should consider influenza co-infections with S. aureus when
empirically treating children with influenza and severe respiratory illness."
"No lab data for this event."
"454523-1" "454523-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, pre-existing conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused out analyses on those patients from who S. aureus was isolated from a
specimen collected within three days of hospital admission. as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical
age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were
recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known
vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended
children received at least one dose of influenza vaccine in the 2007-2008 season at
least 14 days prior to illness onset. Of these 11 children, six were completely
vaccinated, one was partially vaccinated, and complete vaccination status could not
be determined in four. One child who received the vaccine in the 2007-2008 season
did not meet an age-related or ACIP-defined high-risk criteria for vaccination.
This case (5 of 6) relates to 6 of 11 children who were completely vaccinated. S.
aureus continues to be the most common bacteria isolated from children with
influenza-associated mortality. S. aureus isolated were associated with older age
and lack of high-risk medical conditions. Healthcare providers should consider
influenza co-infections with S. aureus when empirically treating children with
influenza and severe respiratory illness." "No lab data for this event."
"454525-1" "454525-1" "This literature report concerns a series of 10 cases
of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults
and 1 elderly reported. This case (3 of 10) concerns a 19-year-old female patient,
who had a medical history of Rett syndrome and severe muscle wasting/physical
disability. The patient died of Bilateral pneumonia and respiratory failure, nine
days after H1N1 vaccination (type: monovalent inactivated, split-virus or subunit
vaccine; manufacture: unknown). Reporters comment: VAERS (Vaccine Adverse Event
Reporting System) received 13 reports of deaths occurring after receipt of H1N1
vaccine; 3 deaths occurred after receipt of LAMV (live, attenuated monovalent
vaccine) and 10 after receipt of MIV (monovalent inactivated, split-virus or
subunit vaccines). In 9 of these deaths, significant underlying illness (including
illness that might be indication for vaccination) was present; 1 death resulted
from a motor vehicle crash, and the remaining 3 deaths await review of final
autopsy results or death certificates by CDC (Centers for Disease Control)." "No
lab data for this event."
"454526-1" "454526-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, pre-existing conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused out analyses on those patients from who S. aureus was isolated from a
specimen collected within three days of hospital admission. as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC of the 88 children, 47 (53%) were boys and the medical
age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age (Figure 1). Fifty-six (66% of 85 children were
recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known
vaccination status for the 2007-2008 influenza season. Eleven (23%) recommended
children received at least one dose of influenza vaccine in the 2007-2008 season at
least 14 days prior to illness onset. Of these 11 children, six were completely
vaccinated, one was partially vaccinated, and complete vaccination status could not
be determined in four. One child who received the vaccine in the 2007-2008 season
did not meet an age-related or ACIP-defined high-risk criteria for vaccination.
This case (4 of 4) relates to 4 of 11 children whose vaccination status could not
be determined, but they received at least one dose of vaccine. S. aureus continues
to be the most common bacteria isolated from children with influenza-associated
mortality. S. aureus isolated were associated with older age and lack of high-risk
medical conditions. Healthcare providers should consider influenza co-infections
with S. aureus when empirically treating children with influenza and severe
respiratory illness." "No lab data for this event."
"454529-1" "454529-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, pre-existing conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused out analyses on those patients from who S. aureus was isolated from a
specimen collected within three days of hospital admission. as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median
age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were
recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known
vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48
recommended children received at least one dose of influenza vaccine in the 2007-
2008 season at least 14 days prior to illness onset. Of these 11 children, six were
completely vaccinated, one was partially vaccinated, and complete vaccination
status could not be determined in four. One child who received the vaccine in the
2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for
vaccination. This case (2 0f 4) relates to 4 of 11 children whose vaccination
status could not be determined, but they received at least one dose of vaccine. S.
aureus continues to be the most common bacteria isolated from children with
influenza-associated mortality. S. aureus isolated were associated with older age
and lack of high-risk medical conditions. Healthcare providers should consider
influenza co-infections with S. aureus when empirically treating children with
influenza and severe respiratory illness." "No lab data for this event."
"454530-1" "454530-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, pre-existing conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused out analyses on those patients from who S. aureus was isolated from a
specimen collected within three days of hospital admission. as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median
age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were
recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known
vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48
recommended children received at least one dose of influenza vaccine in the 2007-
2008 season at least 14 days prior to illness onset. Of these 11 children, six were
completely vaccinated, one was partially vaccinated, and complete vaccination
status could not be determined in four. One child who received the vaccine in the
2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for
vaccination. This case (4 0f 6) relates to 6 of 11 children who were completely
vaccinated. S. aureus continues to be the most common bacteria isolated from
children with influenza-associated mortality. S. aureus isolated were associated
with older age and lack of high-risk medical conditions. Healthcare providers
should consider influenza co-infections with S. aureus when empirically treating
children with influenza and severe respiratory illness." "No lab data for this
event."
"454531-1" "454531-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, preexisting conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
from all patients from whom S. aureus was isolated from one of the designated
sites. We focused our analyses on those patients from whom S. aureus was isolated
from a specimen collected within three days of hospital admission, as we were
attempting to identify patients in whom a bacterial co-infection may have
contributed to their severe presentation (as opposed to having been acquired during
hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-
associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were
boys and the median age at death was 5. Forty-two (47%) of the children were <5
years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of
85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of
these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven
(23%) of 48 recommended children received at least one dose of influenza vaccine in
the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children,
six were completely vaccinated, one was partially vaccinated, and complete
vaccination status could not be determined in four. One child who received the
vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-
risk criteria for vaccination. This case (case 6 of 6) related to 6 to 11 children
who were completely vaccinated. Authors comment: S. aureus continues to be the most
common bacteria isolated from children with influenza-associated mortality. S.
aureus isolates were associated with older age and lack of high-risk medical
conditions. Healthcare providers should consider influenza co-infections with S.
aureus when empirically treating children with influenza and severe respiratory
illness." "No lab data for this event."
"454532-1" "454532-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates were performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, pre-existing conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
for all patients from whom S. aureus was isolated from one of the designated sites.
We focused out analyses on those patients from who S. aureus was isolated from a
specimen collected within three days of hospital admission. as we were attempting
to identify patients in whom a bacterial co-infection may have contributed to their
severe presentation (as opposed to having been acquired during hospitalization).
During the 2007-2008 influenza season, a total of 88 influenza-associated pediatric
deaths were reported to CDC of the 88 children, 47 (53%) were boys and the median
age of death was 5. Forty-two (47%) of the children were <5 years of age, and 14
(16%) were <1 year of age (Figure 1). Fifty-six (66%) of 85 children were
recommended for vaccination by 2007-2008 ACIP criteria, and of these 48 had a known
vaccination status for the 2007-2008 influenza season. Eleven (23%) of 48
recommended children received at least one dose of influenza vaccine in the 2007-
2008 season at least 14 days prior to illness onset. Of these 11 children, six were
completely vaccinated, one was partially vaccinated, and complete vaccination
status could not be determined in four. One child who received the vaccine in the
2007-2008 season did not meet an age-related or ACIP-defined high-risk criteria for
vaccination. This case relates to 1 of 11 children who was partially vaccinated. S.
aureus continues to be the most common bacteria isolated from children with
influenza-associated mortality. S. aureus isolated were associated with older age
and lack of high-risk medical conditions. Healthcare providers should consider
influenza co-infections with S. aureus when empirically treating children with
influenza and severe respiratory illness." "No lab data for this event."
"454533-1" "454533-1" "This literature report concerns a series of 10
fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7
adults and 1 elderly reported. This case (5 of 10) concerns a 46-year-old female
patient, who had a medical history of hypertension, hyperlipidemia, pulmonary
embolism and deep vein thrombosis. The patient died of pulmonary embolus (negative
for H1N1 in lung tissue) two days after H1N1 vaccination (type: monovalent
inactivated, split-virus or subunit vaccine;manufacturer: unknown). VAERS (Vaccine
Adverse Event Reporting System) received 13 reports of deaths occurring after
receipts of H1N1 vaccine: 3 deaths occurred after receipt of LAMV (live, attenuated
monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated, split-
virus or subunit vaccines). In 9 of these deaths, significant underlying illness
(including illness that might be indication for vaccination) was present; 1 death
resulted from a motor vehicle crash, and the remaining 3 deaths await review of
final autopsy results or death certificates by CDC (Centers for Disease Control)."
"No lab data for this event."
"454534-1" "454534-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, preexisting conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
from all patients from whom S. aureus was isolated from one of the designated
sites. We focused our analyses on those patients from whom S. aureus was isolated
from a specimen collected within three days of hospital admission, as we were
attempting to identify patients in whom a bacterial co-infection may have
contributed to their severe presentation (as opposed to having been acquired during
hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-
associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were
boys and the median age at death was 5. Forty-two (47%) of the children were <5
years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of
85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of
these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven
(23%) of 48 recommended children received at least one dose of influenza vaccine in
the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children,
six were completely vaccinated, one was partially vaccinated, and complete
vaccination status could not be determined in four. One child who received the
vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-
risk criteria for vaccination. This case (case 3 of 4) relates to 4 of 11 children
whose vaccination status could not be determined, but they received at least one
dose of vaccine. Authors comment: S. aureus continues to be the most common
bacteria isolated from children with influenza-associated mortality. S. aureus
isolates were associated with older age and lack of high-risk medical conditions.
Healthcare providers should consider influenza co-infections with S. aureus when
empirically treating children with influenza and severe respiratory illness."
"No lab data for this event."
"454537-1" "454537-1" "This literature report concerns a series of 10
fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7
adults and 1 elderly. This case (9 of 10) concerns a 61-year-old male patient, who
had a medical history of hypertension, diabetes, peripheral vascular disease and
end stage renal disease. The patient died of cardiac / respiratory arrest and gram-
negative sepsis, 13 days after H1N1 vaccination (type: monovalent, inactivated,
split-virus or subunit vaccine; manufacture: unknown). Reporters comments: VAERS
(Vaccine Adverse Event Reporting System) received 13 reports of deaths occurring
after receipt of H1N1 vaccine; 3 deaths occurred after receipt of LAMV (live,
attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent inactivated,
split-virus or subunit vaccines). In 9 of these deaths, significant underlying
illness (including illness that might be indication for vaccination) was present; 1
death resulted from a motor vehicle crash, and the remaining 3 deaths await review
of final autopsy results or death certificates by CDC (Centers for Disease
Control)." "No lab data for this event."
"454538-1" "454538-1" "This literature report concerns a series of 10
fatalities cases after H1N1 vaccinations. These 10 cases involved 2 children, 7
adults and 1 elderly. This case (10 of 10) concerns a 77-year-old male patient, who
had a medical history of lung cancer, atrial fibrillation, recurrent deep venous
thrombosis, hypertension and hyperlipidemia. The patient died of suspected
myocardial infarction, two days after H1N1 vaccination (type: monovalent
inactivated, split-virus or subunit vaccine: manufacture: unknown). Reporters
comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of
deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of
LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent
inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant
underlying illness (including illness that might be indication for vaccination) was
present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths
await review of final autopsy results or death certificates by CDC (Centers for
Disease Control)." "No lab data for this event."
"454540-1" "454540-1" "This literature report concerns a series of 10 cases
of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults
and 1 elderly reported. This case (6 of 10) concerns a 49-year-old patient, who had
a medical history of Type 2 diabetes, stroke, chronic obstructive pulmonary
disease, emphysema and substance abuse. The patient died of a suspected
cardiovascular event three days after H1N1 vaccination (type: monovalent
inactivated, split-virus or subunit vaccine; manufacturer: unknown). Reporters
comment: VAERS (Vaccine Adverse Event Reporting System) received 13 reports of
deaths occurring after receipt of H1N1 vaccine; 3 deaths occurred after receipt of
LAMV (live, attenuated monovalent vaccine) and 10 after receipt of MIV (monovalent
inactivated, split-virus or subunit vaccines). In 9 of these deaths, significant
underlying illness (including illness that might be indication for vaccination) was
present; 1 death resulted from a motor vehicle crash, and the remaining 3 deaths
await review of final autopsy results or death certificates by CDC (Centers for
Disease Control)." "No lab data for this event."
"454541-1" "454541-1" "This literature report concerns a series of 10 cases
of fatalities after H1N1 vaccinations. These 10 cases involved 2 children, 7 adults
and 1 elderly reported. This case (7 of 10) concerns a 53-year-old female patient,
who had a medical history of end-stage renal disease and atrial fibrillation. The
patient died (of unknown cause) (under review), five days after H1N1 vaccination
(type: monovalent inactivated, split-virus or subunit vaccine; manufacture:
unknown). Reporters comment: VAERS (Vaccine Adverse Event Reporting System)
received 13 reports of deaths occurring after receipt of H1N1 vaccine; 3 deaths
occurred after receipt of LAMV (live, attenuated monovalent vaccine) and 10 after
receipt of MIV (monovalent inactivated, split-virus or subunit vaccines). In 9 of
these deaths, significant underlying illness (including illness that might be
indication for vaccination) was present; 1 death resulted from a motor vehicle
crash, and the remaining 3 deaths await review of final autopsy results or death
certificates by CDC (Centers for Disease Control)." "No lab data for this event."
"454552-1" "454552-1" "This literature report concerns a retrospective,
descriptive study of all reported influenza-associated pediatric deaths in 2007-
2008 influenza season. A case was defined as the death of a resident aged <18 from
October 1, 2007 to September 30, 2008 with laboratory evidence of an influenza
virus type A or B infection. A positive laboratory test for influenza type A or B
could occur before or after death and may be determined by any of the following
methods: rapid influenza diagnostic test, viral isolation, enzyme immunoassay,
fluorescent antibody staining, immunohistochemical staining of tissue samples, or
reverse transcription polymerase chain reaction. Specimens for bacterial and viral
culture were collected as part of routine clinical care and the postmortem
examination, when applicable. CDC requested that respiratory specimens and
postmortem lung specimens were sent to CDC laboratories if available. Influenza
virus isolates, other viral isolates, and bacterial isolates were characterized at
local, hospital, state, or CDC laboratories. Genotyping of available S. aureus
isolates was performed at CDC by pulsed field gel electrophoresis (PFGE) using
SmaI-digested DNA. Gel patterns were analyzed as previously described. State or
local health departments completed a standardized reporting form for each case of
influenza-associated pediatric mortality and transmitted the information to CDC via
a web-based interface hosted on CDC's Secure Data Network. Through the standardized
reporting form, information was collected on patient demographics, influenza
laboratory test results, date and location of death, preexisting conditions,
complications during the acute illness (including radiologically confirmed
pneumonia), influenza vaccination history, and results of bacterial cultures
obtained from normally sterile (blood, pleural fluid, chest tube fluid, or cerebral
spinal fluid) and specified non-sterile (endotracheal tube aspirates, tracheal
aspirates, and bronchial washes) sites. Information was not collected on bacterial
cultures obtained from nares or sputum, as positive cultures from these sites are
more likely to represent colonization rather than infection. The reporting form
includes a notes section for reporting additional information and for
clarification. Information regarding bacterial isolation from postmortem lung
biopsies and fungal co-infections was not directly solicited; however, this
information could be reported in a notes section of the reporting form. For our
analysis, bacterial isolation from postmortem lung biopsies were included only if
the specimen was collected on the calendar day of death or the calendar day
following death. Dates of hospital admission and specimen collection were obtained
from all patients from whom S. aureus was isolated from one of the designated
sites. We focused our analyses on those patients from whom S. aureus was isolated
from a specimen collected within three days of hospital admission, as we were
attempting to identify patients in whom a bacterial co-infection may have
contributed to their severe presentation (as opposed to having been acquired during
hospitalization). During the 2007-2008 influenza season, a total of 88 influenza-
associated pediatric deaths were reported to CDC. Of the 88 children, 47 (53%) were
boys and the median age at death was 5. Forty-two (47%) of the children were <5
years of age, and 14 (16%) were <1 year of age. Most were white. Fifty-six (66%) of
85 children were recommended for vaccination by 2007-2008 ACIP criteria, and of
these 48 had a known vaccination status for the 2007-2008 influenza season. Eleven
(23%) of 48 recommended children received at least one dose of influenza vaccine in
the 2007-2008 season at least 14 days prior to illness onset. Of these 11 children,
six were completely vaccinated, one was partially vaccinated, and complete
vaccination status could not be determined in four. One child who received the
vaccine in the 2007-2008 season did not meet an age-related or ACIP-defined high-
risk criteria for vaccination. This case (case 3 of 6) relates to 6 of 11 children
who were completely vaccinated. Authors comment: S. aureus continues to be the most
common bacteria isolated from children with influenza-associated mortality. S.
aureus isolates were associated with older age and lack of high-risk medical
conditions. Healthcare providers should consider influenza co-infections with S.
aureus when empirically treating children with influenza and severe respiratory
illness." "No lab data for this event."
"455297-1" "455297-1" ""Information has been received from a consumer,
concerning a 16 month old brother, who approximately in May 1982 (""30 years
ago""), was vaccinated with a dose of MMR II (Lot #, dose and route not reported).
It was reported that approximately in May 1982 (""30 years ago"") the patient died
after getting a MMR II shot. The cause of death was unknown. It was reported to the
Center for Disease Control. Additional information is not expected."" "No lab data
for this event."
"455358-1" "455358-1" "Pt. died of unknown causes. Autopsy. Toxicology
testing in process." "None"
"455522-1" "455522-1" "Pt returned from arduous bike ride, took long time
in bathroom, wife entered, pt started to speak, turned blue and fell to floor. CPR
attempted, EMS took to ER where pulseless. Ventricular tachycardia found.
Intubated, CCU care, minimal brain activity, died on 4th day." "No lab data for
this event."
"455738-1" "455738-1" "Pt received vaccines on 5/3/12. Died on 5/4/12."
"None"
"455795-1" "455795-1" ""None observed directly, within 30 min, after
vaccine administration at the Health Dept. Mother notified Health Dept. on
5/17/2012 to report that her infant had expired at home in the early AM of
5/15/2012. She stated she called 911 when she determined her infant was
unresponsive and that the Emergency Personnel had pronounced her ""dead"" on
arrival."" "Autopsy performed: results pending"
"456061-1" "456061-1" "This is a spontaneous report by a non contactable
nurse. This nurse reported through Pfizer sales representative for a 12-year-old
male patient who was administered a dose of PREVNAR 13 on an unknown date. Relevant
medical history and concomitant medication were not reported. The patient
experienced streptococcus pneumoniae for which he was hospitalized in 2012. In
2012, he experienced unspecified condition due to which he passed away. At the time
of the report it was unknown if the autopsy was performed.""No lab data for this
event."
"456170-1" "456170-1" "Death." "No lab data for this event."
"456560-1" "456560-1" "Information has been received from a consumer
concerning her 10 month old niece with no known allergies who on 09-MAY-2012 was
vaccinated with a dose of RECOMBIVAX HB (dose, route and lot # not provided). The
consumer stated that on 09-MAY-2012, the patient received the vaccine during the
day and then went to sleep for a few hours and woke up at 7:00 pm that evening
without any issues. The patient then went to sleep again at 10 pm followed by the
mother discovering the baby later that night deceased at an unspecified time. The
baby's skin was blue in color when the mother discovered her indicating that the
baby passed away. Additional information has been requested." "Unknown"
"456644-1" "456644-1" ""On 5/28/2012 began having diarrhea. On 5/29/12 am,
he was a little fussy in the morning - mom gave gripe water and baby oragel. The
babysitter called dad in the afternoon saying that the patient was not himself.
When the dad picked him up he said the child was ""out of it"". Went to
grandfathers house and called EMS. On EMS arrival patient had pulse in the 140's
and RR in the 30's, by the time patient arrived at the ED patient was apneic and
asystolic with bag valve mask ventilation being performed. Resusscitation was
unsuccessful and the patient passed away. Upon attempt at a rectal temperature,
bloody stool was noted in the diaper. There was also a palpable mass in the
abdomen. The medical examiner confirmed the presence of intussusception on the
autopsy."" "Xray: No focal pulmonary consolidation. Multiple prominent air
filled bowel loops. No free air."
"456713-1" "456713-1" "Initial report was received on 29 May 2012 from an
electronic lay press article. A 19-year-old female had received an injection of
MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date of
administration not reported) and an unspecified amount of time developed
meningococcal meningitis. The patient was taken to the hospital on 25 May 2012 and
died on 26 May 2012. No further information was available at the time of the
report. The patient's outcome was fatal. Documents held by sender: None." "Not
reported"
"457319-1" "457319-1" "This social media report (initial receipt: 04-Jun-
2012) concerns a 7-year-old female patient. On ??-Dec-2011 the patient received her
fatal dose of flu vaccine (manufacturer, brand name and batch number were not
reported) and was pronounced dead about 92 hours later on 06-Dec-2011. The cause of
death was not reported." "No lab data for this event."
"457374-1" "457374-1" "Infant died." "No lab data for this event."
"457526-1" "457526-1" "Dr. experienced muscle aching and spasm on 4 May. He
also had joint pain and swelling. This resolved by 9 May 12. He died in his sleep
on 21 May 12." "Cardiologist thought he had arrhythmic death."
"457541-1" "457541-1" ""Began with bilateral neuritis type symptoms both
arms. Proceeded to ""walking pneumonia"", CHF polymyositis, mixed connective tissue
disease, kidney failure & death. Tx- 2 inj of steroids, long term high dose
steroids, immune suppression, dialysis & death."" "No lab data for this event."
"457904-1" "457904-1" "Information has been received from a physician
concerning a 14 year old male with no pertinent medical history and no drug
allergies who was vaccinated intramuscularly with the first and second 0.5ml dose
of GARDASIL (Lot# not reported) respectively on 02-APR-2012 and 04-JUN-2012. There
was no concomitant medication. On 07-JUN-2012 the patient committed suicide. He
shot himself in head. Physician stated this young male was happy go lucky, healthy,
and never had any psychiatric issues in the past. It was not known if the patient
sought for medical attention. On 07-JUN-2012 the patient died of suicide.
Additional information has been requested." "Unknown"
 "458211-1" "458211-1" "Case number PHHY2012US053744 is an initial
literature report received on 20 Jun 2012. Authors searched for adverse events
following H1N1, which were reported to the the Vaccine Adverse Event Reporting
System from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex
not reported). The patient was vaccinated with H1N1 (manufacturer and batch number:
unknown) on an unspecified date. On an unknown date after vaccination the patient
died due to cardiomyopathy. The causality of the event cardiomyopathy was not
reported. Authors stated that the adverse event profile after H1N1 in VAERS was
consistent with that of seasonal influenza vaccines, although the reporting rate
was higher after H1N1 than seasonal influenza vaccines, this may be, at least in
part, a reflection of stimulated reporting. Death, Guillain Barre Syndrome and
anaphylaxis reports after H1N1 vaccination were rare (each <2 per million doses
administered)." "No lab data for this event."
"458218-1" "458218-1" "Case number PHHY2012US053750 is an initial
literature report received on 20 Jun 2012. Authors searched for adverse events
following H1N1, which were reported to the Vaccine Adverse Event Reporting System
from 01 Oct 2009 to 31 Jan 2010. This case refers to a patient (age and sex not
reported). The patient's medical history included of congenital heart disease (not
specified). The patient was vaccinated with H1N1 (manufacturer and batch number:
unknown) on an unspecified date. On an unknown date after vaccination the patient
died to congenital heart disease. No other information was available. Authors
stated that the adverse event profile after 2009-H1N1 in VAERS was consistent with
that of INFLUENZA, although the reporting rate was higher after 2009-H1N1 than
INFLUENZA, this may be, at least in part, a reflection of stimulated reporting.
Death, Guillain Barre Syndrome and anaphylaxis reports after 2009-H1N1 vaccination
were rare (each <2 per million doses administered)." "No lab data for this event."
"458346-1" "458346-1" "Case number PHHY2012US054996 is an initial
literature report received on 25 Jun 2012. Authors presented the importance of
clinicians alertness to possible influenza among children and young adults with
neurologic and neurodevelopmental conditions, especially during influenza season.
This case refers to a patient (age and sex not specified). The patient's medical
history included severe to profound neurologic and neurodevelopmental disabilities,
including physical limitations, cerebral palsy and intellectual disability. He was
vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown)
on an unspecified date during Oct 2010 to Nov 2010. On an unspecified date after
vaccination, the patient developed influenza. On an unknown date the patient died
due to multiple organ failure. No other information pertaining to this patient was
available. Authors concluded that clinicians should be alert to possible influenza
among children and young adults with neurologic and neurodevelopmental conditions,
especially during influenza season. Prompt testing and early empiric antiviral
treatment in residents with respiratory symptoms in residential or long-term care
facilities is important. Influenza prevention efforts should include vaccination of
residents, health-care personnel, and others who might transmit influenza to
residents, use of infection control precautions, and appropriate use of antiviral
medications." "No lab data for this event."
"458350-1" "458350-1" "Family noticed baby was blue and called 911. Baby
was coded and pronounced at approx 1755. At this time I do not have exact times."
"No lab data for this event."
"458414-1" "458414-1" ""Information has been received from a physician
concerning a 13 week old (reported as 3 month) female patient with a history of
vomiting, diarrhoea, dehydration and hospitalization (the patient was hospitalized
from 11-MAY-2012 to 14-MAY-2012 due to vomiting, diarrhoea, dehydration) with a
negative results of medical test including stool cultures, ""rotavirus"", fecal
blood cell, urine, blood, cerebral spinal fluid and respiratory cultures (the
patient was administered unspecified antibiotics and was rehydrated) who on 15-MAY-
2012 was vaccinated with a 2.0 ml first dose of ROTATEQ, (Lot # not reported).
There was no concomitant medication. On 18-MAY-2012 the patient was found
unresponsive at home after a nap. The patient was admitted to the hospital. Her
rectal temperature was 100.01 and blood tests reflected dehydration. The patient
was given IV fluids and supportive measures. The patient was pronounced dead on 18-
MAY-2012. The physician reported, at autopsy, negative stool culture and positive
rotavirus antigen ID. The caused of death has not yet been determined. Additional
information has been requested. All adverse events were determined as significant
disability, life threatening and other important medical events."" ""Diagnostic
laboratory, 05/11/12, ""rotavirus results were negative""; Diagnostic laboratory,
05/18/12, blood test reflected dehydration; Stool culture, 05/18?12, negative;
Stool rotavirus antigen, 05/18?/12, positive; Urine culture, 05/11/12, negative;
Cerebrospinal fluid, 05/11/12, negative; Body temp, 05/18/12, 100.1 F; Upper
respiratory, 05/11/12, negative; Blood culture, 05/11/12, negative; Stool for
fecal, 05/11/12, negative; Stool culture, 05/11/12, negative""
"458458-1" "458458-1" "Case number PHHY2012US054673 is an initial
literature report received on 25 Jun 2012. Authors presented the importance of
clinicians alertness to possible influenza among children and young adults with
neurologic and neurodevelopmental conditions, especially during influenza season.
This case refers to a male patient (age not specified). The patient's medical
history included of severe to profound neurologic and neurodevelopmental
disabilities, including physical limitations. With his neurologic impairment, he
was able to make sounds but unable to speak or move on his own volition. He had
multiple prior admissions for aspiration pneumonia and a history of abnormalities
noted on chest radiography. He was vaccinated with season influenza vaccine
2010/2011 (manufacturer and batch number: unknown) on an unspecified date during
Oct 2010 to Nov 2010. On 19 Feb 2011, he had fever of 101.2 F (38.4 C), and his
oxygen saturation was 88% on room air. Empiric treatment with ciprofloxacin was
initiated. On illness day 2, he developed mild cough and wheezing and was given
supplemental oxygen. On illness day 3, he became tachypneic and required increased
respiratory suctioning. On illness day 5, he was hospitalized with fever of 101.3 F
(38.5 C) and respiratory rate of 24 breaths-per-minute; empiric treatment with
piperacillin/tazobactam and vancomycin was initiated. On illness day 6, he tested
positive for influenza A by rapid influenza diagnostic test (RIDT) and was treated
with oseltamivir (60 mg twice daily). On the same day, he developed both acute
respiratory distress syndrome requiring mechanical ventilation and sepsis with
hypotension requiring vasopressor support. On illness day 7, chest radiography
showed diffuse lung opacities that progressed to complete opacity of both lungs. He
died on illness day 8, Authors concluded that clinicians should be alert to
possible influenza among children and young adults with neurologic and
neurodevelopmental conditions, especially during influenza season. Prompt testing
and early empiric antiviral treatment in residents with respiratory symptoms in
residential or long-term care facilities is important. Influenza prevention efforts
should include vaccination of residents, health-care personnel, and others who
might transmit influenza to residents, use of infection control precautions, and
appropriate use of antiviral medications." "Body temperature, 38.5 degrees C,
High; Chest X-ray, Abnormalities, Significant, Abnormalities noted on chest
radiography; Chest X-ray, Lung opacities, Significant, On illness day 7, chest
radiography showed diffuse lung opacities that progressed to complete opacity of
both lungs. Influenza A virus test positive, Positive, Significant, He tested
positive for influenza A by rapid influenza diagnostic test. Oxygen saturation
decreased, 88%, Low"
"458605-1" "458605-1" "Information has been received from a pharmacist
concerning his over 65 year old mother who on an unspecified date was vaccinated
with a dose of PNEUMOVAX 23 (lot number, dose and route not reported). Subsequently
on an unspecified date the patient died. The cause of death was unknown. The
reporter felt that the patient's death was not related to therapy with PNEUMOVAX
23. No further information is available." "Unknown"
"458613-1" "458613-1" "The baby found unresponsive in the morning on
6/30/12. Resuscitation attempts done by Paramedics and in the ER failed." "CBC
with diff; Chem 7; X-ray chest; CT scan brain; Skeletal survey; Blood; CSF culture;
Culture of tracheal aspirate"
"458702-1" "458702-1" "Death: 2-3 days following immunizations." "No
lab data for this event."
"458862-1" "458862-1" ""Initial report was received on 12 October 2011 from
an investigator participating in the study under the reference number M5A11. A 17
month-old female patient with no reported past medical history experienced
respiratory arrest due to aspiration (resulting from vomiting) 123 days after
receiving dose four of PENTACEL, lot number C3747AB (route and site of
administration not reported) on 27 April 2011. Additional vaccine history included
a first dose of MMR, lot number 1644Z (route and site of administration not
reported) received on 01 July 2011. According to the investigator, a representative
from the coroner's office was told that the ""child likely choked on a ravioli as
fed by a parent"". No autopsy was performed as it was not a coroner's case. The
outcome was fatal. According to the investigator, the event was not related to the
trial product. Documents held by sender: none."" "Not reported"
"459278-1" "459278-1" "On 05/07/1990 patient went to the Doctor and had a
physical, which the doctor said he was in good health and doing well for his age
and he also received 2 vaccinations MMR and DPT. He was congested and had a fever
after receiving his shots. I gave him infant Tylenol during the day and before I
put him to sleep. At 7am approximately 12 hours later I found patient in his bed
not breathing and without a pulse. I performed CPR but patient died. The coroner
determined that the cause of death was SIDS." "No lab data for this event."
"459500-1" "459500-1" "Pt received vaccines 6/27/12 - found dead in crib
(prone) next morning." "Autopsy results (P)"
"459641-1" "459641-1" "No previous problems known. Pt was found
unresponsive in rec room of home with treadmill running." "Death certificate -
cause of death - dilated cardiomyopathy, excessive exercise on treadmill"
"459685-1" "459685-1" "Found unresponsive by parents just after midnight
6/30/12, transported to local hospital with external CPR by EMS. ER able to
intubate and establish HR, then transferred to another hospital. Died at 2148 on
6/30/12." "Autopsy to be performed. Hospital records will be sent to VAERS via
regular mail."
"460432-1" "460432-1" "The patient had a screening CBC done the same day as
vaccinations (7/16/12) that showed leukocytosis with blasts, anemia and
thrombocytopenia. She was admitted to the hospital on 7/17/12. On 7/19/12, she was
diagnosed with AML by bone marrow aspirate. She also started having fever and was
started on broad spectrum antibiotics. Had surgical placement of CVC on 7/20/12 and
received intrathecal cytarabine. She had postoperative respiratory issues, which
was treated with high flow nasal cannula oxygen and diuretics. On 7/21/12, she
received dexamethasone, cytarabine, daunorubicin and etoposide. Bortezomib (a
tyrosine kinase inhibitor) was given per experimental treatment protocol. Beginning
7/21/12, she developed vomiting, diarrhea, tachypnea and tachycardia with worsening
desaturations. She progressed over the course of the day on 7/22/12 despite
increasing respiratory support from high flow nasal cannula oxygen to bilevel
positive airway pressure, to endotracheal intubation with mechanical ventilation.
The team caring for her was unable to increase oxygenation, improve carbon dioxide
retention or correct acidosis. The patient died on 7/22/12 at 2151. Cultures from
blood and urine did not grow bacteria. An autopsy is being done." "Autopsy is
pending"
"460993-1" "460993-1" ""Initial case received via search of scientific
literature on 26 July 2012. The following is verbatim from the article abstract:
""Objective: In 2010, an area experienced the highest number of pertussis cases in
>60 years, with >9000 cases, 809 hospitalizations, and 10 deaths. This report
provides a descriptive epidemiologic analysis of this epidemic and describes public
health mitigation strategies that were used, including expanded pertussis vaccine
recommendations. STUDY DESIGN: Clinical and demographic information were evaluated
for all pertussis cases with onset from January 1, 2010 through December 31, 2010,
and reported to the Department of Public Health. RESULTS: Infants younger than 6
months had the highest disease rates; all deaths and most hospitalizations occurred
in infants younger than 3 months. Most pediatric cases were vaccinated according to
national recommendations, although 9% of those aged 6 months to 18 years were
completely unvaccinated against pertussis. High disease rates also were observed in
fully vaccinated preadolescents, especially 10-year-olds. Mitigation strategies
included expanded tetanus, diphtheria, and acellular pertussis vaccine
recommendations, public and provider education, distribution of free vaccine for
postpartum women and contacts of infants, and clinical guidance on diagnosis and
treatment of pertussis in young infants. CONCLUSIONS: Infants too young to be fully
vaccinated against pertussis remain at highest risk of severe disease and death.
Data are needed to evaluate strategies offering direct protection of this
vulnerable population, such as immunization of pregnant women and of newborns. The
high rate of disease among preadolescents suggests waning of immunity from the
diphtheria, tetanus, and acellular pertussis series; additional studies are
warranted to evaluate the efficacy and duration of protection of the diphtheria,
tetanus, and acellular pertussis series and the tetanus, diphtheria, and acellular
pertussis series."" The following is verbatim from the article: ""The remaining
fatality was a 2-month-old infant born prematurely at 28 weeks gestational age who
had received the first dose of diphtheria, tetanus, and accelular pertussis (DTaP)
vaccine 15 days prior to disease onset."" A two-month-old infant (date of birth and
gender not reported), who was born at 28 weeks gestation, received dose one
injection of DTaP, manufacturer unknown, (lot number, route and site not reported)
on an unspecified date. On an unspecified date, 15 days after vaccination, the
patient developed Pertussis. Other than premature birth, the patient's past medical
history, concomitant medications or vaccinations were not reported.
Hospitalization, laboratory/diagnostic studies, treatments and date of death were
not reported. The patient's outcome was reported as fatal. Documents held by
sender: None."" "Not reported."
"462360-1" "462360-1" "This spontaneous report was received from a
pharmacist refers to a 72 years old male patient with no known drug allergies who
was vaccinated subcutaneously into upper left deltoid with a dose of 0.65 ml
ZOSTAVAX (lot # 672563/1649AA, expiration date 21-JAN-2013) on 19-JUL-2012. No
other co-suspects were reported. Concomitant medications included lisinopril,
COUMADIN, spironolactone and carvedilol. Pharmacist stated she read in the local
paper and found out that client was died at her home residence on 24-JUL-2012.
Cause of death was unknown. It was unknown if autopsy was performed. Pharmacist
stated the patient did have health conditions, unspecified, but she wanted to make
sure that no problem existed with this ZOSTAVAX lot number. This event (death) was
considered to be life-threatening and disabling. This is one of the two reports
from the same reporter. Additional information has been requested." "No lab data
for this event."
"462383-1" "462383-1" "We would like to report that this death occurred
within one week of 2 month vaccines. Coroner reported cause of death undetermined -
possible SIDS vs. co-sleeping." "None"
"462902-1" "462902-1" "This spontaneous report as received from a
pharmacist refers to a 63 years old female patient with no known allergies. The
patient was vaccinated subcutaneous into upper left deltoid with 0.65 ml ZOSTAVAX
(lot # 672563/1649AA, expiration date 21-JAN-2013) on 16-APR-2012. No other co-
suspects were reported. Concomitant medications included acyclovir, acetaminophen,
PERCOCET, clonazepam, lovastatin and amlodipine. Pharmacist stated she read the
local paper and found out that client was found dead at her home residence on 18-
APR-2012, due to natural causes. Pharmacist stated the patient did have health
conditions, unspecified, but she wanted to make sure that no problem existed with
this ZOSTAVAX lot number. Lot check was requested by the reporter. Event was
considered to be disabling and life-threatening. This is one of the two reports
from the same reporter. Additional information has been requested." "No lab data
for this event."
"463159-1" "463159-1" "DEATH" "No lab data for this event."
"463731-1" "463731-1" "Well child exam on 7-11-12. No problems at birth."
"No"
"463942-1" "463942-1" "Baby was found dead in parents bed (she sleeps in
parents bed). She was on the side with face down in the memory foam mattress. This
happened on 8-28-12. Day after she received her 2 months vaccines on 8-27-12. Most
probably a case of SIDS." "None"
"464200-1" "464200-1" "Cough, fussiness, fever, persistent crying, lack of
appetite, cough, constipation, death." "No lab data for this event."
"464953-1" "464953-1" ""Information has been received from a receptionist
of the registered nurse, concerning rumor going around that a 19 years old girl who
on an unspecified date received the first shot of GARDASIL (dose, route and lot #
not reported), developed a brain infection, and passed away. The patient died this
summer, June/July 2012. The reporter was not even 100% sure if the patient had had
the GARDASIL shot because the nurses found that there was no record of the patient
in local registry for GARDASIL patients. They were assuming that she was vaccinated
out of state because she had joined the military (unspecified). The patient might
have gotten vaccinated by the military. Another part of the rumor that was going
around was that ""the girl was fine one day, not the next, and it must be the
GARDASIL shot that did this"". The time from receiving the GARDASIL shot to the
time of her death was unknown. It was unknown if she had any adverse experience
from the GARDASIL or if it caused the brain infection. Additional information has
been requested."" "No lab data for this event."
"465224-1" "465224-1" ""Initial report was retrieved from the scientific
literature on 06 September 2012. The following information is verbatim from the
abstract: ""Meningococci have historically caused extensive illness among members.
Three successive meningococcal vaccine types were used from 1971 through 2010;
overall disease incidence dropped by >90% during this period. During 2006-2010,
disease incidence of 0.38 (cases per 100,000 person-years) among members was not
significantly different from the incidence of 0.26 among the age-matched general
population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness
in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis
serogroup Y. Incidences among 17- to 19-year-old trainees and among others were
significantly higher than among comparison populations (p<0.05). No apparent change
in epidemiology of meningococcal disease was observed after replacement of
quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data
demonstrate that vaccination with meningococcal vaccine is effective."" According
to the report, the cases were confirmed by culture, PCR or both. The information
included in this case concerns a 20-24-year-old male patient who had received
MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not
reported) and 15 months after vaccination developed meningococcal meningitis and
sepsis, year reported as 2008 (Q 4). Neisseria meningitidis serogroup was
determined to be serogroup Y. Treatments were not reported. No further information
was available at the time of report. The patient's outcome was fatal. The reporter
for this case is the same as for cases 2012-08240, -08241, -08242, -08243, -08244,
-08245, -08246, -08247, -08249, -08250, -08251, -08252, -08253, -08254, -08255, and
-08256. Documents held by sender: None."" "Culture, PCR or both: Neisseria
meningitidis, serogroup Y"
"465234-1" "465234-1" ""Initial report was retrieved from the scientific
literature on 06 September 2012. The following information is verbatim from the
abstract: ""Meningococcal have historically caused extensive illness among members.
Three successive meningococcal vaccine types were used from 1971 through 2010;
overall disease incidence dropped by >90% during this period. During 2006-2010,
disease incidence of 0.38 (cases per 100,000 person-years) among members was not
significantly different from the incidence of 0.26 among the age-matched general
population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness
in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis
serogroup Y. Incidences among 17- to 19-year-old basic trainees and among were
significantly higher than among comparison populations (p<0.05). No apparent change
in epidemiology of meningococcal disease was observed after replacement of
quadrivalent polysaccharide vaccine with conjugate vaccine in 2007. The data
demonstrate that vaccination with meningococcal vaccine is effective."" According
to the report, the cases were confirmed by culture, PCR or both. The information
included in this case concerns a 20-24 year-old male patient who had received
MENOMUNE A/C/Y/W-135 (lot number, route, site and date of administration not
reported) and 12 months after vaccination developed meningococcal meningitis and
sepsis, year reported as 2006 (Q 1). Neisseria meningitidis serogroup was
determined to be serogroup C. Treatments were not reported. No further information
was available at the time of report. The patient's outcome was fatal (date of death
not reported). The reporter for this case is the same as for cases 2012-08241,
-08242, -08243, -08244, -08245, -08246, -08247, -08248, -08249, -08250, -08251,
-08252, -08253, -08254, -08255, and -08256. Documents held by sender: None.""
"Serogroup C was confirmed by culture, PCR or both (exactly which test was
not reported)."
"465345-1" "465345-1" ""Initial report was retrieved from the scientific
literature on 06 September 2012. The following information is verbatim from the
abstract: ""Meningococci have historically caused extensive illness among members.
Three successive meningococcal vaccine types were used from 1971 through 2010;
overall disease incidence dropped by >90% during this period. During 2006-2010,
disease incidence of 0.38 (cases per 100,000 person-years) among members was not
significantly different from the incidence of 0.26 among the age-matched general
population. Of the 26 cases, 5 were fatal, 15 were vaccine failures (e.g., illness
in a person who had been vaccinated), and 9 were caused by Neisseria meningitidis
serogroup Y. Incidences among 17- to 19-year-old were significantly higher than
among comparison populations (p<0.05). No apparent change in epidemiology of
meningococcal disease was observed after replacement of quadrivalent polysaccharide
vaccine with conjugate vaccine in 2007. The data demonstrate that vaccination with
meningococcal vaccine is effective."" According to the report, the cases were
confirmed by culture, PCR or both. The information included in this case concerns a
17-19-year-old male patient who had received MENACTRA (lot number, route, site and
date of administration not reported) and three months after vaccination developed
meningococcal sepsis, year reported as 2007 (Q 3). Neisseria meningitidis serogroup
was determined to be serogroup C. Treatments were not reported. No further
information was available at the time of report. The patient's outcome was fatal.
The reporter for this case is the same as for cases 2012-08240, -08241, -08242,
-08243, -08245, -08246, -08247, -08248, -08249, -08250, -08251, -08252, -08253,
-08254, -08255, and -08256. Documents held by sender: None."" "Culture or PCR,
or both: Neisseria meningitidis, serogroup C"
"465397-1" "465397-1" "Patient found at home not breathing, CPR started.
EMS continued CPR & brought patient to our ED. Patient still in full
cardiopulmonary arrest. Patient never recovered heart rate." "No lab data for
this event."
"465434-1" "465434-1" "Child received vaccines on 9/14/12. Parent reported
found child unresponsive on 9/15/12. Taken by ambulance to ER and pronounced."
"None"
"465543-1" "465543-1" "Severe weakness, severe pain, difficulty breathing.
Pain meds, heart meds, aspirin, TYLENOL. Could not walk without assistance."
"Coroner assumed it was massive heart failure"
"465858-1" "465858-1" "Vaccines given 8/28/12, 850am. Catastrophic event
about 6pm 8/30/12. Found by family to be apneic, blue, unresponsive. To ER then to
Hosp PICU. Hypoxic ischemic encephalopathy & multisystem organ failure. Brain dead
& expired 09/02/12. Law enforcement & DSS notified - autopsy pending. No indication
that death related to immunizations." "Extensive evaluation at hospital"
"465916-1" "465916-1" ""Patient complained of ""achiness"" around 2:30 to
3:00 pm. His symptoms progressed to stiffness and soreness by bedtime and needed
help with his clothing before bed. Around Midnight, there was a loss of bowel
control and he passed away."" "Since flu vaccine was adminstered within such a
close timeframe, medical examiner thought that we should be aware and report to
VAERS, the possible link of the vaccine to the patient's death."
"465936-1" "465936-1" ""Woke up to baby face up, she looked fine, when I
went to pick her up she was stiff still warm, but stiff, and not breathing, called
911 paramedics arrived and tried to resuscitate, she had been dead approx 12 mins.
Med ex. said it was SIDS. Autopsy report cause of death ""undetermined"" manner of
death: ""undetermined, prematurity by history"""" "No lab data for this event."
"465968-1" "465968-1" ""Information has been received from a published
article. Encephalitis associated with varicella-zoster virus (VZV), rare among
children in the varicella vaccine era, has generally been associated with a rash.
Authors reported fatal wild-type VZV encephalitis without a rash in a child who had
received 1 dose of varicella. VZV encephalitis should be considered in the
differential diagnosis for children neurologic symptoms, even vaccine recipients.
In June 2011, a pediatrician notified the that a 4-year-old female patient died of
VZV encephalitis. A varicella death investigation was conducted, because varicella
is a notifiable disease in the state. The patient was admitted to the hospital in
February, 2011, after complaining of sudden severe headache and right eye pain.
During the 10 days before admission, she had experienced frequent and intermittent
episodes of vomiting, headaches, seizures, lethargy, low-grade fever, mental status
changes, poor interaction, and poor appetite. She did not have cough, abdominal
pain, diarrhea, or rash. No history of recent travel, or known sick contacts at
home or the child care center she attended were noted. She had received 1 dose of
varicella vaccine (manufacturer unspecified) at age 13 months and had no history of
varicella disease. Her medical history was remarkable for nasal septum perforation
with subsequent recurrent sinusitis requiring prolonged courses of antibiotics
therapy. Additionally, she had hypocalcemia-related seizures at age 1 year
secondary to partial hypoparathyroidism; a DiGeorge syndrome workup including a
fluorescence in situ hybridization test for 22q11 chromosomal deletion was
negative. No documentation of T & B cell subsets being performed was found. She
received calcium supplements and had no more seizures. The patient had no history
of chronic medical conditions or immunosuppressive medications, was born full-tern
without reported complications, had reached appropriate developmental milestones,
and had performed adequately at preschool. On physical examination, the patient was
drowsy, drooling, lethargic, and increasingly unresponsive to verbal stimuli. Her
vital signs were normal. Neck was supple. Pupillary reflexes and fundoscopy were
normal. She had a right gaze preference and probable left hemianopia with some
tremors in her extremities. No rash or dysmorphic features were noted. Her general
and neurologic examinations were otherwise unremarkable. Laboratory data revealed a
white blood cell count of 10x10^9L (neutrophils 85%, lymphocytes 7%, monocytes 8%):
platelet count was 287x10^9/L. Total calcium was 8.6 mg/dL (normal, 8.5 10.1) and
ionized calcium was 1.07mmol/L (normal, 1.15 1.27). The patient's electrolyte
panel, glucose, liver enzymes, and renal function tests were within normal limits.
Blood cultures were negative. Lumbar puncture and cerebrospinal fluid (CSF) tests
were not performed. No extensive laboratory evaluation of immunocompetence was
performed. A computed tomography (CT) brain scan showed a discrete enhancing lesion
measuring 3x3 cm without ring enhancement in the right posterior parietal lobe with
surrounding vasogenic edema, indicating an infectious or inflammatory process. A
well-defined abscess was not clearly identified and an underlying mass lesion could
not be excluded. Follow-up magnetic resonance imaging was consistent with a primary
glial neoplasm with local mass effect. A head CT scan in 2008 after her
hypocalcemic seizure indicated no brain abnormalities. A facial CT scan in February
2011, approximately 2 weeks before her hospital admission, demonstrated a
perforated nasal septum, paranasal sinus opacification, and an enhancing mass
suggestive of redundant nasal mucosa, enlarged vomeronasal organ, or nasal glioma.
Recommended nasal endoscopy and biopsy were not performed. The patient was given a
preliminary diagnosis of primary brain tumor, with mild local mass effect, and
treated with supportive measures. No antibiotics or antivirals were administered.
The patient's condition worsened, and during hospital day 4 she developed symptoms
of increased intracranial pressure. An electroencephalogram (EEG) revealed strong
epileptiform activity in the area of the suspected tumor and subclinical seizures
on video EEG monitoring. A head CT scan indicated no changes. During hospital day
5, the patient's symptoms worsened, and she had no pupillary light reflex. An
emergent head CT scan indicated an obstruction of the fourth ventricle and evidence
of herniation. She underwent emergenct external ventricular device placement.
Intraventricular pressure monitoring beginning at that time revealed extremely
elevated pressures. On hospital day 6, the day the patient died, a cerebral
perfusion study indicated no intracranial blood flow, consistent with brain death.
A postmortem examination was performed. The brain appeared swollen with tissue
softening and hemorrhages. No discrete brain lesion was grossly visible. A biopsy
of the right side of the brain was performed. Microscopic examination revealed
necrosis with inflammation, including clusters of microglia, consistent with
encephalitis. No evidence of a tumor was observed. Brain specimens were sent to the
Centers for Disease Control and Prevention for additional testing. Multifocal
encephalitis with viral-like inclusions was seen by hematoxylineosin stain.
Extensive multifocal immunohistochemical staining of VZV antigens was seen in
association with tissue damage; no evidence of herpes simplex virus or bacterial
infection was observed. Polymerase chain reaction (PCR) testing of DNA extracted
from specimens was positive for wild-type VZV. VZV encephalitis was determined to
be the cause of death. ""To our knowledge, this is the first reported fatal case of
VZV encephalitis in a child who had received 1 dose of varicella vaccine.
Additionally, the child did not have rash. Two major pathologic mechanisms have
been proposed as contributing to the development of VZV encephalitis: direct viral
invasion of the brain and an autoimmune process. The findings in this case,
including acute presentation, localization of viral antigens in encephalitic
lesions, and detection of VZV DNA from brain tissue, suggest direct viral
invasion."" ""Detection of wild-type VZV, and the absence of varicella rash
history, indicate this patient had unrecognized varicella, either previously or at
the time of this fatal illness. We were unable to determine whether the patient's
encephalitis was because of breakthrough infection or herpes zoster. In healthy
vaccinees, breakthrough varicella is usually mild. However, in this patient, we
cannot exclude the possibility of an underlying immunocompromising condition, given
some features of her medical history that could have led to severe breakthrough. If
the patient's illness was breakthrough, its severity might also be attributable to
lack of response to vaccination (i.e. primary vaccine failure)."" Additional
information has" "DiGeorge syndrome workup (at 1 year old) including a
fluorescence in situ hybridization test for 22q11 chromosomal deletion was
negative. No documentation of T & B cell subsets being performed was found. WBC
count: neutrophils 85%, lymphocytes 7%, monocytes 8%. CT brain: showed a discrete
enhancing lesion measuring 3x3 cm without ring enhancement in the right posterior
parietal lobe with surrounding vasogenic edema, indicating an infectious or
inflammatory process. A well-defined abscess was not clearly identified and an
underlying mass lesion could not be excluded. MRI: consistent with a primary glial
neoplasm with local mass effect. Head CT in 2008 after the hypocalcemic seizure
indicated no brain abnormalities. Facial CT scan, approximately 2 weeks before her
hospital admission, demonstrated a perforated nasal septum, paranasal sinus
opacification, and an enhancing mass suggestive of redundant nasal mucosa, enlarged
vomeronasal organ, or nasal glioma. Recommended nasal endoscopy and biopsy were not
perform"
"466002-1" "466002-1" "Patient seen in office for well child check, normal
healthy child with viral symptoms. Immunizations performed, child tolerated well.
Following morning found deceased." "Toxicology pending / autopsy results pending"
"466029-1" "466029-1" ""Initial report was received from a health care
professional on 12 September 2012. A 24-year-old female patient received dose one
of an intramuscular injection of (""the rabies series"") IMOVAX Rabies, sanofi
pasteur SA, H1091-1 (indication and site and side of administration were not
reported) on 11 September 2012. According to reporter, the patient did not have any
reactions when she went home. The next day, it was reported that the client died
during the night. Exact date of death was reported as unknown, either 11 September
2012 or 12 September 2012, as reported ""during the night"". The medical examiner
was called to verify the death, and details were not available at the time of the
report. No information was reported at this time on if an autopsy was performed.
The patient's outcome was fatal. Documents held by sender: None."" "Not
reported."
"467247-1" "467247-1" "11AM-O2 sats @74%, HR 204, temp 97.7, moaning, upper
extremities cold. Tylenol given for pain. 1:10PM-nasal flaring, O2 sats @ 74%, HR
82, temp 99.9, RR 42. EMS called and subsequent code blue. Chest compressions and
ambu-bagged, epinephrine given. Transferred to hospital. Pronounced dead at
hospital." "None. Family waived Medical Examiner review."
"467340-1" "467340-1" "Case number PHEH2012US019182 is an initial
spontaneous report received from a pharmacist on 28 Sep 2012. This report refers to
a 49-years-old male patient whose medical history and concomitant medications were
not reported. He was vaccinated with FLUVIRIN (batch number: 1204901, expiry date:
May 2013) intramuscularly on 25 Sep 2012. On 26 Sep 2012, he felt sick and
nauseous. It was reported that he suffered a heart attack at his work site and
expired before the ambulance arrived on 27 Sep 2012. No further information was
available." "No lab data for this event."
"467381-1" "467381-1" "Case number PHEH2012US018706, is an initial
spontaneous report received from a consumer on 21 Sep 2012 with a follow up
information received on 24 Sep 2012: This report refers to a female patient whose
age was not reported. She was vaccinated with influenza vaccine (unknown
manufacturer and batch number) on an unknown date. On an unspecified date she died
following a flu shot. Cause of death was not reported. Causality assessment was not
reported. No further information was provided. Follow up information received on 24
Sep 2012: Gender of the patient was updated." "No lab data for this event."
"468865-1" "468865-1" "Per family pt had a good day and eve, no signs of
allergic reaction or difficulty. He failed to wake up the next morning. Time of
death 10:37 AM." ""Pt had chronic illnesses including being very malnourished,
weighing 102# and being 6'2"".""
"469542-1" "469542-1" "Patient expired on 9/08/2012 at 4:00 AM, in her
home." "No lab data for this event."
"469573-1" "469573-1" "Initial information received on 10 October 2012 from
a patient's parent. An 18-year-old male patient received a dose of MENACTRA (lot
number U4256AA) intramuscularly in the arm on 27 July 2012. The patient was
autistic and had a history of seizures. Concomitant medications included DEPAKOTE,
KEPPRA, and KLONOPIN as needed for seizures. The patient had no illness at the time
of vaccination. The patient's parent reported that her son was very sleepy on 29
July 2012 and slept all day. He went to summer session at regular time the
following day, 30 July 2012, and returned home at regular time at 12:30 pm. He went
into his room and played computer games. At 3:30 pm the patient was found with his
head slumped on his computer. Cardiopulmonary resuscitation (CPR) was initiated and
emergency services (911) was called. The patient was transferred to the hospital
and CPR continued for 45 minutes before the patient was pronounced dead. An autopsy
was completed, but no results were provided at the time of this report. Documents
held by sender: none." "An autopsy was performed on an unspecified date. No
results were provided."
"471586-1" "471586-1" "No information." "No lab data for this event."
"471590-1" "471590-1" "This spontaneous report as received from a consumer,
who learned from a foreign radio channel of fatal cases after GARDASIL vaccination
in one country (1210USA012211) and a second country (2 fatal cases, 1210HKG011628)
and in a third country (3 fatal cases, this case). The reporter himself experienced
serious adverse events (1210HKG011385). This report refers to three patients of
unknown age. The patients were vaccinated with GARDASIL (date and route of
administration not provided). No other co-suspects were reported. No concomitant
medications were reported. On an unknown date the patients died. No details for
death are available. The relatedness for death is unknown for GARDASIL. Additional
information has been requested." "No lab data for this event."
"472279-1" "472279-1" "This medically confirmed spontaneous report (initial
receipt: 18-Oct-2012) concerns a 62-year-old male patient, who had a medical
history of recent massive heart attack and narcolepsy. He had no known drug
allergy. He was taking 'a lot of medications' (type unspecified). On 11-Oct-2012
the patient received AFLURIA (batch number: P58306) injection at a dose of 0.5 mL
intramuscularly. On the day of vaccination, the patient did not complain of any
symptoms and went home without any adverse events. On 13-Oct-2012 the patient was
found dead. The cause of death was still being investigated. According to the
pharmacist (reporter), the patient had many health problems including a recent
massive heart attack (date unspecified)." "No lab data for this event."
"472525-1" "472525-1" "This spontaneous report as received from an other
health professional refers to a female patient of unknown age. The patient was
vaccinated with 0.65 ml ZOSTAVAX in 2008. No other co-suspects were reported.
Concomitant medications included: PREDNISONE and inhaled corticosteroids (not
otherwise specified). The nurse reported that she administered ZOSTAVAX to a
patient that had completed a MEDROL Dosepak. The patient completed the MEDROL
Dosepak a month prior to the administration of the ZOSTAVAX (administration of the
ZOSTAVAX was believed to be in 2008, but nurse was not sure). The nurse reported
that the patient had no adverse reaction associated with the administration of the
ZOSTAVAX, but then stated that the patient has since died at age 93. On an unknown
date the patient experienced death (death). No treatment information was reported.
The outcome of death was reported as fatal. The date of death is not known. Nurse
did not feel death was associated with ZOSTAVAX vaccination. The nurse asked about
using ZOSTAVAX in a patient that is on 10 mg of Prednisone and inhaled
corticosteroids. The nurse did not wish to provide additional information at the
time of the call and did not wish follow up. Additional information is not
expected. It has been determined that case 1210USA013797 is a duplicate of case
1210USA013349. Therefore, case 1210USA013797 is being deleted from our files and
the cases consolidated into case 1210USA013349. No new information was reported."
"No lab data for this event."
"473483-1" "473483-1" "Pronounced dead at home in bed." "No lab data for
this event."
"473692-1" "473692-1" "Child passed away 11/4/12. Autopsy pending - cause
of death unknown." "No lab data for this event."
"473737-1" "473737-1" "Patient died from unknown cause within 3 days of
vaccine series. Death deemed SIDS." "No lab data for this event."
"475174-1" "475174-1" "Initial report was received from a consumer on 14
November 2012, and involves a case of misuse, inappropriate age at vaccine
administration. An 88-year-old female patient received an injection of FLUZONE
Intradermal, sanofi pasteur Inc., (lot number, route, site, side and dose in series
not reported) on 22 September 2012, which is indicated for patients 18 to 64 years
of age. On 08 October 2012, 16 days post vaccination, the patient was found dead.
The patient's past medical history was reported as not applicable (n/a) and illness
at time of vaccination was reported as none. The patient used home oxygen. It was
not reported if an autopsy was done. No other details were provided. The patient's
outcome was reported as fatal on 08 October 2012. Documents held by sender: None."
"Not reported."
"475176-1" "475176-1" "Died of SIDS 2 days after receiving vaccines." "No
lab data for this event."
"475315-1" "475315-1" "This literature report (initial receipt: 13-Nov-
2012) concerns a 49-year-old male patient. The patient had a recent history of
viral infection status post flu vaccination (manufacturer, brand name and batch
number were not provided). On an unknown date (post viral infection) the patient
presented with a 2-week history of bilateral lower extremity weakness and
paresthesias starting at the level of the axilla. He was evaluated by Neurology and
initially diagnosed with transverse myelitis. He underwent intravenous
immunoglobulin and steroid treatment without improvement. The patient's physical
examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower
extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs
visualized. He was medically stabilized and transferred to inpatient rehabilitation
facility. Ten days post admission, the patient experienced acute motor loss (0/5)
in bilateral lower extremities and worsening paresthesias, now involving bilateral
upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse
cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the
completion of his medical work-up, the patient passed away due to unclear causes.
Death was most likely related to respiratory compromise. Post mortem autopsy
results showed histopathological diagnosis of primary glioblastoma multiforme of
the spinal cord. Reporter's comment: This is a rare documented case of primary
spinal glioblastoma multiforme in an adult patient. Mean survival time after onset
is between 6-16 months. The major cause of death is leptomeningeal spread and
cerebral metastasis. Cervical glioblastoma multiforme may have an even poorer
outcome because of early involvement of the phrenic nerve nucleus and vasomotor
centers." "No lab data for this event."
"476377-1" "476377-1" "Fevers (102.6 max), sweating, fatigue, malaise,
anemia, thrush. Adverse effects lasted until day of death.""Blood cultures, blood
analysis (CBC, etc), urine cultures and analysis, CT scans, chest x-rays, sonogram,
echo-cardiogram, and possibly more tests were given."
"476400-1" "476400-1" "Patient died after receiving a HIGH DOSE flu shot on
the morning of 11/21/12. The shot was administered at pharmacy. The shot was given
to the patient at approximately 11:00 am on November 21, 2012. By late afternoon
the patient was experiencing flu-like symptoms; chills, body aches, vertigo, nausea
and confusion. The patient spoke with his eldest son late that evening by phone and
told his son of his symptoms and the fact that he had been given a flu shot early
that day. Patient died after receiving a HIGH DOSE flu shot on the morning of
11/21/12. The shot was administered at pharmacy. The shot was given to the patient
at approximately 11:00 am on November 21, 2012. By late afternoon the patient was
experiencing flu-like symptoms; chills, body aches, vertigo, nausea and confusion.
The patient spoke with his eldest son late that evening by phone and told his son
of his symptoms and the fact that he had been giving a flu shot early that day. At
approximately 10:30 pm on 11/21/12 the phone conversation ended with the patient
stating that he was going to the bathroom because he did not feel well. The next
morning the patient did not respond to phone calls or knocking on the door by
relatives. Upon gaining entry to the home, the patient was found dead on the floor
between his bedroom and bathroom hallway. The patient was naked and face down on
the floor when found. The patient had no history of heart problems and had never
experienced a heart attack." "No autopsy was performed as it appeared at the time
to be a natural cause of death due to the patients advanced age."
"476687-1" "476687-1" "This case was reported in a literature article and
described the occurrence of glioblastoma multiforme in a 49-year-old male subject
who was vaccinated with influenza vaccine unspecified (manufacturer unspecified).
On an unspecified date the subject received unspecified dose of Influenza vaccine
unspecified (unknown route, unknown lot number). At an unspecified time after
vaccination with Influenza vaccine unspecified, the subject presented with a 2-week
history of bilateral lower extremity weakness and paresthesia starting at the level
of the axilla. The subject had a recent history of viral infection status post flu
vaccination. He was evaluated by Neurology and initially diagnosed with transverse
myelitis. He underwent intravenous immunoglobulin and steroid treatment without
improvement. The subject's physical examination revealed 3/5 proximal and 5/5
distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with
no upper motor neuron signs visualized. He was medically stabilized and transferred
to our inpatient rehabilitation facility. Ten days post admission, the subject
experienced acute motor loss (0/5) in bilateral lower extremities and worsening
paresthesia, now involving bilateral upper extremities. At 10 days post admission,
imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of
intramedullary enhancement. Prior to the completion of his medical work-up the
subject passed away due to unclear causes. The subject died from glioblastoma
multiforme and respiratory failure. Post mortem autopsy results showed
histopathological diagnosis of primary glioblastoma multiforme of the spinal cord."
"Neurological examination, see text"
"477186-1" "477186-1" ""This spontaneous report was received from the
patient's brother refers to a 13 months old female patient with no pertinent
Medical History or Drug reactions/allergies who on unspecified date in
approximately November 1994 (when the patient was 13 months of age) was vaccinated
with MMR II (dose, lot number and route no reported). No other co-suspects were
reported. No concomitant medications were reported. The night the patient received
the vaccine, the patient developed a high fever (107-108 F) and was sent to an
unspecified hospital where she was admitted and treated for an unspecified period
of time. On unknown date, the patient had multiple unspecified surgeries, became
blind and her ""immune system failed."" The patient was two years of age when she
died (approximately in 1995). The outcome of the events patient developed a high
fever (107-108 F), became blind and her ""immune system failed"" was unknown. The
relatedness for the event and MMR II was unknown. Additional information is not
expected."" "1993, Body temperature, 107-108 F"
"478039-1" "478039-1" "This spontaneous report as received from a licensed
practical nurse refers to an approximately 68 years old female patient with lupus
and merkel cell carcinoma. About 3 months ago (reported on 12-DEC-2012)(September
2012) the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot number and
route were not reported) at an unspecified pharmacy in an unspecified location. No
other co-suspects were reported. No concomitant medications were reported. The
nurse reported that the patient was given the vaccine even though he had both lupus
and merkel cell carcinoma. The nurse reported that after the vaccination, over the
following 2 months, the cancer progressed more aggressively (death, medically
significant, life threatening and hospitalization). On an unknown date the patient
sought medical attention. The patient was admitted to the hospital (date not
provided) and died while in the hospital. The patient died about a month ago.
(November 2012) and the cause of death was reported as cancer. The patient's doctor
at the hospital told the patient's family that he believed that the cancer's
progression was caused by ZOSTAVAX. Discrepant information reported in Source
Document: patient is referred to as 'female' in the patient section of the report,
but referred to as 'he' in Narrative. Additional information has been requested."
"No lab data for this event."
"478157-1" "478157-1" "This case was reported in a literature article and
described the occurrence of death nos in a 2-month-old subject of unspecified
gender who was vaccinated with DTP (manufacturer unspecified). The subject was born
prematurely at 28 weeks' gestational age. On an unspecified date, the subject
received 1st dose of DTP (unknown route of administration, unknown site of
injection, batch number not provided). 15 days after vaccination with DTP, the
subject experienced pertussis. The subject died from unknown cause of death. It was
unknown whether an autopsy was performed. Summary of literature article: Pertussis
is an endemic, underdiagnosed bacterial respiratory tract infection caused by
Bordetella pertussis. The incidence of pertussis is cyclical, with peaks every 2-5
years as the proportion of susceptible people in the population who are
immunologically naive or have lost immunity grows sufficiently large. The incidence
of pertussis reported decreased substantially after extensive childhood
immunization, falling from more than 265 000 cases in 1934 to a nadir of 1010 cases
in 1976. Subsequently, the number of report cases has increased. During the
cyclical peak year of 2005, more than 25 000 cases were reported, including more
than 3000 cases; cases included 8 deaths in infants younger than 3 months. Possible
explanations for the rising incidence of pertussis include large birth cohorts of
susceptible infants, the replacement of more reactogenic whole cell vaccines with
less effective acellular pertussis vaccines in the 1990s, more rapid waning of
immunity conveyed by acellular pertussis vaccines, and increased detection of
cases; and increased detection of cases through greater clinician awareness and the
availability of more sensitive polymerase chain reaction (PCR) tests for laboratory
confirmation. Pertussis PCR tests have been used since the 1990s and became the
predominant testing method in 2004. In 2010, experienced the highest number of
pertussis cases in more than 60 years, with more than 9000 cases, 809
hospitalizations, and 10 deaths. This report provides a descriptive epidemiolgic
analysis of this epidemic and describes public health mitigation strategies that
were used, including expanded pertussis vaccine recommendations. Clinical and
demographic information were evaluated for all pertussis cases with onset from
January 1, 2010, through December 31, 2010, and reported to the Department of
Public Health. A total of 9154 pertussis cases with onset in 2010 were reported:
5482 (60%) confirmed, 1706 (19%) probable, and 1966 (22%) suspect. Of the confirmed
cases, most (82%) were laboratory-confirmed by PCR testing, 6% were confirmed by
culture, and the remaining 12% were epidemiologically linked to a laboratory-
confirmed case. Of the suspected cases, 88% were confirmed by PCR testing and the
remaining were epidemiologically linked to confirmed cases. The majority (56%) of
reported patients became ill from June through September 2010; the peak month was
July. The reported incidence of cases per 100 000 population was 23.4 statewide but
varied 0-138.4 by county. Incidence was highest among infants younger than 6 months
and lowest in adults 19 years of age and older. Relatively high numbers of cases
were observed in fully vaccinated older children and adolescents, with the peak at
age 10 years; after age 10, the number of cases declined with age and remained low
among those aged 14-18 years. Information was reported for 8028 (88%) cases.
Overall, the incidence per 100 000 population. Infants younger than 6 months had
the highest case incidence (587.7 per 100 000); however, among young children and
adolescents aged 1-18 years, the highest incidence (70.3). A total of 809 (8.9%)
patients were hospitalized, of whom 584 (72%) were younger than 6 months and 446
(55%) were younger than 3 months. Sixty-two percent of all 720 infants younger than
3 months were hospitalized. The hospitalization rate among all infants younger than
6 months was 46%. The median age at disease onset among all hospitalized cases was
2.6 months (range less than 1 month to 92 years), and the median length of stay was
4 days (range 1-48 days). Of 1506 patients reported to have undergone radiography
or computed tomography of the chest, 285 (18%) had a diagnosis of pneumonia.
Nineteen patients had seizures and 3 had acute encephalopathy. Ten fatal cases were
reported, all in infants. Nine were previously healthy infants younger than 2
months at illness onset who had not been immunized against pertussis; 7 of these
infants were younger than 6 weeks. The remaining fatality was a 2-month-old infant
born prematurely at 28 weeks' gestational age who had received the first dose of
DTAP 15 days prior to disease onset. Nine of 10 fatalities were infants. The case-
fatality rate among infants younger than 3 months was 1.3%. Seven infants were
brought to medical attention for their pertussis illness at least once prior to the
visit that led to hospital admission. Five of these 7 infants had multiple prior
medical visits; however, only 1 received macrolide antibiotic therapy for
pertussis. All had leukocytosis with a median white blood cell count of 78 200
cells/mm3. All deaths occurred in infants with symptom onset in the first 9 months
of 2010. Of 4415 (76%) pediatric cases in infants aged 6 months through 18 years
with vaccination information, 380 (9%) were completely unvaccinated against
pertussis and 1621 (37%) had not received 1 or more recommended pertussis vaccine
doses; 745 (46%) of incompletely immunized individuals were 11-18 years old and had
not received TDAP. The remaining 2414 (55%) were reported to be fully immunized for
their age; most (66%) of these were children aged 7-10 years who had received 5
prior doses of DTAP immunized younger than the recommended age for immunization
with TDAP. Among 314 unvaccinated patients aged 6 month to 18 years. Infants
younger than 6 months had the highest disease rates; all deaths and most
hospitalizations occurred in infants younger than 3 months. Most pediatric cases
were vaccinated according to national recommendations, although 9% of those aged 6
months to 18 years were completely unvaccinated again pertussis. High disease rates
also were observed in fully vaccinated preadolescents, especially 10-year-olds.
Mitigation strategies included expanded tetanus, diphtheria, and acellular
pertussis vaccine recommendations, public and provider education, distribution of
free vaccine for postpartum women and contacts of infants, and clinical guidance on
diagnosis and treatment of pertussis in young infants. In conclusion, infants too
young to be fully vaccinated against pertussis remain at highest risk of severe
disease and death. Data are needed to evaluate strategies offering direct
protection of this vulnerable population, such as immunization of pregnant women
and of newborns. The high rate of disease among preadolescents suggests waning of
immunity from the diphthe" "UNK"
"480310-1" "480310-1" "According to son who was interrogated, decedent
received flu vaccine 12/19 at hospital and was not feeling well after that; found
dead at home 12/23, hemorrhagic pericarditis." "Viral and bacterial cultures of
pericardial blood pending"
 "480899-1" "480899-1" "Neighbor reported that the patient died 1-7-13.
Inital cause has been diagnosed as vomiting and diarrhea probably caused by a
virus. Due to its close approximation to vaccination I am reporting this incident."
"No lab data for this event."
"480995-1" "480995-1" "Vaccine 10-3-12. To ER 10-12-12 with (L) arm pain.
Seen 10-13-12 & transferred to cardiologist at hospital she declined there, was
diagnosed with Guillain-Barre, transferred to where she expired." "No lab data
for this event."
"481268-1" "481268-1" "None." "None"
"482344-1" "482344-1" "This spontaneous report as received via social media
refers to a female patient of unknown age, who on an unspecified date was
vaccinated with a dose of GARDASIL (dose and lot number were not reported). No
other co-suspects were reported. No concomitant medications were reported. The
other reported that the patient died after vaccination. The relatedness for the
adverse event was unknown for GARDASIL. This is one of the several reports from the
same source. Additional information is not expected." "No lab data for this event."
"482352-1" "482352-1" "This spontaneous report as received via social media
who reported multiple patients (unknown age and gender) who on an unspecified date
were vaccinated with a dose of GARDASIL (dose and lot number were not reported). No
other co-suspects were reported. No concomitant medications were reported. The
reporter stated that on an unspecified date, the patients died from the vaccine. No
treatment information was reported. At the time of the report, the patients outcome
for the adverse event was fatal. The relatedness for the adverse event was related
for GARDASIL. This is one of the several reports from the same source. Additional
information is not expected." "No lab data for this event."
"482371-1" "482371-1" "Hospitalized 12/12/12 through 12/22/12 at medical
center. Complaints of 6 months' increasing edema in hands and feet, current
unsteady gait, decreased strength. Diagnosed with Guillain-Barre Syndrome. Readmit
1/3/13 with worsening weakness, dysphasia. 1/5/13, expired during transport by
ambulance. Stopped at community hospital while en route. DOA at community
hospital. Medical center reporting seen at another medical center prior to current
medical center 1/3/13 admission for chest pain. Ruled out MI at that time." "No
lab data for this event."
"483009-1" "483009-1" "12-17-2012 - Acute Respiratory Illness, ? SIDS."
"Umbilical Vbg; bilirubin"
"483055-1" "483055-1" "MD visit at 1 week - healthy baby. 6 lbs 9 oz born
at 39 weeks. ? SIDS death." "No lab data for this event."
"483215-1" "483215-1" "Patient deceased." "No lab data for this event."
"483614-1" "483614-1" ""No documentation of any problem. Have received word
autopsy done - ""child died of natural causes."""" "No lab data for this event."
"483818-1" "483818-1" "Reported by family that he was found dead on
2/2/13." "No lab data for this event."
"483916-1" "483916-1" "Initial report was received from a healthcare
professional on 04 February 2013. A 19-year-old female patient had received an
injection of MENINGOCOCCAL VACCINE (manufacturer, lot number, route, site and date
of administration not reported) and an unspecified amount of time later became ill
and was hospitalized on 01 February 2013. The patient was diagnosed with bacterial
meningitis. The patient died on 03 February 2013. No additional information was
provided. Outcome was fatal. Documents held by sender: None." "Not reported"
"485004-1" "485004-1" "Per hospital and family reports, child was talking
to grandfather when she collapsed and stopped breathing. Grandfather performed CPR
until EMS arrived and child was transported via AirMed to Medical Center. Child
expired on 01/30/2013." "Child had been seen at Emergency Room on 01/27/2013 and
had positive rapid influenza A testing. No influenza testing through second Medical
Center but did have series of testing to determine cardiac related event. Autopsy
was declined by family."
"485188-1" "485188-1" "This spontaneous report as received from internet
referred to three patients of unknown age. On an unknown date the patients were
vaccinated with GARDASIL (Lot#, dose/frequency, route and duration were
unspecified). Then on an unknown date the patients died (three deaths have been
reported along with more reports of paralysis in girls who had gotten the poorly
tested HPV vaccine). The date and cause of death were not reported. It was unknown
whether autopsy was done. This is one of several reports that received from the
same source. Additional information has been requested." "No lab data for this
event."
"485434-1" "485434-1" "Born at 39 weeks gestation. Newborn screenings WNL.
May have been a twin." "None noted"
"485686-1" "485686-1" "This spontaneous report as received from a consumer
refers to an 82 year old male patient. The patient's medical history and concurrent
conditions were not provided. On 15-NOV-2012 the patient was vaccinated with a dose
of ZOSTAVAX. Dose, route and lot number were not provided. No concomitant
medications were reported. On an unknown date the patient experienced multi-organ
failure and cardiac arrest. The outcome of multi-organ failure and cardiac arrest
was reported as fatal. The patient died on 13-DEC-2012 at 1515 (military time) in
the hospital. The cause of death was reported as cardiac arrest and multi-organ
failure, according to the Death Certificate. No reporter causality was provided.
Additional information has been requested." "No lab data for this event."
"485757-1" "485757-1" ""2/19/13 23:24 Pt brought in by ambulance in cardiac
arrest, ""mother states pt has been having cough & URI symptoms since 5 days - seen
by doctor 2/19/13 & given 4 vaccines. Pt sleeping & crying - suddenly pt turned
white & was not breathing - 911 called & intubated. Doctor states he was not aware
of any illness & child's DILANTIN level was 1.0. No lab found in medical record
child revived & transfer to another hospital where child died on 2/20/13."" "See
reverse"
"485762-1" "485762-1" "This is a spontaneous report from a contactable
physician through Pfizer Vaccine Representative. This physician reported for a 8
year old (unknown gender) patient who received a dose of PREVNAR 13 on unknown
date. Relevant medical history and concomitant medication were unknown. It was
reported that on an unknown date the patient had streptococcus pneumonia and
meningitis. Therapeutic measures taken, if any, were unknown. The patient had not
recovered from the reported events and passed away on an unknown date in Feb2013
due to streptococcus pneumonia and meningitis. At the time of reporting, it was
unknown if autopsy was performed." "No lab data for this event."
"487277-1" "487277-1" "A report was received from a physician via a medical
representative concerning a 3 year old female. Her medical history, concurrent
diseases, and concomitant medications were not reported. On an unknown date, she
received nasal FLUMIST. The medical doctor mentioned that two to three years ago a
previously healthy 3 year old female died within three days of receiving FLUMIST in
her office. The medical representative was uncertain whether symptoms began shortly
after dose or three days later. At an unspecified time period after FLUMIST, the
patient started vomiting and collapsed. She was taken to hospital three days after
receiving FLUMIST and died. The physician stated that all the tests were negative,
and the child was afebrile. The medical representative was uncertain whether an
autopsy was performed. She also stated that the doctor thought the death was
related to FLUMIST. The official cause of death was cardiac arrest. On an
unspecified date, the patient died from the event of cardiac arrest, and at the
time of reporting the outcome of the event of collapse and vomiting was unknown.
According to the reporter the adverse event of cardiac arrest was considered to be
serious with the serious criteria of death and the adverse event of vomiting was
considered to be non-serious. According to the company physician the adverse event
of collapse was considered to be serious with the serious criteria of important
medical event. According to the reporter the adverse events were causally related
to the suspect drug of FLUMIST." "No lab data for this event."
"487403-1" "487403-1" "Initial report was received 11 March 2013 from a
health care professional. A four-month-old male patient had received an injection
of ACTHIB lot number UH609AA (corresponding sanofi pasteur SA lot number H1123-1),
PEDIARIX (manufacturer GSK, lot number AC21B357 and PREVNAR (manufacturer Pfizer,
lot number 918175) on 07 March 2013, and two days later on the evening of 09 March
2013, the patient passed away. He had previously received a first dose of RSV
vaccine on an unspecified date. The patient had been chronically ill with a history
of T fistula with esophageal atresia which was repaired, traceomalacia, PDA (patent
ductus arteriosus), PFO (patent foramen ovale), and cardiac issues. He had no known
allergies. The event outcome was fatal. Documents held by sender: None." "Not
reported"
"487601-1" "487601-1" "Child was found unresponsive in crib on 3/21/13 am.
Mom had fed at approx. 3 am and baby was fine. Found at 7 am face down in bassinet.
911 called. Pronounced dead at hospital." "No lab data for this event."
"487759-1" "487759-1" "He started having high grade fever on 3/12, reaching
up to 102.9. I asked him to go to his primary care physician who thought he had
ear infection and prescribed Levofloxacin. He called me on 3/16/13 complaining of
severe shortness of breath and choking sensation in the neck. He deteriorated over
the next few days with worsening shortness of breath, persistent fever, renal and
respiratory failure requiring hemodialysis and ventilator support. He also
underwent a single course of plasmapharesis with presumed diagnosis of Guillain
Barre Syndrome but did not respond. He had upper GI bleed and subsequent CT scan
showed free air in the abdomen. He underwent emergency surgery that showed gastric
gangrene and perforation. Total gastrectomy was performed. He had increasing
abdominal distention post-surgically and passed away approximately 5 am on
3/21/2013." "As above"
"489163-1" "489163-1" "Information has been received from a mother for
GARDASIL, a Pregnancy Registry product, concerning her 8 week old baby. On an
unknown date in December 2011 the mother was vaccinated with the first dose of
GARDASIL (lot number 0626AA) (dose, route and injection site were not reported). On
28-FEB-2012, the mother was vaccinated with the second dose of GARDASIL (lot
number, dose, route and injection site were not reported). On 23-MAR-2012 the
mother found she was pregnant and on 26-NOV-2012 she delivered the infant. The baby
was born on 26-NOV-2012, and died on 25-JAN-2013. Toxicology tests are being run to
see the cause of death. The action taken and causality of death was not provided.
The mother's information was captured in MARRS # 1304USA006478 (Parent-Child Link).
Additional information is not expected." "No lab data for this event."
"489391-1" "489391-1" "Initial report was received on 08 April 2013 from an
electronic lay press article. A 10-year-old female patient had received an
injection of INFLUENZA VACCINE (trade name, manufacturer, lot number, route, site
and exact date of administration not reported) in December 2012. The patient was
diagnosed with strain B flu on 20 March 2013. Three days after the patient was
diagnosed with the flu, she was rushed to the hospital after complaining of stomach
and chest pains and difficulty breathing. She went into cardiac arrest the
following morning, and doctors revived her after performing CPR for about two
hours. She was placed on a life support system to restore oxygen to her blood.
Doctors also put her on a machine to do the work of her heart while waiting for a
transplant. The infection morphed into a serious case of myocarditis. The patient
died from flu complications at 10:45 AM on 05 April 2013. Outcome was fatal.
Documents held by sender: none." "Not reported"
"490219-1" "490219-1" "No known reaction to vaccine. Patient passed away
4.21.13." "None"
"490225-1" "490225-1" "Patient found unresponsive in crib at daycare.
Resuscitative efforts unsuccessful." "None"
"491544-1" "491544-1" "This literature report (initial receipt: 30-Apr-
2013) concerns an 85-year-old male patient who had a medical history of congestive
heart failure and idiopathic pulmonary fibrosis. He had no history of illicit drug
use, excessive alcohol consumption, toxic exposures or family history of neurologic
disorders. On an unspecified date, the patient received influenza vaccine
(manufacturer and batch number not specified). On an unspecified date, 1 week after
vaccination the patient developed tingling in his feet. 1 week later he developed a
similar sensation in both hands. He reported difficulty unbuttoning his shirt and
unsteadiness when walking. He had no prior similar symptoms, preceding illnesses,
or recent changes in his health or medications. On examination, he had no cranial
nerve deficits and full strength. He had preserved light touch, temperature, and
pinprick sensation, but symmetrically diminished vibration sense and proprioception
to the level of both wrists and ankles. Reflexes were absent bilaterally in his
upper and lower extremities. On pronator drift testing, his arms drifted upward,
and his fingers made small involuntary movements. On finger-nose testing the
patient had difficulty reaching and maintaining contact with a target, which
worsened with eyes closed. He had no Romberg sign, but had mild gait instability.
The patient's gait unsteadiness, upward drift of the arms with pseudoathetosis of
the fingers (subtle movements suggestive of a proprioceptive deficit), and
worsening of finger-nose testing with eyes closed suggest a sensory ataxia. Sensory
ataxia, diminished vibration sense, decreased proprioception, and areflexia
localized to the posterior columns, large fibers of peripheral nerves, or
intervening dorsal root ganglia or nerve roots; the bilaterality, symmetry, and
areflexia made a supratentorial etiology improbable. Before referral to the
neurologist, the patient underwent laboratory evaluation for etiologies of
peripheral neuropathy, revealing normal vitamin B12, thyroid stimulating hormone,
hemoglobin A1C, serum and urine protein electrophoresis, and liver enzymes. Given
the rapidly evolving nature of his symptoms and absent reflexes, he was admitted
due to concern for possible Guillain-Barre syndrome (GBS). CSF analysis to assess
for inflammation or infection revealed normal glucose (60 mg/dL), mildly elevated
protein (64.2 mg/dL), and no red or white blood cells. Electromyography (EMG) and
nerve conduction studies (NCS) were performed to distinguish between axonal and
demyelinating etiologies of presumed polyneuropathy. NCS demonstrated reduced
amplitudes of sensory nerve action potentials (SNAPs) in the sural (left 3.3 mV,
right 0.60 mV), superficial peroneal (left 3.7 mV, right 3.3 mV), median (left 6.0
mV, right 6.1 mV), and ulnar nerves (left not recordable, right 5.2 mV); slightly
reduced amplitudes of combined motor action potentials (CMAPs) of bilateral median
(left 4.5 mV, right 2.5 mV), left ulnar (3.4 mV), and bilateral peroneal nerves
(left 1.7 mV, right 1.9 mV); and normal nerve conduction velocities (NCV), distal
latencies, and F waves. EMG was normal in bilateral tibialis anterior, left first
dorsal interosseous, and left extensor digitorum brevis muscles. Due to the lack of
weakness and bulbar symptoms and the NCS lacking features of demyelination with
preserved F waves, GBS and subtypes of GBS including acute inflammatory
demyelinating polyradiculoneuropathies (AIDP) and AIDP variants including Miller
Fisher syndrome were ruled out. He underwent extensive but unrevealing evaluation
for possible autoimmune, infectious, or paraneoplastic processes (serum antinuclear
antibodies, SS-A [Ro], and SS-B [La]; rapid plasma reagin and HIV; anti-Hu, anti-
GQ1B, and anti-GM1 autoantibodies; and computed tomography (CT) of the chest,
abdomen, and pelvis). Although the etiology of his illness was unclear, intravenous
immunoglobulin (IVIg) 0.4 g/kg/day was administered for 5 days. His symptoms
remained stable and he was discharged for rehabilitation. He initially noted
improvement in his gait and only minimal persistent numbness in his hands and feet.
One month later, however, his gait acutely worsened over several days, such that he
was too unsteady to walk or stand unassisted. He had a Romberg sign, swayed from
side to side when standing, and had a magnetic gait. His sensory, motor, and reflex
examinations were otherwise unchanged from his initial examination. The
differential diagnosis of the patient's progressive sensory symptoms includes
chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and
ganglionopathy. Ganglionopathy was diagnosed as it presents with sensory ataxia and
deficits in proprioception and vibration sense with reduced SNAPs all seen in the
patient. EMG/NCS were repeated and demonstrated relatively unchanged SNAPs and
CMAPs compared to his prior NCS. Since worsening axonal neuropathy or
ganglionopathy would have been expected to result in further decrement in his
SNAPs, his clinical progression in the setting of stable electrodiagnostic studies
suggested a more proximal lesion at the level of the nerve roots or posterior
columns. In this patient, somatosensory evoked potentials (SSEPs) revealed no
reproducible waveforms at any site. Given the presence of SNAPs on routine NCS, the
absence of SSEPs suggests block of conduction more proximally (e.g., at the level
of proximal nerve roots or posterior columns). Magnetic Resonance Imaging (MRI) of
the spine with gadolinium was performed, demonstrating enhancement of numerous
lumbosacral nerve roots and dorsal root ganglia with a normal-appearing spinal
cord. Nerve biopsy was proposed, but deferred by the patient and his family. This
constellation of clinical, electrodiagnostic, and imaging features is suggestive of
chronic immune sensory polyradiculopathy (CISP). He was treated with another course
of 5 days of IVIg followed by 1 g/kg over 2 days monthly for 4 months and
prednisone 60 mg daily. His neurologic status did not improve with therapy,
suggesting that he had developed irreversible damage to his proximal nerve
segments. He died several months later from complications of his underlying
cardiopulmonary disease." "CSF analysis, Protein, 64.2 mg/dL, Elevated"
"491893-1" "491893-1" "Immediately after the vaccines, the child looked
pale and blood like foam came in the mouth. The child pooped too. The doctor came &
stated after checking his mouth that he is normal and it is due to immunization."
"No lab data for this event."
"492001-1" "492001-1" ""Spontaneous information received on 03MAY2013 and
08MAY2013 from a family member of a consumer. An adult male experienced Valley
Fever (coccidioidomycosis), and subsequently died. Medical history - the subject
was reportedly in good physical condition. No known medical history. History of
events per adult subject's father. Subject was immunized in October of 2007. Within
a day of vaccination he experienced pain and illness, though the father could not
remember the nature of immediate post-vaccination symptoms. He was eventually
diagnosed with Valley Fever (coccidioidomycosis) contracted during his time at
work. ""He did not respond to treatment. The doctors said his immune system was not
working. He had several surgeries. He was given many drugs that did not stop the
infection."" Reportedly, he was let go due to his illness. In 2011 he had 3
surgeries to remove 2 1/2 ribs and portions of his spinal bones, and further
surgery to reinforce his spine. In 2013, he had ""pockets"" of infection in his
bones; belly, and brain as well as his lungs. He refused treatment with a
ventilator and subsequently died on 22APR2013. Per the subject's father: ""His work
gave him the vaccines. The doctors treated his infection. The doctors said the
vaccine did not cause his infection. They said the vaccines did not cause his
immune system to stop working. The employer said we could not sue. The employer is
not telling us everything."""" ""No test results provided. Per reporter, ""too
many to remember"".""
"492023-1" "492023-1" ""This spontaneous report as received from a consumer
refers to an approximately 77 years old male patient with cancer. Approximately in
May 2010, reported as approximately 3 years ago, patient was vaccinated with a dose
of ZOSTAVAX (dose, route and lot number and expiration date not reported). Reporter
stated that patient wasn't on anything and was pretty healthy. No concomitant
medications were reported. On an unknown date the patient experienced cancer.
Approximately in May 2011, reported as about two years ago, patient died. Reporter
stated that she didn't know if it was from cancer or vaccine and none of doctors
could pinpoint the reason of death. On an unknown date the patient even had to have
open heart surgery. Consumer reported also that at the end of his life
(approximately in 2011) he experienced breaking out over his entire body, extremely
painful, he couldn't eat, couldn't sleep and had temporary loss of bowel control.
The patient complained also about pain through his entire body and severe fatigue.
On an unknown date patient was hospitalized and then moved to hospice facility. He
sought medical attention. The treatment given for the events were reported by the
consumer as: the doctors said ""maybe it's this maybe it's that"". The outcome of
open heart surgery, cancer, breaking out over his entire body, extremely painful,
couldn't eat, couldn't sleep, temporary loss of bowel control, pain through his
entire body and severe fatigue was not reported. The relatedness open heart
surgery, cancer, breaking out over his entire body, extremely painful, couldn't
eat, couldn't sleep, temporary loss of bowel control, pain through his entire body
and severe fatigue between and ZOSTAVAX was not reported. Additional information is
not expected."" "No lab data for this event."
"492174-1" "492174-1" "This spontaneous report as received from a other
health professional (medical student) refers to a currently 15 years old male
patient with T cell precursor lymphoblastic leukemia (ALL) undergoing chemotherapy.
On an unknown date the patient's brothers were vaccinated with a dose of varicella
virus vaccine live (manufacturer unknown) lot # dose not reported, it was not known
if the patient had been vaccinated. On an unknown date, the patient experienced
disseminated varicella (hospitalization) and died (on an unspecified date). The
cause of death was unknown. At the time of the report the outcome for disseminated
varicella, patient's brothers were vaccinated with a dose varicella virus vaccine
live were unknown. Additional information has been requested." "No lab data for
this event."
"492192-1" "492192-1" "Infant was found expired in her crib on the morning
following vaccination. Mother reports that she had a tactile fever on the evening
prior to her death." "An autopsy has been conducted by the Medical Examiner and
results are pending at this time."
"492468-1" "492468-1" "This spontaneous report as received from a female
consumer via company representative who refers to her niece. On an unknown date the
patient was vaccinated with GARDASIL (route, dose, number of doses, lot# not
reported). As was reported that on an unknown date the patient died from
complications while using GARDASIL. No more information were provided. Additional
information has been requested." "No lab data for this event."
"492545-1" "492545-1" "This spontaneous report was received from a
physician via a company representative concerning an 86 year old female patient
with diabetes, hypertension, lumbar spondylosis, hyperlipidemia and chronic
allergies. Patient's medical history included elevated c-reactive protein and
elevated eosinophil levels. On 11-MAR-2013, the patient was vaccinated with a dose
of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant
therapies included PRAVACHOL (20 milligrams), KLOR-CON 10 milligrams(mg),
hydrochlorothiazide (dose unspecified), SOMA (350 mg), atenolol (50 mg) and
amitriptyline hydrochloride (50 mg). On 31-MAR-2013, the patient experienced
palpable purpura and vasculitis covering her body two weeks after receiving
ZOSTAVAX. Her physician advised her to immediately go to the hospital. The patient
was admitted to the hospital (name unspecified) on 31-MAR-2013 and was given
medication to treat her condition (prednisone-dosage unspecified). The patient was
discharged on 02-APR-2013. Approximately on an unknown date in April 2013, upon
returning home the patient developed a urinary tract infection, and experienced
profound weakness and anemia. The patient was readmitted to the unspecified
hospital for these symptoms on 18-APR-2013. Upon discharge (exact date unspecified
in 2013) the patient was sent to a rehabilitation center (unspecified) where she
remained until two days before her death. The events were not resolved at the time
of reporting. On 11-MAY-2013, the patient died due to sepsis. It was unknown if the
autopsy was done. The physician noted that blood work that was taken from the
patient directly preceding vaccination indicated that she had elevated C-reactive
protein levels directly before she received the vaccine which may have been an
indicator of the declining conditions of the patient. The relatedness for the
events was unknown for ZOSTAVAX. The reporter considered the events to be life
threatening. Additional information has been requested." "Blood work (March
2013): Elevated C-reactive protein levels."
"492765-1" "492765-1" "This spontaneous report as received from a consumer
refers to the consumer's neighbor of unknown age and gender. On an unknown date the
patient was vaccinated with PNEUMOVAX23 (strength, dose, via, indication, lot
number and expiration date not reported). There was no concomitant medication
reported. The reporter stated that the unspecified neighbor died on an unknown date
from PNEUMOVAX23. This is one of several reports from the same source (MARRS case #
1305USA014871). Additional information has been requested.""No lab data for this
event."
"493595-1" "493595-1" "? SIDS (death cert. not yet available)." "No lab data
for this event."
"493596-1" "493596-1" "? SIDS (death cert. pending)." "No lab data for
this event."
"493598-1" "493598-1" "? SIDS (final death cert not avail.)." "No lab data
for this event."
"493599-1" "493599-1" "? SIDS (death cert. not yet available)." "No lab data
for this event."
"493734-1" "493734-1" "This spontaneous report as received from a
pharmacist (or pharmacy technician - it was not confirmed) via company
representative refers to a female patient of unknown age and unknown medical
history. The husband reporting on his wife to the pharmacist, on an unknown date
the patient was vaccinated with ZOSTAVAX, (0.65 ml in one shot; subcutaneously)
(lot number, exp. date not reported). On an unknown date reported as shortly after
receiving ZOSTAVAX the patient had developed an infection in her heart and died
from the infection in her heart shortly after having development of infection on an
unknown date. It was reported that the patient may had been immunodeficient because
her husband stated that she was not the healthiest prior to receiving ZOSTAVAX and
that she might also have developed a rash after receiving ZOSTAVAX but neither the
presence of immunodeficiency or the development a rash had been confirmed. The
outcome of the heart infection was fatal. The cause of death was heart infection.
The patient's husband was adamant that ZOSTAVAX caused the infection in the
patient's heart. No legal issues was suspected at this time. Additional information
has been requested." "No lab data for this event."
"493988-1" "493988-1" "Infant found blue and limp in bassinet with twin
(who was crying to be fed). 911 called. Ambulance crew could not resuscitate
infant." "No lab data for this event."
"494024-1" "494024-1" "On 1/25/2012, as per mother patient developed a
black bruise to the left upper arm where vaccines had been administered that
covered most of the entire upper arm. On February 1, 2012, he developed a sore
throat and fever that lasted a week. On February 7, 2012 at 11 am he reported to
hospital. As per mother, patient was non-responsive and was throwing up blood-
tinged saliva. He was flown out due to an internal hemorrhage. He was admitted to
hospital at around 3 pm. After admission, he remained unresponsive. As per mother,
the internal cerebral hemorrhage was too advanced and the patient was not a
candidate for surgery so patient eventually became comatose. He passed away on
2/10/2012 at 2 am. Final diagnosis was cerebral hemorrhage and leukemia. As per
parent, the client had no previous history of illnesses at the time of vaccination
on 1/25/2012." "No lab data for this event."
"494498-1" "494498-1" "This is an initial spontaneous report by a
contactable physician. A female patient received PREVNAR 13 (Lot number: G54897,
Expiration Date: 09Jan2014) unknown dose unknown, frequency ,unknown anatomical
location of the administration for an unknown indication in May2013. Relevant
medical history was unknown. Relevant concomitant medications were unknown.
Vaccines given on the same day was unknown. Vaccines taken within the last four
weeks were unknown. In 2013 she experienced pneumococcal pneumonia, pneumococcal
sepsis and an unspecified condition to which she passed away. Relevant lab data was
unknown. It was unknown if an autopsy was performed. At the time of report she had
not recovered from an unspecified condition. At the time of report the clinical
outcome for the other events were unknown." "No lab data for this event."
"494747-1" "494747-1" "Symptoms = Serum sickness. Addison's disease,
bacteremia, sepsis, pneumonia in both lungs, swollen lymph nodes in chest, neck,
underarms, daily chills & fever, rash all over, intense itching, nausea, dizziness,
extreme weakness, hunger, swollen hands and feet, extreme joint pain in hands,
feet, and knees, thrush, diarrhea. The last 2 weeks he would not eat (no appetite)
and his mouth was very painful. There were times when he couldn't think clearly.
Most symptoms appeared soon after the vaccine and got worse with time. For the last
week, he was too weak to stand for more than a few minutes. Treatment: Steroid
shots, prednisone daily, BENADRYL, CLARITIN, anti-itch pills and cream, intravenous
antibiotics (VANCOMYCIN, ROCEPHIN, ZITHROMAX, GENTAMYCIN), ZOSYN, ZANTAC, ZOFRAN,
oxygen after 5-16-13, breathing treatments, COMBIVENT, SYMBICORT, MAGIC MOUTHWASH.
My husband was in the ER 4 times, had 10 doctor visits, and was admitted to the
hospital 3 times: 5-10-13 to 5-16-13; 5-21-13 to 5-31-13; 5-31-13 was taken by
ambulance to hospital. He was discharged 6-4-13 and he died the next day. On 6-5-
13, Dr at hospital inserted a breathing tube and a central line. My husband was to
be flown to another hospital when he went into cardiac arrest on the plane and did
not survive. Please tell me what happened. On February 8 before he got this
vaccine, he was healthy and strong. I hope you will contact me." "ESR; CBC with
diff; CMP; Urinalysis; Lymph node biopsy"
"494750-1" "494750-1" "This medically confirmed spontaneous report (initial
receipt 18-Jun-2013) concerns a female patient approximately 2 years old. Some time
in January or February of 2013, the patient developed sepsis and subsequently
passed away. The patient had received a flu shot (influenza vaccine, batch and
manufacturer unspecified) prior to developing sepsis. The patient had been
hospitalised (hospital information and duration unspecified) and CPR
(cardiopulmonary resuscitation) had been conducted. The event outcome was fatal.
Reporter's comments: The reporter considered events serious due to hospitalisation,
intervention to prevent serious criteria (CPR conducted), life threatening events
(patient passed away) and death." "No lab data for this event."
"494783-1" "494783-1" "This case was reported in a literature article and
described the occurrence of unknown cause of death in an adult subject of
unspecified gender who was vaccinated with Influenza vaccine unspecified
(manufacturer unspecified). On an unspecified date, the subject received an
unspecified dose of Influenza vaccine unspecified 2011-2012 season (administration
site and route unknown, batch number not provided). At an unspecified time after
vaccination with Influenza vaccine unspecified 2011-2012, the subject was
hospitalised. The subject died from cause undetermined. It was unknown whether an
autopsy was performed. Summary of the literature article: Annual influenza vaccine
has been recommended for adults at high risk for influenza complications since
1960; universal vaccination has been recommended since 2010. Two recent reviews
both reported that there is little evidence to support vaccine effectiveness
against serious influenza complications for adults. Clinical trials have been too
small to evaluate influenza complications, and most observational studies have not
used laboratory-confirmed influenza as an outcome. The case-positive, control-
negative study design is an efficient method to determine vaccine effectiveness
that assures appropriate classification of cases and identifies controls with risk
factors for both acute respiratory illness and propensity to seek medical care
similar to those of influenza-positive patients. During the 2011-2012 influenza
season, the authors enrolled hospitalized adults with acute respiratory illness and
tested each for influenza using reverse transcription polymerase chain reaction.
Influenza vaccination was verified in 35% (6/17) of adults with influenza-
associated hospitalizations compared to 64% (97/152) of test-negative controls;
adjusted vaccine effectiveness was 71.4% (95% confidence interval, 17.1% - 94.9%).
Although the authors enrolled subjects with fairly broad eligibility criteria,
discharge diagnoses were not associated with either influenza diagnosis or
vaccination status. These data are among the first estimates of vaccine
effectiveness for the 2011-2012 influenza season. More important, this study adds
to the evidence indicating that inactivated influenza vaccine can prevent more than
half of all influenza-associated hospitalizations in older adults. Influenza causes
an average of 294 128 hospitalizations annually; most are in adults aged. 50 years.
The authors's conclusion stated that given current vaccination rates and a vaccine
effectiveness of 60%, more than one-third of these hospitalizations could be
prevented by increasing vaccination uptake in this population." "UNK"
"494837-1" "494837-1" "Unknown-patient died at home on 5/15/13. Time of
death not indicated on death certificate. Manner of death indicated as natural and
pulmonary aplasia listed as cause of death." "No lab data for this event."
"495254-1" "495254-1" "Pt died at Hospital 5 days after imm received no
adverse reactions reported after immunizations given. Baby reported to have fallen
off of couch on June 24th and put to bed with a bottle propped. No obvious signs of
trauma or aspirations. No problems that day besides some congestion. Has a history
of being seen in the ER for febrile seizures never reported at the health
department. Child was going the next day for 9 month old check up. No history of of
problems with any vaccine." "Cororner will release copy of autopsy and coroners
report will not be back for 2 months. Please submit a request on your letter head."
"495685-1" "495685-1" "Possible SIDS (SUID)." "Autopsy by medical examiner"
"496785-1" "496785-1" "This case was reported in a literature article and
described the occurrence of acute myocardial infarction in a 53-year-old male
subject who was vaccinated with DTPa (with small D and P, manufacturer
unspecified). Concurrent medical conditions included multiple cardiac and
neurological conditions. On an unspecified date, the subject received unspecified
dose of DTPa (with small D and P) (administration site and route unknown, batch
number not provided). 69 days after vaccination with DTPa (with small D and P), the
subject experienced acute myocardial infarction and died. It was unknown whether an
autopsy was performed. This is one of the 11 cases created from the same literature
article. Summary of the literature article: Pre-licensure clinical trials for two
licensed Tdap vaccines did not reveal any major safety concerns. However, routine
use in large adolescent and adult populations could reveal rare and potentially
serious adverse events (AEs). To characterize reported AEs following Tdap
vaccination and identify potential safety concerns warranting further evaluation,
we analyzed data from Vaccine Adverse Event Reporting System (VAERS) and assessed
the frequency and proportions of AEs and reporting rates (reports per 100,000
vaccine doses distributed). A total of 2090 reports (7% were serious; 55% listed
Tdap alone) involving Tdap vaccines were submitted to VAERS May 2005 - June 2007.
The crude reporting rate was 10.2 per 100,000 vaccine doses distributed. The median
age of vaccinees was 22 years, and the female to male ratio was about 2 to 1. The
majority of reports distributed. The majority of reports described common local and
systemic signs and symptoms, such as injection site reactions, fever, and headache.
Rarely reported AEs included myopericarditis, demyelinating diseases of the central
nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis,
seizure, Bell's Palsy, anaphylaxis, and thrombocytopenia. The author's conclusion
stated that because adolescents and adults were not routinely vaccinated against
pertussis in the past, this surveillance summary provides important - and
reassuring - information about the use of Tdap in these age groups. Although
subject to the limitations of passive surveillance, the findings of this VAERS
review support the pre-licensure clinical trial data with regard to the safety of
the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that
are temporally associated with Tdap vaccination and further assessment of such
events using controlled observational studies may provide additional information
about the safety of these vaccines." "UNK"
"498463-1" "498463-1" "?SIDS/SUIDS. Death cert. not yet avail. For autopsy
report, contact Medical Examiner or HCP." "No lab data for this event."
"498956-1" "498956-1" "Information has been received from a lawyer
concerning a male (age unspecified) who on an unspecified date received a dose of
PNEUMOVAX23 (route, dose, site and lot number not reported). Subsequently the
patient died. The exact cause and date of death was not reported. It was unknown
whether the patient underwent an autopsy. The reporter stated that it is believed
that the PNEUMOVAX23 caused the patients death. Additional information has been
requested." "No lab data for this event."
"499752-1" "499752-1" "None at time of vaccination. Pt died 3-30-13 per
family report. No known connection to vaccine administration." "No lab data for
this event."
"500201-1" "500201-1" "He received vaccines 8-20-13 at 11:30 AM in the
office and was notified by Coroner's office he had expired 8-21-13 by fax." "No
lab data for this event."
"500297-1" "500297-1" "My son was administered the Hep B vaccination at one
day old and died at 18 days old almost to the minute of original vaccination date
and time. I was told by VAERS if your gonna have a deadly reaction it will happen
w/n 18 days." "Deceased"
"500517-1" "500517-1" "Excessive fussiness, vomiting, came to urgent care
asystolic, time of death called after resuscitative efforts failed, small bowel
necrosis determined at autopsy." "Full autopsy/medical examiner report pending"
"500986-1" "500986-1" "Felt hot but no temp. taken. Died in sleep." "No
lab data for this event."
"501076-1" "501076-1" "Death." "No lab data for this event."
"501081-1" "501081-1" "This spontaneous report as received from a health
care worker refers to a female patient of unknown age. On 22-AUG-2013 the patient
was vaccinated with a dose of GARDASIL (dose, route, lot number not provided). On
25-AUG-2013 the patient was found dead in her dorm room. The cause of dead had not
been specified. Additional information has been requested.""No lab data for this
event."
"501276-1" "501276-1" "Found in early morning app 0630 layed down at 2200."
"No lab data for this event."
"501663-1" "501663-1" "Initial report was received 26 August 2013 from a
health care professional. A 17-year-old female patient with no known allergies had
received a second dose intramuscular injection of MENACTRA, lot number U4584BA and
a first dose intramuscular injection of GARDASIL (manufacturer Merck, lot number
H020848) (sites of administration not reported) on 09 August 2013, and 13 days
later on 22 August 2013, the patient died. There was no contact with the physician
after MENACTRA had been given. The patient had previously received a first dose
injection of MENACTRA on 04 September 2008. The reporter had been contacted by the
county medical examiner who informed the reporter about the death and requested the
patient's medical history. The reporter contacted the CDC (Centers for Disease
Control and Prevention) who told them to call and report the event to VAERS. No
additional information was provided at the time of the report. Documents held by
sender: None." "Not reported"
"502563-1" "502563-1" "Past away. 12-4-2011." "No lab data for this event."
"503830-1" "503830-1" "This case was reported in a literature article and
described the occurrence of anti-neutrophil cytoplasmic antibody positive
vasculitis in a 70-year-old male subject who was vaccinated with Influenza vaccine
(unspecified) (unknown route, site of injection and batch number). On on
unspecified date, the subject received unspecified dose of influenza vaccine
(unspecified) (unknown route, site of injection and batch number). Three weeks
after vaccination with Influenza vaccine (unspecified), the subject experienced
anti-neutrophil cytoplasmic antibody positive vasculitis
(perinuclear/myeloperoxidase), granulomatosis with polyangiitis which led to a end-
stage renal disease. The kidney was the only organ involved. The subject was
treated with cyclophosphamide and prednisone. At an unspecified date, the subject
died. In the article, the cause of death of two fatal cases was reported
(refractory vasculitis and bilateral pneumonia). However, no precision was
available to link this case to one these two reported causes of death. This case is
linked to 7 cases coming from the same publication." "UNK"
"504269-1" "504269-1" "Patient given Pedvax HIB, PPV23 and MPSV4 on 28 Jan
2013 in facility per Dr prescription from PCM for splenectomy. Copy of vaccines
given to patient before leaving clinic. On 06 Feb 2013 Patient was admitted to
hospital and given as vaccines again due to pharmacist/doctors saying he had not
recieved the vaccines. On 02/21/2013 patient passed away at the hospital from
kidney failure." "No lab data for this event."
"504528-1" "504528-1" "S.U.I.D/S.I.D.S? Death cert. not yet available. For
autopsy result, contact medical examiner or child's HCP." "No lab data for this
event."
"504693-1" "504693-1" "Initial report was received from a healthcare
professional on 20 September 2013. A 67-year-old female had received an
intramuscular injection in the left deltoid of FLUZONE HIGH-DOSE, lot number
U4759AA, on 13 September 2013. On 19 September 2013, the patient went to the
emergency room (ER) and was seen by her oncologist. She presented with coughing up
blood, bruising and a fever. The patient died four hours after arrival to the ER.
There was no bleeding or bruising at the injection site after vaccination and a 1
inch, 25 gauge needle was used. Lab data included platelets 88K, hemoglobin 12.9,
hematocrit 38, INR 8 and WBC 6.5. Concomitant medication included COUMADIN,
acetylsalicylic acid (ASA), CELEBREX, PLAQUENIL, SINGULAIR, hydrochlorothiazide
(HTZ) and ATIVAN. The patient had a history of lupus, idiopathic thrombocytopenic
purpura (ITP), anxiety and asplenia and allergies to DEMEROL, phenobarb and
nitrofurantoin. The patient received regular FLUZONE in the past without problems.
Outcome was fatal. Documents held by sender: None." "No lab data for this event."
"504792-1" "504792-1" "Patient received FLUZONE high dose 9/29/13. Patient
died 9/30/13, family believes the death is due to advanced age, not the
vaccination." "No lab data for this event."
"504856-1" "504856-1" "This spontaneous report as received from a
pharmacist via company representative refers to a patient of unknown age and
gender. On 23-AUG-2013 the patient was vaccinated with ZOSTAVAX, injection (dose,
route and lot number unknown). Other suspect therapies included diphtheria toxoid,
pertussis acellular vaccine (manufacturer unknown) and FLUZONE. On an unknown date
in 2013 the patient experienced death, following unspecified surgery. The
pharmacist stated that a physician (unspecified) called the pharmacy on 24-AUG-2013
and was inquiring about the 3(three) vaccinations that the patient had received.
The physician stated that the patient had exhibited a fever. A request was made for
the patient's Primary Care Physician's, name and contact information. A request was
made for a copy of the patient's Death Certificate and/or Autopsy Report. The
pharmacist stated that there were several physician's involved with the patient's
case. The pharmacist refused to give any information and stated that the patient's
information was being handled by Clinical Risk Management for Pharmacy. Relatedness
between vaccination with ZOSTAVAX and death was not reported. Upon internal review
surgery was considered medically significant. Additional information has been
requested." "No lab data for this event."
"505344-1" "505344-1" "Information has been received from a consumer via a
website concerning a female patient of unknown age. On an unknown date the patient
was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown
date, the patient died in her shower. The patient was so healthy prior to the
vaccination. The post mortem result stated cause of death unknown. This is one of
several reports received from the same source. Additional information has been
requested." "No lab data for this event."
"505350-1" "505350-1" "Information has been received from a consumer via a
website concerning a female patient of unknown age. On an unknown date the patient
was vaccinated with GARDASIL (lot#, dose, and route not provided). On an unknown
date, the patient died 40 hours after her third shot of GARDASIL. The patient had
been so healthy prior to the vaccination. The post mortem result stated cause of
death unknown. This is one of several reports received from the same source.
Additional information has been requested." "No lab data for this event."
"505358-1" "505358-1" "This case was reported in a literature article and
described the occurrence of cardiac arrhythmia in a 13-year-old male subject who
was vaccinated with DTPa (with small D + P), (manufacturer unspecified). On an
unspecified date, the subject received an unspecified dose of DTPa (with small D +
P) (administration site and route unknown, batch number not provided). 14 days
after vaccination with DTPa, the subject died from cardiac arrhythmia. An autopsy
was performed and showed cardiac arrhythmia. This is one of the 11 cases created
from the same literature article. Summary of the literature article: Pre-licensure
clinical trials for two licensed Tdap vaccines did not reveal any major safety
concerns. However, routine use in large adolescent and adult populations could
reveal rare and potentially serious adverse events (AEs). To characterize reported
AEs following Tdap vaccination and identify potential safety concerns warranting
further evaluation, we analyzed data from the Vaccine Adverse Event Reporting
System (VAERS) and assessed the frequency and proportions of AEs and reporting
rates (reports per 100,000 vaccine doses distributed). A total of 2090 reports (7%
were serious; 55% listed Tdap alone) involving Tdap vaccines were submitted to
VAERS May 2005 - June 2007. The crude reporting rate was 10.2 per 100,000 vaccine
doses distributed. The median age of vaccinees was 22 years, and the female to male
ratio was about 2 to 1. The majority of reports described common local and systemic
signs and symptoms, such as injection site reactions, fever, and headache. Rarely
reported AEs included myopericarditis, demyelinating diseases of the central
nervous system, Guillain-Barre Syndrome, syncope, encephalopathy/encephalitis,
seizure, Bell's palsy, anaphylaxis, and thrombocytopenia. The author's conclusion
stated that because adolescents and adults were not routinely vaccinated against
pertussis in the past, this surveillance summary provides important - and
reassuring - information about the use of Tdap in these age groups. Although
subject to the limitations of passive surveillance, the findings of this VAERS
review support the pre-licensure clinical trial data with regard to the safety of
the licensed Tdap vaccines. Continued monitoring of clinically significant AEs that
are temporally associated with Tdap vaccination and further assessment of such
events using controlled observational studies may provide additional information
about the safety of these vaccines." "No lab data for this event."
"505364-1" "505364-1" "Information has been received from a consumer via a
website concerning a female patient of unknown age. On an unknown date, the patient
was vaccinated with GARDASIL (lot#, dose, and route not provided). On unknown date,
the patient died in her bath. The patient had been so healthy prior to the
vaccination. The post mortem result stated a cause of death unknown. Additional
information has been requested." "No lab data for this event."
"506338-1" "506338-1" "She started to have a fever of 100.4 about 3:00 PM
on 09/16/2013. I gave her Tylenol to lower the temperature. She continued to have
a fever off and on for the night and following day. About 6:30 AM on 09/17/2013,
she had diarrhea that leaked out of her diaper down her left leg onto her foot. On
the morning of 09/18/2013, she was cranky and fussy. I was unable to calm her.
She even refused her pacifier that she loved. About 11:00 AM, she was found on her
back without a pulse and not breathing. She was pronounced dead at the hospital
later that day." "According the autopsy, she did not suffocate nor drown. Her
heart appears to be good. At her doctor's visits, Dr. checked to make sure her
heart and lungs sounded good as well. He said they sounded great. Further results
from the toxicology and tissue biopsy will be ready in about 4 more weeks."
"507356-1" "507356-1" ""Initial report was received on 30 September 2013
from another manufacturer who received the report from a consumer. An unidentified
male patient with no reported past medical history had received tetanus adsorbed
toxoid (manufacturer, lot number, route, site and date of administration not
reported and an unspecified amount of time later died. According to the report, the
patient's sister reported that patient died after ""12 doses of tetanus vaccine"".
No further information was available at the time of the report. The patient's
outcome was fatal. Addendum 09 October 2013: Upon internal review of this case, the
vaccine was amended from tetanus adsorbed toxoid to tetanus toxoid. Documents held
by sender: none."" "Lab tests unknown"
"507897-1" "507897-1" ""Received call from coroner 10/17/13 that the
patient had ""died in the morning""."" "No lab data for this event."
"509086-1" "509086-1" ""Initial report was received from a healthcare
professional on 07 October 2013. An 86-year-old female patient had received an
injection of FLUZONE HIGH-DOSE (lot number, route and site of administration not
reported) on 24 September 2013 and an unspecified amount of time following
vaccination experienced decreased appetite, stomach and back pain, was dehydrated
and had increased white blood cells. The patient passed away on 02 October 2013, 8
days post-vaccination. The patient had a history of a ""bone marrow issue in that
did not make enough red blood cells"". No additional information was provided.
Outcome was fatal. Documents held by sender: None."" "Lab tests unknown"
"509650-1" "509650-1" "PATIENT RECEIVED THE INFLUENZA VACCINE IN 10/24/2013
AT 7:20 PM DURING A MASS VACCINATION. THE FAMILY REFERS THE PATIENT WENT TO SLEEP
AND DURING THE MORNING OF 10/25/2013 THE PATIENT'S DAUGHTER FOUND HER DEAD IN HER
BED. THE FAMILY INDICATES THAT THEY KNEW THE PATIENT HEART CONDITION HISTORY AND
BELIEVE HER DEATH WAS A RESULT OF NATURAL CASUES, STILL A VAERS REPORT WAS CREATED
DUE TO THE SHORT TIME BETWEEN THE VACCINATION AND HER TIME OF DEATH." "NONE
AVAILABLE"
"509901-1" "509901-1" "This spontaneous report as received from a consumer
refers to a his male friend of unknown age with CLL (Chronic lymphocytic
leukaemia). On an unknown date, the patient was vaccinated with ZOSTAVAX (Lot, dose
and route not provided). On an unknown date, the patient experienced died. On an
unspecified date, the patient sought medical attention by doctor's visit. The
patient cause of death was not provided. The reporter considered this report as
life threatening. Additional information has been requested." "No lab data for
this event."
"510130-1" "510130-1" "Victim was found unresponsive/cardiac arrest in bed
at home in the morning of 8/20/13. Autopsy showed cause of death was myocarditis."
"Autopsy."
"510192-1" "510192-1" "Patient presents to outside ED for evaultion of new
onset weakness with numbness/tingling in hands with progression to feet. He was
having difficulty walking. CT and blood work was negative. Sent home with Dilaudid.
On 9/16, he presents to his primary care docto. He is now unable to stand or hold
objects in his hands. Denies fever, chills sweats or vision changes. He is admitted
to hospital for neurologic work up. On 9/19, he is transferred to the MICU.
Neurology consulted. based on findings from lumbar puncture and nerve conduction
studies, diagnosis most consistent with GBS related to flu vaccine (FLUARIX
QUADRIVALENT). Therapy with IVIG started on 9/19. On 9/27, patient became
unresponsive with PEA arrest and expired." "No lab data for this event."
"510310-1" "510310-1" "This is a spontaneous report from a contactable
consumer. A patient of unspecified age, ethnicity, and gender received PREVNAR, via
an unspecified route of administration on an unspecified date at a single dose for
an unspecified indication. The patient's medical history and concomitant
medications were not reported. On an unknown, the patient passed away from an
unknown cause. Therapeutic measures taken in response to the event were unknown.The
clinical outcome was fatal and it was unknown if an autopsy was performed." "No
lab data for this event."
"511031-1" "511031-1" "This spontaneous report has been received from a
pharmacist concerning to a patient of unknown age and gender. Current conditions,
medical history and drug reactions/allergies were not reported. On an unknown date,
the patient was vaccinated with PNEUMOVAX23, (dose, lot# and route not reported).
On an unknown date (the following day)by accident the patient received a second
dose of PNEUMOVAX23,(dose, lot# and route not reported). On an unknown date, the
patient was hospitalized prior to patient's demise. On an unknown date, the patient
died. At the time of the report, the outcome was fatal and unknown for other
events. Additional information has been requested." "No lab data for this event."
"511264-1" "511264-1" "This spontaneous report as received from a
pharmacist refers to an unspecified patient of unknown age and gender. On an
unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#,
expiration date, dose, frequency, route and indication not reported). The following
day, on an unspecified date, the same patient received a second dose of PNEUMOVAX23
(lot#, expiration date, dose and route not reported) by accident. The pharmacist
stated that the patient was hospitalized, in an unspecified hospital, on
unspecified dates, prior to the patient's demise. The patient, on an unspecified
date, died. Additional information has been requested." "No lab data for this
event."
"511528-1" "511528-1" ""This spontaneous report as received from a consumer
via a twitter refers to his/her daughter of unknown age. On an unknown date the
patient was vaccinated with GARDASIL, reported as ""Merck HPV vaccine"" (dose,
frequency, route, lot# and expiration date unknown). On an unknown date the
perfectly healthy patient died 2 weeks after vaccine acute liver failure. The
reporter considered the vaccine murdered his/her daughter. Upon internal review,
vaccine acute liver failure was considered to be medically significant. Additional
information has been requested."" "No lab data for this event."
"512092-1" "512092-1" "Death." "No lab data for this event."
"512570-1" "512570-1" "The vaccine was given on Nov 4, 2013. My son died
that night in his sleep. He was 15 days old." "No lab data for this event."
"513224-1" "513224-1" ""Initial report was received on 23 October 2013 with
additional information received on 03 November from a health care professional. A
13 month-old male patient who had no illness at the time of vaccination and no
reported past medical history had received on 18 October 2013 at 1045 AM an
intramuscular right thigh injection of FLUZONE QIV, lot number U4779AA and an
unspecified amount of time later was found with no chest movement and blue. The
patient was put to bed at 9 PM and at 1145 PM or 1245 AM the mother checked on the
child who was found with no chest movement and the child was blue. Cardiopulmonary
resuscitation (CPR) was performed with no response. An ""autopsy done: gross
examination unrevealing; no obvious cause of death identified; results of cultures,
toxicology pending (will take up to ~6 weeks for results to come back)."" No
further information was available at the time of the report. The patient's outcome
was fatal. Documents held by sender: none."" "No lab tests"
"513554-1" "513554-1" ""Initial report was received on 07 November 2013
from a nonhealth care provider from an unverified internet source. A 14 year-old
female patient (date of birth not reported) had received on an unspecified date in
August 2012 a Influenza vaccine (manufacturer, lot number, route, site and date of
administration not reported) and five months later on 08 January 2013 ""died from
complications of infection with Influenza Type A"". The patient was evaluated at
and urgent care with a bad sore throat, treated with Prednisone and was sent home.
The sore throat evolved into a serious fever that included shortness of breath and
wheezing. The patient's lungs filled with fluid and was hospitalized. The patient
had a heart and lung bypass with an ""ACMO"" machine and blood transfusions.
Diagnostic and laboratory testing were not reported. The patient's outcome was
fatal. Documents held by sender: none."" "UNK"
"513728-1" "513728-1" "This spontaneous report as received from a consumer
(patients mother) via an unspecified person from an Immunization Coalition and
company representative refers to a female patient of unknown age. No information
regarding the patients medical history was provided. On an unknown date the patient
was vaccinated with GARDASIL injection. Dose and route of administration were not
provided. No concomitant medication was reported. In the email from the
Immunization Coalition was stated that an unspecified mother claimed that her
daughter died in 2008 as a result of GARDASIL. Additional information has been
requested." "No lab data for this event."
"513769-1" "513769-1" "Initial report was received on 07 November 2013 from
a non-health care provider from an unverified internet source. The reporter for
this case is the same as case number 2013SA114788. A 7 year-old female patient
(date of birth not reported) had received an Influenza vaccine (manufacturer, lot
number, route, site and date of administration not reported) at her annual checkup.
The patient was reported to have no pre-existing health conditions and was a very
healthy child. The patient developed a severe headache and fever one day after
vaccination. Three days later, the patient stopped breathing and died without
warning in her mother's arm. Diagnostic and laboratory testing were not reported.
No further details were available at the time of the report. The patient's outcome
was fatal. Documents held by sender: None." "Lab tests unknown"
"514396-1" "514396-1" "Client presented at PH office requesting Flu vaccine
- came with spouse. Reviewed screening questions - no contraindications. Received
phone call at home from spouse at 630. Client had shaking episode and
weakness/fever. Went to hospital admitted - had heart attack next day and deceased.
Spouse received flu vaccine at same time as client with no adverse events. Same
vaccine from same multi-dose vial. Client denied any allergies or problems with any
previous vaccines. No egg allergies. He was admitted to the hospital. No
confirmation received from attending physician that flu vaccine caused heart
attack." "None"
"514607-1" "514607-1" "My co-worker told me Sunday evening that patient
died Sunday morning. I do not know details only that he passed away." "No lab data
for this event."
"514612-1" "514612-1" ""This case was reported by a consumer (patient's
mother) and described the occurrence of septic shock in a 48-year-old female
patient who was vaccinated with Influenza vaccine (unspecified, manufacturer
unspecified). A physician or other health care professional has not verified this
report. Concurrent medical conditions included seizure. Concurrent medications
included Gabapentin and Herbal medication. Co-suspect medication included LAMICTAL.
In early 2012, the patient started Lamotrigine (oral) at 100 mg twice per day. In
2012, the patient initially experienced some numbness and tingling in her fingers
(numbness in finger and tingling in finger) that made her fingers feel funny. She
then was doing okay on Lamotrigine until she started having some light seizures
over the last 6 months [2013]. As a result, the physician had just increased her
dosase from 2 pills a day to 3 a day but the mother of the patient was not sure if
she had actually started the increased dosage. In October 2013 the patient received
a dose of Influenza vaccine unspecified (unknown). On the evening of 30 October
2013 the patient collapsed and lost consciousness. The patient never regained
consciousness. She was taken to the hospital right away. The patient was
hospitalised and it was discovered that the patient was hemorrhaging. She did not
have any platelets in her blood (low platelet value) and when she was given
platelets, her blood just was not clotting. She had a slight infection in her
bowel, which cleared up within one day with antibiotics. The patient was also
retaining fluid and was all swelled up and puffy. The patient was put on life
support because she was not breathing properly. The patient's kidneys failed on 01
November 2013 and on the 02 November 2013 her brain failed. She was therefore taken
off life support on 02 November 2013 and died the same day. The death certificate
listed septic shock as the cause of death. The patient's mother reported that the
doctors did not know what caused the septic shock but did not think it was
medication-related. The patient had received the Influenza vaccine unspecified at
work and within 2-3 weeks of the events leading to her death. According to the
mother, the Influenza vaccine unspecified ""may have triggered all of it."" The
patient had mentioned after receiving the vaccine that she ""felt terrible/awfully
bad afterwards"" (onset less than 2-3 weeks after vaccination). At the time of
reporting, the events were fatal. The patient died on 2 November 2013 from septic
shock. It is unknown whether an autopsy was performed."" "UNK"
"514814-1" "514814-1" "This spontaneous report as from an other via social
media who obtained the information from a campaign against the HPV vaccine and
released a video, who reported that a 20 year old female patient prior to receiving
GARDASIL was healthy, vibrant and fun-loving. It was reported that the patient's
physician gave her all the right reasons to receive GARDASOL. On an unknown date,
was vaccinated with a dose of GARDASIL (dose and route not reported). Prior to
receiving GARDASIL there was no mention of GARDASIL side effects. On an unspecified
date, the patient began fainting and days later was found dead in bed. It was
reported that it was no coincidence that the patient died after receiving GARDASIL.
This is one of several reports received from the same source. No further
information is available." "No lab data for this event."
"514858-1" "514858-1" "Patient's husband indicated she had reaction from
vaccine and passed away. Do not have specific details." "No lab data for this
event."
"514980-1" "514980-1" "Cardiac arrest < 12 hours following administration.
Prelim autopsy with unknown cause of death." "Autopsy pending"
"515346-1" "515346-1" "Infant was under the care of his Dad - information
was obtained from Mom that was not present at the moment of the event. As per mom
the infant was as usual in the morning and he went to take his nap from what he
never woke up." "Pending"
"515469-1" "515469-1" "Headache, sore throat, tingling of feet and hands,
blood sugar unusually fluctuated. Patient had paralysis earlier in the day on day
of death." "No lab data for this event."
"516246-1" "516246-1" "None stated." "No lab data for this event."
"517250-1" "517250-1" "This spontaneous report as received from a
pharmacist via a company representative refers to a female patient of unknown age.
On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (Lot #,
expiry not reported). No concomitant medication was reported. On an unknown date
the patient developed shingles and was hospitalized. Length of hospitalization was
not reported. The patient eventually died. It was unknown what treatment the
patient received for shingles. The outcome of shingles was reported as fatal.
Additional information has been requested." "No lab data for this event."
 "517719-1" "517719-1" "Initial report received from a healthcare
professional (pharmacist) on 09 December 2013. This case is linked with cluster
cases: 2013SA131929 and 2013SA131928 (Same vaccine, same reporter). A male patient,
whose medical history and concomitant medications were not reported, had received a
dose of Influenza QIV vaccine (manufacturer: not provided, lot number, dose number,
route and anatomical site of administration were not reported) on an unspecified
date. On an unspecified date after vaccination, the patient developed Guillain
Barre Syndrome and the patient was died. Laboratory investigations and corrective
treatments were not reported. No autopsy details were reported. Documents held by
sender: none." "Lab tests unknown"
"518204-1" "518204-1" "This case was reported by a healthcare professional
via sales representative and described the occurrence of death (cause unknown) in a
male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline).
On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown).
In 2013, 2 months after vaccination with FLULAVAL, the subject experienced death
(cause unknown). The subject died on an unspecified date in 2013, cause of death
was not unknown. It was unknown whether an autopsy was performed." "UNK"
"518872-1" "518872-1" ""This spontaneous report as received from nurse
refers to a 14 year old female patient with attention deficit disorder and anxiety
and with no drug reaction or allergies. On 14-JUL-2011 the patient was vaccinated
with first dose of GARDASIL (dose, route of administration, lot number and
expiration date were not provided), on 25-JUL-2012 patient received second dose of
GARDASIL (dose, route of administration, lot number and expiration date were not
provided) and on 21-NOV-2013 patient received third dose of recalled GARDASIL (lot
number: J007354, expiration date 20-FEB-2016) (dose and route of administration
were not provided). Secondary suspect therapy included FLUMIST which was given on
21-NOV-2013. Concomitant therapies included ADDERALL XR and CELEXA. It was reported
that patient complained of headache on 04-JAN-2014 and she went to bed early that
night. It was reported that ""she never woke up"". Patient died on 04-JAN-2014.
Nurse has not been informed of the autopsy result so she could not determinate
cause of death. Lab diagnostic studies were not performed. It was also reported
that approximately 27 doses of the recalled lot of GARDASIL were also administered
at reporter's facility but she has not heard of any other adverse effects. The
outcome of headache was unknown. The relatedness between death, headache and
GARDASIL was unknown. Additional information has been requested."" "No lab data
for this event."
"518930-1" "518930-1" "Generalized varicella rash. Pt admitted to hospital
05/05/2013. Treated with Acyclovir. Developed pneumonia and ARDs." "No lab data
for this event."
"519235-1" "519235-1" "Information has been received from a lawyer
regarding a case in litigation concerning a male patient. On or about 02DEC2011,
the patient received PNEUMOVAX23 for its intended purpose: the prevention of
invasive pneumococcal disease. On or about 04DEC2011, the patient experienced
fever, dizziness, weakness, vomiting, confusion, shortness of breath, and jaundice.
On or about 04DEC2011 the patient was transported via ambulance to the hospital. On
or about 04DEC2011, approximately 3 hours after his arrival, the patient died. On
or about 06DEC2011, an autopsy revealed suggested pneumonia. The patient's cause of
death was dilated cardiomyopathy. As a direct and proximate result of PNEUMOVAX23
the patient died on 04DEC2011 (conflicting information received from the lawyer
indicates that the patient died on 06DEC2011, therefore there are two different
dates of death). Additional information has been requested." "No lab data for
this event."
"519375-1" "519375-1" "Information was received regarding a case in
litigation concerning a 26 year old female who suffered from Type 1, Juvenile
Diabetes for the majority of her lifetime. On or about 13-DEC-2011, the patient was
admitted to the hospital with a diagnosis of uncontrolled diabetes mellitus with
ketoacidosis (DKA). The patient was treated with an insulin drip and met with a
dietician while in the hospital. On 14-DEC-2011, while preparing for discharge, the
patient was administered PNEUMOVAX23 and FLUZONE. The patient began experiencing
shortness of breath on 18-DEC-2011 and was taken to hospital via ambulance. At the
hospital the patient was diagnosed with pneumonia, acute respiratory failure and
diabetic ketoacidosis (DKA). The patient was orally intubated and mechanically
ventilated. Shortly after admission, the patient went into acute respiratory
distress and became septic. The patient fell into a coma for approximately one
month. The patient was hospitalized for a total of two months and was discharged on
or about 09-FEB-2012. The patient never fully recovered from this hospitalization
and spent the remainder of her life in and out of hospitals. The patient passed
away on 02-NOV-2013 as a result of pneumonia. The patient suffered pneumonia,
sepsis, respiratory distress/failure, coma and death which were a direct and
proximate result of PNEUMOVAX23 and FLUZONE vaccinations. Upon internal review,
coma, sepsis, and diabetic ketoacidosis were determined to be medically significant
events. Additional information has been requested." "No lab data for this event."
"520688-1" "520688-1" "This spontaneous report as received from a nurse
practitioner via a company representative refers to a 9 week old male patient. No
medical history was provided. On 17-DEC-2013 the patient was vaccinated with the
first dose of ROTATEQ (lot number, expiration date were not reported) (suspension 2
ml, orally, indication: 'routine'). Seven days later, on 24-DEC-2013 the patient
was hospitalized in medical clinic. The patient was diagnosed with a bowel
obstruction and congenital malrotations on an unspecified date approximately in
December 2013. The patient died on an unspecified date. The outcome of bowel
obstruction and congenital malrotation was not reported. No cause of death
reported. The relatedness between the events of bowel obstruction and congenital
malrotation and ROTATEQ was not reported. The events of bowel obstruction and
congenital malrotation were considered to be life threatening and disabling. Upon
internal review the event of congenital malrotation was considered to be congenital
anomaly. Additional information has been requested." "No lab data for this event."
"521295-1" "521295-1" "None stated." "No lab data for this event."
"521877-1" "521877-1" "None." "None"
"522070-1" "522070-1" ""This spontaneous report as received from a nurse
via field representative refers to multiple unspecified patients of unknown age and
gender. The nurse reported that multiple unspecified patients have come to her with
concerned about GARDASIL due to reading unspecified Internet articles that claim
multiple unspecified patients had died after receiving GARDASIL (lot#, dose and
route not reported). The reporter stated the article was from ""someone that
claimed to be involved with the development of GARDASIL"". The nurse did not have
any patients that reported an adverse effect after receiving GARDASIL. The reporter
stated ""they got a call from the mother of a patient who just got GARDASIL who was
crying and in hysterics on the phone because she had heard about all these side
effects. This was happening on a daily basis"". The reporter stated ""I don't have
any details about the article"". Additional information is not expected."" "No
lab data for this event."
"522177-1" "522177-1" "Death." "No lab data for this event."
"522595-1" "522595-1" "This case was reported by a consumer (spouse of
subject) and described the occurrence of cancer in a 59-year-old male subject who
was vaccinated with Hepatitis A vaccine (manufacturer unspecified). A physician or
other health care professional has not verified this report. On an unspecified date
the subject received a dose of Hepatitis A vaccine (unknown details). At an
unspecified time after vaccination with Hepatitis A vaccine, the subject
experienced hepatitis A infection, cancer and possible vaccination failure. The
subject died from cancer in September 2013. It was unknown whether an autopsy was
performed. The reporter had previously reported another case with HAVRIX. See
A0993321A for details on the other case. The cases have been noted as potentially
legally significant." "UNK"
"523158-1" "523158-1" "None - pt found unresponsive and deceased 2/20/14
approximately 5 AM." "No lab data for this event."
"523430-1" "523430-1" ""This spontaneous report as received from a health
care worker via a field representative refers to her mother, a 75 year old female
patient. On an unspecified date the patient was vaccinated with ZOSTAVAX (dose,
frequency, route, lot # unknown) and then received a second dose of ZOSTAVAX ""a
year later"" on an unspecified date. No untoward effects reported. The patient had
since died. Healthcare worker stated that the cause of death of patient was
unrelated to the ZOSTAVAX. Additional information has been requested."" "No
lab data for this event."
"523573-1" "523573-1" "Death." "Unavailable."
"523759-1" "523759-1" "This literature marketed report as received from a
physician refers to a 4 year old girl who had received her first dose of VARIVAX
(Merck) in March 2009. She was diagnosed with acute lymphoblastic leukemia (ALL) in
March 2011. At that time, she was varicella-zoster virus (VZV) immunoglobulin G
(IgG)-positive. On 10-APR-2012, the girl was exposed to a mildly ill cousin who
developed a varicella rash 2 days later (12-APR-2012). The episode was reported to
the child's oncologist after 13 days. The girl was prescribed 7 days of oral
acyclovir (manufacturer unknown) and concurrently began her scheduled chemotherapy,
which included a 5-day course of dexamethasone (manufacturer unknown) (prednisone
equivalent dose of 23 mg/day). Twenty-two days after her varicella exposure (01-
MAY-2012) the girl was taken to an emergency department for fever and abdominal
pain. She was treated symptomatically; her caretakers were instructed to
discontinue chemotherapy and to follow up with her oncologist. Two days later on
03-MAY-2012 the girl returned to the emergency department with a generalized rash.
She was hospitalized and treated with intravenous acyclovir (manufacturer unknown)
and antibiotics. However, she developed multi-organ failure and died on 07-MAY-
2012. Varicella was confirmed by polymerase chain reaction testing, and no
alternative diagnoses were found for her acute illness. This patient's fatal
varicella likely was the result of profound immunosuppression, resulting in part
from the chemotherapy and corticosteroid treatment. Additional information has been
requested." "Varicella-zoster virus (VZV) immunoglobulin G (IgG) (MAR-2011):
Positive; 05/2012, Polymerase chain reaction, Varicella"
"523828-1" "523828-1" "2-6-14 pt presents to Hosp. with resp s/s dx with
bronchitis and allergic rhinitis tx with amoxicillin, ZYRTEC and Guaifenesin. On 2-
9-14 back to Hosp dx per CT scan with early pneumonia aspiration or atelectasis
pulse ox 88-92. Pt given tetracycline, FLAGYL and IMODIUM in addition to other meds
given early pt d/c to home. On 2-11-14 pt presents to another Hosp. Dx with double
pneumonia, admitted 2-18-14 placed on vent, 2-22-14 pt died." "Dx of pneumonia
on 2-9-2014 at Hospital"
"524014-1" "524014-1" ""Initial report was received on 20 February 2014
from an electronic lay press article. A 55 year-old male patient (date of birth not
reported) with a history of diabetes had received an influenza vaccine
(manufacturer, lot number, route, site and date of administration not reported) and
an unspecified amount of time later developed the flu. The patient first became ill
on a Thursday. ""That afternoon, his blood sugar spiked, and they were unable to
get it down. So they took him to the hospital and from there he flat - lined three
times"". By Friday night the patient was flown to another hospital where he died in
a diabetic coma. Outcome was fatal. Documents held by sender: none."" "Flat-lined
three times; blood glucose, Unknown, Unknown, Unknown"
"525268-1" "525268-1" "Patient was a former 23 wk 6 day gestation premature
infant who was discharged home from NICU on 2/27/14 into child protective services.
She had her 2 mo immunizations in hospital and followed up with us on 3/3/14. She
was given her 4 mo vaccines - which were the same as 2 mo shots. Became more
lethargic on 3/3/14 and decreased PO intake. Died the following day." "No lab data
for this event."
"525311-1" "525311-1" "This spontaneous report as received from CDC
(Centers for Disease Control) via company representative refers to 53 patients of
unknown age and gender. On an unknown date these patients was vaccinated with
GARDASIL (lot#, expiration date, dose, route not reported). These patients died
after receipt of the vaccine. The causes of death were unknown. Additional
information has been requested." "No lab data for this event."
"525431-1" "525431-1" "I have to confirm the dates with her Nursing school,
but approximately two weeks after receiving the shot my sister experienced stroke
like symptoms, she went to the doctors and had to take off from school. Her heart
was not checked, but had never been diagnosed with heart problems about a year
later she died in her sleep from a heart problem that was misdiagnosed." "Na"
"525494-1" "525494-1" "Deceased 1/11/14 - mom found at 5AM no previous
signs." "Well child check up 2 month"
"525546-1" "525546-1" "This spontaneous report as received from a physician
refers to a male patient of unknown age. On 19-DEC-2013 the patient was vaccinated
with ZOSTAVAX, subcutaneous. No details regarding the dosing regimen were provided.
It was unknown if the patient received any co-suspected or concomitant medications.
On 09-JAN-2014, the patient experienced patient deceased. No further details were
provided. The action taken with ZOSTAVAX was unknown and a causality assessment was
not provided. Additional information has been requested." "No lab data for this
event."
"526290-1" "526290-1" "Died of status epilepticus and respiratory arrest on
3-21-14." "Treated at Medical Center ER"
"526390-1" "526390-1" "Pt arrived to ED in respiratory distress and was
intubated, became asystolic and did not return. Pronounced at 19:05 March 14."
"No lab data for this event."
"526544-1" "526544-1" "Patient was in usual state of health. Had bottle at
about 2:30 AM and then put back to sleep in bed with father. Another family member
checked on baby few hours later and found she was unresponsive with vomit in her
mouth. Father attempted CPR; CPR en route to ED by EMS. Asystole noted on arrival
in ED. Patient deceased." "No lab data for this event."
"526545-1" "526545-1" "Pt. found expired in bed with parents. Final autopsy
pending." "None"
"527072-1" "527072-1" "This spontaneous report as received from a consumer
refers to a patient of unknown age. On an unknown date the patient received
ZOSTAVAX (dose, route of administration, lot#, indication unspecified). On an
unknown date the patient developed shingles after receiving ZOSTAVAX and passed
away on an unspecified date. The outcome of shingles after receiving ZOSTAVAX was
reported as fatal. The cause of death was reported as shingles. Autopsy results
were not provided. This case is linked to 2 more reports from same reporter.
Additional information has been requested." "No lab data for this event."
"527097-1" "527097-1" "Patient died." "No lab data for this event."
"527362-1" "527362-1" "This case was reported by a physician via a sales
representative and described the occurrence of influenza B in a 10-year-old male
subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical
conditions included automatic implantable cardioverter defibrillator pacer,
congenital heart defect repaired by heart surgery. On 29 October 2013, the subject
received a dose of FLUARIX (administration site and route unknown). On 23 March
2014, 5 months after vaccination with FLUARIX, the subject experienced sore throat.
No test for flu was conducted and no antivirals were given. No swab testing for
culture or sensitivity was done. At that time, he was stable from cardiac
standpoint. On 25 March 2014, he was found unresponsive. A culture was took around
pronouncement of the death which showed positive results for influenza B which was
considered as a vaccination failure. The subject died on 25 March 2014 from cardiac
complications and influenza B infection." "UNK"
"527990-1" "527990-1" "This spontaneous report as received from a physician
via Company Representative refers to a 15 unspecified patients of unknown gender
and unknown age. The reporting physician informed the representative that a friend
of his posted an unspecified link on Facebook stating that 15 unspecified patients
died after receiving GARDASIL (dose, lot/batch number, expiry date and indication
was not reported). The physician would like to know where the information was
coming from. The representative did not have any further information by the time of
the report. The relatedness between the event and GARDASIL was not reported.
Additional information has been requested." "No lab data for this event."
"528355-1" "528355-1" "Seizure resulting in death." "No lab data for this
event."
"528766-1" "528766-1" "This spontaneous report was received from a
registered nurse who read about the life story of a patient of unknown age on a
website. On an unknown date the patient was vaccinated with GARDASIL, (dose, lot
no. route not reported). On an unknown date the patient died from an unspecified
cause. This is one of reports received from the same source. Additional information
is not expected." "No lab data for this event."
"528914-1" "528914-1" "On 14APR2014, information was received from a
consumer on behalf of his cousin. The reporter stated that his male cousin had
received the Anthrax vaccine (date, dose, lot# not reported). On an unspecified
date he experienced high liver enzyme levels. Subsequently, he died. Date of death,
unknown. Cause of death, unknown. Follow up information has been requested."
"Unknown"
"529028-1" "529028-1" "Took Flu shot in January 2013 - the next day could
not walk. Went to hospital was told had bladder infection - Live about 13 months.
Could never walk again. Had flu shot in January 2013 - could not walk or stand the
next day - was in a wheelchair until her death 1-2-14." "Was in hospital 7 times
the next 12 mo."
"529682-1" "529682-1" "Initial report received from literature on 11 April
2014. A 6 adult patients of age below 65 years, whose concomitant medications were
not reported, had received 2013-14 seasonal Influenza Vaccine (batch number, route
and anatomical site of administration were not reported) of unknown manufacturer on
an unspecified date. The department of public health conducts surveillance on
severe influenza like illness aged less than 65 years. This case includes the
influenza with symptom onset on or after 29 September 2013 of 2013-14 influenza
seasons. There were only 6 out of 28 patients whose vaccination status were known
had received 2013-14 influenza seasonal vaccine greater than or equal to 2 weeks
before symptoms onset. DPH sought the data from autopsy and medical records for
fatal cases and reviewed available data for all severe cases for 2013-14 season
vaccine. Data review includes patient's demographics, clinical courses and
treatment underlying medical conditions, influenza vaccination status and
underlying medical conditions. There were 3 fatal influenza cases includes children
aged less than 18 years and one fatal case includes a patient less than 5 years
old. Of six patients with no known comorbid conditions predisposing them to
complications from influenza, as defined by ACIP three were obese with body mass
indices of 30-39. The data from 2013-14 influenza vaccination season indicates that
the patients aged 41-64 years are at the higher risk of influenza. The antiviral
treatment was underutilized by these patients and overreliance on rapid diagnostic
test with poor sensitivity. The patient's died on unspecified date. Documents held
by sender: none." "The patient had undergone RT PCR test for the diagnosis of
influenza."
"530241-1" "530241-1" "Agitation, Blurred Vision, Confusion, Depression,
Dizziness, Hallucinations, Headache, Intracranial Bleed, Sedation, Seizures,
Parkinsonism, Tardive Dyskinesia, TIA Stroke, Bleeding, Thrombocytopenia,
Leukopenia, Anemia, Myalgia, Arthralgia, Phlebitis, Anaphylaxis, Fever, Angioedema,
Skin Rash, Tachypnea, Resp Depression, Cough Wheeze, Rash, Erythema Multiforme,
Urticaria Pruritus, Purpura, Sloughing, Constipation, Diarrhea, Nausea Vomiting,
Gastric Bleeding, Palpitations, Hypertension, Hypotension, Syncope, Angina,
Bradycardia, Tachycardia, Abnormal INR, Elevated Liver Enzymes, Jaundice, Elevated
BUN SCr, Nephritis, Acute Tubular Necrosis, Acute Renal Failure, Hyperglycemia,
Hypoglycemia and turned purple. Bupropion 300 mg BID, Aspirin 4 mg BID, Lisinopril
20 mg BID, Hydrochlorothiazide/propranolol 20 mg every day." "Relevant tests
and labs"
"531898-1" "531898-1" "My mother began feeling achy, very uncomfortable,
unable to eat. By Thursday she was hospitalized with uncontrollable high blood
pressure and a potassium level of 2.9. This was precipitated by the DTAP vaccine
given by Dr." "No lab data for this event."
"532074-1" "532074-1" "NO information available to describe any adverse
effects." "No lab data for this event."
"532797-1" "532797-1" "11/14/2007 - Seizure. Confirmed by EEG. Begun using
DEPAKOTE. CBC and LFT's - within nml limits." "ECG = normal sinus rhythm, normal
ECG; Head MRI - Pineal cyst (6mm); Head CT - no evidence of acute intracranial
abnormalities"
"533336-1" "533336-1" "Information has been reported in a study. The report
includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other
health professional refers to 4 patients. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The outcome of death was reported as fatal. The cause of death was reported
as 'other non infectious'. The death of the patients was confirmed with medical
records, autopsy reports and/or death certificates. The report has been split into
cases according to cause of death. This case is linked to same reporter linked
cases 1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003858
(other infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861
(Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular).
Additional information has been requested." "No lab data for this event."
"533337-1" "533337-1" "Information has been reported in a study. The report
includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from an other
health professional refers to 16 patients. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The outcome of death was reported as fatal. The cause of death was reported
as Cardiovascular. The death of the patients was confirmed with medical records,
autopsy reports and/or death certificates. The report has been split into cases
according to cause of death. This case is linked to same reporter linked cases
1406USA003857 (respiratory disorder), 1406USA003858 (Other infectious disorder),
1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal),
1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003863
(Unknown). Additional information has been requested." "No lab data for this
event."
"533339-1" "533339-1" "Information has been reported in a study. The report
includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other
health professional refers to 2 patients. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The outcome of death was reported as fatal. The cause of death was reported
as neurological. The death of the patients was confirmed with medical records,
autopsy reports and/or death certificates. The report has been split into cases
according to cause of death. This case is linked to same reporter linked cases
1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other
non infectious disorder), # 1406USA003860 (gastrointestinal), 1406USA003858 (other
infectious), # 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular).
Additional information has been requested." "No lab data for this event."
"533341-1" "533341-1" "Information has been reported in a study. The report
includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from a other
health professional refers to 5 patients. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The outcome of death was reported as fatal. The cause of death was reported
as other infectious. The death of the patients was confirmed with medical records,
autopsy reports and/or death certificates. The report has been split into cases
according to cause of death. This case is linked to same reporter linked cases
1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other
non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861
(Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular).
Additional information has been requested." "No lab data for this event."
"533480-1" "533480-1" "Information has been reported in a study. The report
includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from an other
health professional refers to 4 patients. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The outcome of death was reported as fatal. The cause of death was reported
as 'undetermined'. The death of the patients was confirmed with medical records,
autopsy reports and/or death certificates. The report has been split into cases
according to cause of death. This case is linked to same reporter linked cases #
1406USA003857 (respiratory disorder), 1406USA003863 (Unknown), 1406USA003859 (other
non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861
(Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular).
Additional information has been requested." "No lab data for this event."
"533481-1" "533481-1" "Information has been reported in a study. The report
concerns death reports in adult ages 19 years and Older following PNEUMOVAX 23. The
report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from an other
health professional refers to 1 patient. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The cause of death was reported as gastrointestinal. The death of the
patients was confirmed with medical records, autopsy reports and/or death
certificates. The report concerns death reports in adult ages 19 and Older
following PNEUMOVAX 23. The report has been split into cases according to cause of
death. This case is linked to same reporter linked cases # 1406USA003857
(respiratory disorder), # 1406USA003863 (Unknown), # 1406USA003859 (other non
infectious disorder), # 1406USA003858 (other infectious), # 1406USA003861
(Neurological), # 1406USA003862 (Undetermined) and # 1406USA003351
(Cardiovascular). Additional information has been requested." "No lab data for
this event."
"533482-1" "533482-1" "Information has been reported in a study. This
report concerns death events in adult ages 19 years and Older following PNEUMOVAX
23. The report includes US VAERS reports following PNEUMVOAX 23 or PPSV 23 brand
unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-
JAN-2014. This spontaneous report as received from a registered nurse refers to 18
patients. The median age of the patients was 69 years old; range between 23 to 98
years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX
23. ON an unknown date the patients experienced death. The cause of death was
reported as unknown. The death of the patients was confirmed with medical records,
autopsy reports and/or death certificates. The report concerns death reports in
adult ages 19 years and Older following PNEUMVOAX 23. The report has been split
into cases according to cause of death. This case is linked to same reporter linked
cases # 1406USA003857 (respiratory disorder), # 1406USA003858 (Other Infectious
disorder), # 1406USA003859 (other non infectious disorder), # 1406USA003860
(gastrointestinal), # 1406USA003861 (Neurological), # 1406USA003862 (Undetermined)
and # 1406USA003351 (Cardiovascular). Additional information has been requested."
"No lab data for this event."
"533483-1" "533483-1" "Information has been reported in a study. The report
includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide
vaccine (PPSV23) brand unknown after 2002. The report includes reports information
from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from a other
health professional refers to 11 patients. The median age of the patients was 69
years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients
were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced
death. The outcome of death was reported as fatal. The cause of death was reported
as 'Respiratory'. The death of the patients was confirmed with medical records,
autopsy reports and/or death certificates. The report has been split into cases
according to cause of death. This case is linked to same reporter linked cases
1406USA003351 (Cardiovascular), 1406USA003858 (Other infectious disorder),
1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal),
1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351
(Cardiovascular). Additional information has been requested." "No lab data for
this event."
"533788-1" "533788-1" "Information has been received from a third party
claims administrator on behalf of a pharmacy concerning a male patient, who 11-MAR-
2014 was vaccinated with ZOSTAVAX (lot # J013134, expiration date 17JAN2015). On
12-MAR-2014, the patient died (not further specified) a day after receiving the
ZOSTAVAX vaccine. Additional information has been requested." "No lab data for
this event."
"533907-1" "533907-1" "This case was reported in a literature article and
described the occurrence of pertussis in a 2-year-old subject of unspecified gender
who was vaccinated with DTaP (manufacturer unspecified). Concurrent medical
conditions included rhabdomyosarcoma for which chemotherapy had been started after
he had completed the course of vaccinations. The authors report that no coughing
contact was identified for the subject. No further information regarding the
subject's medical, family history or concurrent medication has been provided. On
unspecified dates, the subject received 4 doses of DTaP vaccine (unknown route,
injection site and batch number). In 2012, at an unspecified time after vaccination
with DTaP vaccine, the subject experienced pertussis. No information has been
provided regarding any symptoms displayed by the subject or any clinical
examinations performed on him; but the authors report that the pertussis cases
described in the article had to have at least one of the following symptoms along
with a nasopharyngeal polymerase chain reaction positive test for Bordetella
pertussis to be considered as confirmed pertussis cases: paroxysmal cough, whoop or
post-tussive emesis. Therefore, this was considered as a vaccination failure. In
2012, the subject also experienced RSV infection (rhinitis). His level of white
blood cells at presentation was 200/ mm3 (83% lymphocytes) and it rose to a maximum
of 31000/mm3 (3% lymphocytes) during the course of the illness. The subject was
treated with a prolonged extracorporeal membrane oxygenation course including
necrotizing pneumonia and tumour progression. Neither leukophoresis nor exchange
transfusion was performed. The subject died from death unspecified 78 days after
the onset of pertussis. An autopsy was performed and showed evidence of pulmonary
fibrosis and pulmonary hypertension. Lung metastasis and metastases to pericardium
were noted. There was no evidence of ongoing infection." "Lymphocytes, 83%;
Lymphocytes, 3%; White blood cells, 200/mm3; White blood cells, 31000/mm3"
"534345-1" "534345-1" ""This literature marketed report as received from a
public article, refers to a 75 year old male patient. The patient initially
developed radiographic evidence of a mediastinal mass at the age of 65 years.
Further evaluation and biopsy revealed the presence of a thymoma. Three years after
the resection of the thymoma, the patient developed recurrent thrush, esophageal
candidiasis, and onychomycosis. The patient was hospitalized for pneumonia 4 times
per year before treatment. At the age of 73 years, with no prior history of muscle
disease, he developed proximal muscle weakness that involved, most prominently, the
muscles of his neck and shoulders. Elevated muscle enzyme levels (creatine
phosphokinase, aldolase, and serum glutamic oxaloacetic transaminase) suggested a
myopathy. A left deltoid muscle biopsy specimen revealed inflammatory myopathy
without inclusive bodies. Degeneration and regeneration of muscle fibers were noted
accompanied by focal perimysial and endomysia lymphatic infiltrates.
Electromyographic analysis suggested myopathic changes. Laboratory evaluation
performed at 75 years of age revealed a low total absolute CD3+ cell count of 570
cells/mm3, an absolute CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+
CD8+ cell count of 141 cells/mm3. The response to mitogen and antigen stimulation
was markedly diminished (phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311
cpm; concanavalin A: 20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm.
Absolute CD19+ cells counts were low at 30 cells/mm3. Serum IgG levels were low at
a level of 535 mg/dL. He received the PNEUMOVAX 23 (for antigen stimulation), and
both the prevaccine and 30-day postvaccine titers were absent. He was treated with
intravenous immunoglobulin, 1 g/kg every 4 weeks, and oral fluconazole every other
day. These therapeutic options stabilized his condition for several years. He
eventually died of respiratory failure during a pneumonia infection. The
association of thymoma with autoimmune and paraneoplastic disorders is well
documented. Polymyositis is found in approximately 5% of thymoma cases; however,
polymyositis has never been previously documented in a patient with confirmed GS.
This case represents the first association of Good Syndrome (GS) (with thymoma and
immunodeficiency) and polymyositis. Clarification was received stating that the
indication should be changed to ""prophylaxis"" since the patient was hospitalized
4 times for pneumonia and the event of absent titers should be captured as it
synonymously conveys vaccine failure even though not reported. Additional
information has been requested."" "Laboratory evaluation performed at 75 years of
age revealed a low total absolute CD3+ cell count of 570 cells/mm3, an absolute
CD3+ CD4+ cell count of 414 cells/mm3, and an absolute CD3+ CD8+ cell count of 141
cells/mm3. The response to mitogen and antigen stimulation was markedly diminished
(phytohemagglutinin: 10,870 cpm; pokeweed mitogen: 8,311 cpm; concanavalin A:
20,962 cpm; Staphylococcus aureus Cowan strain: 2,644 cpm. Absolute CD19+ cells
counts were low at 30 cells/mm3. Serum IgG levels were low at a level of 535 mg/dL.
At the age of 73 year, elevated muscle enzyme levels (creatine phosphokinase,
aldolase, and serum glutamic oxaloacetic transaminase) suggested a myopathy.
Degeneration and regeneration of muscle fibers were noted accompanied by focal
perimysial and endomysia lymphatic infiltrates. Electromyographic analysis
suggested myopathic changes. Patient received the PNEUMOVAX 23, and both the
prevaccine and 30-day postvaccine titers were absent."
"534975-1" "534975-1" "Initial report received from the literature article
on 18 June 2014. A 2-year-old patient (gender not reported) had received fourth
dose of TDAP vaccine (dose, lot number, route and site of vaccination not reported)
on an unspecified date. The patient had received all previous three doses on
unspecified dates. The patient had a reported medical history of rhabdomyosarcoma
and respiratory syncytial viral coinfection. The patient underwent prolonged ECMO
course including necrotizing pneumonia and tumor progression. After fourth
vaccination of TDAP, the patient underwent chemotherapy. On an unspecified date,
the patient developed pertussis. The patient died on an unspecified date. Time to
death from illness onset was 78 days. The autopsy results were evident for
pulmonary hypertension and fibrosis, metastasis to lung and pericardium, but no
trace of ongoing infection found. Documents held by sender: none." "WBC count,
Unknown, 200 cell/MM3; WBC count, Unknown, 31000 cell/mm3"
"534988-1" "534988-1" "Unknown. Patient was at work. Taken to hospital and
died. Details unknown." "No lab data for this event."
"535052-1" "535052-1" "Patient had fever of approx 101 on eve of date
received vaccines, then had an episode described as eyes staring off and whole body
going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of
seconds. He then returned to normal with total episode time ~10 sec. He then had
another similar episode the following afternoon with return to normal. The eve
following receiving vaccination mom heard loud scream from child's room. She picked
up child who was awake, alert. He then had another episode of eyes staring followed
by going limp. This time he did not return to baseline and stopped breathing. EMS
was called. Patient was in cardiac arrest. Required chest compressions upon arrival
to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe
neurological impairment s/p prolonged cardiopulmonary arrest. Patient was
terminally extubated." "Urine cx NGTD, blood cx NGTD, RVP with +adenovirus.
Cardiac - h/o VSD/PFO, systolic murm on exam (baseline), repeat EKG with incomplete
RBBB vs RVH, no conduction delay, Non accidental trauma work up negative, MRI
6/19/14 with progressive diffuse ischemia or white matter tracts as compared to
priror consistent with global injury"
"535209-1" "535209-1" ""This spontaneous report as received from a
pharmacist via a company representative refers to a 87 year old male patient. The
pharmacist received this information from the patient's daughter. On 04-JUL-2011
the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose,
frequency were unspecified). Concomitant therapies included COUMADIN and FLOMAX. On
04-JUL-2011, 12 hours of receiving ZOSTAVAX the patient passed away. The patient
received the ZOSTAVAX and started to bleed heavily from the injection site.
According to the patient's daughter, on the day of the ZOSTAVAX injection and the
patient stated that ""he did not feel well and had lost a profuse amount of
blood."" He was taken by ambulance to an unspecified hospital and sought medical
attention. The patient was intubated in the hospital. He passed away on 04-JUL-
2011. No cause of death was provided. The outcome of the other events was unknown.
The events were considered as disability and life threatening by the reporter.
Additional information has been requested."" "No lab data for this event."
"535858-1" "535858-1" ""This spontaneous report was received from a medical
assistant via a field employee regarding an older male patient of unknown age.
Medical Assistant said that the patient had ""multiple unspecified comorbidities""
regarding his health. No information about drug reactions and allergies was
specified. On an unknown date in October 2013, The patient received ZOSTAVAX vial
(dosing regimen unspecified). No concomitant medications were reported.
Approximately on an unknown date in 2013, the patient developed a rash 3 days after
the ZOSTAVAX was given. The rash was diagnosed as a severe case of shingles on an
unspecified date. Medical Assistant stated that the patient died a few weeks later
on an unspecified date. There was no product quality complaint with ZOSTAVAX. Cause
of death and autopsy details were not provided. The outcome of the event severe
case of shingles is unknown. The causality of the events was not specified by the
reporter. Additional information is not expected."" "No lab data for this event."
"537090-1" "537090-1" "Child found dead the next morning by family member."
"Autopsy was performed."
"537166-1" "537166-1" "Pt was found unresponsive and not breathing by
mother approximately 6 hours after receiving vaccinations. Pt was transferred to
hospital at 5:30pm via ambulance and was expired at 6:20pm. Unknown at this time
cause of death." "No lab data for this event."
"538295-1" "538295-1" "Cardiorespiratory arrest and death." "No lab data
for this event."
"538342-1" "538342-1" "Information has been received from the authors in a
published letter to the editor, regarding a 14 year old male patient who did not
respond to repeated vaccinations of PNEUMOVAX and PREVNAR. The patient presented at
3 years of age with recurrent otitis media and sinusitis. He had normal lymphocyte
and monocyte counts, platelet numbers, and hematocrit levels. He had IgG2 and IgA
deficiency and absent tetanus and low PRP (52 ng/mL) antibody titers. Tetanus and
Haemophilus influenzae type b (Hib) vaccine boosters resulted in protective tetanus
(0.4 IU/mL) and PRP (>1200 ng/mL) titers. Two years later, his tetanus titer was
undetectable, his polyribosylribitol phosphate (PRP) titer decreased to 1S5 ng/mL,
and his IgG level was decreased at 444 mg/dL, prompting intravenous immunoglobulin
(IVIG) initiation. At 10 years of age, IVIG was discontinued to reassess his
antibody response. His tetanus titer increased from 0.14 to 0.27 IU/mL after a
booster but waned within 1 year to 0.03 IU/mL. At 14 years of age, his PRP titer
increased significantly after the Hib vaccine, but he did not respond to repeated
vaccinations of PNEUMOVAX and PREVNAR; additionally, his IgG level was low, and his
IgA level was undetectable. He had pneumonia and pansinusitis in the setting of
absent B cells and CD4+ T-cell lymphopenia, and therefore IVIG was restarted. He
had absent tonsils, which had been barely visible on previous examinations. No
mutations were found in the TACJ, PNP, ADA, BTK, or SH2DJA genes. At 16 years of
age, he had persistent warts on his hands and severe bronchiectasis. Sputum
cultures were positive for Mycobacterium kansasii. Lymphocyte proliferation to
mitogens and antigens was normal, but NK cell, monocyte, and platelet counts were
low. Progressive respiratory decline led to his death at 22 years of age. Whole-
exome sequencing on both patients identified a heterozygous mutation in GATA2 (c.
C1061T) that was confirmed by means of Sanger sequencing. The mutation results in
amino acid change from threonine to methionine at position 354 (T354M) in the
second zinc finger domain9 and is predicted to be damaging to protein function by
using both the PolyPhen (score 0.997) and SIFT (score 0) tools. The T354M mutation
does not affect GATA2 expression or nuclear localization, but significantly impairs
GATA2 binding to DNA and to the transcription factor PU.l, resulting in a dominant
negative effect on transcriptional activation. The phenotypes associated with the
T354M mutation autosomal dominant MDS/acute myeloid leukemia, MDS with
pancytopenia, multilineage cytopenias, and opportunistic infections. One patient
with this mutation had 1 episode of parainfluenza and Mycoplasma infection with
normal immunoglobulin levels, another had pneumonias limited to childhood, and 3
others had mycobacterial and viral infections. Four subjects were healthy into
adulthood. The patient presented with IgG2 and IgA deficiencies and an abnormal
vaccine response, which has not been previously reported in patients with GATA2
mutations. No additional mutations were found through whole-exome sequencing that
would account for the hypogammaglobulinemia seen in both patients. This report
highlighted the importance of considering mutations in GATA2 in patients with
hypogammaglobulinemia, particularly in the setting of abnormal lymphocyte subsets
and monocyte counts. Additional information has been requested." "Lymphocyte count
(unknown date / age 3): normal; Monocyte count (unknown date / age 3): normal;
Platelet level (unknown date / age 3): normal; Hematocrit level (unknown date / age
3): normal; IgG2 level (unknown date / age 3): deficiency; IgA level (unknown
date / age 3): deficiency; Ribitol (PRP) titer (unknown date / age 3): 52 ng/mL;
Ribitol (PRP) titer (unknown date / after booster): >1200 ng/mL; Polyribosylribitol
(PRP) titer (unknown date / age 5): 185 ng/ml decreased; Polyribosylribitol (PRP)
titer (unknown date / age 14): increased significantly after the Hib vaccine; IgG
level (unknown date / age 14): low; IgA level (unknown date / age 14):
undetectable; B cells (unknown date / age 14): absent; CD4+ T-cell lymphopenia
(unknown date / age 14): absent; He had absent tonsils, which had been barely
visible on previous examinations. No mutations were found in the TACJ, PNP, ADA,
BTK, or SH2DJA genes; Tetanus, 0.03 IU/ml; Tetanus, 0.14 IU/ml; Tetanus, 0.27
IU/ml"
"539685-1" "539685-1" "Patient found deceased in his home. He had reported
flu like symptoms to a family member via phone day before.""No lab data for this
event."
"539960-1" "539960-1" "Patient was found blue in crib around 7:30 pm on the
evening of July 2nd. 911 was call they got patient oxygen and was stabilized at
hospital then was med flighted to another hospital where they put patient on a
ventilator and he passed away July 4th around 845pm." "No lab data for this event."
"540269-1" "540269-1" "This spontaneous report as received from a physician
via a company representative refers to a 12 year old female patient. On an unknown
date the patient was vaccinated with a dose of GARDASIL (lot#, dose, route not
reported). Concomitant medications were not provided. The physician reported that
she read a report, possibly online, about the patient who had a seizure on an
unknown date after administration of GARDASIL and died on 31-JUL-2014. The cause of
death was unspecified. The patient had sought unspecified medical attention.
Outcome of seizure was unknown. Causality was not provided. Upon internal review,
seizure was determined to be medically significant. Additional information is not
expected because the reporter did not want to be contacted." "No lab data for
this event."
"540483-1" "540483-1" ""Initial report received from a consumer, who is
also the patient's mother, on 14 August 2014. The following is verbatim from the
report: ""I lost my son at year and a half. But after 10 months. After he got the
meningitis enoculation. He became brain dead blind dead outward posturing constant
seizes. Gastrostomy tube and a shunt in his brain. Shot was what killed him.
Panhandlers health."" No further information was available at the time of the
report. The patient outcome was fatal. Documents held by sender: None."" "Lab
tests unknown"
"540590-1" "540590-1" "Non stop crying, fever 102 degrees, refusal to eat."
"Autopsy confirmed she had an undetected congenital heart defect and the
vaccines sped up her death."
"540899-1" "540899-1" "Information was received from a physician via a
company representative regarding unspecified patients (demographics or details of
patients not provided). The physician stated that an unspecified pediatrician sent
an email with an article from an unspecified pediatric or infectious disease
journal that stated that there have been deaths associated with GARDASIL. No
further information is expected." "No lab data for this event."
"541912-1" "541912-1" "This spontaneous report as received from a physician
via company representative via on-line document (social media) (source unspecified)
refers to an 11 or 12 year old female patient. Pertinent medical history, drug
reactions or allergies were not reported. On an unknown date the patient was
vaccinated with GARDASIL (strength, dose, dose number, dose schedule, route,
anatomical location, lot number and expiration date were unspecified). No
concomitant therapies were reported. On 27-AUG-2014 the 11 or 12 year old female
died after receiving GARDASIL. At the time of this report it was not known if an
autopsy were performed. The outcome of the event was reported as fatal. The
relatedness between the event and GARDASIL was not reported. Additional information
has been requested." "No lab data for this event."
"541916-1" "541916-1" "This spontaneous report was received from a consumer
who read an article on the internet refers to a 12 year old female patient. No
medical history reported. On an unknown date, same day or day after they took her
home the patient was vaccinated with GARDASIL (dose number and route of
administration unknown) (lot number unknown). No concomitant therapies reported. On
19-AUG-2014 the patient went to bed and didn't wake up (death). The patient died on
19-AUG-2014. The cause of death according to the consumer was reported as GARDASIL.
The causality was unknown. Additional information has been requested." "No lab data
for this event."
"543649-1" "543649-1" "This spontaneous report was received from a Nurse
professional via a company representative regarding her mother (age unknown).
Pertinent medical history and concurrent conditions were unspecified. On an unknown
date the patient was vaccinated with PNEUMOVAX 23, injection due to a chronic
respiratory issue (dose and route not reported). No other concomitant therapies
reported. On an unknown date, the patient developed pneumococcal disease, a strain
which PNEUMOVAX 23, was supposed to cover. On an unknown date in March 2014 (about
6 months ago) the patient died from an aneurysm which was after she developed the
pneumococcal disease. The lab diagnostic tests were unspecified. It was unknown
whether patient sought medical attention. The outcome of the event aneurysm was
reported as fatal. The outcome of the event pneumococcal disease was unknown. The
causality of the events was unspecified. No PQC involved. Additional information is
not expected." "No lab data for this event."
"544217-1" "544217-1" "This spontaneous report as received from a physician
(who heard from an unspecified media source) via a company representative refers to
a 14 year old female patient. On an unknown date the patient was vaccinated with
her first dose of GARDASIL (dose, route, lot number and expiration date not
provided). Physician stated that the patient went home, felt a little sick, laid
down and died on an unknown date. The outcome of felt a little sick was unknown.
Relatedness between the events: felt a little sick and the patient died was not
reported. Follow up information was received from a physician via company
representative. Physician reported that media source stated that the patient was 12
years old (not 14 years as previously reported). Company representative stated that
she found the article on a website and it may have been reported via other media
channels. An official cause of death was not mentioned. Additional information has
been requested." "No lab data for this event."
"544517-1" "544517-1" "Pt received influenza vaccination previous day and
passed away from believed to be heart attack the following morning. An autopsy is
being performed." "Autopsy to be done"
 "544718-1" "544718-1" "This medically confirmed report (initial receipt 19-
Sep-2014) concerns a 63-year-old male patient. The patient recently underwent a
surgery for aortic aneurysm excision (exact date unknown). It was unknown whether
the patient received any other medications or immunizations. If the patient
received anything else, it would have been outside the facility. On 17-Sep-2014,
the patient received intramuscular AFLURIA injection (batch number T56805) at 0.5
ml annually. On 18-Sep-2014, approximately 12 hours after vaccination, the patient
passed away. The cause of death was unknown. It was believed that no autopsy would
be performed. The outcome was reported as 'death'. Reporter's comments: The
reporter assessed the causality as serious and unlikely due to AFLURIA." "No
lab data for this event."
"544978-1" "544978-1" "Patient found unresponsive on 9/22/14 by parents in
his bed. 911 called, ACLS protocol initiated, however pt expired and pronounced
dead in ED." "No lab data for this event."
"545039-1" "545039-1" "No adverse events after vaccine, but patient's
mother reported he passed away in sleep." "No lab data for this event."
"545049-1" "545049-1" "Fussiness and crying onset 9/12/14 early AM, blood
in stool that AM. More lethargic 9/13/14, not tolerating feeds. Seen in Emergency
Room 9/13/14 - 9/14/14 - diagnosed with right upper quadrant intussusception
reduced with air enema. Symptoms of shock, disseminated intravascular coagulation,
third spacing of fluid, difficulty ventilating and ultimate death on 9/15/14."
"Abdominal US 9/14/14 confirmed intussusception"
"546064-1" "546064-1" "This spontaneous report from an adverse event tweet
as received via social media from a consumer refers to a healthy 12 year old female
patient. On an unknown date, the patient was vaccinated with GARDASIL (route, lot #
and expiration date were not provided). The reporting consumer published the
following: healthy 12 year old girl died, on an unknown date, after unspecified HPV
vaccine. It was unknown if the patient sought medical attention. It was unknown if
autopsy was performed. The cause of death was not provided. The reporting consumer
stated her daughter (nor son) would never get this vaccine. Clarification was
received that the social media AE documented two different tweets, by two different
twitter users, about the same 1 patient, regarding GARDASIL. Additional information
is not expected, as there is no consent for followup." "No lab data for this
event."
"546331-1" "546331-1" "Was at daycare - had taken nap/aroused fussy -
consoled/but then noted not breathing 911 - to ER/dx with cardiac arrest ELLD."
"Autopsy pending results."
"546781-1" "546781-1" "Patient Died." "MDMA 3,4-
metilendioximetanfetamina"
"547820-1" "547820-1" "UNKNOWN." "No lab data for this event."
"548418-1" "548418-1" "Pt received influenza vaccine 10/2/14. Called office
10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted
in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and
headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent
home. Pt presented to hospital 10/13 in the evening critically ill, was intubated
and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ
failure/septic shock." "Labs done day of 10/2/14 physical basically normal"
"549045-1" "549045-1" "Initial literature report received on 11 October
2014. A 7-month-old male patient, whose concomitant medications were not reported,
had received a dose of BCG (in left deltoid, batch number and route of
administration were not reported) and a dose of OPV (batch number, route and
anatomical site of administration were not reported) of unknown manufacturer on an
unspecified date. The patient has a medical history of SCIDS (severe combined
immunodeficiency). It was reported that, after vaccination, the patient was brought
to hospital emergency department in July 2013; he had a 6-week history of
intermittent fever associated with draining skin lesion over the left deltoid at
the site of BCG vaccination. The patient was diagnosed with acute lymphadenitis and
prescribed trimethoprim and sulfamethoxazole and sent home. The patient was again
brought to the emergency department with increased irritability and decreased
movement of the left leg and was admitted to the hospital for the further
evaluation. The patient appeared tired and anxious but was responsive to touch. The
physical examination was negative for meningococcal signs, no evidence of
respiratory distress was found. A firm, mobile, tender, 2x2 cm mass was palpated
under the left axilla. The patient did not move his left leg spontaneously or in
response to pain. Deep tendon reflexes were absent in the left leg and diminished
in the right. Decreased anal sphincter tone was noted. The rest of the physical
examination was found to be normal. The patient was diagnosed with VAPP (vaccine-
associated paralytic poliomyelitis) after laboratory investigations. Laboratory
investigations: Complete blood count- ALC-216 cells/mm3, lymphocytes subsets- CD3 6
cells/mm3, CD4 2, CD8 0, CD 19 1, CD16/56 189, HIV 1/2 was negative,
Immunoglobulins- IgA and IgM undetectable, IgG 140 mg/dl. Cerebrospinal fluid test:
White blood cell 83 cell/mm3, Polymorph nuclear neutrophils 50%, mononuclear cells
2%, protein 48 mg/dl, glucose 49 mg/dl. Imaging: Chest radiograph was normal, Brain
and Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2
weighted signal at cord T11 level on the left: additional abnormal signal and
contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan
showed enlarged lymph nodes, left supraclavicular, and left axilla,
retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours,
later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid
showed negative bacterial meningitis screen and gram stain, negative fungal smear
and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus
isolated, identified as immunodeficiency associated vaccine derived poliovirus
type, Lymph node fine needle aspiration showed AFB stain positive. On an
unspecified date, the child progressed to respiratory distress during further
observation. It was reported that after consultation with multiple specialist
physicians and with ethics committee review, the family chose to withdraw support
and the child died shortly thereafter. Documents held by sender: None." "CD3=6
cells/mm3, CD19=1, CD16/56=189; Imaging: Chest radiograph was normal, Brain and
Spine MRI showed 8 mm lesion in right cerebral peduncle, prominent abnormal T2
weighted signal at cord T11 level on the left: additional abnormal signal and
contrast enhancement of several nerve roots. Chest, abdomen and pelvis CT scan
showed enlarged lymph nodes, left supraclavicular, and left axilla,
retroperitoneal. Microbiology: Blood test showed no bacterial growth at 48 hours,
later positive for AFB identified as mycobacterium bovis/BCG. Cerebrospinal fluid
showed negative bacterial meningitis screen and gram stain, negative fungal smear
and culture, negative PCR for HSV-1, HSV-2 and CMV. Stool analysis- enterovirus
isolated, identified as immunodeficiency associated vaccine derived poliovirus
type, Lymph node fine needle aspiration showed AFB stain positive. Complete blood
count, Unknown, ALC-216 cell/mm3; CD4 lymphocytes, Unknown, 2; CD8 lymphocytes,
Unknown, 0; HIV tests, Unknown, Negative; IgA, Unknown, Undetectabl"
"549295-1" "549295-1" "None were reported to the pharmacy. Clinical
director wanted it reported for documentation purposes." "No lab data for this
event."
"549512-1" "549512-1" "Patient told me that she had not felt well since she
got the high dose flu shot last week. She was light headed and experienced
syncope. As result of syncope she fell and hit the back of her head and fractured
her left hip. Hip surgery ensued and was successfully performed. Upon release
from hospital she was moved to a rehabilitation facility where she died the next
morning. Patient attributed the syncope to the administration of the flu shot."
"CT scans, x-rays, carotid ultrasound, bloodwork"
"549727-1" "549727-1" "Pt was found unresponsive at home by family taken to
ER and pronounced dead. Autopsy report not available at this time." "Unknown at
this time from ER."
"549873-1" "549873-1" "Patient had severe lung disease and I did consider
him terminal but he had high dose flu vaccine and died soon after getting vaccine.
Vaccine given 9/25/14 and patient died 10/2/2014. Presumed cause of death
respiratory failure with underlying pulmonary fibrosis." "(To date, I am aware of
5 of my patients that have died within 6 months of getting high dose flu vaccine
since 2010.)"
"549876-1" "549876-1" "Patient had high dose flu vaccine and presented to
ER non-responsive less than 2 days later. Date of vaccine 10-8-2014. Date of death
10-10-2014. Patient had underlying COPD and CHF but he was stable when I saw him
10-8-2014." "To date, this is the 5th patient that I am aware of that has died
within 6 months of getting high dose flu vaccine in my practice since 2010."
"550386-1" "550386-1" "Patient ended up hospitalized 3 days later with
severe pneumonia he was hospitalized on 9/25/14 and placed in ICU. He signed out
AMA on 9/26/14 and died of self inflicted gun shot." "CXR showed multifocal
pneumonia of (R) lung; Sputum light growth yeast; Rapid flu negative for flu A and
B; CBC, WBC 14.2"
"550758-1" "550758-1" "My son was born a healthy 7lb baby boy with no
underlying issues. On his 2nd day of life he quickly became ill and died within
hours of being sent to the NICU. He was given Hep B vaccine the day before. Autopsy
and WES test were all normal." "No lab data for this event."
"551921-1" "551921-1" "This case was reported by a consumer and described
the occurrence of death in a 6-week-old male patient who received PEDIARIX (batch
number S232P5, expiry date 30th August 2016). Co-suspect products included PEDIARIX
(batch number S232P5, expiry date 30th August 2016), PEDIARIX (batch number S232P5,
expiry date 30th August 2016), PEDIARIX (batch number S232P5, expiry date 30th
August 2016), ROTARIX (batch number A41CB452A, expiry date 31st January 2016) and
Hib (batch number SUI062AEA, expiry date 10th October 2015). On 27th October 2014,
the patient received the 1st dose of PEDIARIX (unknown) .5 ml, the 2nd dose of
PEDIARIX (unknown) .5 ml, the 3rd dose of PEDIARIX (unknown) .5 ml, the 4th dose of
PEDIARIX (unknown) .5 ml, the 1st dose of ROTARIX (oral) 1 ml and the 1st dose of
Hib (unknown) .5 ml. On 27th October 2014, Not Applicable after receiving PEDIARIX,
PEDIARIX, PEDIARIX and ROTARIX and an unknown time after receiving PEDIARIX, the
patient experienced overdose, overdose and overdose. On 28th October 2014, the
patient experienced death (serious criteria death and GSK medically significant),
blood coming out from nose (serious criteria death) and blood coming out from mouth
(serious criteria death). On 28th October 2014, the outcome of the death, blood
coming out from nose and blood coming out from mouth were fatal. On an unknown
date, the outcome of the overdose, overdose and overdose were unknown. The patient
died on 28th October 2014. The reported cause of death was unknown cause of death.
The reporter considered the death, blood coming out from nose and blood coming out
from mouth to be almost certainly related to PEDIARIX, PEDIARIX, PEDIARIX, PEDIARIX
and ROTARIX. Additional information received: The reporter was the patient's
maternal grandmother. She reported that her family had dual citizenship. Her
daughter gave birth to the child in one country and was planning to return to
another country on 30 October 2014. The doctor advised the mother to bring child
for immunizations prior to the trip. The patient was growing very well, at 88%
growth percentile for his weight and height with no medical concerns, he passed all
the tests. The patient was administered all three PEDIARIX shots at the same time
on 27 October 2014, in the afternoon, along with ROTARIX and the Sanofi Pasteur flu
shot. The mother reported that the baby received 2 shots on his left leg and 2
shots on his right leg, but the doctor stated in his records that the baby got one
shot on his left leg and the others in the right leg. The grandmother stated that
her daughter returned home with the baby after the doctor visit and the baby slept.
When he woke up, she fed him and then put him to bed around 12 midnight or 1am on
28 October 2014. When she woke up around 7 am he was already dead, with blood
coming out of his nose and mouth. They called 911 and the baby's mother tried to
resuscitate him, then he was taken to hospital. At the hospital, the family was
told he had been dead for a few hours and was formally pronounced death on 28
October 2014. The grandmother was willing to be contacted and the family will seek
legal action because they felt the death was caused by the vaccines administered
that day." "No lab data for this event."
"552234-1" "552234-1" "A consumer report has been received concerning a 5
year old male patient. The patient's concurrent disease included H1N1 virus
infection. No concomitant medication was reported. The patient received FLUMIST
(intranasal) on an unknown date. During an unspecified year in November he received
the flu vaccine and came down with flu on 20-Dec. The patient experienced flu
related complications. He was taken to the pediatrician when he developed a barking
cough often characterizing croup. He was given doses of steroidal medication,
prescribed by his pediatrician to combat the coughing, croup symptoms. His symptoms
did not seem to be improving, so he was taken to the emergency room early Christmas
morning. Doctors took a soft-tissue X-ray of his upper respiratory system and told
it was collapsed a little. After spending the day with the patient, parents felt he
needed to go back to the hospital. When his mother was changing his pants patient
collapsed right in front of her and turned blue. Paramedics secured an airway.
According to the patient's mother, the patient suffered severe brain damage due to
a lack of oxygen from a collapsed airway. The patient died from flu related
complications, collapsed airway and brain damage on December 29. It was unknown if
an autopsy was performed. The reporter considered the events of flu related
complications, collapsed airway and brain damage to be serious based on death and
hospitalization criteria." "Soft-tissue X-ray of upper respiratory system, Upper
respiratory system was collapsed"
"553902-1" "553902-1" "This spontaneous report was received from a
pharmacist via company representative. The pharmacist reported on her 72 year old
father. Information regarding patient's medical history was not reported. On an
unknown date the patient was vaccinated with PCV (manufacturer unknown) (lot#,
expiration date, route of administration, anatomical location were not reported).
Other suspect therapies administered the same day included influenza virus vaccine
(manufacturer unknown). The pharmacist reported that her father died after
receiving a combination of PCV (manufacturer unknown) and influenza virus vaccine
(manufacturer unknown) at the same visit. On an unknown date the patient
experienced pain and tightness similar to gallbladder symptoms. Then the patient
was seen in the office of his unspecified physician again and determined to have an
enlarged spleen. The patient was sent to an unspecified oncologist and was
diagnosed as having leukemia on an unspecified date. The patient was hospitalized
on an unknown date. The patient's spleen was surgically removed, as it was
continuing to enlarge. The patient never fully recovered from the surgery and
experienced breathing problems and died before leaving the hospital on 07-NOV-2014.
The cause of death was not reported. The outcome of pain and tightness similar to
gallbladder symptoms, leukemia and enlarged spleen was not reported. The events of
pain and tightness similar to gallbladder symptoms, leukemia, enlarged spleen which
was surgically removed and breathing problems were determined to be life-
threatening by the reporter. Upon internal review the events of leukemia and
enlarged spleen which required surgical removal were determined to be medically
significant. The relatedness between the events and the therapy with PCV
(manufacturer unknown) was not reported. Additional information is not expected
since the reporter did not want to be contacted in any way regarding this report."
"No lab data for this event."
"554258-1" "554258-1" "Patient was found unresponsive at his home the next
day by his mother. She called 911 and reported very light breathing. She and the
paramedics tried to perform CPR but were unsuccessful and reported him dead at 2pm.
Paramedics stated that it was similar to what they see in heart attack victims. No
autopsy reports have been received as of 11-18-14." "No lab data for this event."
"554842-1" "554842-1" "My father began experiencing loss of motor function.
Distal to proximal pattern. Was taken to the ER. Was transferred to ICU and became
vent depend." "No lab data for this event."
"555192-1" "555192-1" "Unknown if attributed to vaccine. Patient had
vaccination on 11/19/2014 symptoms of fever, dizziness, headache began next day.
Patient demise time unclear may not be related however per process noting that
vaccination had occurred in the previous 36 hours." "No lab data for this event."
"555555-1" "555555-1" "Wife states that her husband (patient) went into
congestive heart failure and died a few days after receiving the flu vaccine."
"No lab data for this event."
"556239-1" "556239-1" "Paralysis, could not breathe, could not get out of
bed, was given antibiotics at emergency room and sent home. Died 10 days later."
"No lab data for this event."
"556244-1" "556244-1" "This case was reported by a physician via call
center representative and described the occurrence of death in sleep in a 18-month-
old female patient who received PEDIARIX. Co-suspect products included PEDVAXHIB
and PREVNAR. Previously administered products included PEDIARIX (at age of 2
months, which went uncomplicated) and PEDIARIX (at age of 4 months, which went
uncomplicated). On 18th November 2014, the patient received the 3rd dose of
PEDIARIX .5 ml, PEDVAXHIB and PREVNAR. On 18th November 2014, less than a day after
receiving PEDIARIX, the patient experienced death in sleep (serious criteria death
and GSK medically significant). On an unknown date, the patient experienced drug
dose administration interval too long. On an unknown date, the outcome of the death
in sleep was fatal and the outcome of the drug dose administration interval too
long was unknown. The patient died on 18th November 2014. An autopsy was performed.
It was unknown if the reporter considered the death in sleep to be related to
PEDIARIX. Additional details were provided: It was unknown if the patient had
concomitant medication or relevant medical history. All previous vaccinations went
uncomplicated. It was unknown if the subject was hospitalized. The patient died at
home. On 18 November 2014, the patient was vaccinated during the office hours, that
evening she died and never woke up from a nap. The physician was waiting for an
autopsy report which has not yet been completed. The physician reported that the
parents requested a delayed dosing schedule: the 3rd dose be given at 18 months,
rather than 6 months. The physician was available to contact." "11/2014, Autopsy,
not yet completed"
"556245-1" "556245-1" "This 73-year-old male subject was enrolled in a
study. On 9th December 2013, the subject received the 2nd dose of Zoster VZV-gE-
AS01B(intramuscular). On 8th October 2013, the subject received the 1st dose of Flu
Seasonal QIV Dresden (intramuscular). The subject's past medical history included
hyperlipidemia and hypertension. Concomitant products included Aspirin,
atorvastatin, lisinopril and hydrochlorothiazide and metoprolol. On 10th March
2014, 91 days after receiving Zoster VZV-gE-AS01B and 153 days after receiving Flu
Seasonal QIV Dresden the subject developed severe - grade 3 cerebrovascular event.
Serious criteria included death. The outcome of cerebrovascular event was fatal on
10th March 2014. The subject died on 10th March 2014. The reported cause of death
was cerebrovascular disorder. An autopsy was not performed. The investigator
considered that there was a reasonable possibility that the cerebrovascular event
may have been caused by Zoster VZV-gE-AS01B and Flu Seasonal QIV Dresden.
Investigator comments: Hospital medical records requested. Death certificate
indicates immediate cause of death to be cerebrovascular accident occurring on
10/MAR/2014 with no specific time indicated (under 1 day) due to or as a
consequence of hypertension. No autopsy was performed. Patient has history of
hypertension and hyperlipidemia since 2000 and was receiving therapy for both
conditions." "No lab data for this event."
"556292-1" "556292-1" "Mother called mid morning that patient was cool and
diaphoretic. Went to ED found to have worsening heart failure. Admitted to PICU
10/17/14, CXR with pneumonia, respiratory virus panel neg x 2, placed on ECMO
10/19/14. Patient died 11/16/14 of heart failure while on ECMO." "Respiratory virus
panel negative x2; CXR with L retrocardiac opacity on admission"
"556731-1" "556731-1" "Initial unsolicited case received from a consumer on
24 November 2014, during routine media monitoring. Five patients, whose ages and
genders were not reported, received Influenza vaccine (manufacturer and lot numbers
not reported) on 07 November 2014. It was reported that the patients immediately
developed a fever, and all died within one week of vaccination. No additional
information pertaining to the patients was reported. Documents held by sender:
None." "Lab tests unknown"
"557160-1" "557160-1" "Case number PHEH2014US024123, is an initial
spontaneous report from a nurse received on 02 Dec 2014. This report refers to a 07
year old female patient. Medical history and concomitant medications were not
reported. She was vaccinated with seasonal Influenza vaccine (manufacturer and
batch number unknown) on an unknown date. On an unknown date, after vaccination,
she experienced myocardial infection and died 4 days after vaccination. Outcome of
the event myocardial infection was not reported. Cause of death and causality of
the events was not reported. Seriousness assessment of myocardial infection was
upgraded based on the NVS-IMS list. No additional information was available."
"No lab data for this event."
"557251-1" "557251-1" "Died from cardiac disease." "No lab data for this
event."
"557253-1" "557253-1" "Died from ??UTI/Sepsis." "No lab data for this
event."
"557260-1" "557260-1" "This spontaneous report has been received from a
consumer concerning 140 anonymous female patients of unknown age. On an unknown
date patients were vaccinated with GARDASIL injection (dose/ dose in series/ route
unknown). The reporter indicated that on an unspecified date, 140 anonymous women
died after receiving GARDASIL. Cause of death was not reported. The reporter stated
'how many reported fatalities were needed for a product to be pulled from the
market'. She further stated, 'with all of the side effects women experienced after
receiving GARDASIL, Merck should not still be pushing the product and the product's
prescribing information needed to be updated'. The reporter indicated that she was
seeking an attorney because 'Merck needs to update the GARDASIL prescribing
information to include the 140 who have died because they received GARDASIL'. She
enquired about the address for the Office of General Counsel. This is one of
several reports received from the same reporter. Additional information has been
requested." "No lab data for this event."
"557396-1" "557396-1" "Pt. had diarrhea during nap. Increased Immodium, no
other complaints following. Patient was found deceased 9:30 AM 10/22/2014. Was
normal with no problems 5 PM previous evening." "No lab data for this event."
"557492-1" "557492-1" "Case number PHEH2014US024100 is a combined initial
and follow up spontaneous report from a nurse received on 02 Dec 2014 and from
quality assurance department (QA reference number: 340811) received on 03 Dec 2014.
This report refers to a 66-year-old female patient. Her current conditions included
type 2 diabetes and elevated cholesterol with values at normal limits and were
being managed. She went for cardiac work up, 1-2 weeks prior to vaccination and
everything was normal. She did not have any blockages, no complaints of chest
pains, but had fever. She was vaccinated with FLUVIRIN (batch number: not reported)
intramuscularly on 04 Nov 2014. On the same date, since vaccination she was feeling
ill and had flu. On an unknown date, she had fever. On 13 Nov 2014, she was burning
up with fever, had taken off her night gown (Not typical behaviour), drank water,
went to sofa, threw up en route and had cardiac arrest. Her husband performed CPR
(cardiopulmonary resuscitation) and called the ambulance. In the emergency room,
she was being resuscitated, but she died on the same day. No autopsy was performed.
It was reported that something caused pulmonary edema. She had no congestive heart
failure and not on any diuretics. The outcome of the events fever, feeling ill, flu
and threw up was not reported. The outcome of the events pulmonary edema and
cardiac arrest reported as death. The seriousness of the events fever, feeling ill,
flu and threw up was not reported. The causality of the events was not reported."
"No lab data for this event."
"558341-1" "558341-1" ""Initial unsolicited case received from a consumer,
who is the patient's wife, on 10 December 2014. An 82 year old male patient, with a
history of allergies to Sulfa and REGLAN, received an intramuscular left deltoid
injection of FLUZONE (lot number UI189AE) on 02 October 2014. The patient had nasal
drainage at the time of vaccination. Three hours after receiving the vaccine, the
patient's right arm began shaking uncontrollably. His fingers were white, and he
was weak and needed help to walk. He presented to the emergency department, where
he was given fluids. The symptoms of shaking became worse, and progressed to ""full
body shaking"". He underwent a CT scan and x-rays; results were not reported. He
experienced chills and fever, and per the reporter had a possible lung infiltrate.
He continued to have nasal drainage. He was treated with an antibiotic and admitted
to the hospital, where he remained for 13 days. According to the reporter, the
patient died from ""respiratory cardiac conditions"" on an unspecified date.
Documents held by sender: None."" "CT scan and x-rays performed, results not
provided."
"559752-1" "559752-1" "Patient was found unresponsive by mother on 12/23/14
about 2:30 AM - paramedics took him to ER - transferred to another hosp. Pronounced
dead." "No lab data for this event."
"559863-1" "559863-1" "This spontaneous report as received from a patient's
mother refers to a 12 year old healthy female patient and was identified during
social media monitoring. Current conditions and medical history was not reported.
On an unknown date, the patient was vaccinated with GARDASIL injection (strength,
route, dose, frequency and indication not provided). No concomitant medication was
reported. On an unknown date, the patient died. The outcome of the event was fatal.
The causality assessment was provided as related (reported as GARDASIL suspected).
Product quality complaint was not reported. Additional information has been
requested." "No lab data for this event."
"560374-1" "560374-1" "This spontaneous report was received from a
physician concerning a 3 year old patient (gender unknown), who on an unknown date
was vaccinated with a varicella containing vaccine which could be possible VARIVAX
(Merck) or PROQUAD (Merck) (vaccines, routes, doses, lot numbers and expiration
dates were not provided). Other suspect therapies or concomitant medication were
not provided. The physician reported, that she was told that a patient's younger
relative developed febrile seizure and on an unknown date died after getting the
varicella containing vaccine. The physician stated that she was not sure the brand
name of the vaccine (possibly VARIVAX (Merck) or PROQUAD (Merck)). The patient
cause of death was febrile seizure. It was unknown if an autopsy was performed.
Upon internal review, the event of febrile seizure was considered to be another
important medical event. This is one of several reports received from the same
source. Additional information is not expected because the physician did not have
much information about the patient and refused to continue with the AE reporting."
"No lab data for this event."
"560533-1" "560533-1" "Pt was found deceased in his crib on the morning of
12/30/2014. He did have a fever of 102 the night before." "No lab data for this
event."
"560982-1" "560982-1" "This medically confirmed spontaneous report (initial
receipt-29-Dec-2014) concerns a patient of unknown demography. The patient had a
concurrent condition of human immunodeficiency virus which was contributing to
death but not resulting in the underlying cause of death. On 12-May-2014, the
patient received influenza virus vaccine (manufacturer and batch number not
reported). On 30-Nov-2014, the patient died due to metastatic esophageal carcinoma.
The Medical Examiner or Coroner was contacted. The outcome was reported as fatal.
Reporter comments: It was unknown if tobacco contributed to death. The manner of
death was natural." "No lab data for this event."
"562128-1" "562128-1" ""This spontaneous non-valid report as received via
social media (Twitter) concerning ""at least 9 girls per year"". It was reported
that ""at least 9 girls per year are killed by the GARDASIL vaccine"" (strength,
dose, route of administration, lot# and expiry date unspecified) (dates of
injections or adverse event not specified). Additional information is not expected
as all available information has been provided and there is no patients and
physician's contact information and we could not do follow up with them."" "No
lab data for this event."
"562167-1" "562167-1" "A report from a physician concerns a 13 year old
female patient. Relevant history, concurrent diseases and concomitant drugs were
not reported. The patient received FLUMIST QUADRIVALENT (intranasal) in Oct-2014 at
a local pharmacy. Apparently patient had received FLUMIST QUADRIVALENT at an
outside pharmacy, so the doctor doesn't have information on lot number. Patient
passed away on 16-Dec-2014. Patient was positive for influenza A. The parents
requested an autopsy, and the preliminary report states following Diagnosis: 1.
Congestive hemorrhagic lungs. 2. Influenza A. 3. Staphylococcus aureaus (+) from
the lungs. Physician said that once they receive the final autopsy report they will
notify our office. The patient died from the congestive hemorrhagic lungs on 16-
Dec-2014. The outcome of the staphylococcus aureus (+) from lungs and influenza A
was unknown. The cause of death was congestive hemorrhagic lungs. An autopsy was
performed. The reporter considered the congestive hemorrhagic lungs to be serious
by the criterion of death and other events to be serious by the life threatening
criterion." "No lab data for this event."
"562739-1" "562739-1" "Death." "No lab data for this event."
"563535-1" "563535-1" "This case was reported by a nurse via other
manufacturer and described the occurrence of unknown cause of death in a 15-month-
old patient who received PEDIARIX. Co-suspect products included PREVNAR 13 (batch
number J11488, expiry date November 2016) and HIB vaccine. On 18th November 2014,
the patient received PEDIARIX, PREVNAR 13 and HIB VACCINE. On 19th November 2014, 1
days after receiving PEDIARIX, the patient experienced unknown cause of death
(serious criteria death and GSK medically significant). On an unknown date, the
outcome of the unknown cause of death was fatal. The patient died on 19th November
2014. The reported cause of death was unknown cause of death. An autopsy was
performed. It was unknown if the reporter considered the unknown cause of death to
be related to PEDIARIX. Additional information was provided: No other medications
and medical conditions. The patient was healthy without a lot of clinic visits. The
patient passed away on 19 November 2014 at 9:50. An autopsy is currently being
done. An investigation was performed on PREVNAR 13. The results showed no issues
impacting the identity, strength, safety, purity or quality of the product." "No
lab data for this event."
"563564-1" "563564-1" "This spontaneous report was received from a
pharmacist who was told about the event by patient's friend. The report refers to a
patient of unknown age and gender with a history of epilepsy. Current conditions
and drug allergies were not specified by the reporter. On an unknown date, the
patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route of
administration, lot# and expiration date were not specified). Concomitant
medication was not specified by the reporter. On an unknown date, the patient
experienced shingles of the brain which caused the patient's death on an unknown
date. It was not specified whether any treatment was given for the adverse event
and whether the patient sought any medical attention. Laboratory test were not
specified by the reporter. It was also reported that the deceased person had never
had the chicken pox and the pharmacist asked if a patient who had never had the
chicken pox can be vaccinated with ZOSTAVAX. The physician correlated the death to
receipt of the ZOSTAVAX without having a prior case of the chickenpox. No product
quality complain (PQC) was filed. Additional information is not expected, because
the reporter did not wish to be contacted." "No lab data for this event."
"563794-1" "563794-1" "Headaches; fever; swelling; hoarseness; weakness;
racing heart; sepsis shock." "Hydrocephalus; encephalopathy; sick euthyroid
syndrome; renal failure; mild hyperkalemia; HFV; CNS toxoplasmosis; lung pleural
effusion, cryptococcal; asthma; meningitis; proteinuria; shock"
"563861-1" "563861-1" "Initial unsolicited report was received via a lay
press article on 27 January 2015. A five year-old female patient (date of birth not
reported) had received on an unspecified date an influenza vaccine (manufacturer,
lot number, route and site of administration not reported) and an unspecified
amount of time later, experienced a cough and fever. The patient was seen in a
clinic and prescribed steroids and a nebulizer. Hours later the patient collapsed
and CPR was performed. The patient was found to have Influenza A. The patient was
hospitalized and placed on life support. The patient suffered a cardiac arrest and
died. Outcome was fatal. Documents held by sender: none." "Lab tests unknown"
"564361-1" "564361-1" "Client received vaccine at 6pm on 10-1-14. Client
was found unresponsive on 10-3-14 at 4:15 AM. Client was pronounced dead at 4:39
AM." "Negative"
"564470-1" "564470-1" "Initial report received from a healthcare
professional on 03 November 2014. A 78-year-old female patient had received first
dose of FLUZONE HD (batch number U5062AA, Exp. date 25 May 2015), intramuscularly
in left deltoid on 24 October 2014. The patient's medical history includes AVELOX
and latex allergy and concomitant medication was not reported. The patient had not
received FLUZONE HD previously. On 24 October 2014 same day after vaccination, the
patient had experienced itchy rash. After the rash patient experienced stiffness in
the legs. Laboratory investigations and corrective treatment was not reported. It
was reported that itchy rash was for 2 days but the outcome of the event was not
reported. Follow-up information was received for this unsolicited case on 30
January 2015 from a consumer who is the patient's daughter. Additional information
was received the same day from the pharmacist who was the original reporter.
According to the patient's daughter, the patient was described as being in good
shape at 78 years of age when she received the vaccine on 24 October 2014. The
patient told her daughter that she had a fever and her bones were sore. The patient
was on Prednisone at the time for nose polyps. On 25 October 2014, she had blisters
on the back of her legs about the size of a dime and a nickel. The patient showed
it to her doctor as she could not walk. She was hesitant to go back to the doctor.
The patient experienced pneumonia like symptoms within the week and was put on
oxygen. She could not drive because she could not move. She was treated with
antibiotics two weeks later. She had swelling in her left leg. The patient was
found dead in her chair on 12 January 2015. A pharmacist also reported the event on
30 January 2015 after the daughter had reported it to him. The patient had died on
12 January 2015. The patient had seen a healthcare provider for the first time
after vaccination on 25 November 2014 and was treated with an antibiotic. Around
this time the patient had developed pneumonia. The daughter reported that the
patient had stopped taking the antibiotic because it made her itch. She returned to
the healthcare practice on 8 December 2014 and was treated with another antibiotic
and was placed on oxygen. The patient outcome is fatal. Documents held by sender:
none." "Lab tests unknown"
"564662-1" "564662-1" "PT RECEIVED PEDIARIX, HIB, AND PREVNAR ON 02/06/15.
NO ADVERSE EVENT REPORTED DURING THAT DAY. NO SYMPTOMS. PT WAS FOUND UNRESPONSIVE
AROUND 8AM ON 02/07/15. CAUSE OF DEATH HAS YET TO BE DETERMINED." "No lab data
for this event."
"564720-1" "564720-1" "Patient passed away 02/10/2015 due to Cardiac
arrest." "No lab data for this event."
"564751-1" "564751-1" "Seen at PMD for adb pain (pt had menses at this
time) on 1/30/15. Dx with UTI, started Bactrim and patient was stopped from meds
after a few days due to neg urine cx and the patient also was feeling better. On
Wed 2/4/15 the abd pain returned and the patient then developed a fever of 102.6
and an all over body rash (non-pruritic). Seen at PMD on that day and was dx with
suspect viral illness. Abd ultrasound was also done at the PMD and negative. On
Thurs 2/5 the patient came in to the hospital due to dramatic altered mental status
and vomiting stomach contents. The mental status worsened throught out
hospitalization. Patient passed away." "No lab data for this event."
"565640-1" "565640-1" "Received first vaccines 2/13/15, no apparent
problems that afternoon or evening, found dead in crib following AM - cold, likely
died hours before. Complex PMH following anoxic/ischemic brain injury at birth. Hx
seizures, weaned off anticonvulsants - 2m ago after EEG normal." "Hospitalization
for bronchiolitis - improved"
"565783-1" "565783-1" "99 y/o female w/ IHD, OA came to office for Wellness
exam. Doing well, no c/o's. Was given a Pneumovax in right deltoid. Was told by
son she was active w/ walker the rest of the day. Ate lunch and dinner well.
Developed nausea, vomiting at 11PM. Became confused. Paramedics called. Caretaker
found a pulse but paramedics did not. Pt taken to ED but was pulseless and
asystolic on arrival. Pronounced dead around 12:25AM." "No lab data for this
event."
"566311-1" "566311-1" "Patient had alarms last night (02/19/2015), mother
tried to stimulate and called 911. EMT's arrived and began transport to hospital,
but patient arrested and was not able to be resuscitated in ED." "n/a"
"566447-1" "566447-1" "Information has been received from a consumer
referring to 109 patients of unknown age and gender. The patients' concurrent
condition and medical history not reported. The reporter had concerned about the
patients were vaccinated with M-M-R II (lot#, dose and route not reported) and (3)
live neurotoxin vaccines (manufacturer unknown) (strength, dose, lot# and route
were not reported) were given in combination on unknown dates could create adverse
effects. Concomitant therapy was not provided. On unknown dates, the patients died
from the M-M-R II. It was not confirmed if autopsies were performed or not. The
cause of death was unknown. Consumer could not confirm where he received this
statistic. Additional information has been requested." "No lab data for this
event."
"566449-1" "566449-1" "This spontaneous consumer report (initial receipt
11-Feb-2015) concerns a female patient. On the 06-Oct-2009, the patient received
influenza virus vaccine (manufacturer and batch number not reported). On an
unspecified date, the patient became very sick. The patient went into fetal
position within 24 hours after vaccination and became hypersensitive, slided her
legs out and moved her head in circles for weeks. Weeks later, the patient went to
the medical centre and the doctor stated that she experienced Guillain Barre
Syndrome and encephalitis. She was treated with antibiotics. The patient did not
recover and passed away in Feb-2014. The exact cause of death was unknown. The
outcome was reported as not recovered. Reporter's comments: It was reported that
the exact cause of death was unknown. The reporter did not specify how her mother
passed away or if it was related to the flu vaccine." "No lab data for this event."
"566633-1" "566633-1" "Patient passed away 2 days after a healthy well baby
check up at the office, was found unresponsive, taken to ER where he was declared
deceased. Results of pathology still pending." "No lab data for this event."
"566923-1" "566923-1" ""This case was reported in a literature article and
described the occurrence of vomiting in a 7-year-old male patient who received
Influenza vaccine. On an unknown date, the patient received Influenza vaccine
(unknown). On an unknown date, 3 days after receiving Influenza vaccine, the
patient experienced vomiting, appetite lost and influenza A virus infection. On an
unknown date, the outcome of the vomiting, appetite lost and influenza A virus
infection were unknown. The reported cause of death was Reye's syndrome. An autopsy
was performed. The autopsy determined cause of death was hepatic steatosis, kidney
tubule disorder, cerebral edema, influenza A virus infection and salicylate
intoxication. It was unknown if the reporter considered the vomiting, appetite lost
and influenza A virus infection to be related to Influenza vaccine. Additional
information received: This case was reported in a literature article and it
described the occurrence of vomiting in a 7-year-old male patient who had received
unspecified influenza A vaccination (manufacturer unknown). No information on the
patient's medical or family history or concurrent condition was provided. On an
unspecified date, the patient received unspecified influenza A vaccine
(administration route and site unspecified; dosages unknown; batch numbers not
provided). On an unspecified date, 3 days after receiving vaccination the patient
developed profound vomiting and loss of appetite. The patient's mother had given
him PEPTO-BISMOL and Gatorade as treatment and sent the patient to bed. The patient
was found unresponsive less than 12 hours later and pronounced dead 4 minutes after
arrival at the hospital. Autopsy findings included diffuse mixed micro and macro
vesicular steatosis of the liver, micro vesicular steatosis in the renal tubule
cells, and cerebral edema. A postmortem nasopharyngeal swab screening was positive
for influenza A. Toxicology was positive for salicylate. The outcomes of the events
were unspecified. The authors did not comment on causality relationship between the
vaccine and the event. The authors concluded that ""Reye's syndrome is a rare
severe neurologic disorder consisting of a biphasic illness characterized by a
viral infection followed by an acute onset of non-inflammatory encephalopathy and
hepatic failure, with rapid progression to death if not properly treated. It most
commonly affects children younger than 16 years of age who are treated with aspirin
during certain viral infections, including varicella and influenza. The exact cause
is unknown, but it is thought to result from mitochondrial impairment resulting
from the actions of salicylate and its metabolites, hydroxyhippurate and gentisate.
This impairment appears to be intensified during viral illnesses""."" "No lab data
for this event."
 "567040-1" "567040-1" "Patient started out with flu-like symptoms starting
on the night after the vaccine was administered. Per family, patient never fully
returned to baseline state of health. Patient went on to develop chest pain and
presented to hospital on 12/27 complaining of chest pain. ACS was ruled out and
patient was discharged home the next day with a course of Ceftin for suspected
pneumonia. Patient presented to the ED again on 1/22 with complaints of weakness,
chills, nausea, dry cough, and increased shortness of breath. Patient was quickly
transferred to the MICU with respiratory failure and acute renal failure. Patient
was treated for pneumonia but did not respond to antibiotics and all cultures were
negative. Patient was subsequently treated for suspected vasculitis based on ANCA
studies with cyclophosphamide and methylprednisolone but subsequently expired on
2/23." "Anti-myeloperoxidase Ab = 5.7 AI on 1/27 Anti-myeloperoxidase Ab = 5.2
AI on 2/6 Anti-proteinase 3 Ab = < 1.0 AI on 1/27 Anti-proteinase 3 Ab = < 1.0 AI
on 2/6 Renal and lung biopsies both negative for vasculitis"
"567070-1" "567070-1" "A spontaneous health professional report from a
regulatory authority in an article, concerns a 19 year old female. The patient's
medical history included cold sweat, nausea, dizziness, and difficulty reading
numbers on the day prior to death. Concomitant medications included quadrivalent
human papilloma virus vaccine and meningococcal conjugate. Patient received Nasal
FLUMIST QUADRIVALENT on an unknown date. The patient died 10 days after these
vaccinations from unknown causes. Despite an extensive post-mortem examination
including autopsy and microscopic, neuropathological, toxicological, and chemical
evaluation, the immediate cause of death could not be ascertained. Autopsy revealed
no obvious cause of death. The reporter assessed the death to be serious by the
criterion of death." "Autopsy and microscopic, neuropathological, toxicological,
and chemical evaluation, the immediate cause of death: Could not be ascertained."
"567073-1" "567073-1" "A report from VAERS concerns a three year old male
patient. The patient was born prematurely between gestational weeks 32 and 33 and
suffered from atrial septal defect. The patient received nasal FLUMIST and 10 days
later experienced hypoxic-ischemic brain injury. The patient died of the hypoxic-
ischemic brain injury on an unknown date. It was unknown if autopsy was performed.
The reporter assessed the event as serious due to death. Based on the information
in this report, and awaiting the reporter's assessment, the company physician
considered the event to be at least possibly related to FLUMIST." "No lab data
for this event."
"567086-1" "567086-1" "It is a spontaneous report to the VAERS program
concerning a child patient with unknown gender and age. The patient's medical
history, concurrent diseases, and concomitant medications were not reported. On an
unknown date, the patient received nasal FLUMIST. Two days after vaccination, the
patient had a seizure, and the patient died. The cause of death was seizure.
Interval after vaccination unknown. According to the reporter the seizure was
considered to be serious with the serious criteria of death." "No lab data for
this event."
"567087-1" "567087-1" "A spontaneous health professional report from a
regulatory authority in an article. Vaccine Adverse Event Reporting System (VAERS),
July 2013-April 2014, concerns a 7 year old female. The patient's medical history
included subacute sclerosing panencephalitis (SSPE). No concomitant diseases and
concomitant medications were reported for consumer. Patient received Nasal FLUMIST
QUADRIVALENT on an unknown date, and 64 days later she required hospitalization for
16 days for changes in mental status and progression of SSPE. The patient died from
an unknown cause on an unspecified date. The report did not describe whether an
autopsy was performed. The reporter assessed the death to be serious by the
criterion of death." "No lab data for this event."
"567350-1" "567350-1" "This spontaneous report as received from a consumer,
as part of a marketing research program refers to a 49 year old male patient. On an
unknown date, the patient was vaccinated with a dose of pneumococcal vaccine
(manufacturer unknown) (dose, route and lot # not reported). The consumer reported
that on an unknown date, 2 months after vaccination, the patient died from
pneumonia so he had no faith in pneumococcal vaccine (manufacturer unknown). The
relationship between the event and pneumococcal vaccine, (manufacturer unknown) was
not reported. Additional information is not expected. There is no contact
information." "No lab data for this event."
"567978-1" "567978-1" ""Initial unsolicited report was received from a
certified medical assistant on 23 February 2015. This case is one of a cluster of
""almost 10 patients"" (eight of which were identified) received from the same
reporter. The other patients are captured in cases 2014SA157362, 2015SA023267,
2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and
2015SA023928. A 73 year-old elderly male patient had received on 26 September 2014
an intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with
expiration date of 12 May 2015) and an unspecified amount of time later was
diagnosed with pneumonia and died 21 days after vaccination on 17 October 2014. The
patient had a chest x-ray, WBC and CBC results were not reported. Illness at the
time of vaccination was none. Concomitant medications and pre-existing conditions
were reported as ""NA"". No further information was provided. Outcome was fatal.
According to the reporter, the report was reviewed and they had no additional
information to report at the time. Documents held by sender: none."" "Chest X-ray
results not reported. WBC, Unknown, Unknown; CBC, Unknown, Unknown"
"567979-1" "567979-1" ""Initial unsolicited report was received from a
certified medical assistant on 23 February 2015. This case is one of a cluster of
""almost 10 patients"" received from the same reporter (with 8 patients
identified). The other patients are captured in cases 2014SA157362, 2015SA023263,
2015SA023893, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924 and
2015SA023928. An 83 year-old male patient had received on 26 September 2014 an
intramuscular left arm injection of FLUZONE HIGH DOSE (lot number U5024CA with
expiration date of 12 May 2015) and ""shortly after vaccination"" was diagnosed
with pneumonia; the patient died on 17 December 2014, approximately 3 months after
vaccination. The patient had a chest x-ray on which pneumonia was noted; CBC was
obtained, but results were not reported. Illness at the time of vaccination was
none. Concomitant medications and pre-existing conditions were reported as ""NA"".
No further information was provided. Outcome was fatal. According to the reporter,
the report was reviewed and they had no additional information to report at the
time. Documents held by sender: none."" "Pneumonia noted per chest x-ray; CBC,
Unknown, UNK"
"568282-1" "568282-1" "Hives, swollen glands, chills, difficult breathing,
feeling unwell, rash, skin infection, muscle weakness, tiredness, weakness
confusion, leg pain and wheezing." "All tests were complicated"
"568771-1" "568771-1" "Pt was discovered in parent's bed in the morning on
his side with swollen eye, nasal bleeding, swollen tongue, perioral petechiae. He
was taken via paramedics to Hospital and was unable to be resuscitated."
"Unclear/unknown"
"568987-1" "568987-1" ""Initial unsolicited report was received from a
certified medical assistant on 23 February 2015. This case is one of a cluster of
""almost 10 patients"" received from the same reporter (with 8 patients
identified). The other patients are captured in cases 2014SA157362, 2015SA023263,
2015SA023267, 2015SA023902, 2015SA023910, 2015SA023917, 2015SA023924, 2015SA023928.
A 74 year-old patient, gender unknown had received on 13 October 2014 in the
morning, an intramuscular left arm injection of FLUZONE QUADRIVALENT, lot number
UI205AC with expiration date of June 2015 and at an unspecified time after
vaccination was diagnosed with flu and pneumonia; the patient died on 28 December
2014, approximately 3 months after vaccination. Relevant diagnostic tests were
reported as ""ER + flu + pneumonia"". Illness at the time of vaccination was none.
Concomitant medications and pre-existing conditions were reported as ""NA"". No
further information was provided. Outcome was fatal. According to the reporter, the
report was reviewed and they had no additional information to report at the time.
Documents held by sender: none."" ""Lab tests reported as - ""ER + flu +
pneumonia""""
"569399-1" "569399-1" "This spontaneous report as received from a consumer
refers to her cousin, an approximately 3 years old male patient. On an unknown
date, in early 1990's the patient was vaccinated with M-M-R II, (therapy type HSA,
dose and Lot# were not reported). On an unknown date, immediately after
vaccination, the patient experienced general grand mal seizures that continued to
worsen throughout a one year period. On an unknown date, when the patient was
having up to 40 seizures a day, he was admitted to a hospital. On an unknown date,
reported as one year after vaccination with M-M-R II the patient died. The cause of
death was reported as seizure. Relatedness between grand mal seizure and M-M-R II
was not reported. Upon internal review general grand mal seizures were considered
to be medically significant. Additional information has been requested." "No
lab data for this event."
"570312-1" "570312-1" "None stated." "None yet"
"570609-1" "570609-1" "Received call from wife. Approx. 3AM pt. aspirated
and 911 was called. Pt. expired in transport. Due to close proximity of vaccine
administration we are reporting the event." "No lab data for this event."
"570801-1" "570801-1" "Syncope. Died at ER." "No lab data for this event."
"571016-1" "571016-1" "None stated." "No lab data for this event."
"571944-1" "571944-1" "After receiving vaccination, pt asked for ibuprofen
for headache, then he went to church, then saw his attorney. When he came back, he
sat down at a table, put his head down and reportedly had some spastic movements
and fell over. They did CPR and used the AED without results. He coded at 3:25, was
sent to the ED at 3:40 and passed at 4:10." "None"
"572818-1" "572818-1" "This spontaneous report was received from a former
Merck field employee via company representative regarding a patient of unknown age
and gender. The patient was diagnosed with unspecified cancer. On an unknown date
the patient was vaccinated with ZOSTAVAX (lot number, strength, dose, frequency and
route of administration) (medication error). On an unknown date the patient died.
The exact cause of the death was unknown. Causality assessment was not reported.
Additional information has been requested." "No lab data for this event."
"573084-1" "573084-1" ""Died 2 days after receiving routine 4 month
vaccines. Reportedly, developed upper respiratory congestion, limpness, was taken
to the ED, went into respiratory arrest and died. The mom states the death was
linked to ""pneumococcal vaccine in her lungs and blood""."" "No lab data for
this event."
"573401-1" "573401-1" ""This case was reported in a literature article and
described the occurrence of varicella in a 15-year-old female subject who received
DTP (A or W not known) vaccine. Previously administered products included DTP (A or
W unknown) vaccine with an associated reaction of no adverse event (1st dose), DTP
(A or W not known) vaccine with an associated reaction of no adverse event (2nd
dose), DTP (A or W not known) vaccine with an associated reaction of no adverse
event (3rd dose) and MMR vaccine with an associated reaction of no adverse event
(2nd dose). Concomitant products included MMR vaccine. On an unknown date, an
unknown time after receiving DTP (A or W not known) vaccine and Hib vaccine, the
subject developed severe - grade 3 varicella. Serious criteria included death and
hospitalization. Additional event(s) included fever, shortness of breath, face
edema, petechial rash, hypotension, pneumonia with serious criteria of GSK
medically significant, acute respiratory distress syndrome with serious criteria of
GSK medically significant, pancytopenia with serious criteria of GSK medically
significant, multi-organ failure with serious criteria of GSK medically
significant, iatrogenic infection, enterobacter cloacae infection with serious
criteria of GSK medically significant, respiratory tract infection with serious
criteria of GSK medically significant, urinary tract infection pseudomonal with
serious criteria of GSK medically significant, Stenotrophomonas sepsis with serious
criteria of GSK medically significant, thrombocytopenia, leukopenia with serious
criteria of GSK medically significant and lung consolidation. The subject was
treated with acyclovir, antibiotics unknown, antifungals for systemic use,
ciprofloxacin, meropenem, Sulfamethoxazole + Trimethoprim, Ticarcillin +
Clavulanate and tigecycline. The outcome of varicella was fatal. The outcome(s) of
the additional event(s) included fever (unknown), shortness of breath (unknown),
face edema (unknown), petechial rash (unknown), hypotension (unknown), pneumonia
(unknown), acute respiratory distress syndrome (unknown), pancytopenia (unknown),
multi-organ failure (unknown), iatrogenic infection (unknown), enterobacter cloacae
infection (unknown), respiratory tract infection (unknown), urinary tract infection
pseudomonal (unknown), Stenotrophomonas sepsis (unknown), thrombocytopenia
(unknown), leukopenia (unknown) and lung consolidation (unknown). The reported
cause of death was varicella. It was unknown if the investigator considered the
varicella, fever, shortness of breath, face edema, petechial rash, hypotension,
pneumonia, acute respiratory distress syndrome, pancytopenia, multi-organ failure,
iatrogenic infection, enterobacter cloacae infection, respiratory tract infection,
urinary tract infection pseudomonal, Stenotrophomonas sepsis, thrombocytopenia,
leukopenia and lung consolidation to be related to DTP (A or W not known) vaccine
and Hib vaccine. Diagnostic results (unless otherwise stated, normal values were
not provided): On 14th March 2009, Varicella virus test result was Positive absent.
On an unknown date, Aspiration bone marrow result was no evidence of leukaemia
absent. On an unknown date, Blood culture result was Negative absent. On an unknown
date, Blood culture result was Positive for Stenotrophomonas maltophilia absent. On
an unknown date, Body temperature result was 101.1 degree F. On an unknown date,
Chest X-ray result was Alveolar consolidation absent. On an unknown date,
Computerised tomogram result was no intracranial lesions absent. On an unknown
date, Electroencephalogram result was excluded subclinical seizures absent. On an
unknown date, Platelet count result was 30,000 /mcL. On an unknown date, White
blood cell count result was 1,400 /mcL. Additional information received: This case
was reported in a literature article and it described the occurrence of a varicella
infection in a 15-year-old female patient who had been vaccinated with unspecified
DTP vaccines, unspecified Hib vaccine and unspecified MMR vaccines (manufacturers
unknown). The patient had been healthy prior to the event and had no known
underlying medical conditions according to the authors. She lived in a community
with low rates of varicella vaccination and the source individual was never
identified. No further information on the patient's medical or family history,
concurrent medical conditions or concomitant medication was provided. On an
unspecified dates, the patient received 4 doses of an unspecified DTP vaccine, 1
dose of an unspecified Hib vaccine and 2 doses of an unspecified MMR
(administration routes and sites unspecified; dosages unknown, batch numbers not
provided). Please note that the authors commented that she had not been vaccinated
against varicella. On 12 March 2009, an unknown period after the vaccinations she
was admitted to hospital with a 3-day history of a rash consistent with varicella
and a 1-day history of fever and shortness of breath. Upon examination on
admission, she was noted to be awake and alert, febrile (101.1 deg. F) dyspnoeic,
had facial oedema, generalized petechial rash and hypotension; so she was diagnosed
with septic shock. She was initially placed on non-invasive mechanical ventilation,
but her respiratory function continued to deteriorate and she required invasive
mechanical ventilation after 6 hours. In addition to this, she later developed
pneumonia complicated by acute respiratory distress syndrome, pancytopenia, multi-
organ dysfunction, iatrogenic colonization and infection (respiratory tract
colonization with Enterobacter cloacae and urinary tract infection with Pseudomonas
aeruginosa) and sepsis. Further deterioration of her respiratory function require
progressively higher levels of oxygen and pressure during her last week in
hospital. She died on day 21 of admission. Varicella was recorded as the underlying
cause of death, and this was validated by an investigation performed by the state
Department of Health. The authors did not mention if a post-mortem had been
performed. Laboratory tests performed on admission revealed thrombocytopenia
(platelet count: 30,000/mcL) and leucopoenia (white blood cell count: 1,400/mcL).
Blood cultures taken on admission were negative, but direct fluorescent antibody
test performed on a sample of vesicular fluid collected on 14 March 2009 was
positive for varicella-zoster virus. Blood cultures taken on hospital days 19 and
20 were positive for Stenotrophomonas maltophilia. Further blood cultures collected
while she was on antibiotics were negative. In addition to this the authors
commented that she had been diagnosed with Enterobacter cloacae respiratory tract
colonization and Pseudomonas aeruginosa urinary tract infection, but the details of
those tests were not provided. She underwent multiple chest X-Rays that showed
diffuse, tiny nodules in the lung parenchyma consistent with alveolar
consolidation. Computed tomography scan did not identify a""Aspiration bone marrow,
no evidence of leukaemia absent; Blood culture, Positive for Stenotrophomonas
maltophilia absent; Blood culture, Negative absent; Body temperature, 101.1 degree
F; Chest X-ray, Alveolar consolidation absent; Computerised tomogram, no
intracranial lesions absent; Electroencephalogram, excluded subclinical seizures
absent"
"573481-1" "573481-1" "Admitted to hospital on 2/24/15 sepsis. Varicella
verified on PCR with subsequent progressive multi-organ failure. Autopsy: Cause of
death 3/5/15 � disseminated varicella - final histology pending as of 4/6/15."
"Varicella Zoster PCR (+) on 3/3/15"
"573976-1" "573976-1" "Found unresponsive." "None"
"575996-1" "575996-1" "Initial unsolicited case received from a health care
professional on 14 April 2015. A female patient (confidential), whose medical
history and concomitant medications were not reported, had received a dose of
Influenza Vaccine (batch number, route and site of administration were not
reported) on unspecified date. On unspecified date, the patient experienced a
severe reaction, swollen throat and anaphylactic shock and died while using the
vaccine. Laboratory investigations and corrective treatments were not reported. At
the time of this report, the outcome of the events was fatal. Documents held by
sender: None." "Lab tests unknown"
"576026-1" "576026-1" ""This case was reported in a literature article and
described the occurrence of death in a 84-year-old female patient who received
Influenza vaccine. Concurrent medical conditions included hypertension,
hyperlipidemia, myelofibrosis and acute myeloid leukemia. Concomitant products
included 5-Azacytidine. On an unknown date, the patient received influenza vaccine
(unknown). On an unknown date, 91 days after receiving influenza vaccine, the
patient experienced death (serious criteria death and GSK medically significant),
takotsubo cardiomyopathy, vaccination failure (serious criteria GSK medically
significant), influenza (serious criteria hospitalization), respiratory distress
(serious criteria hospitalization and GSK medically significant), labored
respiration (serious criteria hospitalization), tachycardia, crackles lung, hypoxia
(serious criteria GSK medically significant), respiratory alkalosis, ventricular
arrhythmia (serious criteria GSK medically significant) and lung congestion
(serious criteria GSK medically significant). The patient was treated with
oseltamivir, operations and procedures (intubation), non-drug therapy (ventilation)
and non-drug therapy (cardiopulmonary resuscitation). On an unknown date, the
outcome of the death was fatal and the outcome of the takotsubo cardiomyopathy,
vaccination failure, influenza, respiratory distress, labored respiration,
tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia
and lung congestion were unknown. The reported cause of death was unknown cause of
death. It was unknown if the reporter considered the death, takotsubo
cardiomyopathy, vaccination failure, influenza, respiratory distress, labored
respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis,
ventricular arrhythmia and lung congestion to be related to influenza vaccine.
Additional information received: This case was reported in a literature article and
it described the occurrence of a vaccination failure in an 84-year-old female
patient who had received unspecified seasonal influenza vaccine (manufacturer
unknown). Concurrent conditions included hypertension, hyperlipidemia,
myelofibrosis and associated acute myeloid leukemia. Concomitant medication
included chemotherapy of which she had received the last cycle with 5-Azacytidine 3
weeks before the event. No further information on the patient's concurrent medical
conditions, medical and family history or concomitant medication was provided. On
unspecified dates, the patient received a dose of unspecified seasonal influenza
vaccine (dosage unknown; administration route unspecified; batch number not
provided). On an unspecified date, approximately 3 months after the vaccination,
the patient developed flu-like symptoms. She was seen at the oncology clinic 3 days
later where a nasopharyngeal swab was taken that was positive for influenza A
antigen of the H3N2 strain. Despite antiviral treatment, she required admission to
hospital 2 days later due to respiratory distress and deterioration of the
symptoms. Upon initial examination, she was noted to have important respiratory
distress with laboured respiration; her temperature was 103.4 deg. F, her
respiratory rate was 31 rpm and her oxygen saturation was 88% on air and 92% on an
non-rebreather mask. According to the authors, her blood pressure and heart rate
were within normal limits and her pulmonary auscultation was unremarkable. The
patient seemed to improve with the continuation of the treatment on the following
days; but 3 days after admission she required intubation and mechanical ventilation
as she had become acutely short of breath, tachycardic with bibasilar crackles on
auscultation, hypoxic and was noted to have respiratory alkalosis. After further
examination she was first believed to have acute coronary syndrome but she was
finally diagnosed with Takotsubo cardiomyopathy. However she developed a
ventricular arrhythmia and she died on day 4 of hospitalisation despite aggressive
medical treatment and cardiopulmonary resuscitation. This case was considered
serious as it had a fatal outcome. Cause of death was unspecified, it was unknown
if a post-mortem was performed. Her initial chest x-ray and electrocardiogram were
unrevealing, but when repeated after 3 days the X-ray showed pulmonary vascular
congestion and left basilar airspace disease; and the electrocardiogram showed new
T-wave inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL,
creatinine was 1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She
underwent a bedside echocardiogram performed by a cardiologist that revealed a
reduced left ventricular ejection fraction (30%) and severe hypokinesis of all mid
to distal walls and apex. According to the authors, these results were suggestive
of apical ballooning syndrome or Takotsubo cardiomyopathy. Initial treatment
consisted of oral oseltamivir that was started at her oncology outpatient clinic.
She later required intubation and mechanical ventilation, dieresis, unspecified
medical management and unspecified cardiopulmonary resuscitation. The authors did
not comment on any causal relationship between the events and the vaccination. The
authors concluded that ""Influenza A infection has rarely been linked to the
development of Takotsubo cardiomyopathy. Excessive catecholamine release is
believed to play a role in the pathogenesis and the treatment is largely empirical
and supportive. Although Takotsubo cardiomyopathy -related mortality rates are low
(1-3.2%), patients with associated severe infections such as influenza have a worse
prognosis. Identifying influenza patients with higher mortality risks may allow for
more favourable clinical outcomes in these patients""."" "3 months after
vaccination, nasopharyngeal swab was taken that was positive for influenza A
antigen of the H3N2 strain. At admission, upon initial examination, she was noted
to have important respiratory distress with laboured respiration, her temperature
was 103.4 deg. F, her respiratory rate was 31 rpm and her oxygen saturation was 88%
on air and 92% on a non-rebreather mask. According to the authors, her blood
pressure and heart rate were within normal limits and her pulmonary auscultation
was unremarkable. Her initial chest x-ray and electrocardiogram were unrevealing,
but when repeated after 3 days the X-ray showed pulmonary vascular congestion and
left basilar airspace disease; and the electrocardiogram showed new T-wave
inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL, creatinine was
1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She underwent a bedside
echocardiogram performed by a cardiologist that revealed a reduced left ventricular
ejection fraction (30%) and severe hypok"
"576576-1" "576576-1" "Information has been received from a published
literature article. The patient in this case was a 15-year-old male patient with T-
cell precursor acute lymphoblastic leukemia undergoing re-induction chemotherapy.
His immunization records from school revealed that the boy had received one
varicella vaccination (manufacturer unknown, lot #, dose and route were not
reported) when he was 5 years old but none thereafter; he was up-to-date on other
vaccines. We defined Day 1, as the day when the patient presented to the Emergency
Department for fever and a sharp stabbing back pain. He had blood cultures drawn
and received levofloxacin. On Day 2, he presented again with high fever and
decreased peripheral perfusion, with prolonged capillary refilling time. Thus, he
was admitted to the Pediatric Intensive Care Unit (PICU) and received intravenous
antibiotics. Laboratory data on admission showed lymphocytopenia (200 count/mm2).
After his general condition was stabilized, the re-induction chemotherapy regimen
with vincristine, doxorubicin, asparaginase, and dexamethasone (manufacturer
unknown) was resumed. On Day 3, he developed a non-vesiculated acne-like rash,
believed to be related to the high dosage of dexamethasone (manufacturer unknown),
based on its appearance. On Day 7, the rash started to vesiculate. Vesicular fluid
was obtained and Varicella-Zoster Virus (VZV) deoxyribonucleic acid (DNA) was
detected with polymerase chain reaction (PCR) analysis. Intravenous acyclovir was
started. On Day 9, he developed hepatitis, which subsequently progressed to multi-
organ failure and death. DNA analysis of the PCR product from the vesicle indicated
that the virus was wild type VZV (5). VZV antibody titers were never obtained. The
authors considered the event as vaccination failure and the patient died of
disseminated varicella. This is one of 2 reports received from the same literature
(other case # 1505USA000527). Additional information has been requested."
"Lymphocytes on admission (date unspecified): 200 count/mm2, showed
lymphocytopenia. Polymerase chain reaction, virus was wild type VZV"
"576747-1" "576747-1" "No known adverse event." "No lab data for this
event."
"576974-1" "576974-1" "After flu shot developed autoimmune disease which
kept her from eating and eventually her airway which led to her death 3-25-15."
"Medical records included"
"577000-1" "577000-1" "Death." "No lab data for this event."
"577134-1" "577134-1" "This is a spontaneous report from a contactable
physician. An 88-year-old female patient received PREVNAR 13 (Lot # L36485, Exp.
date 01Oct2016, NDC code 00005197101), via an unspecified route of administration
at 0.5 ml, single on 28Apr2015. Medical history included congestive heart failure,
hypertension, hyperlipidemia, coronary artery disease and stroke. The patient had
these medical conditions for at least 10-20 years. Patient was bedbound or
wheelchair bound prior to receiving the vaccine. Blood work revealed elevated white
blood cell count. Reporter said that she broke her hip, wasn't able to stand on the
scale, and had lost a lot of weight. The patient's concomitant medications were not
reported. On 28Apr2015, the patient experienced cardiac arrest. Therapeutic
measures were taken as a result of cardiac arrest. The patient died on 29Apr2015.
It was not reported if an autopsy was performed. The event was described as
follows: about a half an hour after the vaccination, she had a cardiac arrest.
Reporter did not witness the event. Patient had an arrest, and emergency was
called. They resuscitated her and brought to the ER. She arrested again in the ER.
Patient just saw reporter for a follow-up visit and reporter decided to give her
the vaccine. The reporter called because she was wondering if it was an
anaphylactic reaction to the PREVNAR or if there have been any similar reports, she
stated she can't prove or disprove that is what happened, but it is a possibility."
"Blood work (date unspecified) Elevated white blood cell count"
"577375-1" "577375-1" "No known adverse event." "No lab data for this
event."
"577427-1" "577427-1" "The infant received Pediarix, ActHIB, PCV13 and
Rotarix on 5/4/2015 at 3:35pm. No immediate issues post-vaccination in the clinic.
The infant was found deceased the next morning, 5/5/2015. The coroner reported
onset of rigor mortis upon arrival to pick infant up and approximate time of death
4-6 hours previously. The infant was sent to the Medical Examiner for autotopsy.
The parents reported the infant had mild irritability/fussiness about 72 hours
prior to death but no fever, diarrhea, oral intolerance, flaccidity or seizures. No
history of seizures. The autopsy was essentially normal with no findings that would
explain an acute death. The Medical Examiner did report that the child was co-
sleeping between the two parents with heavy adult sized bedding." "No lab data
for this event."
"577882-1" "577882-1" "After day of vaccination, all of sudden he started
giving up on feeding and stop turning on side. That never happen before
vaccinations. His growth percentile was perfect at his 2 months pediatric visit
(the day he got his 2 months vaccines)." "X-ray, and all other lab test (hospital
has all the reports)"
"577926-1" "577926-1" "This spontaneous report was received from a
pharmacist via company representative concerning a patient of unknown age and
gender. The patient's medical history included an unspecified lymphoma and bone
marrow transplant (date was not provided). On an unknown date, the patient was
vaccinated with ZOSTAVAX, subcutaneously (anatomical location, dose, strength and
lot number were not provided). Co-suspect or concomitant therapies were not
provided. On an unknown date, after receiving ZOSTAVAX, the patient died of
possible complications of Epstein Barr Syndrome, it was unknown if an autopsy was
performed. The patient sought medical attention through an office visit. No product
quality complaint was involved. At the time of the report, the outcome of Epstein-
Barr virus infection was fatal. the causal relationship between Epstein-Barr virus
infection/death and vaccination with ZOSTAVAX was unknown. Additional information
has been requested." "No lab data for this event."
"578421-1" "578421-1" "Infant found dead at home." "No lab data for this
event."
"578479-1" "578479-1" "Difficulty breathing taken to hospital SAO2 level 75
put on 15 liters O2 sent home on the 01/22/2015." "Unknown"
"578511-1" "578511-1" ""This spontaneous report was received from a
pharmacist via a company representative refers to a 60 year old male patient. On an
unknown date the patient was vaccinated with ZOSTAVAX (lot # and expiry unknown).
The company representative read in the newspaper dated 14-MAY-2015, that was
released on 13-MAY-2015, that a patient passed away on 11-MAY-2015, because of
""complications due to a disseminated zoster virus"". The representative stated
that his wife overheard some unspecified individuals discussing the patient's death
and mentioned that the patient had received one dose of ZOSTAVAX. Another company
representative reported that a pharmacist had reported to him that the same patient
had died after receiving the ZOSTAVAX. Causality of event was not reported.
Additional information has been requested."" "No lab data for this event."
"579462-1" "579462-1" "Information has been received from the authors of
the literature report. Learning Objective #1: To diagnose splenic infarction based
on radiologic findings and the importance of vaccinations and early antibiotics in
asplenic patients. Learning Objective #2: To suspect and perform hypercoagulable
workup in patients presenting with evidence of end organ damage (splenic infarcts
and abdominal pain) due to ischemia. Case: The authors present the case of a 26
year old female with past medical history significant for stercoral ulcer,
complicated by bowel perforation who presented to the Emergency Department (ED)
complaining of abdominal pain, vomiting, headache, subjective fever and facial
pain. She was alert and oriented in the emergency department on arrival. She was
given pain medications and fluids in the ED and basic labs were ordered. Four hours
after her initial presentation, the patient was obtunded and minimally responsive
to commands and intubated for airway protection. On repeat physical examination,
her pupils were noted to be dilated and sluggish, with no corneal, cough or gag
reflex. Stat computerized tomography (CT) scan of the head was negative for acute
process and she was started on broad-spectrum antibiotics for suspected infection.
Stat Magnetic Resonance Imaging (MRI) of the brain was suspicious for meningitis.
Lumbar puncture was positive for Streptococcus pneumoniae, with protein 924 mg/dl,
glucose <10 mg/dl, and white blood cells 3120 /UL with 86% polynuclear cells. Old
records were reviewed. The patient's spleen was small in size compared to prior
abdominal CT. On an initial admission CT for bowel perforation, the spleen was 8.5
cm on coronal section with wedge-shaped pattern appearing to be a splenic infarct.
Three months later, on admission with meningitis diagnosis and repeat abdominal CT
noted the spleen 5.5 cm on coronal section. She had received PCV (manufacturer
unknown) (lot # not provided) on her previous admission with low streptococcus
pneumoniae antibody response to the vaccine except for a few subsets. Pathologic
report findings from her previous bowel perforation (documented as stercoral ulcer)
showed ischemic mucosal injury pattern with mesenteric fat necrosis and
intravascular organizing thrombi. During the prior admission, hypercoagulable
workup was initiated and noted a positive antinuclear antibody (ANA) with a titer
of 1:5120 and positive antiphospholipid antibodies (Lupus anticoagulant IgM 22 M
units, Beta 2 Glycoprotein IgA 47 A units, Anticardiolipin IgM 39M units). The rest
of the hypercoagulable workup including protein C, protein S, antithrombin III,
homocysteine, and Factor V Leiden mutation was negative. Further workup revealed
positive anti double stranded (ds) DNA antibody; anti Ro/SSA antibody >8 and Anti
La/SSB antibody >8. Her C3 was normal and C4 and CH50 were low. The patient
underwent 2 weeks of meningitis treatment with ventilator support without any
clinical or neurological improvement. Repeat CT head was consistent with cerebral
edema and anoxic changes. Goals of care were addressed with family, treatment was
withdrawn and unfortunately the patient passed away. Her autopsy findings were
significant for a possibly infarcted spleen which weighed 35 g. Discussion:
Systemic lupus erythematosus (SLE) is a chronic inflammatory disorder characterized
by multiorgan involvement. Antiphospholipid (ApL) antibodies are positive in 33% of
patients with SLE. Antiphospholipid antibody syndrome (APS) is an acquired
thrombophilia, caused by autoantibodies to beta 2 glycoprotein, lupus anticoagulant
or anticardiolipin. Splenic involvement is seen in 9-20% of patients with SLE. Auto
splenectomy can occur in patients with SLE due to vasculitis or due to splenic
artery thrombosis. Splenic artery thrombosis is more commonly seen in patients with
positive ApL antibodies. Thrombocytosis along with presence of Howell Jolly bodies,
target cells, ovalocytes and spherocytes on peripheral smear, and evidence of
atrophic spleen on imaging studies are imperative tip-offs of autosplenectomy among
these patients. Asplenic patients must be vaccinated against encapsulated
organisms. Prompt initiation of antibiotics in asplenic patients with symptoms
suggestive of infection; along with vaccination; have shown to reduce mortality.
Mesenteric vasculitis and infarction are life threatening lower gastrointestinal
manifestations of SLE. These patients may develop necrotic bowel segments, sepsis
or perforation of their intestine. Patients with SLE can also develop thrombosis
causing an acute presentation of the disease; more commonly seen among patients
with coexisting APS. Autoimmune conditions, particularly SLE and APS are known
causes of hypercoagulable state along with other hematologic conditions. Young
patients with pathology findings suggestive of ischemia and vascular thrombosis
must undergo a hypercoagulable workup, as early detection of these conditions and
initiation of anticoagulants may decrease morbidity and mortality among these
patients. Additional information has been requested." "(Date not provided):
antibody test abnormal."
"579761-1" "579761-1" "This unconfirmed spontaneous report was received
from a consumer and refers to two patients (children) (unspecified) of unknown age
and gender. The consumer read in some publication or article, that on an unknown
date, a couple of the children were vaccinated with Hepatitis B vaccine
(manufacturer unknown) or a couple of other (unspecified) vaccines (route of
administration, doses, lot number and expiry dates were not reported). On an
unknown dates, after the vaccination, an unspecified number of the patients died.
The cause of death was not reported. The relatedness between the vaccinations and
death was not reported. Additional information has been requested." "No lab data
for this event."
"580234-1" "580234-1" ""This information is regarding the description of
adverse events and treatment. Most of the information is basically being obtained
from the pediatric intensivist information when the child was in the pediatric
intensive care unit. At the time of vaccination, which was on May 28, 2015 Mom
stated that her daughter had some cold symptoms that had actually gotten better.
She was otherwise doing well. She did well the day of the vaccines and her visit
for the well check with no issues nor significant exam findings. She apparently on
May 29, 2015, the following day, decreased her oral intake and slept a lot during
the day. At 1830 in the evening she had normal feed and went to sleep after 2 loose
stools. At 2100 she refused to feed and was not crying and was limp. Once Mom put
her in the car seat she was alert and looking around, crying, and kicking and at
2200 she went to sleep. On May 30, 2015 the mother woke her up at 8 o'clock in the
morning and she began ""gasping"" and was limp after 1 ounce of formula feeding.
The mother assessed or believed the child to be in cardiopulmonary arrest and
started CPR. The EMS was called and intubated her and gave her epinephrine and
continued CPR. She was taken to the local emergency room and then taken to the
referral center with the pediatric intensive care unit."" ""No relevant labs as
labs were secondary to ""cardiac arrest""; head CT -> c/w severe anoxic brain
injury""
"580653-1" "580653-1" "This retrospective pregnancy case was reported by a
consumer via call center representative and described the occurrence of
cardiomyopathy in a neonate female patient exposed to Hepatitis B vaccine at birth.
The baby received the product. Co-suspect product exposures included ZOFRAN
solution for injection/infusion and VALTREX unknown. The parent's medical history
included nausea and vomiting (The patient took ZOFRAN), cough and live birth (The
patient had 2 previous pregnancies. Babies were born healthy). In 2013, the mother
started ZOFRAN (intravenous) 4 mg at an unknown frequency. In January 2014, the
mother started VALTREX (unknown) at an unknown dose and frequency. The patient
experienced a drug exposure during pregnancy. The mother's last menstrual period
was on an unknown date and estimated date of delivery was on an unknown date. In
2013, during her pregnancy, she had an ultrasound antenatal screen which showed a
single fetus in a longitudinal lie, breech presentation. The amount of the amniotic
fluid was normal. The placenta was anterior. Good fetal cardiac and extremity
motion were seen. The fetus had a biparietal diameter of 5.7cm, a femur length of
4.2cm, both consistent with the gestational age of 23 weeks and 3 days. Head
abdomen ratio was 1.16 and fetal heart rate was 156 beats per minute. The estimated
weight based on this exam was 599+/-90g. Concomitant product exposures included
medication unknown (Epidural). The neonate received Hepatitis B vaccine. At 41
weeks gestation, the patient was born via unknown delivery and weighed 2855 grams
(6lbs 5oz) at birth. APGAR scores were 8 and 9, her length was 46cm and her head
circumference was 33cm. Within 2 hours after the vaccination with Hepatitis B
vaccine, the patient experienced cardiomyopathy (serious criteria death), shock
(serious criteria death and GSK medically significant), sepsis (serious criteria
GSK medically significant), respiratory distress (serious criteria GSK medically
significant), tachycardia, heart murmur, metabolic acidosis and hypotension. On an
unknown date, the patient experienced labeled drug-drug interaction medication
error. The patient was treated with ATIVAN, phytonadione, aeptimyoclin, gentamicin,
alprostadil, sodium chloride, hydrocodone bitartrate, Hydrocodine, ZOVIRAX,
dopamine, epinephrine, Cefotaxima, milrinone, poractant alfa, vecuronium, sodium
acetate and glucose + water (D5W). On 7th March 2014, the outcome of the drug
exposure during pregnancy was unknown. On 9th March 2014, the outcome of the
cardiomyopathy and shock were fatal. On an unknown date, the outcome of the sepsis,
respiratory distress, tachycardia, heart murmur, metabolic acidosis, hypotension
and labeled drug-drug interaction medication error were unknown. The patient died
on 9th March 2014. The reported cause of death was cardiomyopathy and shock. It was
unknown if the reporter considered the cardiomyopathy, shock, sepsis, respiratory
distress, tachycardia, heart murmur, metabolic acidosis, hypotension, labeled drug-
drug interaction medication error and drug exposure during pregnancy to be related
to Hepatitis B and VALTREX. The reporter considered the cardiomyopathy, shock,
labeled drug-drug interaction medication error and drug exposure during pregnancy
to be related to ZOFRAN. It was unknown if the reporter considered the sepsis,
respiratory distress, tachycardia, heart murmur, metabolic acidosis and hypotension
to be related to ZOFRAN and VALTREX. Additional details were provided as follow
from the legal department: The mother was taking ZOFRAN injection after going to
the hospital at the beginning of the pregnancy for nausea and vomiting. The mother
was sent home with one pill to take after leaving the hospital. She was given a
prescription for the product that she did not fill. The baby was fine all through
the pregnancy. The patient was given the product during the same time she was
receiving an epidural. A healthy baby girl was born with no problems. The baby
weighed six pounds and five ounces. The baby's APGAR scored was noted as being 8/9
after birth in the medical records. The overall health of the baby after birth was
good. The baby had ZOFRAN in her system and within two hours after giving birth,
the baby started to have side effects (tachycardia, respiratory distress,
cardiomyopathy and metabolic acidosis). The baby's heart started to deteriorate and
APGAR score began to fall. The baby suffered from tachycardia and then
cardiomyopathy. During the time span from birth until March 9, 2014 the baby had
metabolic acidosis before death. The doctor tried to counteract ZOFRAN with ATIVAN.
After 2 days, the baby passed away from cardiomyopathy and irreversible shock.
According to the death certificate the cause of death is listed as metabolic
irreversible shock and did not put metabolic acidosis on the certificate. The
mother also mentioned that the left ventricle was shortened and there was a hole in
the heart. The mother noted all of the medications her daughter was given after
birth and during the time she was in the hospital before her death. The mother
believes that being given ZOFRAN by injection during the epidural was the cause of
the heart problems her daughter experienced after birth leading to her death. The
mother has been doing research to find out more information about the medications
and possible drug interactions with the product. It is not known if she was given
the generic or brand but believes that she received the brand name when she went to
the hospital during the first trimester with her daughter. In her research, the
mother noted that ZOFRAN and erythromycin has a drug interaction that can cause a
serious reaction that can cause death. The hepatitis B vaccine can also cause a
drug interaction with ZOFRAN. This is a legal significant cause according to the
mother." "2013, Heart rate, 156/min"
"580878-1" "580878-1" "My daughter got her vaccines and within hours was
lethargic, no appetite, clammy to the touch, whimpering and pale." "Too dang
many to list you are welcome to get her records"
"581306-1" "581306-1" "This spontaneous report was received from a Licensed
Practical Nurse who obtained the information from the web site where read an
article which refers to two baby patients of unknown ages and genders. Concurrent
conditions or pertinent medical history were not reported. On unknown date the
patients were unsafe administer with a dose of hepatitis b vaccine (recombinant)
(manufacturer unknown), rotavirus vaccine, live, oral, pentavalent (manufacturer
unknown) orally, and BCG (manufacturer unknown) (lot #, expiration date, route of
administration (for hepatitis B vaccine (recombinant) and BCG)) and doses were not
reported for either vaccines). On unspecified dates, the two babies died (due to an
unspecified reason) after receiving those vaccines. It was unknown if autopsy was
performed. The nurse also mentioned that the consumer was now scared about having
her child vaccinated in other country, therefore, the nurse would like to know any
comparative information between the vaccines produced in different countries as
lot#s and ingredients used or if those vaccines were in question. The relatedness
of the suspected vaccines with death was not reported. This is one of several
reports from the same source. Additional information has been requested." "No
lab data for this event."
"582912-1" "582912-1" "This spontaneous report as received from a consumer,
as part of a marketing research program, and refers to his/her father of unknown
age. The patient's medical history and concurrent conditions were not reported. On
an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine
(manufacturer unknown) (administration route, lot number and expiration date were
not provided). No concomitant therapies were reported. The reporter stated that the
patient died 3 months (also reported as 6 months) after being vaccinated from a
stroke (cerebrovascular accident), for which the patient was hospitalized (dates
not reported). The outcome of the cerebrovascular accident was reported as fatal.
The cause of death was reported as cerebrovascular accident and it was unknown if
an autopsy was performed. The relatedness between the cerebrovascular accident the
Pneumococcal vaccine (manufacturer unknown) was not reported. Additional
information is not expected, since the reporter did not want the company to contact
the physician to discuss further." "No lab data for this event."
"583142-1" "583142-1" "Found down at babysitters, attempted recusitation,
DOA in ER." "No lab data for this event."
"583871-1" "583871-1" "Patient died. Diagnosis by coroner was SUIDS."
"No lab data for this event."
 "584129-1" "584129-1" "Patient expired approximately 24 hours after
receiving Tdap vaccine. Patient experienced seizure like activity and
cardiopulmonary arrest while on sports field." "No lab data for this event."
"586133-1" "586133-1" "Cold, Blue, not breathing, Lifeless, no pulse."
"No lab data for this event."
"586425-1" "586425-1" "Slight fever on Thursday night. Friday put to sleep
on stomach for 2 hours and mother found him deceased." "No lab data for this
event."
"586965-1" "586965-1" ""This spontaneous report as received from a
physician via company representative, refers to a 84 year old female patient. On an
unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and
route of administered was not reported) and PREVNAR. On an unknown date the patient
experienced ""local reaction which was not specified"" and swelling in her feet.
The patient did not seek medical attention. On an unknown date the patient passed
away. Relatedness between therapy and adverse event was not reported. Additional
information is not expected, physician refused to contact to him."" "No lab data
for this event."
"586988-1" "586988-1" "Disseminated zoster infection, MRSA infection--
sepsis and pneumonia, acute respiratory failure, altered mental status."
"Abdominal punch biopsy with herpes virus cytopathic effect, compatible with
herpes zoster, collected 2/25/15. MRSA detected in serum at admission 2/25/15."
"587213-1" "587213-1" "Intussusception; 15 days after receiving
vaccinations. Presented to local ER with vomiting and irritability." "None"
"588137-1" "588137-1" "Patient has extreme prematurity 25 wks. Has Hx of
Apnea, Tracheomalacia, GER, Breath-holding spell. Infant died on the same day
vaccines were administered. Infant died in her sleep." "CBC"
"588222-1" "588222-1" "Initial unsolicited report received from a consumer
(patient's parent) on 25 July 2015. A male child patient (age not reported), whose
medical history and concomitant medications were not reported, had received a dose
of Meningococcal vaccine (batch number, route of administration and site of
administration were not reported) on an unspecified date. On an unspecified date,
two days later the patient died of viral meningoencephalitis. Laboratory
investigations and corrective treatments were not reported. Documents held by
sender: none." "Lab tests unknown"
"589497-1" "589497-1" "Initial unsolicited report received from a non-
healthcare professional (patient's relative) via social media on 01 August 2015. A
07-month-old female infant, whose medical history and concomitant medications were
not reported, had received a dose of meningococcal vaccine (dose, dose in series,
batch number, expiry date, route and site of administration were not reported) on
an unknown date. Reporter stated that her neighbour back in the eighties was not
fortunate enough as on an unknown date her daughter contacted meningitis after
receiving the vaccination (time from first dose to onset not specified) and she
died within few hours of having fever which her mother thought to be a simple
fever. Laboratory investigations and corrective treatments were not reported. It
was unknown if autopsy was performed. Documents held by sender: none." "Lab tests
unknown"
"590214-1" "590214-1" "This spontaneous report was received from a
physician via company representative regarding 100 unspecified patients. The
physician reported an adverse event involving an unspecified measles vaccine. The
physician stated that he had read an unspecified article in a locally published
newsletter (name of the newsletter not provided). The article stated that there
were hundred deaths caused by Measles, Mumps, and Rubella Virus Vaccine,
(manufacturer unknown) (dose, strength, dose number, Lot no, vaccination site not
specified). Concurrent conditions, medical history and concomitant medications were
not provided. No further information was provided. The cause of death was not
reported. Product quality complaint (PQC) was not reported. Additional information
has been requested." "No lab data for this event."
"590788-1" "590788-1" "This is a spontaneous report from a contactable
licensed practitioner nurse. A 4-month-old male patient received on 07Jul2015 at
09:50 am the second dose of PREVNAR 13 (Lot/batch number: H65078, expiry date
30Jun2015, NDC number: 00005-1971-02) intramuscular on the right thigh at 0.5 ml
single. Medical history included failure to thrive on 21Apr2015 and ongoing.
Concomitant medications given on an unspecified date in 2015 included: second dose
of ROTATEQ (manufactured by Merck, lot number K001832) oral and second dose of
PENTACEL (manufactured by Sanofi, lot number C4679AA) administered intramuscular in
left thigh. The patient previously received on unknown date, the first dose of
PREVNAR 13 and on 21Apr2015 ROTATEQ and PENTACEL. The patient had no illness at the
time of vaccination. The patient underwent on unknown date a hearing test and it
showed a bilateral abnormality. The patient was administered with a 7 days expired
PREVNAR 13. The patient did not receive any treatment after the vaccine was
administered and no emergency room or doctor visit was requested. The patient
passed away. The cause of death was not reported. Follow up (07Jul2015): New
information reported from a contactable nurse includes: patient's date of birth,
date and time of vaccination, site of vaccination and dose, medical history, lab
data, past vaccine history, causality assessment. Follow-up (12Aug2015): New
information reported from a contactable nurse includes onset date of the medical
history and siblings. Death added as event. Case upgraded to serious." "Acoustic
stimulation tests, bilateral abnormality"
"591496-1" "591496-1" "This spontaneous report as received from a physician
via company representative refers to a 12 year old patient of unknown gender. On an
unknown date, the patient was vaccinated with GARDASIL (dose, lot# and route of
administration was not reported). No concomitant medication was reported. The
physician stated that unspecified person watched television show which reported
that on an unknown date the patient died after receiving GARDASIL. Causality
assessment was not provided. Additional information has been requested." "No
lab data for this event."
"591741-1" "591741-1" "A report has been received from a Study investigator
concerning a 15 year old, female subject, Height: 5.1 inches; Weight: 140.0 Pounds,
enrolled in study. FLUMIST QUADRIVALENT (intranasal) started on 19-Oct-2013. The
patient experienced suicide/intentional self-harm with a firearm which started on
04-May-2014. The patient died from the event of suicide/intentional self-harm with
a firearm on 04-May-2014. Assessment of the Serious criteria for the report was as
follows: Death. The patient died on 04-May-2014. The cause(s) of death was/were
suicide/intentional self-harm with a firearm and gunshot wound of head. The
investigator considered that there was no causal relationship between
suicide/intentional self-harm with a firearm and FLUMIST QUADRIVALENT." "No
lab data for this event."
"597263-1" "597263-1" "Information has been received from news article via
an unspecified reporter in a website referring to 140 patients of unknown age and
gender. Information about concurrent conditions, medical history and concomitant
medication was not provided. On unknown dates the patients were vaccinated with
GARDASIL (strength, dose, dose#, route and lot# unknown). On unknown dates the
patients died. It was unknown if autopsy was done. The cause was death was unknown.
The reporter considered death to be associated with GARDASIL. This is one of
several reports received from the same source. Additional information is not
expected since there was no contact details provided." "No lab data for this
event."
"601733-1" "601733-1" "Pt at well-baby office visit 10/08/15. Received
Fluzone quadrivalent, preservative-free, 0.25 mL IM dose appropriately. About ~6
hours later, found unresponsive at home. Parents called 911. EMS arrived at ~22:15
and began CPR. Brought to the ED where CPR and ACLS continued. Death pronounced at
~22:50. Unclear by hospital summary whether sudden infant death or vaccine-related.
Autopsy being conducted to provide further details." "Afebrile, no acute illness
noted."
"602879-1" "602879-1" "Patient died with the cause of death being reported
as Acute Myocarditis. Due to: Neisseria Meningitis Septicemia. Isolate tested as
Group Y. Being reported as a breakthrough case." "Isolate tested as group Y"
"603438-1" "603438-1" "Information has been received from a new article via
an journalist in a website referring to 32 female patients of unknown age.
Information about concurrent conditions, medical history and concomitant medication
was not provided. On unknown dates the patients were vaccinated with doses of
GARDASIL (dose, dose number, lot number, application and route were not reported).
According to the research of Centers for Disease Control and Prevention, the
researchers looked at problems reported to the Vaccine Adverse Events Reporting
System in the 2.5 years since GARDASIL was licensed. Overall, 6.2 percent of the
reported problems were considered serious. This included 32 deaths among women who
received the vaccine. The exact adverse events were not reported. It was unknown if
autopsy was done. The cause was death was unknown. It was reported that these types
of reports could not determine whether adverse events were caused by the vaccine or
just a coincidence. This is one of several reports received from the same source.
Additional information is not expected since there was no contact details
provided." "No lab data for this event."
"604092-1" "604092-1" ""This spontaneous report as received from a
physician via a company representative refers to an approximately 2.5 year old male
patient. The patient's medical history included ""hyperplastic left heart"" and
multiple unspecified heart surgeries. There was no information about the patient's
concurrent conditions or concomitant therapies provided. On 19-OCT-2015, at 12:30,
the patient was vaccinated with a dose of M-M-R II, subcutaneously (lot # and
expiration date were not reported), a dose of VARIVAX (Merck) (route of
administration, lot # and expiration date were not reported) and a dose of an
unspecified flu vaccine. On 19-OCT-2015, at 12:50, the patient was brought back to
the provider's office, apparently in cardiac arrest. The reporter stated they began
performing cardiopulmonary resuscitation (CPR) on the patient and called for an
ambulance. The ambulance took the patient to an emergency room. The reporter stated
they received a call from the coroner's office at 15:00, and was informed that the
child died (on 19-OCT-2015). The event of cardiac arrest was reported as life
threatening. The outcome of cardiac arrest was reported as fatal, however the cause
of death was not provided. The relatedness between the adverse event and suspect
therapies was not reported. Upon internal review, the event of cardiac arrest was
considered to be medically significant. Additional information has been
requested."" "No lab data for this event."
"604306-1" "604306-1" "I personally have no way to know if the Prevnar was
the cause, so I thought you should know that this report is on behalf of my mother.
I'm not sure what time on the tenth she actually got the vaccine, but at
approximately 4:30pm the same day, she had a massive stroke and passed away. If
possible, I would like to have someone contact me. Thank you." "No lab data for
this event."
"604651-1" "604651-1" "On 2-2-2015 pt. had arm pain. On 2-6-2015 pt. had
extreme arm and shoulder pain, couldn't breathe. Was transported by ambulance to
hospital. Pt. was never well, and died on April 10,2015 at hospital." "No lab data
for this event."
"604906-1" "604906-1" "Death - pt had co-morbities at the time, poss
pneumonia, pneumothorax. Death occurred on a subsequent admission not the same as
Prevnar 13 administration." "No lab data for this event."
"604925-1" "604925-1" "As per patient spouse, He was admitted in hospital
on 10/04/2015 due to pnuemonia and died on 10/12/2015. We don't have hospital
report." "Unknown"
"605086-1" "605086-1" "Pt. was a home care hospice patient w/ a terminal
diagnosis of CHF. Was in usual state of health on 10/08/2015. Son reports that
patient began to rapidly decline over the next few days, ultimately dying on
10/15/15. RN reports no local reaction to vaccine. PMH significant for: DM II;
cardiomyopathy; glaucoma; hypothyroidism; osteoporosis; renal insufficiency."
"Family requested reporting of event."
"605430-1" "605430-1" "This is a spontaneous report from a non-contactable
consumer. A male patient of an unspecified age and ethnicity received a single dose
of PREVNAR 13 on an unspecified date. Medical history and concomitant medications
were not reported. The patient died from Guillain-Barre syndrome on an unspecified
date. It was not reported if an autopsy was performed. No follow-up attempts
possible. No further information expected." "No lab data for this event."
"605991-1" "605991-1" "Cardiac Arrest at home while in bed sleeping next to
wife. Brought in to ER in Cardiac Arrest. Coded for 20 minutes until time of death
was called at 1:30am." "Labs done in ER with elevated cardiac enzymes and elevated
D-dimer. Chest xray was negative."
"606526-1" "606526-1" "On or about 10/2/15 the pneumonia shot was
administered. On 10/11/15 he began to have difficulty breathing and spiked a fever.
He was transported to the hospital and treated with antibiotics and oxygen." "No
lab data for this event."
"606644-1" "606644-1" "Patient had no signs of anything. She had no fever,
no cough, no raspyness. The night before/of her passing she was giggling and
laughing and just a warm bright joy to be around. My husband put her to bed, and
when we woke up we found that she had passed. The coroner was going to rule it was
a SIDS death but then a few days pass we had been told it was Viral Pneumonia."
"No lab data for this event."
"607441-1" "607441-1" ""Information was received from a consumer on 30-OCT-
2015 via Sanofi Pasteur (MSD) and refers to an unspecified number of children
patients of unknown ages and genders. This report was found in the comments part of
a petition about HPV vaccine. On an unspecified date, the patients were vaccinated
with a dose of GARDASIL (lot number, expiration date, dose and route of
administration were not reported). There was no concomitant medication reported.
The reporter stated that ""it's hard to imagine that GARDASIL and other vaccines
for the HPV virus were still on the market knowing the hundreds of our children
that had died (dates were not specified) and those that had harmful adverse
reactions and were living with new medical conditions after receiving the
vaccine"". The cause of death was not reported and it was unknown if autopsy was
performed. This is one of several reports from the same reporter. Additional
information is not expected as no reporter details were provided."" "No lab data
for this event."
"608144-1" "608144-1" "Feeling poorly, fever, malaise. By Oct 31 dyspnea,
weak admitted to hospital. Dx with CAP. Nov 6 died due to complications of CAP."
"No lab data for this event."
"608222-1" "608222-1" "Flushing, dizziness, sweating and disoriented. Then
he had an asthma attack. Was put on steroids. They helped minimally. Within the
next few days he lost appetite, started hallucinating, lost continence and 17 days
after his vaccination, he died." "No lab data for this event."
"609504-1" "609504-1" "Patient received Flu shot on October 20 and became
ill the same day. He was vomiting and shivering. He died the day after receiving
Flu shot." "Autopsy denied at hospital by medical examiner"
"609819-1" "609819-1" "Initial unsolicited report received from a physician
on 05 November 2015. This case was linked to 2015SA179115 and 2015SA179116 (same
reporter). This case involves a patient (age and gender was not reported) who was
vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose, dose in
series and site of administration were not reported) intramuscularly on an
unspecified date in 2015. Illness at time of vaccination and pre-existing physician
diagnosed allergies, birth defects, medical conditions was not reported.
Concomitant medications were not reported. On an unspecified date in 2015,
following the vaccination, the patient died. Relevant diagnostic tests/laboratory
data and corrective treatment was not reported. The outcome was fatal. List of
documents held by sender: none." "Lab tests unknown"
"610282-1" "610282-1" "Information has been received from the authors in a
literature article concerning a patient with VARIVAX (Merck) (manufacturer
unknown), M-M-R II and methylprednisolone (manufacturer unknown) therapy. At 13
months of age, a previous healthy girl with RAG2 deficiency presented acutely with
fever, jaundice, cough, rhinorrhea, diarrhea and approximately 10 erythematous
papules on her torso and extremities. Preliminary studies revealed direct Coombs
positive anemia and leukocytosis with granulocytes predominating. Initial treatment
measures included blood transfusions, intravenous immunoglobulin (MG) and high dose
methylprednisolone (manufacturer unknown) (up to 80 mg/day), leading to transient
resolution of hemolysis. In addition, she developed autoimmune thrombocytopenia
(nadir 25,000 platelets/1/4.L). Three weeks after onset of illness, her rash
evolved into discrete 3-mm eschars; however, very few, if any new skin lesions
developed. Skin biopsy revealed intranuclear inclusion bodies typical of
Herpesviridae and intravenous acyclovir was initiated. Despite antiviral therapy,
which later included foscarnet, her clinical status deteriorated over subsequent
weeks. Obtundation ensued, and the patient died due to complications of hepatic and
renal failure, disseminated intravascular coagulation and recalcitrant autoimmune
hemolytic anemia. Three weeks before onset of illness, the patient received her
first VARIVAX (Merck) (manufacturer unknown) (dose and route unknown), MMR
(manufacturer unknown) (dose and route unknown) and hepatitis A (manufacturer
unknown). There was no obvious contraindication to the administration of live virus
vaccination. She had previously received all vaccinations as per the Advisory
Committee on Immunization Practices (ACIP) recommended schedule, including the
rotavirus series, which were well tolerated. Prior to death, vaccine strain
varicella zoster virus (VZV) was detected in her cerebrospinal fluid (723
copies/mL), skin (137,156 copies/mL) and esophagus by PCR assays and
immunohistochemistry staining, respectively. Throat swabs, also obtained prior to
death, detected mumps and rubella by PCR assays. Stool samples submitted for viral
electron microscopy were negative, including assessment for rotavirus. Ophthalmic
examination revealed corneal dendrites with typical features of VZV infection.
Autopsy demonstrated VZV dissemination in the lungs and liver as well as profound
lymphoid depletion of lymph nodes and thymic tissue. VZV, mumps and rubella
isolated from the patient were confined as vaccine genotypes Oka, Jeryl-Lynn and RA
27/3, respectively. The reporter considered the events to be related to VARIVAX
(Merck)(manufacturer unknown), MMR (manufacturer unknown), methylprednisolone
(manufacturer unknown) and hepatitis A (manufacturer unknown). Upon internal
review, renal failure, hepatic failure and disseminated intravascular coagulation
were considered to be medically significant. Additional information has been
requested." "Immune thrombocytopenic purpura (date unknown): nadir 25,000
platelets/microliter. Varicella zoster virus (VZV) was detected in her
cerebrospinal fluid (723 copies/mL), skin (137,156 copies/mL) and esophagus by PCR
assays and immunohistochemistry. Stool samples submitted for viral electron
microscopy were negative, including assessment for rotavirus. Lymphoblast count
(date unknown): lymphopenic. White blood cell count (date unknown): leukocytosis.
Biopsy skin, intranuclear inclusion bodies typical of Herpesvi; Blood test,
autoimmune hemolytic anemia; Ophthalmological examination, corneal dendrites with
features of VZV infection; Polymerase chain reaction, mumps and rubella"
"611113-1" "611113-1" "Information has been received from an unspecified
reporter on a digital media via SPMSD on 18-NOV-2015, referring to a boy of unknown
age. The patient's pertinent medical history and concurrent condition were not
reported. On an unknown date the patient was vaccinated with GARDASIL (lot#,
expiration date, strength, dose and route were unknown). The patient's concomitant
medication was not reported. On an unknown date the patient died after vaccination.
The cause of death was not reported. It was unknown if autopsy had done. The
causality between the events and GARDASIL was not reported. Additional information
has been requested." "No lab data for this event."
"611176-1" "611176-1" "Initial unsolicited report received from the
literature on 12 November 2015. This case is linked to 2015SA184887, 2015SA188405,
2015SA188406, 2015SA188407, 2015SA188408 (same literature). Since 2012, three
clusters of serogroup C meningococcal disease among men who have sex with men (MSM)
have been reported. During 2012, 13 cases of meningococcal disease among MSM were
reported by Department of Health and Mental Hygiene (1); over a 5-month period
during 2012-2013, the Department of Public Health reported four cases among MSM;
and during May-June 2015, the Department of Public Health reported seven cases of
meningococcal disease among MSM. MSM have not previously been considered at
increased risk for meningococcal disease. Determining outbreak thresholds for
special populations of unknown size (such as MSM) can be difficult. The health
department declared an outbreak based on an estimated increased risk for
meningococcal infection in 2012 among MSM and human immunodeficency virus (HIV)-
infected MSM compared with city residents who were not MSM or for whom MSM status
was unknown. The Department of Public Health also declared an outbreak based on an
increase in case counts and thresholds calculated using population estimates of MSM
and HIV-infected MSM. Local public health response included increasing awareness
among MSM, conducting contact tracing and providing chemoprophylaxis to close
contacts, and offering vaccination to the population at risk. To better understand
the epidemiology and burden of meningococcal disease in MSM populations and to
inform recommendations, CDC analyzed data from a retrospective review of reported
cases from January 2012 through June 2015. In May 2013 and again in August 2015,
CDC requested that health departments review all cases of probable or confirmed
meningococcal disease caused by any serogroup and reported among males during
January 2012-June 2015 to the National Notifiable Disease Surveillance System, and,
if possible, determine MSM status. The requests were made through a system, a
secure communications network for public health officials, and follow-up with each
health department occurred through individual e-mail correspondence. All health
departments and the health departments responded to CDC's request for information.
Analysis of the data was restricted to cases occurring among MSM ages 18-64 years.
During the case review period, 527 meningococcal disease cases among males aged 18-
64 years were reported. Although MSM status is not routinely collected as part of
national meningococcal case reporting and might be underreported, 74 cases were
identified among MSM: 23 from one city, 14 from another, 11 from another, and 26
sporadic cases occurring in geographic areas where fewer than three cases of the
same meningococcal serogroup were reported among MSM during a 3-month period. MSM
status could not be verified for the other 453 meningococcal disease cases among
men aged 18-64 years using available data, nor could CDC distinguish between health
departments reporting zero cases in MSM and those that had no data on MSM status.
Among the 74 reported cases among MSM aged 18-64 years, the median age was 31
years. Thirty-seven (52 percent) of 71 patients were one race, 29 (41 percent) were
another race, two (3 percent) were another race, and three (4 percent) were other
race. Neisseria meningitis serogroup C accounted for 62 (84 percent) cases;
serogroup B, W, and Y accounted for five two, and three cases, respectively; and
the serogroup for two patients were unknown. Overall, 24 (32 percent) cases were
fatal, including six of the cases from one city (26 percent), five (36 percent) of
another city cases, three (27 percent) of the other city cases, and 10 (38 percent)
of the sporadic cases. Among 63 patients for who HIV status was reported, 37 (59
percent) were HIV-positive; among these, 11 (30 percent) died. Meningococcal
vaccinations status was known for 41 patients; among these, six (15 percent) were
vaccinated with a quadrivalent meningococcal vaccine. Five of the six vaccinated
patients had serogroup C meningococcal disease, and two of the five died. Further
analysis of meningococcal disease rates, risk factors, and pulsed-field gel
electrophoresis data from all cases identified among MSM is ongoing. Information on
MSM and HIV status of men reported with meningococcal disease is not currently
noted on most meningococcal case report forms. However, representative and complete
data on MSM and HIV status are needed to better understand the epidemiology of and
potential risk factors for meningococcal disease among MSM and to inform prevention
and control recommendations. Health departments are encouraged to attempt to
determine MSM and HIV status during investigations of meningococcal disease cases
caused by any serotype occurring among males aged 16 years. This case involves one
of the six male patients (Age group between 18-64 years) who was vaccinated with a
dose of Meningococcal vaccine (batch number, expiration date, dose, dose number,
route and site of administration were not reported) on an unknown date. Medical
history included Homosexuality (Men Who Have Sex With Men) and concomitant
medication were not reported. The HIV status of the patient was not reported. On an
unspecified date, following the vaccination, the patient developed serogroup C
meningococcal disease. Laboratory test and corrective treatment were not reported.
The outcome of the event was fatal. It was unknown if autopsy was performed. List
of documents held by sender: none." "Lab tests unknown"
 "611452-1" "611452-1" "11/12 Developed chest pain while playing basketball,
seen at outside ER. By mom's report CXR, ECG, blood nl. Was better slight URI sx
11/13 - 11/16 was at school sitting, laughing and talking to friends, collapsed and
unable to be resuscitated. Pronounced dead at outside ER." "Unknown, pt should be a
coroners case"
"611701-1" "611701-1" "Initial unsolicited report received from the
literature on 12 November 2015. This case is linked to 2015SA184887, 2015SA184911,
2015SA188406, 2015SA188407 and 2015SA188408 (same literature). Since 2012, three
clusters of serogroup C meningococcal disease among men who have sex with men (MSM)
have been reported. During 2012, 13 cases of meningococcal disease among MSM were
reported by a Department of Health and Mental Hygiene (1); over a 5-month period
during 2012-2013, another Department of Public Health reported four cases among
MSM; and during May-June 2015, a third Department of Public Health reported seven
cases of meningococcal disease among MSM in that area. MSM have not previously been
considered at increased risk for meningococcal disease. Determining outbreak
thresholds for special populations of unknown size (such as MSM) can be difficult.
The first health department declared an outbreak based on an estimated increased
risk for meningococcal infection in 2012 among MSM and human immunodeficiency virus
(HIV)-infected MSM compared with city residents who were not MSM or for whom MSM
status was unknown (1). Another Department of Public Health also declared an
outbreak based on an increase in case counts and thresholds calculated using
population estimates of MSM and HIV-infected MSM. Local public health response
included increasing awareness among MSM, conducting contact tracing and providing
chemoprophylaxis to close contacts, and offering vaccination to the population at
risk (1-3). To better understand the epidemiology and burden of meningococcal
disease in MSM populations and to inform recommendations, CDC analyzed data from a
retrospective review of reported cases in January 2012 through June 2015. In May
2013 and again in August 2015, CDC requested that health departments review all
cases of probable or confirmed meningococcal disease caused by any serogroup and
reported among males during January 2012-June 2015 to the Surveillance System and,
if possible, determine MSM status. The requests were made through a secure
communications network for public health officials, and follow-up with each health
department occurred through individual e-mail correspondence. All health
departments and the health departments of specific cities responded to CDC's
request for information. Analysis of the data was restricted to cases occurring
among MSM aged 18-64 years. During the case review period, 527 meningococcal
disease cases among males aged 18-64 years were reported. Although MSM status is
not routinely collected as part of national meningococcal case reporting and might
be underreported, 74 cases were identified among MSM: 23 from one city, 14 from
another, 11 from yet another, and 26 sporadic cases occurring in geographic areas
where fewer than three cases of the same meningococcal serogroup were reported
among MSM during a 3-month period. MSM status could not be verified for the other
453 meningococcal disease cases among men aged 18-64 years using available data,
nor could CDC distinguish between health departments reporting zero cases in MSM
and those that had no data on MSM status. Among the 74 reported cases among MSM
aged 18-64 years, the median age was 31 years (range is equal to 20-59 years).
Thirty-seven (52 percent) of 71 patients were one race, 29 (41 percent) were
another race, two (3 percent) were yet another race, and three (4 percent) were
other race. Neisseria meningitidis serogroup C accounted for 62 (84 percent) cases;
serogroup B, W, and Y accounted for five, two, and three cases, respectively; and
the serogroup for two patients was unknown. Overall, 24 (32 percent) cases were
fatal, including six of the cases from one city (26 percent), five (36 percent) of
another city cases, three (27 percent) of the other city cases, and 10 (38 percent)
of the sporadic cases. Among 63 patients for who HIV status was reported, 37 (59
percent) were HIV-positive; among these, 11 (30 percent) died. Meningococcal
vaccination status was known for 41 patients; among these, six (15 percent) were
vaccinated with a quadrivalent meningococcal vaccine. Five of the six vaccinated
patients had serogroup C meningococcal disease, and two of the five died. Further
analysis of meningococcal disease rates, risk factors, and pulsed-field gel
electrophoresis data from all cases identified among MSM is ongoing. Information on
MSM and HIV status of men reported with meningococcal disease is not currently
noted on most meningococcal case report forms. However, representative and complete
data on MSM and HIV status are needed to better understand the epidemiology of and
potential risk factors for meningococcal disease among MSM and to inform prevention
and control recommendations. Health departments are encouraged to attempt to
determine MSM and HIV status during investigations of meningococcal disease cases
caused by any serotype occurring among males aged 16 years. This case involves one
of the six male patients (age group between 18-64 years) who was vaccinated with a
dose of Quadrivalent meningococcal vaccine (Manufacturer: unknown, batch number,
expiration date, dose, dose number, route and site of administration were not
reported) on an unspecified date. Medical history included Homosexuality (Men Who
Have Sex With Men) and concomitant medication were not reported. The HIV status of
the patient was not reported. On an unspecified date following the vaccination, the
patient developed serogroup C meningococcal disease leading to death on an
unspecified date. Laboratory investigation and corrective treatment were not
reported. The outcome of the event was fatal. It was unknown if autopsy was
performed. List of documents held by sender: none." "Lab tests unknown"
"611827-1" "611827-1" "This spontaneous report was received from a
physician via company representative regarding a female patient of unknown age.
Patient's concurrent condition, medical history and drug allergies were not
reported. On an unknown date the patient was vaccinated with an injection of
GARDASIL 9 (lot #, expiry date and dose number was not specified) intramuscularly
and FLUMIST. The patient went back to the physician's office the same day of
vaccination for an unspecified reason. The next day, she did not participate in gym
class at her school for an unspecified reason and died at an unknown time. Medical
attention was not sought. The cause of death was unknown. There was no information
as to if autopsy was performed or not. Causality assessment was not reported.
Additional information has been requested." "No lab data for this event."
"612719-1" "612719-1" "In 10/2013 she said I don't fell well, I have
something in my head. She have CT scan, but in 11/25/2013 she awoke with nausea,
dizzy she get another CT scan. But on January 13, 2014 I bring her E.R. in Hospital
and they Dx with Pontine Glioma Tumor Brain." "She receive MENACTRA vaccine in
2/25/2009 and FLUZONE in 10/03/2013"
"613330-1" "613330-1" "This spontaneous report was received from a non-
healthcare professional via Twitter website as part of market research and refers
to 32 patients at the age of 18 years old of unknown gender. No information
regarding the patients' medical history, concurrent conditions and concomitant
therapies was provided. On an unknown date, the patients were vaccinated with a
dose of GARDASIL (lot #, expiration date, exact doses and route of administration
were not provided). On unknown dates, reported as 2 to 405 days after the last
GARDASIL injection, the patients died. The cause of death was not reported. The
reporter considered the event to be related to GARDASIL. Additional information has
been requested." "No lab data for this event."
"613332-1" "613332-1" "Infant died by alleged abuse by mother's boyfriend."
"No lab data for this event."
"613449-1" "613449-1" ""This spontaneous report was retrieved from a social
network via Pfizer (assigned manufacturer control number: 2015420009) and was
originally reported by the uncle of a male patient of unknown age. Information
about the patient's medical history and concurrent conditions was not provided. On
an unknown date, the patient started therapy with TYLENOL and MOTRIN (for both
therapies indication, dose, frequency, route of administration, lot number and
expiration date were not provided). Subsequently, the patient was vaccinated with
M-M-R II (dose, dose number, route of administration, lot number and expiration
date were not provided). Other suspect therapies included SARA (indication, dose,
frequency, route of administration, lot number and expiration date were not
provided). Concomitant medication was not reported. According to the reporter, on
an unknown date, SARA and M-M-R II ""killed"" his nephew. The reporter stated that
he was life flighted to hospital and died. It was also reported that the patient
was alive and flew to a county hospital and died. It was unknown if an autopsy was
performed. The cause of death was also unknown. Additional information is not
expected, since the reporter's details were not provided."""No lab data for this
event."
"613593-1" "613593-1" "Case number PHHY2015US158435 is an initial
spontaneous report received from a consumer (patient's daughter) on 23 Nov 2015.
This report refers to a female patient whose age was not reported. Her medical
history and concomitant medications were not reported. The patient was vaccinated
with influenza vaccine (manufacturer and batch number: not reported) on an unknown
date. On an unspecified date, she passed away from heart failure. The reporter
stated that she did not think having the influenza vaccine over the years was
related to the event. No further information was provided.""No lab data for this
event."
"613846-1" "613846-1" "11/30/15 received vaccines. Drove out of town after
vaccines and was unresponsive when arriving. Remained in ICU and pronounced dead on
12/3/15." "No lab data for this event."
"615110-1" "615110-1" "Initial unsolicited case received from non
healthcare professional (consumer) on 04-Dec-2015. This case was linked to
2015SA206294 and 2015SA206306 (same reporter and same vaccine). This case involves
a female patient (age was not reported) who was vaccinated with a dose of
Meningococcal vaccine (manufacturer: unknown, dose, route and site of
administration were not reported) on an unspecified date. Medical history and
concomitant medications were not reported. On an unspecified date, after
vaccination patient had experienced encephalitis and then died. Lab tests and
corrective treatments were not reported. The outcome of the event was fatal.
Documents held by Sender: none." "Lab tests unknown"
"615613-1" "615613-1" "This spontaneous report as received from a consumer
refers to a 12 year old patient of unknown gender. The patient's medical history,
concurrent condition and concomitant medication were not reported. The reporter
stated that he had seen a video on the website about a year ago, saying that a
patient was vaccinated with a dose of GARDASIL (formulation, strength, dose, lot
number and expiry date were not reported) (date of vaccination was not reported).
On an unknown date, a week after vaccination (reported as a week after) the patient
died. Product quality complaint (PQC) was not involved. The relatedness between the
event and GARDASIL was not reported. Additional information has been requested."
"No lab data for this event."
"615623-1" "615623-1" "This spontaneous report was received from a
consumer. The reported an article. This report refers to a 149 patients of unknown
age and gender. On unknown dates, the patients were vaccinated with GARDASIL (dose,
route, lot # and expiration date were not provided). On unknown dates, the patients
died. The cause of death was not provided. It was unknown whether the autopsies
were performed or not. This is one of several reports received from the same
reporter. Additional information is not expected as reporter details were not
provided." "No lab data for this event."
"615626-1" "615626-1" "This non-valid social media spontaneous report as
received from an unspecified reporter refers to unspecified number of children
patients of unknown age and gender. The patients' medical history, concurrent
conditions and concomitant therapies were not reported. On unknown dates, the
patients were vaccinated with GARDASIL (dose, frequency, route, lot # and
expiration date were not reported). It was reported that, parents who injected
their children with GARDASIL were murdering and maiming them (onset date unknown).
The outcome of adverse event was fatal. Upon internal review the event of murdering
and maiming was considered to be disabling. This is one of several reports received
from the same reporter. Additional information is not expected as no reporter's
contact details were provided." "No lab data for this event."
"615815-1" "615815-1" "Child died while sleeping. No reported evidence of
illness prior to death." "Cloudy cerebrospinal fluid on autopsy, without
growth on bacterial culture. Repeat bacterial studies, in addition to viral,
fungal, and mycobacterial testing planned or in process."
 "616361-1" "616361-1" "This is a spontaneous report from a non-contactable
consumer that reported for a patient (patient's sister-in-law). A female patient of
an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of
administration, on an unspecified date, single dose. The patient medical history
and the patient's concomitant medications were not reported. The patient
experienced pneumococcal pneumonia on an unspecified date and then died. It was not
reported if an autopsy was performed. No follow up attempts possible. No further
information expected." "No lab data for this event."
"616734-1" "616734-1" "This patient Died at Hospital on 12/09/2015 of
complications related to ACTA2." "Echo Cardiogram, Ultra sounds, XRAY"
"616858-1" "616858-1" "No s/s. Patient passed away at daycare." "No lab data
for this event."
"616930-1" "616930-1" "According to parents, child developed some fever and
runny nose 2 days after vaccine. Was doing OK - had a bottle at 3 AM on 12-24-2015
and was put back to bed and found dead in crib in morning. Autopsy by County
coroner found no cause." "Autopsy was performed."
"617885-1" "617885-1" "Case number PHHY2015US170668, is an initial
literature case report received on 24 Dec 2015. The author in the article discussed
about acute respiratory infections (ARI) in children and adolescents with acute
lymphoblastic leukemia. Patients (less than or equal to 18 years) who were newly
diagnosed with acute lymphoblastic leukemia (ALL) and were enrolled on an ALL
treatment protocol (total therapy XVI) between Oct 2007 and May 2011 were
evaluated. The total therapy XVI therapy consisted of a 6-week remission induction,
8-week consolidation and 120-week continuation phase that included two 3-week
periods of more intensive chemotherapy (reinduction I and reinduction II). This
report refers to an 11-month-old female patient. Past medical history and
concomitant medication was not reported. The patient started therapy with
cytarabine (manufacturer: not reported) for acute lymphoblastic leukemia at an
unknown dose and route from an unknown date. The patient received palivizumab
(manufacturer: not reported) for immunoprophylaxis at an unknown dose and route on
an unknown date. The patient was vaccinated with two doses of seasonal influenza
vaccine (manufacturer and batch number: not reported) on unknown dates. It was
reported that 10 days before developing illness, the patient had received
palivizumab. Also it was reported that on an unknown date the patient received high
dose of cytarabine for reinduction II chemotherapy. The patient was presented in
the hospital with a 3-day history of progressively worsening cough, nasal
congestion, fever, respiratory distress with profound neutropenia and lymphopenia
for which the patient was hospitalized. Initial evaluation revealed the patient had
bilateral peribronchial thickening and respiratory syncytial virus (RSV) was
detected on a nasopharyngeal wash specimen by polymerase chain reaction (PCR).
Treatment was started with aerosolized ribavirin in addition to oxygen support and
broad spectrum antibiotic therapy. However, due to progressive respiratory
deterioration and increasing fever, a chest x-ray was repeated on day 5 of
hospitalization which demonstrated left lower lobe consolidation pneumonia
suggestive of secondary bacterial infection. The patient's treatment regimen
included vancomycin, meropenem, azithromycin, voriconazole, palivizumab and
aerosolized ribavirin. On day 28 of hospitalization, the patient experienced
respiratory and hemodynamic failure which required mechanical ventilation and
vasopressor followed by extracorporeal mechanical oxygenation support. The patient
died 2 months after onset of the RSV infection. The outcome of events respiratory
syncytial virus infection, respiratory failure, circulatory failure and pneumonia
bacterial was fatal and outcome of events lymphopenia and neutropenia was not
reported. Action taken with palivizumab and cytarabine was unknown. The author
stated that despite the low incidence of viral ARI in children with ALL, the
associated morbidity, mortality and delay in chemotherapy remain clinically
significant. Viral lower respiratory tract infection was especially associated with
high morbidity requiring intensive care-level support. The author concluded that in
spite of current advances in ALL cure rates, molecular diagnostic techniques,
antiviral therapies and active and passive immune prevention approaches,
respiratory viral infections remain a significant burden in children with ALL."
"Chest X-ray, Abnormal, Significant, Left lower lobe consolidation pneumonia
suggestive of secondary bacterial infection; Polymerase chain reaction, Abnormal,
Significant, Respiratory syncytial virus was detected"
"618174-1" "618174-1" ""This spontaneous non-valid report as received from
an unknown source via Twitter refers to a patient of unknown age and gender. There
was no information about the patient's concurrent conditions, concomitant therapies
or medical history provided. On an unknown date, the patient was vaccinated with a
dose of GARDASIL (dose, route of administration, lot # and expiration date were not
reported). On an unknown date, the patient experienced death (reported as
""GARDASIL is killing""). The reporter considered death to be related to GARDASIL.
Additional information is not expected as there were no contact details provided.""
"No lab data for this event."
"618364-1" "618364-1" "This spontaneous report as received from a physician
via an issue of a magazine refers to unspecified patients of unknown age and
gender. No medical history or concurrent conditions were reported. On unknown dates
the patients were vaccinated with GARDASIL (lot number and frequency unknown)
(dosing regimen and frequency unknown). No concomitant medications were reported.
It was reported that, the GARDASIL had absolutely no effect on cervical cancer
(vaccination failure) and it had very many adverse effects which destroys lives and
also even kills (adverse event) (life threatening and death). It was also reported
that cases of Guillain-Barre syndrome, paralysis of the lower limbs, vaccine
induced multiple sclerosis (MS) and vaccine induced encephalitis could be found
whatever the vaccine. The outcome of many adverse effects which destroys lives and
also even kills was reported as fatal. The outcome of the other events were
unknown. Additional information has been requested." "No lab data for this event."
"618411-1" "618411-1" ""This spontaneous report as received via social
media from an unspecified reporter, who obtained the information from the articles
published on a web page, refers to many female patients of unknown age. The
patients' concurrent conditions and medical history were not reported. On unknown
dates, the patients were vaccinated with unknown doses of GARDASIL (lot #, expiry
date, route and site of administration were not reported). Concomitant medications
were not reported. On unknown dates, many of patients died. The reason of death was
not reported. The reporter considered the events to be related to GARDASIL (it was
reported that ""vaccine which has killed many women""). This is one of two reports
received from the same reporter. Additional information has been requested.""
"No lab data for this event."
"618812-1" "618812-1" "Patient received flu vaccine on 12-16-15 at a well
child 9 month check. Patient had no preexisting conditions, no adverse reaction.
Patient died on 12-18-15 from unknown causes pending autopsy/coroner report. No
adverse reaction occurred prior to death." "No lab data for this event."
"619115-1" "619115-1" "Information has been received from an unspecified
reporter via social media referring to thousands of unspecified female patients. On
unknown dates the patients were vaccinated with GARDASIL (dose, lot # and route
were unknown). On unknown dates. the patients were killed and disabled by therapy
with GARDASIL. Outcome of disability was unknown. It was unknown if autopsies were
performed. Additional information has been requested." "No lab data for this
event."
"619116-1" "619116-1" "Information has been received from a physician via
company representative referring to a male patient of unknown age. The patient's
pertinent medical history and drug allergies were not reported. On an unknown date
the patient was vaccinated with a dose of GARDASIL (lot#, dose and strength
unknown) subdermally. Later the patient died from bone cancer on an unknown date.
It was unknown if autopsy was done. Causality was not provided. Additional
information has been requested." "No lab data for this event."
"619827-1" "619827-1" "This spontaneous report as received from a consumer
who saw a segment of a broadcast refers to an unspecified number of female
patients. The patient's medical history was not reported. On an unknown dates, the
patients were vaccinated with the doses of GARDASIL. On an unknown dates, the
patients were losing their lives because of those. The reporter considered deaths
to be related to GARDASIL. Additional information is not expected. This is one of
several reports from the same reporter." "No lab data for this event."
"619835-1" "619835-1" "This spontaneous report was received from an
unspecified reporter via an online article published and Vaccine Adverse Event
Reporting System and refers to 236 patients of unknown age and gender. The
patients' medical history, concurrent conditions and concomitant therapies were not
reported. On unknown dates, the patients were vaccinated with doses of quadrivalent
HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not
reported). On unknown dates, the patients experienced death. It was unknown whether
the autopsy was performed. The relatedness between death and quadrivalent HPV
(manufacturer unknown) was not reported. This is one of several reports received
from the same reporter. Additional information is not expected as no contact
details were provided." "No lab data for this event."
"620336-1" "620336-1" ""This spontaneous report was received from a
physician (a patient's colleague) via company representative and refers to a male
patient of unknown age. There was no information about patient's pertinent medical
history, concomitant medications, drug reactions or allergies reported. On an
unspecified date in approximately 2014 (reported as ""approximately 2 years ago""),
the patient was vaccinated with ZOSTAVAX refrigerated vial (lot#, expiration date,
dose, anatomical location and route of administration were not reported). Directly
following the vaccination, in approximately 2014, the patient was diagnosed with
the Lou Gehrig's Disease (ALS). On an unknown date (reported as ""recently""), the
patient passed away. The cause of death was not provided. The outcome of the event
of ALS was not reported. The reporting physician thought there might be a
correlation between the event of ALS and vaccination with ZOSTAVAX. The relatedness
between the patient's death and ZOSTAVAX was not reported. Upon internal review the
event of ALS was considered as medically significant. Additional information has
been requested."" "No lab data for this event."
"620475-1" "620475-1" "My father had interstitial lung disease for about 10
years at this point. He never received a flu shot before, & in the fall of 2009,
there was widespread worry about swine flu. Because of his condition, he decided
it was prudent to get a flu shot. Within 2 weeks of receiving the flu shot, his
lung capacity went from 88% to 44% and he ended up in the hospital on oxygen. His
condition continued to downgrade until 1-1-10 when he received a lung transplant
(he was in such need at that time, he was placed on the list and called for a
transplant in less than a week). I believe he would have died within a week or
two of that time. He did eventually die on May 16, 2010 due to complications of
the lung transplant." "No lab data for this event."
"621477-1" "621477-1" "Developed fever next day then 3 days later developed
sore throat - was seen in an Urgent Care - negative for strep. Two days later had
difficulty breathing and expired in the ED of a large retropharyngeal abscess
occluding airway - grew strep anginosus." "No lab data for this event."
"621565-1" "621565-1" "Possible Lyme disease, 3 and a half years of pain
with seizures and tachycardia. Seizure led to heart attack and death on 1/12/16."
"No lab data for this event."
"621574-1" "621574-1" "Parents reported that pt. had a seizure after
receiving PENTACEL and VARIVAX on 8/8/13 - his seizure occurred on 8/12/13 in
conjunction with fever. Pt was evaluated at ED and released. Dx'd with febrile
seizures. On 12/18/2015 pt was found unresponsive in his bed and was DOA after
transport to Medical Center." "CBC (WNL); Negative blood culture, and negative
chest X-ray"
"621689-1" "621689-1" "We called to schedule next set of shots and were
informed that patient has died." "No lab data for this event."
"621718-1" "621718-1" "Child received three vaccines with Rotateq at age 2,
4, and 6 months, however, he contracted gastroenteritis on 3/12/15 and died from
dehydration and Rota Virus A infection on 3/13/15 which was detected on autopsy."
"Rotavirus A detected by stool culture. Eye vitreous electrolytes detected
low sodium of 116, low chloride and high urea nitrogen level supporting diagnosis
of hyponatremic dehydration."
"622223-1" "622223-1" "Had to wait in waiting room because of my sons eyes
rolling in back of head after shot." "Died of bacterial menigitis"
"622366-1" "622366-1" ""This spontaneous report was received from a
consumer referring to a 14 year old male patient. The patient's concurrent
conditions and medical history were not provided. On an unknown date the patient
was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were
not provided). Concomitant therapies were not reported. On an unspecified date the
patient died. It was unknown if an autopsy was performed and which was the exact
cause of death. On an unknown date the reporter wrote on the ""Merck Corporate
Twitter Account"". The relatedness between death and GARDASIL was unknown.
Additional information is not expected as the reporter did not provide contact
details."" "No lab data for this event."
"622986-1" "622986-1" "Started getting numbness in right hand and face. Was
having trouble with finding words, didn't go to the doctor until a few months later
and they did brain scans and blood tests. Said there was inflammation in her brain
after several tests and ruling out many different things. Inflammation
progressively became worse in her brain, she had 2 brain biopsies in 2015 that came
back inconclusive. Facility could not diagnose her. Inflammation still worsening by
the end of 2015. Hardly able to walk anymore, can't use her right hand at all
anymore, can't speak well at all either. By December 2015 was diagnosed with a
brain tumor and died on 01/16/2016." "MRIs, Cat scans, biopsies"
"623311-1" "623311-1" "literature case report received on 18 Feb 2016. The
author in the article discussed about membranous nephropathy (MN) and severe acute
kidney injury (AKI) following influenza vaccination. This report refers to a male
patient of an unknown age. Medical history was not reported. Concomitant medication
was not reported. The patient was vaccinated with influenza vaccine (manufacturer
and batch number: not reported) on an unknown date. On an unknown date after
receiving vaccination, the patient died from GB syndrome. It was unknown if an
autopsy was performed. The author presented an interesting case of MN and severe
AKI following the 2009 H1N1 vaccination (see case: PHHY2016US023093). Optimal
therapy of influenza vaccine associated glomerular diseases including MN was
unknown. The author concluded that based on the experience one can consider
corticosteroid therapy in patients with MN and AIN following influenza vaccination.
However, further studies are required to investigate the exact pathogenesis of
influenza vaccine-induced MN." "No lab data for this event."
"623724-1" "623724-1" ""09/28/2014 c/o ""BEING SICK"". 10/02/2014 AT 7:00
am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA
& O, moving all extremities. On the way to CT, she had a localized seizure
involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a
longer T/C seizure beginning in BLE and then involving all parts of body. Head
turned upward and to right. Eyes deviated upward and right but conjugate, Not
responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change.
No somulent again. Transferred to ICU. Later on during the same evening, she
experienced a full T/C seizure lasting > 30 minutes. Given paralytics to get her
intubated and started on Diprovan drip along with other meds. Continued with
paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to
show seizure wave patterns. When they let her up from her meds, she was now
paralysed and comatose. Remained ventilated. After a family conference with
Internal Medicine and Pulmonologist, it was decided to extubate her and allow her
to die. Which she did after 45-60 minutes. These were her wishes, in her Durable
Medical POA."" "SEE CHART"
"624251-1" "624251-1" "Death/SIDS." "No lab data for this event."
"624689-1" "624689-1" "This spontaneous report has been received from the
patient's best friend's wife, referring to a male patient of unknown age. The
patient's medical history and concurrent conditions were not provided. On 02-FEB-
2016, the patient was vaccinated with PNEUMOVAX 23, (lot #, route, dose and
expiration date were not provided). Concomitant therapies were not reported. On 10-
FEB-2016, the patient became ill developing trouble breathing, coughing, and
laryngitis. On an unknown date in February 2016, the patient was admitted to the
hospital for acute respiratory distress syndrome (ARDS). The patient also developed
respiratory failure and renal failure, and the patient was treated with dialysis.
The patient also was being treated for pneumonia. The onset date of the events was
reported as 10-FEB-2016. On 17-FEB-2016, the patient died, the cause of death was
reported as pneumonia related issues. The outcome of laryngitis, and renal failure,
was unknown. Upon internal review renal failure, acute respiratory distress
syndrome and respiratory failure were considered to be medically significant
events. Additional information has been requested." "No lab data for this event."
"624988-1" "624988-1" "Pt was found deceased in bed by parent." "Autopsy was
performed by county medical examiner."
"625003-1" "625003-1" "Case number PHHY2016US023690, is an initial
literature case report received on 22 Feb 2016. The author discussed about the
fatal allergic reaction due to influenza vaccine. This report refers to a 42-month-
old female patient. Past drug history included acetylsalicylic acid and the patient
experienced hives for one day during the first year of life which were thought to
follow medication. There was no history of asthma and no family history indicative
of allergy could be elicited. Prior to the injection of the vaccine the physician
had attempted to obtain a history of allergy to eggs or chicken with negative
results. Concomitant medication was not reported. The patient was vaccinated with
seasonal influenza vaccine (manufacturer and batch number: not reported)
subcutaneously at a dose of 0.5 ml on an unknown date. The patient complained of
pains in the abdomen and chills followed by vomiting and convulsions four hours
after the vaccination. On examination the patient had a rectal temperature of 109
F. The patient was hospitalized within two hours after the onset of symptoms. On
admission to the hospital the patient showed pronounced cyanosis, pupils were
widely dilated and unresponsive to light. The lungs showed moist rales over both
pulmonary fields and the heart rate was 180 per minute. The abdomen was not
distended. The extremities showed convulsive contractions during examination.
During the seven hour stay in the hospital the patient became increasingly cyanotic
despite oxygen and epinephrine hydrochloride therapy. It was noted that bleeding
was pronounced at the sites of hypodermic puncture for the administration of
medicaments and that large areas of ecchymosis developed around the injected sites.
Slight bleeding was also noted from the vaginal and oral orifices. Convulsions
occurred at one to two minute intervals. The convulsions ceased after about five
hours and the temperature fell to 103 F. The heart rate increased in rapidity up to
240 per minute but remained regular. The respirations were noted to be Cheyne-
Stokes in type. Two hours after entry to the hospital breathing ceased and
artificial respiration was instituted. After the resumption of respiration constant
bilateral twitching and spasms were noted. This was most decided in the lower
extremities. Five hours after admission and seven hours after the onset of symptoms
the patient showed great shock with pronounced collapse of the veins which rendered
venipuncture difficult. Thirty minutes before death a surgical exposure of the
right ankle vein was considered necessary for intravenous therapy. At that time an
attempt was made to administer dextrose and saline solution with 10 per cent
calcium gluconate. The patient was becoming more cyanotic and it was difficult to
obtain the pulse beat. Artificial respiration was again instituted and after an
intracardiac injection of epinephrine hydrochloride the patient was pronounced
dead. Blood examination showed 80 per cent hemoglobin, 4.02 million red cells and
44,000 white cells with 36 per cent neutrophils, 61 per cent lymphocytes and 3 per
cent eosinophils. The clinical picture of the patient was that of an allergic
reaction which developed four hours after the injection and was characterized by
convulsions, abdominal pain and vomiting with associated hemorrhagic phenomena.,
respiratory arrest, hyperthermia and death. The outcome of the event convulsions
was recovered and outcome of other events was not reported. The cause of death was
ascribed to anaphylactic shock secondary to the injection of influenza vaccine with
air embolism as an immediate terminal contributory cause. A necropsy was performed
about eleven hours after death which revealed the following: Heart: Air embolism
was present in the right side of the heart and in the inferior vena cava; there
were multiple epicardial hemorrhages. Thymus: Petechial subcapsular hemorrhages
were present. Lungs: There were bilateral hypostatic congestion, emphysema of the
right middle lobe and focal intra-alveolar hemorrhage. Adrenal: Decided bilateral
atrophy was observed. Gastrointestinal Tract: Submucosal petechial hemorrhage of
the esophagus was seen. Genitourinary Tract: There were submucosal petechial
hemorrhages of the vagina. General: Multiple puncture wounds of the upper
extremities and a recent phlebotomy wound of the right lower extremity were
observed. Gross Observations: The body was that of the patient about 3 years of age
and of normal height and weight. The left nostril showed abundant dried, blood
tinged, foamy material. On the arms there were multiple hypodermic puncture marks
in the region of the deltoid insertion on either side and small drops of fluid
blood could be readily squeezed from the puncture wounds. The contiguous skin was
ecchymotic. The left inguinal region showed recent venipuncture wounds with
adjacent ecchymoses. The right longer extremity showed the presence of a recent
transverse incision of the skin placed on the medial surface of the ankle and held
together by interrupted sutures. The vagina showed the presence of two zones of
submucosal hemorrhage just inside the fourchet. On incision of the fit it was
noticed that the cut ends of the capillaries oozed fluid blood. When the thorax was
opened both lungs lay free in the pleural sacs and did not appear hyperventilated.
The right ventricle was greatly dilated and though its partly transparent wall
multiple bubbles of air mixed with blood could be readily seen. With the
circulation intact, several of the large venous pathways to the heart were exposed.
The superior vena cava was natural. The left subclavian vain showed no evidence of
air in its lumen. The inferior vena cava exposed along its entire length was seen
to be distended and rounded and to contain a continuous column of frothy fluid
blood along its entire length. The femoral vessels were exposed on both sides. Both
femoral veins were collapsed. When the vessels were milked in a direction from the
periphery to the trunk air bubbles were not recognized in either vessel; on milking
the right iliac vein from the inguinal region in a cephalad direction, bubbles of
air mixed with blood were seen. On exploration of the incised cutaneous wound of
the right ankle at the site of phlebotomy, the underlying vein was readily
identified and showed a ligature around its wall. Just proximal to the ligature a
small nick corresponding to the site of puncture was readily identified. Anatomic
Observations: Heart: The heart on removal weighed 909 Gm. The epicardial surfaces
showed extensive Flame shaped hemorrhages both anteriorly and posteriorly. The
right auricle and ventricle contained abundant fluid blood intimately mixed with
numerous air bubbles of various sizes. The remainder of the examination of the
heart revealed essentially normal structure. Lungs: The right lung weighed 120 Gm.,
the left 130 Gm. The posterior portions of both lobes of the left lung were dark
red and on section cut" "Body temperature, 103 Fahrenheit, Significant; Body
temperature, 109 Fahrenheit, Significant; Culture, Abnormal, Grew a streptococcus
of the alpha group and Staphylococcus aureus; Eosinophil count, 3 %, Significant;
Haemoglobin, 82.2 %, Significant; Haemoglobin, 80 %, Significant; Heart rate,
180/min, Significant; Heart rate, 240/min, Significant; Lymphocyte count, 61 %,
Significant; Lymphocyte count, 74 %, Significant; Neutrophil count, 26 %,
Significant; Neutrophil count, 36 %, Significant; Red blood cell count, 4.02
million red cells, Significant; Red blood cell count, 4.75 million red cells,
Significant; White blood cell count, 7,400, Significant; White blood cell count,
44,000, Significant"
"625196-1" "625196-1" ""This case was reported by a lawyer via other and
described the occurrence of complex febrile convulsion in a 5-month-old male
patient who received DTaP vaccine. Co-suspect products included pneumococcal
vaccine and varicella vaccine. Concurrent medical conditions included Sotos
syndrome, developmental delay, pervasive developmental disorder and macrocephaly.
On 26th December 2000, the patient received the 2nd dose of DTaP vaccine. On 27th
August 2001, the patient received pneumococcal vaccine and varicella vaccine. In
December 2000, less than a day after receiving DTaP vaccine, the patient
experienced complex febrile convulsion (serious criteria death, hospitalization and
GSK medically significant), status epilepticus (serious criteria death and GSK
medically significant), epilepsy (serious criteria death and GSK medically
significant), injection site swelling, injection site erythema, apnea (serious
criteria GSK medically significant), fever, cyanosis, twitching of limbs, Gaze
Palsy (serious criteria GSK medically significant), shallow breathing, grunting and
otitis media. On 6th February 2001, the patient experienced jerkiness and
generalized tonic-clonic seizure (serious criteria GSK medically significant). On
16th November 2007, the patient experienced cardiac arrest (serious criteria death
and GSK medically significant) and cough. On 17th November 2007, the patient
experienced multi-organ failure (serious criteria death and GSK medically
significant). The patient was treated with ATIVAN, ceftriaxone and phenobarbital.
On 16th November 2007, the outcome of the complex febrile convulsion was fatal. On
17th November 2007, the outcome of the status epilepticus, epilepsy, cardiac arrest
and multi-organ failure were fatal. On an unknown date, the outcome of the
injection site swelling, injection site erythema, apnea, fever, cyanosis, twitching
of limbs, Gaze Palsy, shallow breathing, grunting, otitis media, jerkiness,
generalized tonic-clonic seizure and cough were unknown. The patient died on 17th
November 2007. The reported cause of death was febrile seizure, status epilepticus,
epilepsy, cardiac arrest and multi-organ failure. It was unknown if the reporter
considered the complex febrile convulsion, status epilepticus, epilepsy, cardiac
arrest, multi-organ failure, injection site swelling, injection site erythema,
apnea, fever, cyanosis, twitching of limbs, Gaze Palsy, shallow breathing,
grunting, otitis media, jerkiness, generalized tonic-clonic seizure and cough to be
related to DTaP vaccine. Additional details were provided as follows: The patient
was a healthy. On December 26, 2000, the patient received his second dose of the
DTaP vaccine. The patient's parents recalled that there was some swelling around
the injection site (right upper extremity) and site was red. Early in the morning
on 27 December 2000 (within 24 hours of vaccination), the patient's parents found
him seizing in his crib and took him to the emergency room. The seizure lasted
about 15 minutes and was controlled with medication by the doctors. Five minutes
later, the patient began seizing again with apnea and according to the timeline in
the medical records, the second seizure was stopped when the patient was given an
ATIVAN IV and oxygen. The medical records were unclear, but the second seizure
lasted at least a few minutes, and it could have lasted as long as 15 minutes. It
was noted that the first seizure was stopped at 4:30 A.M., the second seizure
started five minutes later, and the second seizure was stopped at 4:50 A.M. The
medical records document the patient's condition on admission and his progression.
On admission, the patient was cyanotic and actively seizing. The neurology consult
on 27 December 2000, noted that the patient had returned to baseline. The patient
had a very high white blood cell count, which suggested that the seizure was
related to fever from infection rather than fever from immunization. The patient
was administered ceftriaxone as a prophylactic, to be discontinued if bacterial
cultures came back negative. His temperature was approximately 102 degrees. It was
noted that the patient had no rash. The patient's seizures involved bilateral arm
twitching, with eyes rolled back with right side deviation. He was in the postictal
phase for about 30 minutes, with shallow breathing, posturing, and grunting. The
patient was admitted to the pediatric intensive care unit for monitoring. On 28
December 2000, the parents reported that the patient seemed to be completely
himself. Although the bacterial cultures came back negative, ceftriaxone was
continued to rule out sepsis. The patient's condition was described as status post,
prolonged seizure associated with fever. The note also stated that given the high
WBC count, this was more likely secondary to infection that simply a febrile
reaction to his immunizations. Later that day, it was found that the patient had
otitis media, and he was to continue on ceftriaxone to treat it. The patient had no
symptoms of an upper respiratory infection. A computerized tomography scan of the
patient's head and an electroencephalogram were normal. The patient was discharged
on 29 December 2000, with instructions to continue using phenobarbital and to
follow up with doctor in one month. On 29 January 2000, the patient saw doctor for
a follow up visit. According to the doctor, the etiology of the seizure was
uncertain, and he was concerned about a possible association with the patient's
DTaP vaccination. Doctor recommended not giving the next DTaP dose until a follow
up EEG was completed. He noted that the patient's height was under the 75th
percentile, weight was above the 95th percentile, and head circumference was above
the 95th percentile. The doctor also observed that the patient's father head
circumference was above the 95th percentile for adults. On 6th February 2001, the
patient was admitted to the hospital again for seizures, the seizure lasted for
approximately 20-25 minutes. When the seizure started, the patient's eyes rolled up
and to the right and he had jerking of the right arm, but these focal aspects
generalized to tonic-clonic movements of all four extremities. The patient's mother
reported that he was afebrile when the seizure started, and the medical records
noted that there was a question as to DTaP's role in causing the first seizure. The
diagnosis was status epilepticus. The patient's overgrowth did not fit the Sotos
syndrome pattern; he was big but proportionally so, and he was not abnormally tall
at birth. His large head could be explained by ordinary genetics (his father's head
was big) or by his autism spectrum disorder. The patient had PDD, which resulted in
developmental delay but it does not appear that this necessarily was related to his
other conditions. At one time, the patient had advanced bone age, but the
literature stated this is a non-specific finding and not limited to persons with
Sotos syndrome. The patient w" "On 9th April, 2002, the patient had a genetics
evaluation, which found that the patient's genetics were normal. An magnetic
resonance imaging taken on 28 February 2001 was mostly normal, but the report noted
the MRI showed evidence of frontal lobe atrophy of uncertain etiology. 12/27/2000,
Body temperature, 102 degree C; 02/20/2001, Body temperature, 90 to 100 degree C;
12/28/2000, Computerised tomogram, normal; 12/28/2000, Electroencephalogram,
normal; 02/21/2001, Electroencephalogram, normal; 11/17/2007, Neurological
examination, no functioning; 02/26/2001, Nuclear magnetic resonance imaging, See
text; 12/27/2000, White blood cell count, very high"
"625345-1" "625345-1" "Patient stopped breathing when napping - no foul
play, no obstruction or suffication. Autopsy diagnosed SIDS as cause of death."
"Autopsy and Labs"
"625642-1" "625642-1" "This medically confirmed literature report (initial
receipt 23-Feb-2016) concerns a male patient. On an unknown date, the patient
received an influenza vaccine (brand, batch number and route unspecified) for
indication not provided. On an unknown date following vaccination, the patient
developed GB syndrome from which he died. The outcome was reported as fatal. Linked
to case: 2016059460 (same reporter). Reporter's Comments: Reporter comments: n/a.
Sender's Comments: Company's evaluation and comment: Seriousness
criterion/criteria: Fatal outcome. Listedness: Unlisted. Brand of Influenza vaccine
not provided. Assessment according to the CSL Inactivated Influenza Virus Vaccine
CCDS and the Afluria Product Information, GBS is unlisted due to the fatal outcome.
Company Causality: Unassessable. Temporal relationship could not be established.
GBS is a known class effect of Influenza vaccine in general and is mediated by
immune attack on peripheral nerve myelin. Risk factors include upper respiratory,
infections, (40% of cases) and or preceding diarrheal illness due to campylobacter
infection (20%). The outcome is usually complete recovery over weeks to months
however fatal outcome is due to autonomic disturbances resulting in cardiac arrest
being the most common cause, in 20-30% of deaths. Due to missing information
causality is unassessable." "No lab data for this event."
"625990-1" "625990-1" "This spontaneous report was received from a consumer
referring to an unspecified number of children of unknown ages and genders. No
concurrent or historical conditions were reported. The reporting consumer stated
that GARDASIL was making lots of children sick and dying. The reporter stated that
her granddaughter got really sick just after her doctor gave her the vaccine, she
considered that this was not a good drug and that the vaccine was not safe
(reported on MARRS case # 1603USA002754). The reporter considered the adverse
events were related to GARDASIL. This is one of two reports received from the same
source. Additional information is not expected, because no contact details were
provided." "No lab data for this event."
"626760-1" "626760-1" "Was diagnosed influenza A, influenza B, and
pneumonia. After having a good prognosis she died. She has both influenza and
pneumonia vaccines in the fall." "No lab data for this event."
"626920-1" "626920-1" "Child found deceased." "Autopsy report"
"627312-1" "627312-1" "This spontaneous report was received from a
pharmacist via a returned survey and refers to unspecified number of patients of
unknown age and gender. There was no information about the patient's concurrent
conditions, concomitant therapies or medical history provided. On unknown dates,
the patients were vaccinated with GARDASIL (dose, frequency, route of
administration, lot # and expiration date were not reported). On unknown dates, the
patients experienced arrhythmogenic events, arrhythmogenic deaths or long QT
episodes. The reporter found out about those events from a Food and Drug
Administration (FDA) document from 2010. Since the pharmacist had a patient with
congenital Long QT syndrome and the patient's family was unsure if GARDASIL was
safe to give, the pharmacist wanted the same information for the most recent 6
years to make an educated assessment for the patient. The pharmacist complained
that these serious events were not mentioned in the package insert, while that
information was needed for the patient. The outcome of arrhythmogenic events and
long QT episodes was unknown. The outcome of arrhythmogenic deaths was fatal. The
reporter considered the events to be associated with GARDASIL. Additional
information has been requested." "Electrocardiogram, long QT"
"628086-1" "628086-1" "This case was reported by a physician via sales rep
and described the occurrence of unknown cause of death in a 2-month-old patient who
received PEDIARIX. Co-suspect products included ROTARIX and PREVNAR. On an unknown
date, the patient received PEDIARIX at an unknown dose, ROTARIX at an unknown dose
and PREVNAR. On 12th March 2016, an unknown time after receiving PEDIARIX and
ROTARIX, the patient experienced unknown cause of death (serious criteria death and
GSK medically significant). On an unknown date, the outcome of the unknown cause of
death was fatal. The patient died on 12th March 2016. The reported cause of death
was unknown cause of death. It was unknown if the reporter considered the unknown
cause of death to be related to PEDIARIX and ROTARIX. Additional details were
received as follows: The reporter stated that, after receiving previous
vaccinations with PEDIARIX, ROTARIX and PREVENAR 13, the patient died." "No
lab data for this event."
"628753-1" "628753-1" "Increase joint pain. Bruise noted (R) subluxed
shoulder. Death - 4 days later." "No lab data for this event."
"628774-1" "628774-1" ""This case was reported in a literature article and
described the occurrence of unknown cause of death in a subject who received dTpa
vaccine. Co-suspect products included human papillomavirus quadrivalent vaccine. On
an unknown date, 11 days after receiving dTpa vaccine, the subject developed
unknown cause of death. Serious criteria included death and GSK medically
significant. The outcome of unknown cause of death was fatal. The reported cause of
death was unknown cause of death. It was unknown if the investigator considered the
unknown cause of death to be related to dTpa vaccine. Additional information was
provided: This case was reported in a literature article and it described the
occurrence of death in a patient of unspecified gender between the ages of 9 and 26
years who had received an unspecified tetanus-diphtheria-acellular pertussis
booster and an unspecified quadrivalent HPV vaccine (manufacturers unknown). The
authors identified this case while performing a retrospective review of medical
records looking for deaths within 30 days of vaccination. No further information on
the patient's concurrent medical conditions, medical and family history or
concomitant medication was provided. On an unspecified date, the patient received
an unspecified tetanus-diphtheria-acellular pertussis booster and an unspecified
quadrivalent HPV vaccine. Dosages unknown; administration routes and sites
unspecified; batch numbers were not provided. On an unspecified date between 1
January 2005 and 31 December 2011, 11 days after the vaccination, the patient died
of unknown causes. This was a fatal case and a post-mortem was performed, but no
cause of death was identified by the coroner. Treatment was unknown. According to
the authors, the Vaccine Safety Datalink working group determined the relationship
between the vaccines and this death to be indeterminate due to the lack of
information that made impossible to confirm or discard a causal association. The
authors concluded that ""to our knowledge, this study currently represents the
largest population-based epidemiologic investigation of the association between
vaccination and death among individuals 9 to 26 years of age. Although there has
been significant research conducted on deaths after vaccination in both infants and
older adults, this study fills a void by investigating deaths among older children
and young adults. We assessed deaths after vaccination on a population level as
well as an individual level to provide a complete evaluation of vaccine safety with
regard to death. This research should reassure the public with regard to the safety
of quadrivalent vaccine, as well as other vaccines routinely administered to
individuals 9 to 26 years of age""."" "No lab data for this event."
"629237-1" "629237-1" "Patient had her routine dialysis and was
administered PPV23. Went home, felt weak. Husband found her slouched over. 911
called. Patient sent to ICU. Placed on comfort cares and passed away." "Cause
of Death: 1.S/P Cardiac arrest likely due to respiratory arrest. 2.Acute hypoxemic
hypercapnic respiratory failure 3.Shock 4.Severe COPD 5.ESRD on HD 6.History of
Afib on Chronic Coumadin therapy 7.Lactic acidosis 8.Leucocytosis 9.Abnormal
LFT's"
"629385-1" "629385-1" ""Weakness, tremors, loss of appetite. My mother
never really recovered after this. She was hospitalized a week or so after
receiving the vaccine. She contracted a ""community aquired pneumonia"" in the
hospital then had to go to a rehab center. his was the beginning of the end for
her. She was weak with tremors and loss of appetite and nausea for weeks."" "No
lab data for this event."
"629846-1" "629846-1" "This medically confirmed literature report (initial
receipt 15-Mar-2016) concerns an 11 months old female patient who had a medical
history of acute lymphoblastic leukemia (ALL) and received a high dose of
cytarabine for reinduction II chemotherapy. She presented with a 3 day history of
progressively worsening cough and nasal congestion and new onset of fever and
respiratory distress with profound neutropenia and lymphopenia for which she was
hospitalised. She had received palivizumab immunoprophylaxis 10 days before the
development of her illness and 2 doses of seasonal influenza vaccine. Initial
evaluation revealed bilateral peribronchial thickening and RSV (respiratory
syncytial virus) was detected on a nasopharyngeal wash specimen by PCR. Aerosolized
ribavirin treatment was initiated in addition to oxygen support and broad spectrum
antibiotic therapy. However, due to progressive respiratory deterioration and
increasing fever, a chest x-ray repeated on day 5 of hospitalization demonstrated
left lower lobe consolidation pneumonia suggestive of secondary bacterial
infection. Her treatment regimen included vancomycin, meropenem, azithromycin,
voriconazole, palivizumab, and aerosolized ribavirin. On hospital day 28, her
condition progressed to respiratory and hemodynamic failure requiring mechanical
ventilation and vasopressor followed by extracorporeal mechanical oxygenation
support. She died 2 months after onset of the RSV infection. The outcome was fatal.
Reporter's Comments: n/a. Sender's Comments: Company comments: Seriousness:
Serious. Fatal Listedness: Unlisted. Vaccine brand unspecified. Assessment
according to the agency for CSL Inactivated Influenza Virus Vaccine and the AFLURIA
Product Information all events are unlisted except pyrexia, nasal congestion, and
cough. Causality: Unassessable. The events pertaining to inappropriate age at
vaccine administration is unassessable. For all other events, it is unrelated. The
reports pertains to a pediatric patient undergoing chemotherapy who developed
various respiratory symptoms. Further investigation revealed that causative agents
were RSV and a bacterial pathogen. Patient has also received chemotherapy which can
cause neutropenia and lymphopenia. In the clear presence of laboratory
demonstration of offending causal agents, and a known recent history of leukemia
and chemotherapeutic treatments, the reported systemic symptoms, respiratory
events, and hematologic parameters are considered unrelated to influenza vaccine."
"Test Name: Nasopharyngeal wash specimen; Result Unstructured Data: bilateral
peribronchial; Test Name: Chest x-ray; Result Unstructured Data: Left lower lobe
consolidation pneumonia"
 "630511-1" "630511-1" "None stated." "Do not have coroner's report"
"630787-1" "630787-1" "Flu like symptoms, followed by death on Jan 19.
Coroner mentioned pneumonia." "No lab data for this event."
"630847-1" "630847-1" "This is a spontaneous report from a contactable
consumer who reported for her mother. An 80-year-old female patient of an
unspecified ethnicity received PREVNAR 13, via an unspecified route of
administration at single dose on 27Oct2015 or 28Oct2015 and influenza vaccine, via
an unspecified route of administration on an unspecified date. The patient medical
history and concomitant medications were not reported. The next day after
vaccination (Oct2015), the patient was still very sick, dizziness/lightheadedness,
loss of appetite, fatigue, listlessness, body aches, sweats, chills, fever,
bedridden, lethargic, unable to stand. No treatment received. These symptoms
started out the next day and increased plus multiplied within the time of her
death. The patient died on 06Nov2015. It was not reported if an autopsy was
performed. Follow-up (13Nov2015): New information reported from a contactable
consumer includes: primary reporter's information. Follow-up (08Jan2016): Follow-up
attempts completed. No further information expected. Follow-up (04Apr2016): New
information obtained from the same contactable consumer includes: additional
events, additional suspect drug, date of administration of PREVNAR 13." "No
lab data for this event."
"631561-1" "631561-1" "She passed away." "No lab data for this event."
"632567-1" "632567-1" "Patient presented in full cardiac arrest, reportedly
found down and not breathing. She was coded for > 20 minutes without success -
presented to hospital 4/11/2016." "No lab data for this event."
"632726-1" "632726-1" "This is a spontaneous report from a non-contactable
physician communicated to a Pfizer sales representative. An elderly female patient
of an unspecified ethnicity received PREVNAR 13, via an unspecified route of
administration at 0.5 ml, single on unknown date. Medical history included that the
patient was very sick. Concomitant medications were not reported. Very very very
old patient received PREVNAR 13 and the next day, she passed away on an unspecified
date. It was not reported if an autopsy was performed. Physician causality
assessment: 100% sure that the PREVNAR 13 had nothing to do with the patient's
passing. No follow-up attempts possible. No further information expected." "No
lab data for this event."
"633027-1" "633027-1" "This spontaneous report was received from a
physician, via company representative, and refers to a patient of unknown age and
gender. The physician mentioned that he recently reviewed a manuscript that
reported a ZOSTAVAX-related death (dose, lot number, route, date of vaccination and
date of the event were not provided). The report would be electronically published
(journal unknown). The cause of death was not provided. It was unknown if autopsy
was performed. The causality between the suspect drug and the event was not
reported. Additional information has been requested." "No lab data for this event."
"634569-1" "634569-1" ""Based on the additional information received on 07
March 2016, this case initially considered as non-serious was upgraded to serious
due to death of the patient. Initial unsolicited report received from a physician
on 03 December 2015. This case involves a male patient (age unknown) who was
vaccinated with a dose of FLUZONE HD (batch number, expiry date, route, dose in
series and site of administration were not reported) on 2 September 2015. Medical
history and concomitant medications were not reported. On an unspecified date,
following the vaccination patient experienced flu symptoms, exhaustion and body
ache. Laboratory investigation and corrective treatment were not reported. The
outcome of event was not reported. List of documents held by sender: none. Follow
up information received from Physician on 07 March 2016. It was reported that,
patient's details could not be obtained as patient died (details not provided) on
an unspecified date. Sender's Comments: Initial case, reported events was flu
symptoms, exhaustion and body ache with patient has since Deceased (from other
reason)"" date was not reported and in follow-up reported that patient has since
Deceased (from other reason)"" date was not reported. limited information was
provided in document. Additional information on patient's medical history and
concomitant medications, health status at vaccination, final diagnosis and
complementary investigations ruling out alternative etiology and autopsy report are
needed for complete assessment. Based on available information, role of vaccine
cannot be established. Reported Cause(s) of Death: death nos."" "No lab data for
this event."
"634742-1" "634742-1" "This spontaneous report was received from a consumer
referring to a young patient of unknown age and gender. The patient's pertinent
medical history and concurrent conditions were not reported. On an unknown date,
the patient was vaccinated with GARDASIL (anatomical route of vaccination, lot
number and expiration date were not provided). The patient's concomitant
medications were not reported. The reported stated, that after watching TV news,
heard about a young child who collapsed and died after receiving GARDASIL. At the
time of the report, the outcome was reported as fatal. Relatedness between the
adverse event and vaccination with GARDASIL was not provided. This is one of
several cases received from the same source. MARRS: 1605USA003026. Additional
information has been requested." "No lab data for this event."
"634789-1" "634789-1" "Initial unsolicited report received from a physician
on 27 April 2016. This case involves a four-year-old female patient who was
vaccinated with a dose of DAPTACEL (batch number C4709AA, expiration date: 24
February 2017, via intramuscular route, dose, dose in series and site of
administration was not reported) and a dose of IPOL (batch number L1001-1, expiry
date: 14 January 2017, via intramuscular route, dose, dose in series and site of
administration was not reported), both on 18 March 2016. Illness at time of
vaccination was reported as none and pre-existing physician diagnosed allergies,
birth defects, medical conditions was not reported. Concomitant medications were
not provided. On an unspecified date following the vaccination, the patient
developed abdominal pain and returned to the physician's office on 23 March 2016
who requested that the child be taken immediately to the emergency room. It was
reported that there was no information on what medical facility the patient was
taken to or whether the patient was actually taken. On 24 March 2016, six days
following vaccination, the patient died. Lab data and corrective treatment were not
reported. Patient had not recovered from abdominal pain event at the time of death.
It was reported that autopsy was pending. List of documents held by sender: none.
Sender's Comments: This is a poorly documented death case of a child who was
vaccinated with diphtheria-15/tetanus/5 AC pertussis vaccine and IPV (VERO). Five
days after vaccination, patient experienced abdominal pain and died the next day.
Patient was taken for physician consultation on having abdominal pain, however was
referred to emergency room and no further details were provided. No information
regarding any previous history of abdominal pain, relevant medical and birth
history, underlying cause of death and any diagnostic testing reports were
provided. Autopsy result was not available. Due to the very limited available
information, causality cannot be assessed for now. Reported Cause(s) of Death:
abdominal pain; death nos." "No lab data for this event."
"636334-1" "636334-1" "Information was received from a physician via an
internet article regarding cases in litigation concerning female patients of
unknown age, who received vaccinations with GARDASIL (lot numbers, dates of
vaccination, dosages, and routes of administration not reported). It was reported
that between May 2009 and September 2010, 16 deaths occurred after GARDASIL
vaccination (causes of deaths not reported). It was unknown if autopsies were
performed. Upon internal review, 16 deaths was determined to be medically
significant. This is one of several reports from the same source. Additional
information is not expected." "No lab data for this event."
"636483-1" "636483-1" "This spontaneous unconfirmed report was received
from a healthcare worker via a company representative and refers to a patient of
unknown age and gender. The reporter read about this information on the internet
(unspecified website). No information regarding the patient's pertinent medical
history, concomitant medication and drug reactions or allergies was reported. On an
unknown date, the patient was vaccinated with a dose of unidentified Merck HPV
vaccine (name, strength, dose, route of administration, anatomical location, lot #
and expiration date were not provided). Reporter could not confirm whether the
product was GARDASIL or GARDASIL 9. On an unknown date, 36 hours after receiving a
dose of unidentified Merck HPV vaccine, the patient died of an unspecified cause.
The relatedness between the patient's death and unidentified Merck HPV vaccine was
not reported. Upon internal review, the event of death was considered to be
medically significant. Additional information is not expected as the reporter did
not have any additional information and did not wish to be contacted regarding this
report." "No lab data for this event."
"636811-1" "636811-1" "Infant was well on examination at visit when got her
vaccines but was apparently found unresponsive that night." "No lab data for
this event."
"637017-1" "637017-1" "Patient was found unresponsive." "No lab data for
this event."
"637176-1" "637176-1" "Death by Suicide." "No lab data for this event."
"637297-1" "637297-1" "This is a spontaneous report from a contactable
physician. A 94-year-old female patient received a single dose of PREVNAR 13, on
09May2016 at in the left deltoid. Medical history included type 2 diabetes
mellitus, high blood pressure, high cholesterol, coronary atherosclerosis and
glaucoma. Concomitant medication (all prescribed by cardiologist) included: baby
aspirin at 81 mg daily, simvastatin at 20 mg daily, CARTIA XT 240, per 24 hours,
cilostazol at 50 mg 2x/day, lisinopril at 10 mg daily, glimepiride at 2 mg 1x/day,
oxybutynin 5 mg daily and nitroglycerin 0.4 mg, as needed sublingual. Past drug
history included allergy to CELEBREX. On Mar2012 patient took PNEUMOVAX without any
complications and with no problems and on unknown date patient had flu shots with
no problems. On 09May2016 after giving the PREVNAR 13, the patient had a shock
(anaphylactic shock) and she began to swell later in evening. She was admitted to
the hospital on 09May2016 with anaphylactic shock. It was also reported that the
patient had developed pneumonitis and her face and lips were swelling. The patient
was intubated. She was in Intensive Care on the ventilator, and was in the
emergency room for about 3 hours and the patient was given SOLU-MEDROL, BENADRYL
and fresh frozen plasma. The patient subsequently died on 19May2016 due to
anaphylactic reaction to PREVNAR 13. No autopsy was performed. The outcome of the
other events was unknown." "No lab data for this event."
"637787-1" "637787-1" "Initial unsolicited report received from the
literature on 23 May 2016. Abstract: Background: Measles is resurging, with more
than 700 confirmed cases since January 2014. During measles outbreaks, vaccination
as early as at 6 months of age is sometimes recommended for infants who are at risk
for exposure. Methods: We searched the Vaccine Adverse Event Reporting System for
reports of measles, mumps, and rubella vaccine combined (MMR) or measles, mumps,
rubella, and varicella vaccine combined (MMRV) vaccination in children less than 9
months of age. We performed a clinical assessment of each report and summarized the
frequency, range, onset time, and severity of adverse events. Results: After
excluding 346 reports because they were duplicates or because they contained
insufficient information about the child's age or vaccine(s), we retained 204
reports in the analysis, including 35 (17%) that were serious. Among the 169 non-
serious reports, more than half (88; 52%) described a vaccination error without any
adverse event per se. Other non-serious reports described fever, injection
reactions, and gastrointestinal symptoms. Serious adverse events included
developmental disorders, fever, and fussiness. There were 44 reports of fever, but
only 4 cases began 5-12 days after immunization, the peak risk window. The vast
majority of fever reports listed concomitant vaccines, such as diphtheria and
tetanus toxoids, acellular or whole-cell pertussis vaccine. Conclusions: This
review did not identify any major safety concerns. These findings may facilitate
discussions about the risks and benefits of vaccinating infants who are potentially
exposed to this life-threatening disease. This case involves a three-month-old male
patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE
(ADSORBED) (DTP) (manufacturer: unknown, batch number, expiration date, dose, route
and site of administration were not reported) and a dose of MEASLES, MUMPS AND
RUBELLA VACCINE (MMR) (manufacturer: other, batch number, expiration date, dose,
route and site of administration was not reported) both on an unspecified date. The
patient had no significant past medical history. Concomitant medications were not
reported. On an unspecified date, same day (reported as within one day) following
vaccination, the patient had experienced congestion and fever (temperature not
specified). On the following morning, one day post vaccination, the patient was
found pulseless, apneic. An autopsy was not performed, but the death certificate
listed sudden infant death syndrome (SIDS) as the cause of death. Laboratory
investigations and corrective treatment were not reported. The outcome of the
events congestion and fever was not reported. List of documents held by sender:
none. Sender's Comments: In this case from medical literature, the 3-month-old
patient died due to sudden infant death syndrome (SIDS) 2 days after having
received vaccination with DTP and MMR. The reason for early administration of MMR
was not stated. SIDS was considered as the cause of death in the death certificate
though autopsy was not performed. The patient had developed fever and some
unspecified congestion the next day after receiving the vaccines which could
suggest the possibility of underlying infection. This case is insufficiently
documented to draw a conclusion on a relationship with vaccine administration. Most
frequent causes of sudden death in infants include infections, sudden infant death
syndrome, inherent errors in metabolism, undiagnosed congenital anomalies. No
information is provided on conditions at the time of death, sleeping position,
patient's history, previous vaccination history, autopsy or results of
investigations; if performed in hospital. Moreover, the patient received two
vaccines simultaneously making it difficult to assess the role of one vaccine in
particular. Reported Cause(s) of Death: sudden infant death syndrome (SIDS)."
"No lab data for this event."
"637892-1" "637892-1" ""Initial solicited report received on 23 May 2016
from an investigator participating in a study. This case involves a 61-year-old
male subject who had heart attack and car accident during the study participation.
Medical history was not relevant on record and there were no concomitant
medications on record. On 02 May 2016, 10 days after receiving a single dose of
blinded therapy 2.5 mcl on 22 April 2016 (route and site of administration were not
reported; batch number: VV-03-011-C and expiry date: 17 May 2016), the subject had
heart attack and car accident. The event appeared after visit was not reported.
Prior to study participation, the subject was a regularly attending plasma donor at
the site since 28 July 2015. The subject was screened for participation in study
protocol on 19 April 2016. There were no abnormalities found during the subject's
physical exam. The ECG showed normal sinus rhythm flat T waves in lead I, aVL and
V2-V6 considered by the cardiologist as abnormal electrocardiogram (ECG) but
insignificant. The set of labs as per standard to protocol and the physical
examination during screening were reviewed on 21 April 2016 and considered
acceptable by the primary investigator for enrollment. The subject was vaccinated
after undergoing a second physical exam and basic cardiopulmonary assessment during
the same visit. There were no abnormal findings during these exams on this day. The
subject was seen at this site for day 3 post-vaccination site check on 25 April
2016 and underwent a basic cardiopulmonary assessment. This was the last contact
this study site had with this subject. On 17 May 2016, after noticing that the
subject had missing 3 visits, the site attempted to contact the subject; the
subject's roommate answered the phone, who in turn notified of the subject's death.
The roommate said that the subject had a heart attack while driving 02 May 2016.
The subject was transported to an emergency room via ambulance and was admitted to
an undisclosed inpatient wing of the hospital. It was currently unknown if the
heart attack preceded the motor vehicle accident or if the motor vehicle accident
preceded the heart attack. The subject was declared deceased on 05 May 2016. No
other information was available at this moment. The principal investigator had
considered that the heart attack and the motor vehicle accident are
""unassessable"" as the information was limited; reason for which he requested
additional information from the treating hospital. The approval for the release of
the subject's medical records was pending until the subject's death certificate had
been issued from the coroner's office. Basic cardiopulmonary assessment showed no
abnormal findings at day 03 post-vaccination. Other lab data was recorded before
vaccination and event onset. The corrective treatment were not reported. The
outcome of the events heart attack and car accident was fatal and the subject died
on 05 May 2016. According to the investigator, at the time of report the
information was inconclusive to properly assess the case. Relationship to
investigational product according to Company: not associated. The information
whether the serious adverse event led to the termination of the subject from the
study or not, was not reported. List of documents held by sender: none. Sender's
Comments: A 61-year-old male subject died 10 days after receiving a dose of
ACAM2000 vaccine due to myocardial infarction and car accident. It was not clear
which event preceded the other. Details of Autopsy and death certificate were not
reported at the time of this report. Based on limited data available, the sponsor
assesses this event as not related to study vaccine or procedure in agreement with
the investigator. Reported Cause(s) of Death: myocardial infarction; road traffic
accident."" "No lab data for this event."
"638043-1" "638043-1" "This spontaneous report was received from a
physician and refers to two patients of unknown demographics. The physician was
told about the event by other patient. The patients' medical history, concurrent
conditions and concomitant therapies were not reported. On unknown dates, the
patients were vaccinated with GARDASIL or GARDASIL 9 (lot #, dose and route were
not provided). On unknown dates, the patients died. The causes of death were not
reported. The relatedness between the event and suspect vaccine was not reported.
Upon internal review, the event of death was considered to be medically
significant. Additional information has been requested." "No lab data for this
event."
"638257-1" "638257-1" "This spontaneous report as received from a physician
refers to two patients of unknown demographics. The patients' pertinent medical
history and drug reactions or allergies were not reported. On an unknown date, the
patients were vaccinated with GARDASIL (strength, dose, frequency, therapy route,
indication and lot number were not reported) (unspecified if the product was
GARDASIL or GARDASIL 9). Concomitant medications were not reported. The physician
reported that, an unspecified patient mentioned that two patients died after
receiving the vaccine. The cause of the death was not reported. The outcome of
event was fatal. Causality assessment was not provided. No product quality
complaint was reported. Upon internal review, death was considered as medically
significant. Additional information has been requested." "No lab data for this
event."
"638374-1" "638374-1" "Infant received PEDIARIX, PREVNAR, PEDVAX and
ROTATEQ vaccines on 3/2/16. He had slight fever that evening. In AM afebrile,
eating well. Mom put down for nap and 2 hrs later found him unresponsive."
"Autopsy by Medical Examiner cause of death congestive heart failure due to
ASD (secundum) and Influenza A"
"638978-1" "638978-1" "Patient started feeling ill after his night shift
started. He worked as an overnight stocker at the location where he received the
vaccination. As the night went on, patient started feeling sick and after his
lunch break around 2 am he got hot, feverish and was sweating profusely. He went
and sat down in the meat cooler to try and cool down for a few minutes. After
awhile he told his supervisor and a co-worker that he was leaving to go home sick.
He asked his co-worker to get the chair for him he left in the cooler and left his
jacket there overnight. It is not like patient to leave work early, much less ask
someone to get a chair for him that he left behind. The next night he called in
sick again from work which was Sunday, Sept. 20, 2015. He died later that evening
according to paramedics whom did not find him until a good friend and next door
neighbor found him laying on the floor in his home dead on Monday, Sept. 21 around
6:39 PM. The paramedics and sheriff said he had been gone for possibly 18-24
hours." "No lab data for this event."
"639404-1" "639404-1" "This spontaneous report as received from a physician
via a company representative refers to a female patient of unknown age. There was
no information about the patient's concomitant medications, allergies and pertinent
medical history reported. On an unknown date, the patient was vaccinated with a
dose of HPV vaccine (manufacturer unknown) (dose, strength, route of
administration, lot# and expiry date were not reported) and a dose of FLUMIST
(dose, strength, route of administration, lot# and expiry date were not reported).
It was reported that the patient went back to the physician office the same day of
vaccination for an unspecified reason. The next day (date unspecified), the patient
died. Cause of death was not reported. The causality between the suspect vaccines
and the patient's death was not reported. Upon internal review the event was
considered to be medically significant. This is one of several reports received
from the same source. Additional information is not expected as there was no
contact details provided." "No lab data for this event."
"639596-1" "639596-1" ""This spontaneous report was received from a
pharmacist via company representative, and refers to an elderly male patient in his
70's or older. Concurrent conditions and medical history were not reported. On an
unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency,
lot and expiration date were not provided) by ""injection"" route). There were no
concomitant medications and co-suspect therapies reported. On an unknown date,
after the vaccination with ZOSTAVAX, the patient developed shingles in his eye,
herpes zoster disseminated and herpes zoster infection neurological (reported as
""spread to the optic nerve and brain). A year later, on an unspecified date, the
patient died. It was unknown if an autopsy was performed. The outcome of ophthalmic
herpes zoster, herpes zoster disseminated and herpes zoster infection neurological
were unknown. The causality between the events and the use of ZOSTAVAX was not
reported. Upon internal review, the events of ophthalmic herpes zoster, herpes
zoster disseminated, herpes zoster infection neurological and death were considered
medically significant. Additional information is not expected due to permission to
contact the reporter was not granted."" "No lab data for this event."
"640247-1" "640247-1" "Patient dropped to the floor and hit her head
shortly after being immunized with Prevnar. CPR administered on site. Patient
later died at hospital. Dr./coroner believes it was not related to the shot but
rather a pulmonary embolism." "No lab data for this event."
"640654-1" "640654-1" "Death." "Pending"
"640843-1" "640843-1" ""Pt was seen in the office for a AWV on 6-20-16 and
was fine. He was given a pneumonia vaccine that day. Wife called the office 6-24-16
stating he started getting sick on 6-22-16 with chills and a cough. Pt became
sicker and went to ER on the 26th and died on the 27th. Patient is a 82 y.o. male
who presents for a ""Annual Wellness"" exam. Current concerns included AWV. Pt
still sees cardio once a year for HTN, HLD, aortic stenosis and
hyperhomocystenemia. Sees neuro once a year for stroke. Chronic constipation -
stable. Takes AMITIZA prn if needed."" "Community acquired bacterial pneumonia"
"641009-1" "641009-1" "This retrospective pregnancy case was reported by a
consumer via other and described the occurrence of asphyxiation in a male neonate
exposed to Tdap in utero. The mother received the product. Co-suspect product
exposures included FLUARIX, ENGERIX B pediatric, PEDIARIX, ROTARIX, ACTHIB and
PREVENAR 13. On an unknown date, the mother received Tdap and seasonal influenza
vaccine. On 19th April 2013, the mother received ENGERIX B pediatric. On 19th June
2013, the mother received PEDIARIX and ROTARIX. On an unknown date, the mother
received ACTHIB at an unknown dose. On 19th June 2013, the mother received PREVENAR
13. The mother's last menstrual period was on an unknown date and estimated date of
delivery was on an unknown date. The neonate was exposed to Tdap during the second
trimester of pregnancy. At [weeks gestation], the neonate was born via vaginal
delivery. The neonate was diagnosed with apnea (serious criteria GSK medically
significant), irritability and dyspnea exacerbated. On 5th July 2013, the neonate
experienced asphyxiation (serious criteria death and GSK medically significant). On
an unknown date, the neonate experienced apnea (serious criteria GSL medically
significant), breathing arrested (serious criteria GSK medically significant),
unresponsive to stimuli (serious criteria GSK medically significant), difficulty
breathing, snoring, eye discharge, oral thrush and maternal exposure during
pregnancy. The neonate was treated with ZANTAC and TYLENOL. On an unknown date, the
outcome of the asphyxiation was fatal and the outcome of the apnea, breathing
arrested, unresponsive to stimuli, apnea, difficulty breathing, snoring,
irritability, eye discharge, oral thrush, dyspnea exacerbated and maternal exposure
during pregnancy were unknown. The neonate died on 5th July 2013. The reported
cause of death was asphyxia. An autopsy was performed. The autopsy determined cause
of death was unresponsive to stimuli, petechia and visceral congestion. It was
unknown if the reporter considered the unresponsive to stimuli to be related to
Tdap and seasonal influenza vaccine. It was unknown if the reporter considered the
asphyxiation, apnea, breathing arrested, difficulty breathing, snoring,
irritability, eye discharge and oral thrush to be related to ENGERIX B pediatric.
It was unknown if the reporter considered the asphyxiation, apnea, irritability and
dyspnea exacerbated to be related to PEDIARIX and ROTARIX. Additional details were
provided as follows: This case was retrieved from a media research. The patient's
mother received Tdap and flu vaccine during her 2nd trimester of the pregnancy. At
40 weeks of gestation, the patient's mother went into labor in a medical center.
She was tested positive for Group B streptococcus and was given 2 doses of the
antibiotic penicillin. Rest of pregnancy and labs negative. Since discharge home,
has been healthy without fever. Soon after, the patient was born unresponsive,
weighing 9 pounds and 2 ounces and had to be resuscitated immediately. After he was
resuscitated, the patient was deemed in good enough health and then was injected
with the vitamin K shot and hepatitis B vaccine. The two combined shots contain
approximately 350 mcg of aluminum and both are linked to breathing problems, among
other things. By the time the patient was 3 weeks old, his mother noticed him
having gasping episodes while sleeping in his bassinet. When he was awoke, he let
out a snoring sound as he would catch his breath, then he would go back to bed.
When the patient was 5 weeks old, his apnoea episodes started occurring more
frequently, about once every hour. The patient's mother had to blow into her son's
mouth and nose to get him breathing again. On 26th May 2013, the patient's mother
rushed her son to the emergency room at hospital, begging for help. She knew
something was very wrong, but the doctor would not listen to her and wrote the
patient's breathing problems off as reflux and gave her a prescription for ZANTAC
and told her to follow up with his paediatrician. She felt helpless and was
frustrated as they would not hook up the patient to a breathing monitor. At this
visit, the patient's emergency documentation included that a 5 week old male,
previously healthy, who presented with abnormal respirations as per his mom. The
patient had been having one gasping episodes for the last 2 weeks which occurred
once a night when he was sleeping and was not associated with any other symptoms.
He was sleeping and his mom hears him gasp more than 1 time, which woke him up for
a few seconds but then he easily goes back to bed. No perioral or acrocyanosis
noted. Last night he would have gasping about once an hour. Also has been having
some left eye purulent discharge and oral thrush. The patient was still being
breastfed. He was breastfed for several weeks and then switched to formula. He had
no congestion, no runny nose, and no swollen eyes, none of the things you would
associate with a food allergy. Believing the doctors knew best, the patient's
mother gave her son the prescription ZANTAC. This did not help him. The patient's
apnoea spells continued while she waited for him to be seen by his paediatrician.
The patient's mother found out the paediatrician and was required to submit a
referral to the hospital for them to test the patient at their sleep disorder
clinic. On 7th June 2013, the paediatrician sent the referral for them to do apnoea
testing on the patient. An appointment was made for him to be seen by a nurse
practitioner at the sleep clinic the following Monday. By this time, the patient's
mother had to breathe in her son's nose and mouth more than once when he stopped
breathing. After getting home from that appointment, the patient received a phone
call about an hour later and was told Monday's appointment was cancelled. She was
told the patient could not be seen by a nurse practitioner because he was too young
and that only a doctor of medicine (MD) could see him, which did not make sense.
The patient's mother was told they would put him on a waiting list to be scheduled
to be seen. She was so shocked and upset at this. None of the doctors were doing
anything to help her son. Weeks went by and the patient was still not scheduled to
be seen. Then on his two-months check-up approached. The patient's mother took all
three of her children in to receive the vaccines on time, but she did not know
vaccines were linked to apnoea and breathing problems. At the patient's two-month
well-baby check-up, the doctor neglectfully recommended him to receive the routine
vaccines. The doctor assured his mother that the vaccines were safe and signed off
for the nurse to vaccinate the patient with 8 more vaccine doses, even though his
breathing problems had not been addressed. The patient's mother entrusted the
doctor with her son's life and signed the paper, giving consent to vaccine. On 19th
June 2013, when the patient's weighed almost 15 pounds, the nurse administered t"
"No lab data for this event."
"641317-1" "641317-1" "Death" "No lab data for this event."
"641781-1" "641781-1" "Patient did not feel well at all within 1 hr of
receiving the flu and PREVNAR 13 vaccines. On Feb 18 he started complaining of
feeling like he had fluid on his lungs, went to emergency room. They did EKG was
ok, chest x-ray showed small amount of fluid in left lung. Was given LASIX seemed
to clear up. This was a Thurs doctor not in on Fri, was going to go to Dr on Tues,
but early Tues 2/23/16 morning around 1:30 am was having trouble getting air into
lungs went to hospital by ambulance around 6 AM. Heart stopped on way to hospital
lungs so full of fluid his heart could not beat. Was resuscitated but due to
already depleted oxygen level irreparable brain damage occurred, was in coma 2
weeks and passed. I know him being given the flu vaccine and the PREVNAR 13
vaccines at the same time killed my husband. This practice has to stop! He was
transferred from one hospital to another. While in hospital we were advised of
bacterial pneumonia, fungal pneumonia and B3 staph were present. Previously thought
CHF or COPD but was never diagnosed with this. X-rays of 2/3/16 show all clear no
signs of problems. Testosterone usage was not understood by doctor, at all. He used
1 mL every 10 days NOT 200 mg a week. Doctors in hospital said his usage had no
relation to his condition. Once pneumonia found CHF and COPD dismissed." "See
attached chest x-ray 2/3/16 was clear"
"642053-1" "642053-1" "Undetermined cause of death within 24 hours of
vaccines." "No lab data for this event."
"643452-1" "643452-1" "Initial unsolicited report received from other
healthcare professional on 08 July 2016. This case involves a 42-year-old female
patient who was vaccinated with a dose of TENIVAC (batch number: U5411AA, expiry
date, site and route of administration not reported) on 16 June 2016. The patient's
pre-existing physician diagnosed allergies, birth defects, medical conditions was
reported as allergies: none known as per reporter; Medical History: none as per
reporter. Concomitant medications were not reported. Any other vaccinations within
4 weeks of vaccinations was not reported. On 30 June 2016, 14 days following the
vaccination, it was reported that the patient did not have any reactions at that
time. Then stated they heard from another patient that, later that night of 30 June
2016, the patient had passed away. Relevant diagnostic tests/laboratory data was
not reported. The patient's corrective treatment was not reported. On 30 June 2016,
the patient had died. List of documents held by sender: none. Sender's Comments:
This case concerns a death in a patient who was vaccinated with DIPHTHERIA-
2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and two other products. This
case is not sufficiently documented. More information including and not limited to
detailed Autopsy report and patient's medical history, laboratory tests are needed
to further assess this case. Based on the information provided; the role of vaccine
cannot be assessed. Reported Cause(s) of Death: passed away." "No lab data for
this event."
"644099-1" "644099-1" "Initial unsolicited report received from consumer
via social media in on 09 Jul 2016. This case is linked to 2016SA128403,
2016SA131479 and 2016SA131486 (same vaccine, same reporter). This case involves a
patient (age and gender were not reported) who was vaccinated with dose of
MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of
administration: not reported) on an unspecified date. The patient's medical history
and concomitant medications were not reported. On an unspecified date, two weeks
after vaccination the patient died. It was unknown whether autopsy was performed
and the cause of death was unknown. Documents held by sender: none. Sender's
Comments: This case corresponds to a poorly documented and non-medically confirmed
social media report. Patient presumably received meningococcal vaccine for which
the manufacturer was unknown. Clinical details- such as patient's age, medical
history, vaccination details, the name of the specific vaccine administered,
clinical details surrounding the event, diagnostic work-up, cause of death and
autopsy reports- are lacking to allow adequate medical assessment. Reported
Cause(s) of Death: DEATH NOS." "No lab data for this event."
"644219-1" "644219-1" "Initial unsolicited report received from consumer
via social media in on 09 Jul 2016. This case is linked to 2016SA128403,
2016SA131486, 2016SA131491 (same vaccine, same reporter). This case involves a
patient (age and gender: not reported) who was vaccinated with dose of
MENINGOCOCCAL VACCINE (batch number, expiry date, route, dose and site of
administration: not reported) on an unspecified date. The patient's medical history
and concomitant medications were not reported. On an unspecified date, two weeks
after getting the vaccination the patient died. It was unknown whether autopsy was
performed and cause of death was unknown. Documents held by sender: none. Sender's
Comments: This case corresponds to a poorly documented and non-medically confirmed
social media report. Patient presumably received meningococcal vaccine for which
the manufacturer was unknown. Clinical details- such as patient's age, medical
history, vaccination details, the name of the specific vaccine administered,
clinical details surrounding the event, diagnostic work-up, cause of death and
autopsy reports- are lacking to allow adequate medical assessment. Reported
Cause(s) of Death: death." "No lab data for this event."
"644220-1" "644220-1" "Initial unsolicited report received from consumer
via social media on 09 Jul 2016. This case is linked to 2016SA128403, 2016SA131479,
2016SA131491 (same vaccine, same reporter). This case involves a patient (age and
gender: not reported) who was vaccinated with dose of MENINGOCOCCAL VACCINE (batch
number, expiry date, route, dose and site of administration: not reported) on an
unspecified date. The patient's medical history and concomitant medications were
not reported. On an unspecified date, two weeks after getting the vaccination the
patient died. It was unknown whether autopsy was performed. Documents held by
sender: none.; Sender's Comments: This case corresponds to a poorly documented and
non-medically confirmed social media report. Patient presumably received
meningococcal vaccine for which the manufacturer was unknown. Clinical details-
such as patient's age, medical history, vaccination details, the name of the
specific vaccine administered, clinical details surrounding the event, diagnostic
work-up, cause of death and autopsy reports- are lacking to allow adequate medical
assessment. Reported Cause(s) of Death: death." "No lab data for this event."
"644887-1" "644887-1" "This spontaneous report was received from a Nurse
Practitioner via a company representative who referred to a 67 year old male
patient. Patient's pertinent medical history, concomitant medication and drug
reaction/allergies were not reported. On an unknown date, the patient was
vaccinated with a dose of ZOSTAVAX subcutaneously, (strength, dose, lot # and
expiration date were not provided). On an unknown date, after receiving the
ZOSTAVAX, the patient was diagnosed with shingles then after a year from receiving
the ZOSTAVAX the patient died. At the reporting time, the outcome of the event of
shingles was unknown. The cause of the death was unknown. It was also unknown
whether an autopsy was performed. The relatedness between the events and the
ZOSTAVAX was not provided. Upon internal review, the patient's death was considered
to be medically significant. Additional information has been requested." "No
lab data for this event."
"644888-1" "644888-1" "This spontaneous report was received from an
unspecified reporter via a company representative, concerning a patient of unknown
age and gender. Patient's pertinent medical history, concomitant medication and
drug reactions/allergies were not reported. On approximately 2015, the patient was
vaccinated with ZOSTAVAX (strength, dose, route, lot # and expiration date were not
provided). On an unknown date, within a year of the injection, the patient died.
The cause of death was unknown. It was unknown whether an autopsy was performed or
not. There was no product quality (PQC) involved. The causality was not stated.
Upon internal review, the event of death was considered as medically significant.
Additional information has been requested." "No lab data for this event."
"645869-1" "645869-1" "Toddler found died in her crib in the morning."
"Toxicology screen; Autopsy"
"648057-1" "648057-1" "Vaccines given 7/26. 7/30 pt awoke with severe
headache and vomiting. Went unconscious. Found to have had a cerebellar aneurysm.
Pt died 7/31." "No lab data for this event."
"648696-1" "648696-1" ""This spontaneous report as received from a health
professional via a company representative refers to a patient of unknown age. No
medical history or concurrent conditions were reported. On an unknown date in May
of 2015, the reporter discussed in an unknown article that she is now pressing
""red alert button on the devastating consequences and irrelevancy of the
vaccine"". The reporter stated in the article that the HPV vaccine is ""more
dangerous that the HPV Virus"". The reporter also stated ""there were many unknown
severe adverse events that occurred and multiple unknown deaths as there are
cervical cancer cases developing each year after vaccination with HPV vaccine"".
The HPV vaccine discussed in the article could not be verified as GARDASIL,
GARDASIL 9 or product from another company. The outcome of cervix carcinoma and
death was reported as fatal. The outcome of adverse event was unknown. The reporter
considered the events to be related to the suspect therapies. Upon internal review,
the events of cervix carcinoma and death were considered to be medically
significant. Additional information has been requested."" "No lab data for this
event."
"648868-1" "648868-1" ""Initial information regarding this clinically
sponsored solicited case was received on 28-Mar-2016 from patient's wife via the
Patient Support Program. This case concerns a male patient of unknown age who had
multitude of health issues, COPD and he came down with influenza B an unknown
duration after commencing treatment with influenza vaccine and PRALUENT. No
information on any past drug, concomitant drug, medical history or concurrent
condition was reported. On an unknown date, the patient commenced treatment with
influenza vaccine (dose, form, route, frequency, lot/batch number and expiration
date: unknown). On an unknown date, the patient received alirocumab injection at a
dose of 75 mg every other week subcutaneously (lot/batch number and expiry date
unspecified) for other and unspecified hyperlipidemia delivered via prefilled pen.
Patient's wife reported that the patient took the flu shot and came down with
influenza B on an unknown date (latency: unspecified), because the patient had COPD
(date and latency: unknown) so he was placed in the hospital. The patient was
taking TAMIFLU as corrective treatment and was getting better. The reporter
informed that the patient expired in April and that he had a multitude of health
issues (onset and latency: unspecified). It was unknown whether an autopsy was done
or not. It was reported that the patient had two injections up to that point.
Action taken: Unknown for both the drugs. Outcome: fatal for multitude of health
issues, Recovering for other events. Seriousness criteria: Hospitalization, patient
died from multitude of health issues. Reporter causality: Unknown with respect to
alirocumab and not reported with respect to influenza vaccine for multitude of
health issues and unknown for both the drugs for other events. Company causality:
Not associated with respect to both the drugs. Additional information was received
on 23-May-2016 from patient's wife: new event ""multitude of health issues"" added,
action taken updated, form of alirocumab added and text updated accordingly.
Reported Cause(s) of Death: multitude of health issues."" "No lab data for this
event."
"649444-1" "649444-1" "This spontaneous report was received from a
physician via company representative, who saw an article by another physician. This
report refers to 44 female patients of unknown age, whose concurrent conditions,
medical history and concomitant medications were not known. On an unknown date, the
patients were vaccinated with GARDASIL (details not known). As per the article the
44 patients died as a result of receiving GARDASIL and hence causality of death was
considered to be related to the vaccine. The reporter considered the event serious
(death). Upon internal review, death was considered to be medically significant.
Additional information is not expected as the physician does not want to be
contacted." "No lab data for this event."
"649671-1" "649671-1" "This spontaneous report was received from a
physician via a company representative and refers to 44 female patients of unknown
age. There was no information regarding the patients' pertinent medical history,
drug reactions, allergies or concomitant therapies provided. The physician found
out about the event reported below from an online article. On unknown dates, the
patients were vaccinated with doses of GARDASIL (lot #, expiration date, exact
dose, site and route of administration were not reported). On unknown dates, the
patients died as a result of receiving GARDASIL (also reported as they died from
these vaccines). The relatedness between the event and GARDASIL was assessed as
related. Upon internal review, the event of death was determined to be medically
significant. This is one of two reports received from the same source. Additional
information is not expected as there was no consent for follow-up." "No lab data
for this event."
"649772-1" "649772-1" "Cardiac arrest, found unattended at home. Per
hospital, had massive MI. Treated in ER/hospital. Passed away following morning."
"Per son, cardiac enzymes elevated, indicating massive MI. No hospital
records available for review."
"650025-1" "650025-1" "This spontaneous report was received from a
physician via a company representative and refers to an unspecified number of
patients of unknown age and gender. No information regarding the patients'
pertinent medical history, concomitant medication and drug reactions or allergies
was reported. The physician reported that she reviewed an unspecified article that
described the patients, who, on unknown dates, were vaccinated with doses of
GARDASIL (strength, dose, route of administration, anatomical location, lot# and
expiration date were not provided). On unknown dates, an unspecified amount of time
after the doses were administered, the patients were diagnosed with Guillain-Barre
Syndrome and there were 44 deaths associated with GARDASIL. The outcome of
Guillain-Barre syndrome was reported as unknown. The reporter considered death to
be related to GARDASIL. The relatedness between Guillain-Barre syndrome and
GARDASIL was not reported. Upon internal review, the events of Guillain-Barre
syndrome and death were considered to be medically significant. Additional
information has been requested." "No lab data for this event."
"650027-1" "650027-1" "Initial unsolicited report received from consumer
(patient's mother) via social media on 22 August 2016. This case is linked with
case 2016SA157332 and 2016SA157340 (same social medica report). This case involves
a two-month-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS
AND PERTUSSIS VACCINE (ADSORBED) (DPT) (Batch number, expiration date, dose, route
and site of administration was not reported) on an unspecified date. Patient's
ongoing illness, medical history and concomitant medications were not reported. On
an unspecified date, post vaccination, patient developed high pitch screaming, a
high fever, vomiting and diarrhea. The patient also developed additional symptoms.
Patient's mother contacted the pediatrician and decided to take her son to the
emergency room. On an unknown date, patient died in the arms of mother on their way
to the emergency room. It was not reported whether autopsy was performed or not.
Laboratory investigations and corrective treatment were not reported. List of
documents held by sender: none. Sender's Comments: This is poorly documented social
medical case where patient died after administration of DIPHTHERIA, TETANUS AND
PERTUSSIS VACCINE (ADSORBED) (Unknown manufacturer). No medical history,
concomitant medications, lab/diagnostic or autopsy results accompany the case to
help identify the cause of death. Investigation results ruling out a concurrent
infection and other etiologies would be helpful to further assess this case.;
Reported Cause(s) of Death: diarrhea; high fever; high pitch screaming; vomiting."
"No lab data for this event."
"653657-1" "653657-1" "Information has been received from a molecular
biology student, who obtained the information from a Vaccine Adverse Event
Reporting System (VAERS) report, concerning 235 patients of unknown age and gender.
No pertinent medical history, drug reactions, allergies or concurrent conditions
were reported. On unknown dates, the patients were vaccinated with unspecified
doses of GARDASIL (strength, dosage schedule, route, anatomical location, lot
number and expiration date were not reported). Other suspect and concomitant
medications were not provided. On unknown dates, the patients died. The causes of
death were unknown, and it was also unknown whether autopsies were performed. The
reporter indicated that he read the deaths were related to GARDASIL and he was
concerned about the number of deaths reported for GARDASIL products. Upon internal
review, death was determined to be medically significant. Additional information
has been requested." "No lab data for this event."
"654870-1" "654870-1" ""This spontaneous report as received from a consumer
refers to her 73 year old husband with complications from cancers and who was
exposed to the agent Orange chemicals in a war. On an unspecified date ""in late
2013"", the patient was vaccinated with a dose of ZOSTAVAX (dose and lot # not
reported) subcutaneously. The consumer stated that the patient was feeling quite
well at the time of vaccination. The consumer reported that on an unknown date, the
patient experienced lung cancer that spread quickly. The consumer stated that they
could not get him enough treatment fast enough and in September 2014, the patient
died, ""about nine months after receiving ZOSTAVAX"". The cause of death was
reported as lung cancer. It was unknown if an autopsy was performed. Upon internal
review lung cancer was considered to be medically significant. Additional
information has been requested."" "No lab data for this event."
"655074-1" "655074-1" "Death" "No lab data for this event."
"655573-1" "655573-1" "This case was reported by a consumer and described
the occurrence of unknown cause of death in a 70-year-old female patient who
received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL
QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after
receiving FLULAVAL QUADRIVALENT, the patient experienced unknown cause of death
(serious criteria death and GSK medically significant). On an unknown date, the
outcome of the unknown cause of death was fatal. The reported cause of death was
unknown cause of death. It was unknown if the reporter considered the unknown cause
of death to be related to FLULAVAL QUADRIVALENT. Additional details were reported
as follows: The age at vaccination was not reported. The patient was the relative
of the reporter. The patient received the vaccine and died on an unknown date due
to an unknown cause. The autopsy details were not provided. Due to the patient's
death after taking the FLULAVAL vaccine, the reporter was afraid to get the
vaccine." "No lab data for this event."
"655670-1" "655670-1" "Death." "No lab data for this event."
"655683-1" "655683-1" "He got flu shot on 8/27/16. According to family
members he was admitted in hospital on 8/28/16 and passed away on 9/8/16." "No
lab data for this event."
"655938-1" "655938-1" "Information has been received from an online article
via a company representative. The article stated that a doctor said that the
incidence of cervical cancer was very low and it was impossible for Merck's Human
papillomavirus (HPV) vaccine to lower the already low incidence of cervical cancer.
It was reported that the promotion of this vaccine to prevent cervical cancer was
entirely groundless, although it was promoted as this. The study confirmed that the
indication of this vaccine had nothing to do with cervical cancer, however, the way
of promotion still ignored this fact. In fact, there was no evidence to support
that this vaccine could prevent any cancer. According to Merck's labeling, this
vaccine (the 1st generation) targeted four types of all the 40 types of HPV, which
could be self-healing in short time. The article also concerned about the potential
risks of this vaccine, as it indicated all the clinical trials were conducted among
the females aged 15-year old or above, however, Food and Drug Administration (FDA)
and Merck had extended the target users to girls of 9-year old and above, even
boys. It was reported that so far there had been 15,037 cases of adverse drug
reaction for this vaccine, and the statistics only included cases that met the very
stringent validation criteria. There had been 44 girls that were confirmed to die
of this vaccine. All kinds of adverse drug reactions included Guillain-Barre
syndrome (paralysis), lupus erythematous, thrombus and encephalitis (Cerebral
palsy) (captured in MARRS# 1609USA012858). This report refers to the 44 girls who
were confirmed to die of this vaccine. Upon internal review, die of this vaccine
was considered to be medically significant. Additional information has been
requested." "No lab data for this event."
"655947-1" "655947-1" "Information was received from a chief researcher
through an online article via a company representative referring to 44 female
patients of unknown age. The patients' medical history, concurrent condition and
concomitant therapy were not reported. On unknown dates, the patients were
vaccinated with GARDASIL (lot#, expiration date, dose and route were unknown). On
unknown dates, the patients died of this vaccine. The cause of death was unknown.
It was unknown if autopsy was performed. The reporter considered death to be
related to GARDASIL. Upon internal review, death was determined to be a medically
significant event. This is one of several reports received from the same reporter.
Additional information is not expected." "No lab data for this event."
"657076-1" "657076-1" "No adverse events at time of immunizations. 7 days
late passed with unexplained cardiac arrest. Autopsy being completed." "Positive
for enterovirus/rhinovirus"
"658368-1" "658368-1" "January 2015 - patient received vaccine during hip
surgery. February 2015 - experienced tingling and numbness in hand/arms and
impaired breathing continued and extreme fatigue. May - difficulty walking, used a
walker. June 2015 - paralyzed, and was diagnosed with GBS. July 2015 - respiratory
distress and had tracheostomy; treatment during period included immunosuppressants.
Died on 6/2/16." "No lab data for this event."
"658520-1" "658520-1" "Per mom, patient was fine when seen at well child
visit and vaccinations on 10/4. He became irritable that night and more irritable
the next day. Pt developed emesis x1 late on 10/05 and again on 10/06. Presented to
outside emergency room where patient was distended, hypoglycemic, and severely ill
appearing. Fluids and antibiotics given. In transport to us, required start of
Dopamine. On arrival patient was hypotensive to 42/20 and epinephrine started. Pt
was obtunded and grey appearing. Intubated emergently without need for sedation.
Based on tense abdomen, patient was taken emergently to the operating room. After
placement of central lines and a urinary catheter, the abdomen was opened. At this
point labs returned with a pH of 6.5. He was felt to have abdominal compartment
syndrome. The bowel was generally ischemic, but perfusion began to improve with the
abdomen open and transfusion of blood and albumin. Exploration revealed an ileo-
ileal intussusception. This was able to be reduced. Additionally, the patient had
dilation of the descending and sigmoid colons with thickening consistent with
colitis. A portion of the sigmoid colon was resected and sent for frozen section.
Ganglion cells were identified and the pathologists noted colitis was more
consistent with infectious etiology. An end colostomy was brought up and the
abdomen was left open with a wound vac. On initial return to the ICU, the blood
pressure was improved to 60-80 systolic. The patient was making good urine.
Extremity perfusion was improved. About an hour and a half later, the patient began
to deteriorate again. Lactic acid was rising to >20. An echocardiogram revealed an
ejection fraction of only 15%. I removed the abdominal dressing and the bowel below
had clear necrosis. I re-explored him at the bedside. With evisceration of the
bowel, the ejection fraction went up to 35%. On inspection, the ileum that had
previously been intussuscepted was necrotic. This was approximately a foot and a
half of bowel. This was resected. The remaining left colon and 1/2 of the
transverse colon was now necrotic as well and was resected. The terminal ileum and
right colon were viable, as was the small bowel proximal to the intussusception.
The remaining bowel was placed in a silo bag. The patient continued to deteriorate.
Six hours later, all visible bowel was necrotic. The patient was made comfort
measures only and expired." "see above. pH 6.5; Lactic acid >20"
"658608-1" "658608-1" "This is a spontaneous report from a contactable
consumer, the patient's daughter. A 73-year-old female patient received PREVNAR 13,
via an unspecified route of administration on 22Mar2016 at 0.5 ml single dose for
immunization. Medical history included chronic obstructive pulmonary disease
(COPD), diabetes, and heart attack. Concomitant medications were unknown; the
patient was taking a lot of medications (medication list was not provided). The
patient vaccination history was unknown. The reporter stated that she was reading
her mother's chart and that her mother had died. While reading the chart she noted
that her mother received pneumococcal 13-valent conjugate vaccine (diphtheria
crm197 protein) on 22Mar2016 from her doctor because she was at high risk. The
patient experienced pneumonia, headache, nausea, itching, could not sleep for 2-3
days, and threw up. The clinical course was as follows: The patient sent a letter
to her doctor dated 14Apr2016 which she refers to previously reporting headache,
nausea, itching, could not sleep for 2-3 days, and threw up after receiving the
vaccine. It was reported that the patient required a trip to the emergency room for
the events of itching, headache, nausea, and difficulty sleeping. The patient had
requested medication for nausea from her doctor and reported that headache was
better. The patient underwent lab tests and procedures which included laboratory
test with unknown results on 02Apr2016. Patient had a consult with internal
medicine doctor on 07Apr2016. Patient complained of sinus issues and was placed on
AMOXICLAV 875 mg for seven days from Apr2016 to completion on 14Apr2016. The
patient saw the doctor because she was so sick from everything. The patient started
to take ZITHROMAX on an unspecified date (described as the Tuesday prior to calling
the ambulance, she was taking a Z Pak). The ambulance was called on 30Apr2016
because patient slipped out of bed and they could not get her back into bed. On the
following Monday, she was unresponsive. She was admitted to the hospital on
30Apr2016, had to be intubated, lung was tapped a couple of times. The patient had
COPD and could not get off of the ventilator. She was transferred to a different
hospital three weeks after admittance and never left that hospital. Therapeutic
measures were taken as a result of headache, nausea and threw up. The patient died
on 10Jun2016 because she got pneumonia on an unknown date. An autopsy was not
performed. Reported Cause(s) of Death: pneumonia." "Test Date: 20160402; Test
Name: Laboratory test; Result Unstructured Data: Test Result: unknown"
"658633-1" "658633-1" "Initial unsolicited report received from a consumer
via other company (Pfizer) on 03-Oct-2016. Manufacturer Report Number: 2016444837.
This case involves a female patient (age not reported) who was vaccinated with FLU
SHOT (manufacturer: unknown) (batch number, expiry date reported as unknown, dose,
dose in series, route and site of administration were not reported) on an unknown
date. The patient's medical history and Concomitant medications were not reported
(reported as none provided). On an unknown date, following the vaccination, the
patient got a touch of the flu and lung cancer. The patient's laboratory data
(reported as none provided) and corrective treatment was not reported. The outcome
of event: flu was not reported. It was reported that patient died 11-year ago and
cause of death was lung cancer. List of documents held by sender: none. Sender's
Comments: This is poorly documented consumer case where influenza was reported
after administration of influenza vaccine and patient died due to lung cancer.
However detail autopsy report, date of death, onset of lung cancer and
administration date would be helpful to assess this case further. According to
provided information no conclusion can be drawn. Reported Cause(s) of Death: lung
cancer." "No lab data for this event."
"659287-1" "659287-1" "Initial unsolicited report received from the
literature on 06-OCT-2016. Following is the verbatim from the article: Background.
We describe the impact of early initiation of influenza antiviral treatment among
pregnant women hospitalized with laboratory-confirmed influenza during the 2010-
2014 influenza seasons. Methods. Severe influenza was defined as illness with less
than or equal to 1 of the following: intensive care unit admission, need for
mechanical ventilation, respiratory failure, pulmonary embolism, sepsis, or death.
Within severity stratum, we used parametric survival analysis to compare length of
stay by timing of antiviral treatment, adjusting for underlying conditions,
influenza vaccination, and pregnancy trimester. Results. Among 865 pregnant women,
the median age was 27 years (interquartile range [IQR], 23-31 years).Most (68%)
were healthy, and 85%received antiviral treatment. Sixty-three women (7%) had
severe influenza, and 4 died. Severity was associated with preterm delivery and
fetal loss. Women with severe influenza were less likely to be vaccinated than
those without severe influenza (14%vs 26%; P equal to .03). Among women treated
with antivirals 2 days versus those treated more than 2 days from illness onset,
the median length of stay was 2.2 days (interquartile range [IQR], 0.9-5.8 days; n
equal to 8) versus 7.8 days (IQR, 3.0-20.6 days; n equal to 7), respectively, for
severe influenza (P equal to .03) and 2.4 days (IQR, 2.3-2.5 days; n equal to 153)
versus 3.1 days (IQR, 2.8-3.5 days; n equal to 62), respectively, for no severe
influenza (P less than .01). Conclusions. Early initiation of influenza antiviral
treatment to pregnant women hospitalized with influenza may reduce the length of
stay, especially among those with severe influenza. Influenza during pregnancy is
associated with maternal and infant morbidity, and annual influenza vaccination is
warranted.+ Keywords. influenza; pregnancy; influenza antiviral treatment; length
of stay; early antiviral treatment This case involves a female patient (age not
reported) who was vaccinated with a dose of INFLUENZA VACCINE (manufacturer:
unknown, batch number, expiry date, route and site of administration: not reported)
on an unspecified date. Patient's medical history and concomitant medications were
not reported. On an unspecified date, post vaccination the patient had severe
influenza and was hospitalized. On an unspecified date, post vaccination, the
patient died (Patient was pregnant when she died). This was a case of vaccination
failure. Patient's laboratory data included: influenza virus test-positive result
(Reported as patient was more likely to have presence of influenza A ((H1N1) pdm
09). Confirmation included a positive result of reverse transcription polymerase
chain reaction analysis, rapid antigen testing, direct or indirect fluorescent
antibody staining, or viral culture. Patient received corrective treatment with
antiviral medication. It was unknown whether autopsy was performed. List of
documents held by sender: none. Sender's Comments: This case corresponds to a
poorly documented literature report with a H1N1 influenza infection with a fatal
outcome in a pregnant women. Patient was died due to severe influenza infection
even though she was received influenza vaccine before for which the name of the
manufacturer was unknown. This case is therefore a suspected vaccination failure.
Clinical details- such as latency from vaccination, relevant medical history,
previous vaccination history, clinical details surrounding the fatal event, the
name of the specific vaccine administered, autopsy report and diagnostic work-up-
are lacking to allow adequate medical assessment. Reported Cause(s) of Death:
severe influenza/ influenza A (H1N1)." "No lab data for this event."
"659512-1" "659512-1" "Child was sleeping in mother's arms sometime in the
evening and noticed child was not breathing and immediately began CPR and called
911. Code called at hospital @1943pm. ONSET TIME ESTIMATED as I will not contact
parents for this." "No lab data for this event."
"659587-1" "659587-1" "Initial unsolicited report received from a consumer
via social media on 10 Oct 2016. This case is linked to 2016SA188144, 2016SA188556,
2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808,
2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814,
2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820,
2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836,
2016SA188837, 2016SA188838, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843,
2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849,
2016SA188850, 2016SA188851. (Same reporter source, same vaccine). This case
involves a male patient (age not reported) who was vaccinated with a dose of Flu
shot (batch number, expiry date, dose, dose in series, route and site of
administration were not reported) on an unspecified date. The patient's medical
history and concomitant medications were not reported. On an unknown date, 30 hours
following the vaccination, the patient died. The patient's laboratory data and
corrective treatment was not reported. It was unknown that Autopsy was performed.
List of documents held by sender: none. Sender's Comments: This is poorly
documented case of death 30 hours following influenza vaccination. Time to onset is
compatible but detail medical history, any co morbidity, past vaccination history
leading to any severe reaction and allergic history is needed to further assess the
case. Reported Cause(s) of Death: Death NOS." "No lab data for this event."
 "660133-1" "660133-1" "Unknown. It was reported to us 2 days later that
patient went to the hospital and died 9/29/2016." "Unknown"
"660712-1" "660712-1" ""This is a 92 y.o., male a 92 year old male with
past medical history of hypothyroidism, HTN, HLD, IBC, vitamin D deficiency, and
anemia who presented with a complaint of progressive weakness in all four
extremities x 2 days prior to presentation. Given concurrent absence of reflexes
and progressive extremity weakness S/P recent immunization (flu shot), a 5 day
course of IVIG was started and completed for a presumptive diagnosis of AIDP. As
part of his evaluation, EMG/NC was remarkable for sensorimotor peripheral
neuropathy with axonal an demyelinating features. No temporal dispersion or
conduction block at this time, per report. A Lumbar puncture was obtained. CSF
studies was not consistent with an infection so far, his HSV was also negative. The
lumbar puncture was a difficult and traumatic tap with limited CSF fluid collected.
We monitored his respiratory parameters with PVC/NIF Q2hrs. On 8/18/16, his
respiratory status declined requiring HFNC 100% FIO2. Given that the family had
requested he be intubated if needed on a temporary basis on admission despite a
Postform stating otherwise, he was transferred to the ICU. However family
eventually decided that the patient would not want to be intubated/trached or PEG
placed. Supportive Care was consulted to facilitate the family discussion.
Following a family meeting, ""they agree with the option of weaning from HFNC while
keeping pt comfortable with morphine."" Early morning, on 10/20/16, the on call
neurology resident was paged that the ""patient does not have any spontaneous
respirations."" He was subsequently pronounced dead at 0250 on 10/20/2016."" "Not
aware of any"
"660763-1" "660763-1" ""Information has been received from a reporter via
social media concerning eight patients of unknown age and gender. Information about
concurrent condition, concomitant medication and medical history was not provided.
On unspecified dates, the patients received HPV vaccine (manufacturer unknown)
(lot#, expire date, dose and route unknown). On unknown dates, the patients died.
It was unknown if autopsy was done. The relationship between the events and vaccine
was not confirmed. Upon internal review, death was determined to be medically
significant. This is one of several reports received from the same reporter.
Additional information is not expected because of lack of privately contactable
information for the reporter. This is a new safety report and has been created due
to safety report ""US-009507513-1610JPN011009"" having been created with the
incorrect primary source country code. Unfortunately our system is not fully ICH-
E2B (R2) compliant, so US-009507513-1610JPN011009 is being nullified and we have
created this new safety report ID to reflect the correct country code. US-
009507513-1610JPN011009 is now listed as an E2B Report Duplicate."" "No lab data
for this event."
"660964-1" "660964-1" ""This prospective pregnancy case was reported in a
literature article and described the occurrence of vaccination failure in a female
subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time
after receiving Flu seasonal TIV Dresden, the subject developed vaccination
failure. Serious criteria included hospitalization and GSK medically significant.
Additional event(s) included unknown cause of death with serious criteria of death
and GSK medically significant, influenza with serious criteria of hospitalization
and vaccine exposure during pregnancy. The subject was treated with TAMIFLU. The
outcome of vaccination failure was unknown. The outcome(s) of the additional
event(s) included unknown cause of death (fatal), influenza (unknown) and vaccine
exposure during pregnancy (unknown). The pregnancy was lost to follow up. The
reported cause of death was unknown cause of death. The investigator considered
that there was a reasonable possibility that the vaccination failure and influenza
may have been caused by Flu seasonal TIV Dresden. It was unknown if the
investigator considered the unknown cause of death to be related to Flu seasonal
TIV Dresden. Relevant Tests: Lab test was performed on unknown date. Diagnostic
results (unless otherwise stated, normal values were not provided): On an unknown
date, Influenza virus test result was positive unknown. Additional information was
provided. This prospective pregnancy case was reported in a literature article and
described the occurrence of suspected vaccination failure in a female aged between
15 and 44-year old who was vaccinated with unspecified influenza vaccine
(manufacturer unknown). The patient was the part of study that described the
epidemiology and clinical outcomes associated with hospitalizations for laboratory-
confirmed influenza among pregnant women during recent influenza seasons and to
assess the impact of early initiation of influenza antiviral treatment. The patient
was a pregnant female. (In this study, 24 out of 63 pregnant women with severe
influenza infection were aged between 15 and 24 year, 31 aged between 25 and 34
year and 8 were between 35 and 44 years. 63 pregnant women with severe influenza
infection 21 had the underlying medical condition of asthma, 7 had metabolic
disease, 5 had cardiovascular disease (excluding hypertension), 4 had
immunocompromised condition, 2 had blood disorders/hemoglobinopathy, 2 had
neurologic/neuromuscular disease and 1 had renal disease. The patient's last
menstrual period was on an unknown date. Estimated date of delivery was on an
unknown date. No information on patient's medical history, family history or
concurrent condition or concomitant medication was provided. On an unspecified date
between 2010 and 2014, the patient received unspecified influenza vaccine
(administration route and site unspecified; dosage unknown; batch number not
provided). On an unspecified date, an unknown period after vaccination, the patient
was hospitalised within 2 days of an influenza virus-positive test result.
Laboratory testing for influenza virus was performed at the discretion of the
clinicians providing medical care, and confirmation included a positive result of
reverse transcription polymerase chain reaction analysis, rapid antigen testing,
direct or indirect fluorescent antibody staining, or viral culture. Out of 63
influenza positive patients, 57 were influenza A positive, 27 were H1N1 pdm09
positive, 7 were H3N2, 6 were influenza B virus positive. Influenza associated
complication among 63 pregnant patients with severe influenza infection were: 35
had pneumonia, 6 had dehydration, 12 had asthma exacerbation, 26 had sepsis/shock,
25 had respiratory failure, 9 had acute respiratory distress syndrome, 7 had acute
renal failure and 4 had pulmonary embolism. This case has been considered as
suspected vaccination failure as time to onset was unknown. This case was
considered serious due to hospitalisation. The patient was treated with TAMIFLU.
The outcome of the pregnancy was lost to follow-up. On an unspecified date, the
patient died. (In this study, 3 out of 4 fatal cases were treated more than 2 days
after illness onset including one who was admitted within 2 days of illness onset,
the date of illness onset was unknown for 1 patient. 3 of the deaths involved women
less than 35 years of age with no underlying medical conditions). It was unknown if
the autopsy was done. The cause of death was unknown. The authors did not comment
on the relationship between influenza infection and unspecified influenza vaccine.
The authors concluded that ""Pregnant women are at risk of influenza complications
during seasonal influenza. Influenza virus infection during pregnancy continues to
be associated with maternal and infant morbidity, including ICU admission, preterm
birth, fetal loss, and maternal death. All pregnant women should receive annual
influenza vaccination to prevent influenza and associated complications for
themselves and their infants. Early initiation of antiviral treatment may reduce
hospital length of stay, particularly among women who have a more severe influenza
presentation. When influenza is suspected among pregnant women, physicians should
initiate antiviral treatment early, without waiting for laboratory test
results."""" "Lab test was performed on unknown date; Influenza virus test,
positive"
"661043-1" "661043-1" "This spontaneous report was received from a
physician via company representative concerning 200 patients of unknown age and
gender. The physician reported that an unspecified article provided information
regarding patients who on dates were vaccinated with GARDASIL and died an
unspecified time after vaccination. There was no product quality complaint
reported. The reporter did not provide the causality assessment for the events. the
cause of death was not specified. Upon internal review death was considered to be
medically significant. Additional information has been requested." "No lab data
for this event."
 "661292-1" "661292-1" "Patient received an influenza vaccine on 11/8/2013.
Pt had no reported signs or symptoms of an adverse reaction to the vaccine. Staff
was informed on 11/10/13 that pt passed away in her sleep.""Pt had PPD planted on
11/8/13 and positive urine dipstick"
"661651-1" "661651-1" "Pt received flu shot approximately 1 pm 10/24/16 -
seemed healthy. No adverse response reported. Pt found deceased in bed 10/25/16
am." "No lab data for this event."
"661663-1" "661663-1" "Blurred vision, double vision, severe headache,
nausea, loss of energy, loss of strength, tingling in arms, hands, legs, feet,
numbness in arms, hands, legs, feet, joint pain, anxiety, stress, shortness of
breath, chest pain, paralysis, indwelling catheter, permanent immobility, memory
loss, loss of appetite, dehydration, insomnia, nightmares, pneumonia, kidney
infection, bladder infection, urinary tract infection, sepsis. Time Course: 1/26/16
(onset of Guillain-Barre)-9/5/2016 (date of death). Treatment: Hospital
confinement, intensive care unit, and rehabilitation centers provided testing,
medications, and physical therapy." "Numerous. Relevant tests began at hospital on
1/26/16. Diagnosis of Guillain-Barre Syndrome made at hospital after extensive
testing on 1/30/16."
"663733-1" "663733-1" "Full arrest noted approximately 45 minutes after
being put to bed at home. EMS notified and pt was transported to ED where she was
intubated, given epi and sodium bicarb. She remained in total asystole during
resuscitation efforts." "HR, BP, RR all 0. iStat unable to run arterial blood gas."
"664017-1" "664017-1" "This spontaneous report as received from a consumer
via social media refers to a 15 year old female patient (reporter friend's
daughter). The patient's medical history, concurrent conditions and concomitant
medications were not reported. On unknown dates, the patient was vaccinated with
all three doses of either quadrivalent human papillomavirus (types 6, 11, 16, 18)
recomb. vaccine (manufacturer unknown) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp
vaccine (yeast) (manufacturer unknown), (dose, route, lot # and expiry date not
reported). On an unknown date, the patient died after receiving all three doses of
vaccine. The cause of death was unknown and it was not reported if an autopsy was
performed. The reporter stated that, his/her friend did some research and she was
convinced that the patient died because of this vaccine. The reporter also stated
that his/her kids had received all other vaccines, but this vaccine had many
risks. Causality was not provided by the reporter. No product quality complaint was
involved. Upon internal review, death was determined to be medically significant.
Additional information is not expected as contact details of the reporter are not
available." "No lab data for this event."
"664201-1" "664201-1" "Parents report intermittent illness since
vaccination: fever(101) every other day x7 days, nausea, vomiting, diarrhea,
headache, fatigue, somnolence, dizziness, cough, Left leg pain." "WBC 16.8,
Platelets 530, neutrophils 13.2, anion gap 13, total protein 8.5, alkaline phos
166, calculated OSMO 273"
"664389-1" "664389-1" ""This case was reported in a literature article and
described the occurrence of death NOS in a male patient who received Hepatitis B
vaccine. The patient's past medical history included acute hepatitis B, kidney
transplant, transplant rejection and transplant rejection. Previously administered
products included Lamivudine/zidovudine, lopinavir/ritonavir, tenofovir and
antithymocyte globulin. Concurrent medical conditions included haemodialysis, HIV
infection and end stage renal disease. Concomitant products included darunavir,
ritonavir, raltegravir, etravirine, mycophenolate, tacrolimus, prednisone and
antithymocyte globulin. In February 2013, the patient received the 1st dose of
Hepatitis B vaccine. On 23rd April 2013, 61 days after receiving Hepatitis B
vaccine, the patient experienced hepatitis B reactivation (serious criteria GSK
medically significant). In December 2013, the patient experienced death NOS
(serious criteria death and GSK medically significant). On an unknown date, the
outcome of the death NOS was fatal and the outcome of the hepatitis B reactivation
was unknown. The reported cause of death was unknown cause of death. It was unknown
if the reporter considered the death NOS to be related to Hepatitis B vaccine. The
reporter considered the hepatitis B reactivation to be related to Hepatitis B
vaccine. Additional information was provided. This case was reported in a
literature article and described the occurrence of hepatitis B virus (HBV)
reactivation in a male aged 40-year or above who was vaccinated with unspecified
HBV vaccine (manufacturer unknown). This case corresponds to source patient in this
literature article. The patient was a part of the study that reviewed HBV serologic
results of all facility haemodialysis patients and the HBsAg testing procedures at
a commercial laboratory. The patient was under haemodialysis treatment. The patient
was the source case in the literature article. No information on patient's family
or concomitant medication was provided. In 1989, the patient was diagnosed with
acute HBV infection. Later, in 1997, the patient was diagnosed with human
immunodeficiency virus (HIV) infection with secondary end-stage renal disease.
Subsequently, long-term haemodialysis therapy was initiated in 1997. The patient
had received antiretroviral therapy1 for HIV infection (Lamivudine/zidovudine,
lopinavir/ritonavir, and beginning in 2005 HBV-suppressive including tenofovir
(dosages unknown for all), which had been discontinued during preparation for
kidney transplantation in November 2011. Between 2002 and 2011, the anti-HBc and
anti-HBs was positive whereas HBsAg was negative. The antiretroviral therapy2
included darunavir (800 mg/d), ritonavir (100 mg/d), raltegravir (400 mg twice
daily), and etravirine (200 mg twice daily). Immunosuppressive regimen included
mycophenolate, tacrolimus, and prednisone; antithymocyte globulin in January 2012.
During early 2012, the patient experienced acute transplant rejection and received
antithymocyte globulin. In May 2012, after transplant failure, the patient returned
to outpatient haemodialysis therapy and was documented as HBsAg negative. The anti-
HBc and anti-HBs was positive and negative respectively. In August 2012, the anti-
HBs were found positive. In October 2012, acute transplant rejection was again
diagnosed and prednisone initiated at 30 mg/day; tapered dosing of 2.5-5 mg every
other day during February 2013 was prescribed. The HBsAg was found negative when
performed at laboratory A (the laboratory used by the facility for urgent testing).
In January 2013, the patient was reported to be anti-HBs negative by routine
testing initiated though standing orders at the facility. This result, interpreted
as possible waning immunity, prompted HBsAg testing in February 2013. On 21February
2013, the patient's first HBsAg test result A was initially reported as positive.
The preneutralisation value was 354 HBsAg. A reduction in HBsAg value did not occur
during the confirmatory neutralisation step, though the sample may not have been
adequately diluted per test kit instructions. However, after a confirmatory
neutralization step, the presence of HBsAg was not confirmed and the final result
was reported as HBsAg negative. On an unspecified date in February 2013, after a
subsequent negative HBsAg test result at Laboratory A with a different source
patient sample, the patient received 1 dose of unspecified HBV vaccine
(administration route and site unspecified; batch number not provided). On an
unspecified date, in March 2013, peak alanine transaminase (ALT) level was 33
(Units: IU/L). During May 2012 to March 2013, the patient shared the same station 3
times weekly for 10 months with the index patient of the same literature article,
who was dialysed immediately after the patient. Between 24 April 2013 and 30 April
2013, the patient was reported to be HBsAg positive at Laboratory B (the laboratory
used by the facility for routine testing), and dialysing in isolation was started.
The ALT level was 155 IU/L. Due to the HBsAg positive result, additional HBV
serologic tests were conducted at Laboratory A and were available in early May
2013; HBsAg was not detected, despite a positive test result for hepatitis B e
antigen (HBeAg) and high viral titre, a discrepancy not identified by facility
staff despite their practice of reviewing all laboratory results upon receipt and
again at weekly rounds. Between 1 May 2013 and 8 May 2013, HBsAg was negative (the
preneutralisation value was 519 HBsAg. A reduction in HBsAg value did not occur
during the confirmatory neutralisation step, though the sample may not have been
adequately diluted per test kit instructions and anti-HBc, anti-HBs and HBeAg were
positive). The HBV DNA was 5.4 x 10E7 IU/mL and ALT was 170. Between 22 May 2013
and 27 May 2013, the patient was reported to be HBsAg with anti-HBs as positive and
ALT as 80. In June 2013, the lab tests revealed HBsAg, anti-HBc, anti-HBs and HBeAg
as positive whereas anti-Hbe and IgM anti-HBc as negative. ALT was noted as 52.
Samples obtained during July 2013 from the patient revealed HBV viral loads greater
than 1.1 x 10E8 IU/mL. Subsequently, the patient was diagnosed with HBV
reactivation. The patient resumed haemodialysis therapy in isolation. The patient's
HBV genotype was A. (In this study, laboratory A failed to strictly adhere to the
HBsAg test manufacturer's guidelines for adequate dilution of patient serum samples
during the confirmatory neutralization step. Therefore, the patient's sample might
not have been adequately diluted in February and May 2013, resulting in potentially
false-negative HBsAg results). The patient's HBV whole genome sequences analysis
indicated 99.9% genetic homology with the index patient of the same literature
article. In December 2013, the patient died. HBV infection was not listed as a
contributing cause. It was unknown if the autopsy was performed. The cause of death
was unknown. " "Lab tests performed on unknown date. Between 1 May 2013 and 8
May 2013, HBsAg was negative (the preneutralisation value was 519 HBsAg. A
reduction in HBsAg value did not occur during the confirmatory neutralisation step,
though the sample may not have been adequately diluted per test kit instructions
and anti-HBc, anti-HBs and HBeAg were positive). ALT was 170. Between 22 May 2013
and 27 May 2013, the patient was reported to be HBsAg with anti-HBs as positive and
ALT as 80. The patient's HBV genotype was A. The patient's HBV whole genome
sequences analysis indicated 99.9% genetic homology with the index patient of the
same literature article. 03/2013, Alanine aminotransferase, 33 IU/L; 04/2013,
Alanine aminotransferase, 155 IU/L; 06/2013, Alanine aminotransferase, 52 IU/L;
06/2013, Blood immunoglobulin M, negative; 05/2013, Hepatitis B DNA assay, 5.4 x
10E7 iu/ml; 07/2013, Hepatitis B DNA assay, 1.1 x 10E8 iu/ml; 05/2013, Hepatitis B
core antibody, positive; 06/2013, Hepatitis B core antibody, positive; 06/20"
"664407-1" "664407-1" "PT rec'd flu shot at an off site school clinic on
10-26-16, a friend of the pt stated pt had died; pt had been found deceased by her
children that morning." "No lab data for this event."
"664784-1" "664784-1" "Death." "No lab data for this event."
"664922-1" "664922-1" "Patient seen in ER on 11-4-16 and pronounced dead -
possible SIDS. She was seen by us on 10-24-16 and given vaccinations - awaiting ME
report." "No lab data for this event."
"665181-1" "665181-1" "Received flu vaccine requisite to his service as a
volunteer at hospital ER. Previously healthy. Within 1 day of vaccination began
complaining of flu-like symptoms. Developed pneumonia, pleural effusion, SOB. Was
hospitalized, then released to home where he expired." "Thoracentsis with
cytology. CAT scan, Chest X-Ray, chemistry, hematology. Autopsy found cause of
death to be cardiac arrhythmia due to acute pericarditis and pericardial effusion."
"665318-1" "665318-1" "This is a spontaneous report from a contactable
health care professional received via a Pfizer sales representative. A 73-year-old
male patient received single dose of PREVNAR 13, via an unspecified route of
administration on an unspecified date for immunisation. The patient medical history
and concomitant medications were not reported. The patient experienced cardiac
arrest 30 minutes after vaccination and died on an unspecified date. It was not
reported if an autopsy was performed. Sender's Comments: The information available
in this report is limited and does not allow a medically meaningful assessment of
the case. In particular, the following relevant information is not available:
medical history and concomitant medications. This case will be reassessed when
additional information becomes available. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s)
of Death: Cardiac arrest." "No lab data for this event."
"665371-1" "665371-1" "Initial and follow-up information has been received
from a healthcare professional and a pharmacist concerning an 85 year old female
patient. Information about concurrent condition and medical history was not
reported. On an unspecified date the patient was subcutaneously vaccinated with
PNEUMOVAX NP injection (vaccination date, lot number, dose and indication not
reported). On an unspecified date (from about 35 years ago), the patient had no
health issue originally, she was continuously administrated with FLUITRAN and
PERDIPINE as blood pressure medication. On an unspecified date (from about 15 days
after vaccination), the patient suffered poor health suddenly. On an unspecified
date (within one month after vaccination), the patient developed bleeding suddenly.
The patient visited the hospital and found bladder cancer. On an unspecified date
(within half a year), the patient died. The cause of death was bladder cancer.
Information on autopsy was not reported. Reporter's comment: The cancer primary
doctor considered the vaccine was not the cause of death and considered the cause
could not be identified. But the patient's family did not agree and considered
there was no other reason except the PNEUMOVAX NP. The reporting pharmacist
considered that the bladder cancer was serious due to death. The reporting
pharmacist did not assess the relationship of bladder cancer to PNEUMOVAX NP. Upon
internal review, the event of bladder cancer was considered to be medically
significant. Follow-up attempt was not made because the reporter did not wish to be
contacted. Updated information received on 07-NOV-2016 from the pharmacist has
been marked with double caret." "No lab data for this event."
"665969-1" "665969-1" "This is a spontaneous report from a contactable
nurse. A 73-year-old female patient received PREVNAR 13, (Lot unknown) 0.5 ml
single, intramuscular in the left deltoid on 23May2016 for immunisation. Medical
history included hypertension, type 2 diabetes mellitus, renal failure, depression,
renal transplant, lipidosis, vitamin d deficiency, heart palpitation and pain.
Concomitant medication included TYLENOL for pain from 29May2013, NORVASC from
04Jan2016, CELEXA for depression from 23May2016, VITAMIN D3 for Vitamin D
deficiency from 03Aug2011, LASIX from 25Jan2016, GLUCOTROL for Diabetes type 2 from
29May2016, LOPRESSOR from 22Jan2014, CELLCEPT from 02Jul2013, DELTASONE from
03Mar2016, ZANTAC from 18Sep2013, PROGRAF from 02Jul2013, and LEVEMIR. The patient
experienced bronchopneumonia on an unspecified date and died on 17Jun2016. The
autopsy was done. The cause of death was Bronchopneumonia. The nurse mentioned that
the day of vaccination it was reported that the patient was clear with her lungs.
The patient underwent lab tests and procedures which included: On 26May2016, blood
culture no growth detected, Influenza virus test not detected. On 27May2016,
clostridium difficile colitis not detected, Culture stool: Mixed flora, probable
contamination; Leukocytes were positive for wbc and urine culture; Negative for
shigella and campylobacter Yersinia; Negative for salmonella. On 28May2016, blood
thyroid stimulating hormone 1.09, Sputum culture: polymorphonuclear leukocytes;
Respiratory flora, light gram positive cocci. SP4 was 1.45. On 02Jun2016, Alanine
aminotransferase 19, anaplastic lymphoma kinase gene mutation 81, anion gap 10,
aspartate aminotransferase 20, atrioventricular block , base excess -7, basophil
count 0.2 , blood albumin 2.1, blood calcium 1.04 and 7.8, blood bilirubin 1, blood
bicarbonate 18.9, blood chloride 103, blood creatinine 3.2, blood glucose 161 and
196, blood lactic acid 0.93, blood magnesium 2, blood phosphorus 4.7, blood
potassium 3.8, blood sodium 134, blood triglycerides 163, blood urea 44, blood
urea/creatinine ratio 14, brain natriuretic peptide 454, carbon dioxide 21, EGFR
status assay 17, eosinophil count 4.5, fraction of inspired oxygen 90, haematocrit
30.9, haemoglobin 10.2, International normalised ratio 1.1, lymphocyte count 13.7
and 1.2, monocyte count 9.8 and 0.9, neutrophil count 70.2, oxygen saturation 90,
PCO2 39.9 and 20, protein total 5.7, prothrombin time 12.4, red blood cell count
3.59, white blood cell count 20 and 8.8, pH body fluid 7.284, pH urine 5.0, Rate hz
arterial 7, Prest/tinsp arterial 26, Peak arterial 10. Sender's Comments: Based on
the information provided in the case, a lack of efficacy with PREVENAR 13 in this
patient cannot be excluded. Further information like causative agent and serotyping
results is needed for a full medical assessment. The impact of this report on the
benefit/risk profile of the Pfizer product is evaluated as part of Pfizer
procedures for safety evaluation, including the review and analysis of aggregate
data for adverse events. Any safety concern identified as part of this review, as
well as any appropriate action in response, will be promptly notified to Regulatory
Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s)
of Death: Bronchopneumonia." "Test Date: 20160602; Test Name: Alanine
aminotransferase; Result Unstructured Data: Test Result: 19; Comments: Rate hz
arterial (02Jun2016): 7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial
(02Jun2016): 10 SP4 (28May2016): 1.45 Polymorphonuclear leukocytes (28May2016):
less than 10 epithelial cells per low power field. Urine (02Jun2016): 612; Test
Date: 20160602; Test Name: ALK gene mutation; Result Unstructured Data: Test
Result: 81; Comments: Rate hz arterial (02Jun2016): 7 Prest/tinsp arterial
(02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4 (28May2016): 1.45
Polymorphonuclear leukocytes (28May2016): less than 10 epithelial cells per low
power field. Urine (02Jun2016): 612; Test Date: 20160602; Test Name: Anion gap;
Result Unstructured Data: Test Result: 10; Comments: Rate hz arterial (02Jun2016):
7 Prest/tinsp arterial (02Jun2016): 26 Peak arterial (02Jun2016): 10 SP4
(28May2016): 1.45 Polymorphonuclear leukocytes (28May2016): less than 10 epithelial
cells per low power field. Urine (02Jun2016): 6"
"666207-1" "666207-1" "Parent found unresponsive around 4 am, arrived at
Hospital at 4:46 am, pronounced dead at 4:48 am." "No lab data for this event."
"666465-1" "666465-1" "Initial unsolicited report received from a nurse on
09 Nov 2016. This case involves a 63-year-old female patient who was vaccinated
with a dose of FLUZONE MULIT-DOSE VIAL QIV (batch number: U1678AB, expiry date: 30
Jun 2017, route, site and dose not reported) on 31 Oct 2016. Patient had previous
history of coagulation disorder. Concomitant medications were not provided. On an
unspecified date, post vaccination, the patient had DIC (Disseminated Intravascular
Coagulation). On 03 Nov 2016, patient went to emergency room. Lab data includes
full vitals, blood planel review and blood was drawn on 18 Oct 2016. Corrective
treatment was not reported. On 04 Nov 2016, the patient passed away. List of
documents held by sender: none.; Sender's Comments: This is a poorly documented
death case where patient passed away from DIC (Disseminated Intravascular
Coagulation) after administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE
PRESERVED. It was to be noted that the patient had previous history of coagulation
disorder of unknown etiology. The detailed autopsy report, detailed past medical
history, concomitant medication and immune status at the time of vaccination would
be helpful to assess this case further.; Reported Cause(s) of Death: Disseminated
Intravascular Coagulation." "No lab data for this event."
"666583-1" "666583-1" "10:13 had pre-op work for upcoming knee surgery.
Took flu shot after had to stop along road twice on way home to throw up stayed
sick 14th 15th of Oct. Got her in bed about 11:30pm on the 15th. Went in to get her
out of bed at 10:00 AM on the 16th, she had passed away several hours prior to.
Patient had taken flu shot for years. She felt good morning of 13th." "Had pre-op
testing done 10-13-16 11:00 AM right before getting flu shot. All pre-op records
were looked at by our family Dr. all were great including EKG"
"667406-1" "667406-1" "This is a literature spontaneous report. This is
fifth of 7 reports and this case refers to Case 5: 9 month-old patient. Fourteen
cases of pneumococcal meningitis and twelve cases of invasive pneumococcal disease
(IPD) not including meningitis were identified. Between Jan2004 and Dec2012 there
were 0 to 2 cases of pneumococcal meningitis each year. In contrast, the authors
identified 7 cases of pneumococcal meningitis presenting in children aged 5 months
to 6 years between Jul2013 and Dec2014. The duration of symptoms prior to
presentation ranged from 2 to 5 days (mean 3.4 days). CSF analysis was remarkable
for very modest pleocytosis observed in all but 1 child. Six children had a
positive CSF Gram stain for Gram-positive diplococci with cultures positive for S
pneumoniae. The 6-year-old child who was moribund on presentation had a positive
blood culture and brain imaging, which showed meningeal enhancement and herniation.
All 5 surviving children with meningitis experienced severe hearing loss and
developmental impairment. In addition, 2 children developed seizures, 2 developed
hemolytic uremic syndrome, 1 developed hydrocephalus requiring a shunt, 2 had
transient cranial nerve palsy, 1 suffered persistent palsy of cranial nerve II, and
2 children died. Two patients completed immunization with pneumococcal 13-val conj
vac (dipht CRM197 protein) and both were infected with nonvaccine serotype 23B. Two
children were partially immunized with pneumococcal 13-val conj vac (dipht CRM197
protein) and both were infected with nonvaccine strains (22F, 15B). Three
infections resulted from serotypes contained within pneumococcal 13-val conj vac
(dipht CRM197 protein): A 5-month-old infant who received 2 doses of pneumococcal
13-val conj vac (dipht CRM197 protein) and a 6-year old with an unknown
immunization history were both infected with serotype 19A, and an unimmunized
toddler was infected with serotype 18C. Immunological studies performed on the 5-
month-old showed normal immunoglobulins and total hemolytic complement. The patient
had no known conditions such as asplenia or sickle cell anemia that would
predispose to a pneumococcal infection. Discussion: The authors reported a cluster
of cases of pneumococcal meningitis in young infants and children in the
pneumococcal 13-val conj vac (dipht CRM197 protein) era associated with a very high
degree of morbidity and mortality. All patients in this cluster experienced
neurologic sequelae in contrast to rates of 40% to 63% reported in the recent
literature. There were several possible explanations for the poor outcomes in these
cases. The decreasing incidence of meningitis in general may lower practitioners'
suspicion for bacterial meningitis, which may lead to delayed diagnosis. The modest
pleocytosis observed in 5 patients may reflect a less robust inflammatory reaction
which in turn may be associated with fewer early symptoms, also leading to delayed
diagnosis. The main limitation to this brief report was that it was not population-
based, and the authors were thus not able to comment on incidence rates.
Accordingly, the high degree of observed morbidity and mortality, in addition to
the clustering of cases, may simply be a chance event. Nonetheless, it was alarming
that 7 of 14 cases occurring during a 10-year period were observed during 17
months. A 9 month-old patient received immunization with three single doses of
pneumococcal 13-val conj vac (dipht CRM197 protein) on unknown dates. On an
unspecified date, the patient presented symptoms of fever, emesis, rhinorrhea,
congestion with decreased oral intake and lethargy on day of admission, was
hospitalized and diagnosed with pneumococcal meningitis. The duration of symptoms
before diagnosis was 5 days. Laboratory data includes: blood culture negative; CSF
Results: Nucleated Cells (/uL): 93; RBC (/uL): 171; Protein (mg/dl) 1370; Glucose
(mg/dL): less than 1, Serotype: 23 B. Complications observed in hospital included:
hemolytic uremic syndrome, kidney injury, respiratory failure. The patient died due
to the events. Pfizer is a marketing authorization holder of pneumococcal 13-val
conj vac (dipht CRM197 protein) in the reporter's country. This may be a duplicate
report if another marketing authorization holder of pneumococcal 13-val conj vac
(dipht CRM197 protein) has submitted the same report to the regulatory authorities.
Sender's Comments: Serotype 23 B is not contained in pneumococcal 13-val conj vac
(dipht CRM197 protein), therefore a lack of efficacy in this patient can be
excluded. The Company considers the pneumococcal meningitis and its reported
complications not related to pneumococcal 13-val conj vac (dipht CRM197 protein).
The impact of this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including the review
and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be
promptly notified to Regulatory Authorities, Ethics Committees and Investigators,
as appropriate. Linked Report(s): US-PFIZER INC-2016518540 different patient/event,
same drug; Reported Cause(s) of Death: Kidney injury; Pneumococcal meningitis
serotype 23 B; Respiratory failure; Hemolytic uremic syndrome." "Test Name: Blood
culture; Result Unstructured Data: Test Result: Negative; Test Name: CSF cell
count; Result Unstructured Data: Test Result: 93, Test Result Unit: /mm3; Test
Name: CSF glucose; Result Unstructured Data: Test Result: less than 1, Test Result
Unit: mg/dl; Test Name: CSF protein; Result Unstructured Data: Test Result: 1370,
Test Result Unit: mg/dl; Test Name: CSF red blood cell count; Result Unstructured
Data: Test Result: 171, Test Result Unit: /mm3; Test Name: Serology test; Result
Unstructured Data: Test Result: 23 B"
"667408-1" "667408-1" "This is a literature spontaneous report. This is the
7th of 7 reports. Fourteen cases of pneumococcal meningitis and twelve cases of
invasive pneumococcal disease (IPD) not including meningitis were identified.
Between Jan2004 and Dec2012 there were 0 to 2 cases of pneumococcal meningitis each
year. In contrast, the authors identified 7 cases of pneumococcal meningitis
presenting in children aged 5 months to 6 years between Jul2013 and Dec2014. The
duration of symptoms prior to presentation ranged from 2 to 5 days (mean 3.4 days).
CSF analysis was remarkable for very modest pleocytosis observed in all but 1
child. Six children had a positive CSF Gram stain for Gram-positive diplococci with
cultures positive for S pneumoniae. The 6-year-old child who was moribund on
presentation had a positive blood culture and brain imaging, which showed meningeal
enhancement and herniation. All 5 surviving children with meningitis experienced
severe hearing loss and developmental impairment. In addition, 2 children developed
seizures, 2 developed hemolytic uremic syndrome, 1 developed hydrocephalus
requiring a shunt, 2 had transient cranial nerve palsy, 1 suffered persistent palsy
of cranial nerve II, and 2 children died. Two patients completed immunization with
pneumococcal 13-val conj vac (dipht CRM197 protein) and both were infected with
nonvaccine serotype 23B. Two children were partially immunized with pneumococcal
13-val conj vac (dipht CRM197 protein) and both were infected with nonvaccine
strains (22F, 15B). Three infections resulted from serotypes contained within
pneumococcal 13-val conj vac (dipht CRM197 protein): A 5-month-old infant who
received 2 doses of pneumococcal 13-val conj vac (dipht CRM197 protein) and a 6-
year old with an unknown immunization history were both infected with serotype 19A,
and an unimmunized toddler was infected with serotype 18C. Immunological studies
performed on the 5-month-old showed normal immunoglobulins and total hemolytic
complement. The patient had no known conditions such as asplenia or sickle cell
anemia that would predispose to a pneumococcal infection. Discussion: The authors
reported a cluster of cases of pneumococcal meningitis in young infants and
children in the pneumococcal 13-val conj vac (dipht CRM197 protein) era associated
with a very high degree of morbidity and mortality. All patients in this cluster
experienced neurologic sequelae in contrast to rates of 40% to 63% reported in the
recent literature. There were several possible explanations for the poor outcomes
in these cases. The decreasing incidence of meningitis in general may lower
practitioners' suspicion for bacterial meningitis, which may lead to delayed
diagnosis. The modest pleocytosis observed in 5 patients may reflect a less robust
inflammatory reaction which in turn may be associated with fewer early symptoms,
also leading to delayed diagnosis. The main limitation to this brief report was
that it was not population-based, and the authors were thus not able to comment on
incidence rates. Accordingly, the high degree of observed morbidity and mortality,
in addition to the clustering of cases, may simply be a chance event. Nonetheless,
it was alarming that 7 of 14 cases occurring during a 10-year period were observed
during 17 months. A 6-year-old patient received a single dose of pneumococcal 13-
val conj vac (dipht CRM197 protein) (manufacturer unknown) on unknown date for
immunization. On an unspecified date the patient presented symptoms of rhinorrhea,
cough, seizure. The patient was hospitalized and diagnosed with pneumococcal
meningitis. The duration of symptoms before diagnosis was 3 days. This child who
was moribund on presentation had a positive blood culture and brain imaging, which
showed meningeal enhancement and herniation. Serotype was 19A. CSF analysis was
done. Complications observed in hospital included: respiratory failure, brain
herniation. Outcome was fatal. Pfizer is a marketing authorization holder of
pneumococcal 13-val conj vac (dipht CRM197 protein) in the reporter's country. This
may be a duplicate report if another marketing authorization holder of pneumococcal
13-val conj vac (dipht CRM197 protein) has submitted the same report to the
regulatory authorities.; Sender's Comments: Serotype 19A is contained in
pneumococcal 13-val conj vac (dipht CRM197 protein), therefore a lack of efficacy
in this patient cannot be excluded. The reported events of respiratory failure,
brain herniation were reported as complication of the pneumococcal meningitis. The
impact of this report on the benefit/risk profile of the Pfizer product is
evaluated as part of Pfizer procedures for safety evaluation, including the review
and analysis of aggregate data for adverse events. Any safety concern identified as
part of this review, as well as any appropriate action in response, will be
promptly notified to Regulatory Authorities, Ethics Committees and Investigators,
as appropriate. Linked Report(s): US-PFIZER INC-2016518540 different patient/event,
same drug; Reported Cause(s) of Death: Brain herniation; infection with serotype
19A; Respiratory failure." "Test Name: Blood culture; Result Unstructured Data:
Test Result: positive, meningeal enhancement and herniation; Test Name: CSF test;
Test Name: Imaging procedure; Result Unstructured Data: Test Result: positive,
meningeal enhancement and herniation; Test Name: Investigation; Result Unstructured
Data: Test Result: 19A"
"667513-1" "667513-1" "Received report from family friend that patient
passed away on 11-21-16, unknown cause of death." "No lab data for this event."
"669289-1" "669289-1" "Pt developed immediate SOB and syncope. Was
hospitalized from 10/28/16 to 11/1/16 for cardiac arrest following Pneumovax. She
then was readmitted 11/9/16 and died." "No lab data for this event."
"670177-1" "670177-1" "Pt. received 2 mo immunizations PEDIARIX ROTATEQ
PEDVAX PREVNAR 13 on 8/24/16. I have no information on autopsy or documented cause
of death only that pt. was declared deceased on 8/25/16." "None known"
"670576-1" "670576-1" "Pt found dead on AM of 11/16/16 at home in bed."
"No lab data for this event."
"670814-1" "670814-1" "This spontaneous report as received from an
unspecified reporter, via social media, refers to a female patient of unknown age.
The event was described in an online article. The patient's medical history,
concurrent conditions and concomitant therapies were not reported. On an unknown
date, the patient was vaccinated with an unidentified HPV vaccine (manufacturer
unknown) 1 shot (name, lot number, route and site of administration were not
provided). On an unknown date, the patient died. The author of the online article
had the patient's death as HPV shot related, however it was proved to be false. The
reporter's causality assessment between death and unidentified HPV vaccine
(manufacturer unknown) was not reported. Upon internal review, the event of death
was considered to be medically significant. Additional information is not expected
as no contact details were provided." "No lab data for this event."
"671533-1" "671533-1" "This spontaneous report was received on 09-DEC-2016
from the grandmother of an 11 year old female who experienced adverse events after
receiving GARDASIL (see case # 1612USA005619). The reporter stated that in
November 2016 (reported as three and a half weeks ago), a friend of her
grandaughter's died. It was unclear from the statement whether this girl received
GARDASIL before her death. Cause of death was not reported. Upon internal review,
died was considered medically significant. Additional information is not expected
as the reporter did not provide contact information. Sender's Comments: US-
009507513-1612USA005619: Reported Cause(s) of Death: died.""No lab data for this
event."
"672116-1" "672116-1" ""This case was reported in a literature article and
described the occurrence of acute respiratory distress syndrome in a adult female
patient who received Influenza vaccine Quadrivalent unspecified season. The
patient's past medical history included breast cancer (in remission), coronary
artery bypass graft, pericarditis (requiring a pericardial window), mediastinitis,
hypertension and diabetes mellitus. On an unknown date, the patient received
Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown
date, an unknown time after receiving Influenza vaccine Quadrivalent unspecified
season, the patient experienced acute respiratory distress syndrome (serious
criteria death, hospitalization and GSK medically significant), metapneumovirus
infection (serious criteria hospitalization and GSK medically significant),
pneumothorax (serious criteria death, hospitalization and GSK medically
significant), pneumonia (serious criteria hospitalization and GSK medically
significant), and shortness of breath (serious criteria hospitalization). On an
unknown date, the outcome of the acute respiratory distress syndrome and
pneumothorax were fatal and the outcome of the metapneumovirus infection, pneumonia
and shortness of breath were unknown. The reported cause of death was acute
respiratory distress syndrome and pneumothorax. The reporter considered the acute
respiratory distress syndrome, metapneumovirus infection, pneumothorax, pneumonia
and shortness of breath to be related to Influenza vaccine Quadrivalent unspecified
season. Additional information was provided. This case was reported in a literature
article and described the occurrence of human metapneumovirus (MPV) infection in an
adult female patient who was vaccinated with unspecified influenza vaccine
(manufacturer unknown). The patient was a nursing home resident with history of
breast cancer (in remission), coronary artery bypass surgery, pericarditis
requiring a pericardial window, mediastinitis, hypertension, and diabetes mellitus.
The patient did not report any sick contacts. No information on patient's family
history or concomitant medication was provided. On an unspecified date, the patient
received unspecified influenza vaccine (administration route and site unspecified;
dosages unknown; batch number not provided). On an unspecified date, an unknown
period after vaccination, the patient presented with shortness of breath and
clinical evidence of pneumonia. The patient's white cell count was elevated with a
left shift in differential count (range and normal value not provided). There was
confirmatory evidence on chest X-ray in the form of infiltrates. [In this study, 3
out of the 4 patients received a CT scan of the chest confirming extensive
bilateral infiltrates and evidence of pulmonary oedema suggesting acute respiratory
distress syndrome (ARDS)]. It was reported that the patient had evidence of
pneumonia with evidence of respiratory failure, and a rapid respiratory viral panel
that confirmed MPV infection. The patient's family refused intubation, and
prolonged non-invasive ventilation causing pneumothorax and ARDS results in the
patient's demise. It was unknown if the autopsy was performed. This case has been
considered serious due to death/hospitalisation. The authors did not comment on the
relationship between MPV infection and unspecified influenza vaccine. The authors
concluded that ""The disease spectrum of MPV can vary widely, and the outcomes vary
largely based on comorbidities. The infection can frequently lead to severe
respiratory failure, progressing to ARDS and death, in the elderly or debilitated
patients."" This is 1 of the 2 valid cases in the same literature article."" "Lab
tests were performed on an unspecified date. White cell count was elevated with a
left shift in differential count (range and normal value not provided). There was
confirmatory evidence on chest x-ray in the form of infiltrates. A rapid
respiratory viral panel that confirmed MPV infection."
"673180-1" "673180-1" "This spontaneous report was received from a
healthcare worker and refers to a patient of unknown demographics. No medical
history, concurrent conditions, concomitant medications or past drugs of the
patient were reported. On an unknown date, the patient was vaccinated with
PNEUMOVAX23 (lot #, expiry date and dosing details were not reported). Later, on an
unspecified date, two weeks after administration of PNEUMOVAX23, the patient died
in an unspecified location from an unspecified cause. Causality assessment was not
provided. Upon internal review, the event, death was considered to be medically
significant. Additional information has been requested. Reported Cause(s) of Death:
unknown cause of death." "No lab data for this event."
"673301-1" "673301-1" "Baby has passed away. We are not sure if vaccines
were the cause." "No lab data for this event."
"673303-1" "673303-1" "Passed away. Not sure if vaccines were the cause?"
"No lab data for this event."
"673760-1" "673760-1" "None stated." "No lab data for this event."
"674054-1" "674054-1" "Had URI, fever, developed respiratory distress,
intubated in ER, ARDS ECMO, coded x2 died 12/18/2016." "Human metapneumovirus,
enterovirus positive"
"674690-1" "674690-1" "Respiratory and cardiac arrest, extensive
resuscitation attempted with short return of heart beat followed by cardiac arrest
that did not respond to resuscitation and resulted in death." "No lab data for
this event."
"674701-1" "674701-1" "Difficulty in breathing, a fast heartbeat, and AFIB.
Taken to the emergency room and patient died within 2 days." "No lab data for
this event."
"675986-1" "675986-1" "Pt deceased of suspected SIDS on the day following
administration of routine 6 month vaccines as well as flu shot." "No lab data for
this event."
"676389-1" "676389-1" "Death." "No lab data for this event."
 "676594-1" "676594-1" ""This case was reported in a literature article and
described the occurrence of vaccination failure in a 9-year-old female patient who
received Hepatitis B vaccine. Co-suspect products included Hepatitis B vaccine,
Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B Immune Globulin. On an
unknown date, the patient received the 4th dose of Hepatitis B vaccine, the 3rd
dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine, the 1st dose of
Hepatitis B vaccine and Hepatitis B Immune Globulin at an unknown dose and
frequency. On an unknown date, 7 years after receiving Hepatitis B vaccine and 8
years after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B
vaccine, the patient experienced vaccination failure (serious criteria
hospitalization and GSK medically significant), chronic hepatitis B (serious
criteria hospitalization and GSK medically significant), unknown cause of death
(serious criteria death and GSK medically significant), hepatomegaly (serious
criteria hospitalization), abdominal pain (serious criteria hospitalization),
scleral icterus (serious criteria hospitalization), palmar erythema (serious
criteria hospitalization), microcytic anemia (serious criteria hospitalization),
hepatocellular carcinoma (serious criteria hospitalization and GSK medically
significant), edema of lower extremities (serious criteria hospitalization),
hepatic cirrhosis (serious criteria hospitalization and GSK medically significant),
multi-organ failure (serious criteria hospitalization and GSK medically
significant), respiratory failure (serious criteria hospitalization and GSK
medically significant), hepatopulmonary syndrome (serious criteria hospitalization
and GSK medically significant), acute renal failure (serious criteria
hospitalization and GSK medically significant), inappropriate schedule of drug
administration and vertical infection transmission. On an unknown date, the outcome
of the vaccination failure, chronic hepatitis B, hepatomegaly, abdominal pain,
scleral icterus, palmar erythema, microcytic anemia, hepatocellular carcinoma,
edema of lower extremities, hepatic cirrhosis, multi-organ failure, respiratory
failure, hepatopulmonary syndrome, acute renal failure, inappropriate schedule of
drug administration and vertical infection transmission were unknown and the
outcome of the unknown cause of death was fatal. The reported cause of death was
unknown cause of death. It was unknown if the reporter considered the vaccination
failure, chronic hepatitis B, unknown cause of death, hepatomegaly, abdominal pain,
palmar erythema, microcytic anemia, hepatocellular carcinoma, edema of lower
extremities, hepatic cirrhosis, multi-organ failure, respiratory failure,
hepatopulmonary syndrome, acute renal failure, inappropriate schedule of drug
administration and vertical infection transmission to be related to Hepatitis B
vaccine, Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. The
reporter considered the scleral icterus to be related to Hepatitis B vaccine,
Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine. Additional
information was provided. This case was reported in a literature article and
described the occurrence of vaccination failure in a 9-year-old female patient who
was vaccinated with unspecified hepatitis B virus (HBV) vaccine (manufacturer
unknown). The patient was a previously healthy female. The patient's mother's
prenatal records revealed that she was HBsAg positive during her pregnancy. She was
unaware of her diagnosis and denied receiving any further testing or treatment. At
the birth hospital, the patient was born full term via Caesarean section due to
failure to progress. The patient was never breastfed. The patient did not have any
other identified risk, either via blood-borne or sexual exposure, for hepatitis B
virus infection by history. No information on patient's concurrent condition or
concomitant medication was provided. On unspecified dates, on day 1 of life, at the
age of 3, 5 and 18-month, the patient received 4 doses of unspecified HBV vaccine
(administration route and site unspecified; batch number not provided). The patient
also received hepatitis B immune globulin (HBIG) on day 1 of life. There were no
records of an evaluation for hepatitis B infection, including HBsAg and anti-HBs
testing after the patient completed her vaccination series. On an unspecified date
at the age of 9 years, an unknown period after the last dose of vaccination, the
patient initially presented to an outside institution where she was noted to have
marked hepatomegaly. Subsequently, the patient was admitted to the other hospital
with 2 weeks and 2 days of pronounced scleral icterus. The patient's examination
was notable for an ill-appearing child with a pulse of 144 beats per minute and
respiratory rate of 48 breaths per minute. She had a non-tender, but distended,
abdomen with a firm liver edge palpable 5 cm below the right costal margin. She had
non-pitting oedema in both lower extremities and palmar erythema. Laboratory
studies revealed a microcytic anaemia (haemoglobin 9.1 g/dl, mean corpuscular
volume 76 fL, elevated transaminases (aspartate aminotransferase 419 U/L, alanine
aminotransferase 78 U/L, and hyper-bilirubinemia (total bilirubin 5.5 mg/dL). Serum
a-fetoprotein was markedly elevated at 100000 ng/mL. Abdominal ultrasound
demonstrated a large, right-sided hepatic mass. Contrast-enhanced computed
tomography (CT) scan was notable for a nodular liver, a large mixed density mass
measuring 15 cm x 12 cm x 18 cm within the right hepatic lobe, multiple smaller
hepatic lesions, splenomegaly, and diffuse pulmonary nodules concerning for
metastatic disease. The patient underwent open wedge livery biopsy, which revealed
a well-differentiated hepatocellular carcinoma (HCC) with active micronodular
cirrhosis that was HBsAg positive. A-Fetoprotein immunostaining was positive in the
tumour cells. Investigation for an underlying ethology revealed positive serum
HBsAg without any detectable hepatitis B surface antibody (anti-HBs). Hepatitis B
virus (HBV) DNA was detected in the blood at 100000 IU/mL and she was hepatitis B
envelope antigen (HBeAg) positive. Her HBV genotype was type A with a P120T surface
antigen mutation. Testing was negative for HIV-1, hepatitis C virus, and inherited
cholestatic diseases that could predispose her to HCC. Subsequently, the final
diagnosis of hepatocellular carcinoma secondary to chronic hepatitis B infection
was made. The patient rapidly deteriorated post-biopsy progressing to multisystem
organ failure. She developed respiratory failure requiring endotracheal intubation
and had echocardiogram findings consistent with hepato-pulmonary syndrome. She
developed acute renal failure. Her liver disease decompensated with a total
bilirubin increasing to a peak of 16 mg/dL with a predominant direct component,
which precluded even palliative treatment of her malignancy. On hospital day 16, t"
"Lab tests were performed on unspecified date. Serum a-fetoprotein was
markedly elevated at 100000 ng/mL. Abdominal ultrasound demonstrated a large,
right-sided hepatic mass. Contrast-enhanced computed tomography (CT) scan was
notable for a nodular liver, a large mixed density mass measuring 15 cm x 12 cm x
18 cm within the right hepatic lobe, multiple smaller hepatic lesions,
splenomegaly, and diffuse pulmonary nodules concerning for metastatic disease. Open
wedge liver biopsy, which revealed a well-differentiated hepatocellular carcinoma
(HCC) with active micronodular cirrhosis that was HBsAg positive, a-Fetoprotein
immunostaining was positive in the tumour cells. Her HBV genotype was type A with a
P120T surface antigen mutation. Testing was negative for inherited cholestatic
diseases. Alanine aminotransferase, 78 u/L; Aspartate aminotransferase, 419 u/L;
Blood bilirubin, 16 mg/dL; Blood bilirubin, 5.5 mg/dL; Echocardiogram, consistent
with hepato-pulmonary syndrome; HIV test, negative; Haemoglobin, 9.1 g/d"
"677021-1" "677021-1" ""Initial unsolicited report received from the
literature on 31-Dec-2016. The following is verbatim from the article: Abstract:
Introduction: This is the 33rd Annual Report. As of 1 January 2015, 55 of the
nation's poison centers (PCs) uploaded case data automatically to database. The
upload interval was 9.52 [7.40, 13.6] (median [25%, 75%]) minutes, creating a near
real-time national exposure and information database and surveillance system.
Methods: We analyzed the case data tabulating specific indices from the database.
The methodology was similar to that of previous years. Where changes were
introduced, the differences are identified. Poison center cases with medical
outcomes of death were evaluated by a team of medical and clinical toxicologist
reviewers using an ordinal scale of 1-6 to assess the Relative Contribution to
Fatality (RCF) of the exposure. Results: In 2015, 2,792,130 closed encounters were
logged by NPDS: 2,168,371 human exposures, 55,516 animal exposures, 560,467
information calls, 7657 human confirmed non-exposures, and 119 animal confirmed
non-exposures. PCs also made 2,695,699 follow-up calls in 2015. Total encounters
showed a 3.42% decline from 2014, while healthcare facility (HCF) human exposure
cases increased by 5.09% from 2014. All information calls decreased by 15.5% but
HCF information calls increased 2.67%, and while medication identification requests
(Drug ID) decreased 31.7%, human exposures reported to PCs were essentially flat,
increasing by 0.149%. Human exposures with less serious outcomes have decreased
2.95% per year since 2008 while those with more serious outcomes (moderate, major
or death) have increased by 4.34% per year since 2000. The top 5 substance classes
most frequently involved in all human exposures were analgesics (11.1%), household
cleaning substances (7.54%), cosmetics/personal care products (7.41%),
sedatives/hypnotics/antipsychotics (5.83%), and antidepressants (4.58%).
Sedative/Hypnotics/Antipsychotics exposures as a class increased the most rapidly
(2597 calls (11.4%)/year) over the last 14 years for cases showing more serious
outcomes. The top 5 most common exposures in children age 5 years or less were
cosmetics/ personal care products (13.6%), household cleaning substances (11.2%),
analgesics (9.12%), foreign bodies/toys/miscellaneous (6.45%), and topical
preparations (5.33%). Drug identification requests comprised 35.0% of all
information calls. Database documented 1831 human exposures resulting in death with
1371 human fatalities judged related (RCF of 1-Undoubtedly responsible, 2-Probably
responsible, or 3-Contributory). Conclusions: These data support the continued
value of PC expertise and need for specialized medical toxicology information to
manage more serious exposures, despite a decrease in calls involving less serious
exposures. Unintentional and intentional exposures continue to be a significant
cause of morbidity and mortality. The near real-time, always current status of
database represents a national public health resource to collect and monitor
exposure cases and information calls. The continuing mission of database is to
provide a nationwide infrastructure for surveillance for all types of exposures
(e.g., foreign body, viral, bacterial, venomous, chemical agent, or commercial
product), the identification of events of public health significance, resilience,
response and situational awareness tracking. Database is a model system for the
real-time surveillance of national and global public health. This case involves 82-
year-old female patient who was vaccinated with TETANUS TOXOID (batch number,
expiration date, dose, route and site of administration were not reported) on an
unspecified date. Patient had tripped and fell next to chicken coup; wound was
sutured. Seven days later patient developed jaw stiffness and had ongoing medical
history of atrial fibrillation which was treated with labetalol; later treated with
amiodarone and digoxin. Concomitant medication was not reported. On an unspecified
date, following vaccination patient developed trismus, hyper salivation, ""lock
jaw"" and could not move neck, had diffuse muscle spasms for which was intubated
and sedated with midazolam and fentanyl; magnesium infusion was continued (day 2),
developed significant autonomic instability, patient was treated with
cisatracurium, lorazepam, midazolam, and fentanyl but her spasms continued,
developed hypomagnesaemia (reported as hypermagnesemia) and the infusion was
stopped (On Day 3 ), decreased urine output, norepinephrine was increased following
profound hypotension (50/30s) paralytic was stopped and the sedation was weaned (on
Day 17), pupils were fixed and an EEG showed profound hypoxic injury (Day 21) and
based on the prognosis, comfort measures were instituted and died on Day 22. On an
unspecified date patient was hospitalized. Laboratory investigation included Blood
Pressure: 73/36 Torr, Heart rates: 58 beats per minutes, Respiration rate 20
breaths per minute , oxygen saturation- 95%, sodium-140 mmol/L , potassium- 4.1
mmol/L, calcium-108 mg/dL, carbon dioxide- 20 mmol/L, blood urea nitrogen (BUN)
test- 40, Creatinine -2.0 mg/dL, creatine phosphokinase (CPK)- 1132 U/L. On an
unspecified date, patient received IVF and norepinephrine for hypotension, received
furosemide for decreased urine output, benzodiazepines, magnesium and tetanus
immunoglobulin and metronidazole as a corrective treatment. Outcome of event acute
tetanus reported as fatal and for other events not reported. On an unspecified date
patient was discharged from hospital. Cause of death: tetanus due to her leg
lacerations. Manner of death: accidental. Autopsy was not performed. Documents held
by sender: none. Sender's Comments: The 82 years old female was reported to have
had a fall during which she had wound which was sutured. Seven days later, she
presented with jaw stiffness which warranted tetanus immunization. She gradually
deteriorated, with symptoms compounding symptoms like lock jaw, muscle spasms,
unable to move her neck, hypotension, autonomic instability. A diagnosis of acute
tetanus was made. She had a history of atrial fibrillation which was before tetanus
and was on treatment with several muscle relaxants, metronidazole, magnesium,
lorazepam and then fentanyl was initiated. Norepinephrine was included in the
therapy for hypotension. Few days later, she presented with magnesium toxicity and
magnesium was discontinued. By day 21 her fixed pupils were fixed with EEG showing
serious hypoxic injury. As there was a time lag between the fall, the wound, the
development of the full symptoms of tetanus and the administration of the vaccine,
it is unlikely that the vaccine (a toxoid) which could be the cause of death.
Details regarding presence of tetanus spore from the wound may further aid in
confirming the diagnosis and cause of death, which in this case is complications of
tetanus. Reported Cause(s) of Death: tetanus."" "Test Name: Blood Pressure; Result
Unstructured Data: 73/36; Comments: UNIT REPORTED AS:TORR; Test Name: oxygen
saturation; Test Result: 95 %; Test Name: sodium; Result Unstructured Data: 140
millimole(s)/litre; Test Name: potassium; Result Unstructured Data: 4.1
millimole(s)/litre; Test Name: calcium; Test Result: 108 mg/dl; Test Name: carbon
dioxide; Result Unstructured Data: 20 millimole(s)/litre; Test Name: Creatinine;
Test Result: 2.0 mg/dl; Test Name: creatine phosphokinase; Result Unstructured
Data: 1132 unit(s)/litre"
"677665-1" "677665-1" "This spontaneous report received from a consumer
(patient's mother) via social media regarding her son of unknown age. The patient's
medical history, concurrent conditions and concomitant medications were not
reported. On an unknown date, the patient was vaccinated with unspecified HPV
Vaccine (manufacturer unknown), (dose, route, lot# not reported) for prophylaxis.
On an unknown date, the patient died. She reported that her son died after
vaccination. No PQC has been filed. Causality assessment was not provided. Upon
internal review the event of death was determined to be medically significant.
Additional information is expected." "No lab data for this event."
"677916-1" "677916-1" ""This non-valid spontaneous report was received from
a consumer via social media and refers to several female patients of unknown ages.
On an unknown dates, the patients were vaccinated with a dose of either
quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer
unknown) injection (dose, route, site of vaccination, lot number and expiration
date were not reported) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)
(manufacturer unknown) injection (dose, route, site of vaccination, lot number and
expiration date were not reported) for prophylaxis. The reporter did not specify
the type of human papillomavirus (HPV) vaccine used. On an unknown date (reported
as hours after this vaccine), the patients expired (reported as ""friends lost
their daughters. Upon internal review, the events of death was considered medically
significant. This is one of the three cases provided by the same reporter.
Additional information is not expected, as there was no contact information for the
reporter provided. Sender's Comments: US-009507513-1701USA005923: US-009507513-
1701USA005922."" "No lab data for this event."
"678221-1" "678221-1" ""This spontaneous report was received from a
consumer via social media, referring to an unspecified number of patients of
unknown age and gender. Information about patients' medical history, concurrent
conditions and concomitant medication were not reported. On an unknown date, the
patients were vaccinated with a dose of an unidentified HPV vaccine (name and lot
number not provided) for prophylaxis. The reporter stated that ""did research and
found out a leading scientist for the drug came out and said it's killing kids"".
The reporter considered the event was related the unidentified Merck HPV vaccine.
Upon internal review, the event ""death"" was considered to be medically
significant. This is one of several reports received from same reporter. Additional
information has been requested. Sender's Comments: US-009507513-1701USA004856: US-
009507513-1701USA005334: Interaction number."" "No lab data for this event."
"678378-1" "678378-1" ""Information was received on 04JAN2017, 09JAN2017,
10JAN2017 and 13JAN2017 from GlaxoSmithKline (GSK) in the form of a blinded CIOMS
report. GSK physician indicated the study drug was unblinded and subject received
ava (lot FAV634) only and did not receive raxibacumab. Death secondary to combined
fentanyl and methamphetamine intoxication. This male subject was enrolled in a
blinded GSK study. The subject received ava vs ava+raxibacumab+diphenhydramine from
29th July 2016 as a study participant. The subject's past medical history included
tonsillitis, tonsillectomy, removal of wisdom teeth and impacted wisdom tooth. On
24th September 2016, 57 days after the first dose of ava (lot FAV634) vs
ava+raxibacumab+diphenhydramine, the subject developed grade 4 unknown cause of
death. Serious criteria included death and medically significant. The outcome of
unknown cause of death was fatal on 24th September 2016. The reported cause of
death was unknown cause of death. The GSK investigator considered that there was no
reasonable possibility that the unknown cause of death may have been caused by ava
vs ava+raxibacumab+diphenhydramine. Additional information: GSK study site called
subject on 27Sep2016 because he had not come to the site for his Day 29 appointment
and was notified by the subject's parent that he was found dead at home on
24Sep2016. Cause of death was unknown at this time. The subject had no medical
history of angina pectoris, myocardial infarction, stroke, diabetes, hypertension
and hyperlipidemia. Follow-up information received by GSK on 24th October 2016: The
subject was a male in his late 30's. Follow up information received by GSK on 01
November 2016: An autopsy was scheduled to be performed. Follow-up information
received by GSK on 09 December 2016: On 24th September 2016, 57 days after the
first dose of ava vs ava+raxibacumab+diphenhydramine, the subject developed grade 4
drug intoxication (combined fentanyl and methamphetamine intoxication). Serious
criteria included death. The subject died on 24th September 2016. The investigator
considered that there was no reasonable possibility that the drug intoxication may
have been caused by ava vs ava+raxibacumab+diphenhydramine. GSK study site
investigator text: autopsy showed evidence of chronic alcohol abuse and
hypertensive cardiovascular disease, which significantly contributed to death.
Autopsy revealed an enlarged (dilated) heart due to repeated alcoholic toxicity
related to alcohol abuse. Long-standing high blood pressure, as evidenced by
microvascular disease in the brain and kidney, also contributed to the enlargement
of the heart. Autopsy report was reviewed by GSK on 09-Dec-2016 and the SAE
information was updated. In addition to the autopsy finding, relevant diagnostic
test results noted ""there were findings of chronic intravenous drug abuse
including needle tracks, inflammation and scarring of the liver, and injected
foreign material within the lungs, liver and spleen. Toxicologic analysis of post-
mortem femoral blood revealed a toxic concentration of fentanyl. Methamphetamine,
amphetamine, norfentanyl, and cotinine were also detected. Analysis of the vitreous
fluid for electrolytes was unremarkable"". The report also noted that ""enlarged
hearts are pathologic, prone to electrical instability and sudden cardiac arrest,
and less tolerant of the combined toxicity of fentanyl and methamphetamine"". It
should be noted that the subject did not report any history of hypertension to the
study site. Additionally, the subject's urine drug screen results at screening were
negative."" "Test Name: Post-mortem femoral blood test; Result Unstructured Data:
Urine drug screen results at screening were negative. Autopsy - unknown date -
Toxicologic analysis of post-mortem femoral blood revealed a toxic concentration of
fentanyl. Methamphetamine, amphetamine, norfentanyl, and cotinine were also
detected. Analysis of the vitreous fluid for electrolytes was unremarkable."
"679107-1" "679107-1" "My son was put down for a nap about 12 or a bit
after and he never woke up." "No lab data for this event."
"680133-1" "680133-1" "This spontaneous report was received from a social
media via physician refers to atleast 32 female patients of unknown age. There was
no information on concomitant medication, medical history and concurrent condition.
On an unknown date, the patients were vaccinated with GARDASI) dose 0.5ml,
intramuscular (lot # not reported). On an unknown date, the patients died. It was
reported that it was unclear whether the death were related to the vaccine, and
patients death after the shot did not mean the shots were necessary to blame. Upon
internal review, the event of death was determined to be medically significant.
This case has been linked with the MARRS case no. 1701USA010389. Additional
information has been requested." "No lab data for this event."
"681597-1" "681597-1" "Information had been received on 06-FEB-2017 from a
lawyer regarding a case in litigation. It was alleged in litigation that female
(age unknown) received ZOSTAVAX on 03-DEC-2015 for prevention of shingles. Within a
matter of days, patient experienced yellowing skin and eyes. Patient was
hospitalized and diagnosed with acute liver failure, acute hypoxic respiratory
failure, coagulopathy and liver disease. It was reported that a known complication
of shingles is that it can attack the liver. Patient also experienced rashes,
seizures and headaches (dates not reported). Patient underwent a liver transplant
but the new liver was rejected (date not reported). Patient experienced
aspergillosis pneumonia and acute renal failure (dates not reported). On 05-FEB-
2015, patient passed away (conflicting information as this date is prior to when
patient was vaccinated). As a result of the manufacture, marketing, advertising,
promotion, distribution and/or sale of ZOSTAVAX, patient sustained severe and fatal
personal injuries, as well as significant conscious pain and suffering, mental
anguish, emotional distress and loss of enjoyment of life. Patient incurred medical
expenses and other economic harm as a direct result of the use of ZOSTAVAX. Patient
sustained serious personal injuries and related losses including, but not limited
to, the following: required healthcare and services, incurred medical and related
expenses and suffered mental anguish, physical pain and suffering, diminished
capacity for the enjoyment of life, a diminished quality of life and other losses
and damages up to and including death. Upon internal review, acute liver failure
requiring liver transplant, acute hypoxic respiratory failure, seizures,
aspergillosis pneumonia, acute renal failure, new liver was rejected and passed
away were considered to be medically significant events. Additional information has
been requested. Reported Cause(s) of Death: death." "No lab data for this event."
"682141-1" "682141-1" "9-13-16 Doctor appt. - within hours patient had some
stomach discomfort that got worse over the week. She had the stroke on 9/20/16. The
stroke in the patient's brain was inoperable, in coma for a while, 6 weeks and 4
days later death." "Normal physical, well developed and nourished"
"682793-1" "682793-1" "Unattended death of infant reported via 911 dispatch
by parents." "No lab data for this event."
"682795-1" "682795-1" "ER called morning of 2-2-17. Child was found
unresponsive. Pronounced deceased at the ER. Cause still being investigated, but
vaccines were given on 1-31-17." "Autopsy is being done"
"684034-1" "684034-1" "None stated." "None"
"684151-1" "684151-1" "None stated." "No lab data for this event."
"684399-1" "684399-1" "Patient died overnight the night following receiving
vaccines." "No lab data for this event."
"684554-1" "684554-1" "This case was reported by a other health
professional and described the occurrence of vaccination failure in a adult patient
who received BEXSERO. On an unknown date, the patient received BEXSERO at an
unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the
patient experienced vaccination failure (serious criteria GSK medically
significant) and meningococcal infection (serious criteria death and GSK medically
significant). On an unknown date, the outcome of the vaccination failure was
unknown and the outcome of the meningococcal infection was fatal. The reported
cause of death was meningococcal infection. It was unknown if the reporter
considered the vaccination failure and meningococcal infection to be related to
BEXSERO. Additional details were provided as follows: The age at vaccination was
not reported. The patient asked for a kit to test the clinical mening isolate if
the strain was covered by the vaccine. The patient died on an unknown date. It was
unknown if the autopsy was performed. This case was considered as suspected
vaccination failure as the details regarding vaccination schedule, time to onset
for the event and lab test confirmation was unknown." "No lab data for this event."
"686401-1" "686401-1" "This spontaneous report was received from a
physician via a company representative and refers to a female patient of unknown
age. The patient's pertinent medical history included unspecified kidney problems.
No information regarding the patient's drug reactions or allergies was provided. On
an unknown date, the patient was vaccinated with a dose of unspecified pneumococcal
vaccine (manufacturer unknown) (dose, route and site of administration, lot # and
expiry date were not reported). Other suspect vaccines included influenza virus
vaccine (unspecified) (date, dose, route and site of administration, lot # and
expiry date were not reported). Concomitant therapies included ENBREL. On an
unknown date, the patient was hospitalized for an unknown reason. The outcome of
the event leading to hospitalization was not reported. On an unknown date, the
patient died due to an unspecified cause. The relatedness between the events and
pneumococcal vaccine (manufacturer unknown) and influenza virus vaccine
(unspecified) was not reported. Upon internal review, the event of death was
considered to be medically significant. Additional information has been requested."
"No lab data for this event."
"686421-1" "686421-1" "6 weeks old found unresponsive by foster parents at
1230 PM. Cyanotic and CPR initiated- brought to ED via ambulance, patient
transferred. Now deceased. Coroner's office." "records sent to Coroner's office
for review"
"686558-1" "686558-1" "This case was reported by a physician via sales rep
and described the occurrence of sudden infant death syndrome in a 2-month-old
patient who received ROTARIX. Co-suspect products included Nystatin unknown for
thrush. Concurrent medical conditions included thrush (treated with Nystatin). On
8th March 2017, the patient received the 1st dose of ROTARIX (oral) and Nystatin at
an unknown dose and frequency. On 9th March 2017, 1 days after receiving ROTARIX
and Nystatin and 1 day after starting ROTARIX and Nystatin, the patient experienced
sudden infant death syndrome (serious criteria death and GSK medically
significant). On 9th March 2017, the outcome of the sudden infant death syndrome
was fatal. The patient died on 9th March 2017. The reported cause of death was
sudden infant death syndrome. The reporter considered the sudden infant death
syndrome to be unrelated to ROTARIX and Nystatin. Additional details were provided
as follows: On 8th March 2017, in morning, the patient received vaccination with
ROTARIX at the physician visit. On the same day, the physician prescribed Nystatin
for Thrush of the mouth. It was reported that the patient played all day and was
fine. On 8th March 2017, in evening, the patient received a dose of Nystatin. On
9th March 2017, in morning, the patient was found dead. The physician mentioned it
was not known if an autopsy was being done but potential Sudden infant death
syndrome (SIDS) might be a cause. The sales representative had a little
information. The contact details of the reporting physician were provided for the
follow up." "No lab data for this event."
"686773-1" "686773-1" "Mother reported patient was abnormal looking and
unresponsive. 911 called and CPR administered by EMTs. Patient arrived to ER, CPR
still in progress, 4 doses epinephrine administered with no change. Patient
declared dead at 6:28 AM (20 hours post vaccine administration)." "Patient's
mother also reported co-bedding, which certainly increased risk of (if not
ultimately caused) patient's death."
"688233-1" "688233-1" "Death; patient was discovered unresponsive, prone in
crib." "autopsy completed with cause of death classified as undetermined"
"689125-1" "689125-1" "Initial unsolicited report received from a nurse via
other company (Pfizer) (manufacturer report number- 2017101323) on 20-MAR-2017.
This case involves a male patient (unknown age) who was vaccinated with a dose of
INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, route and site of
administration were not reported) on an unspecified date. The patient's medical
history and concomitant medications were not reported. On an unspecified date,
following the vaccination, the patient experienced fever. On an unspecified date,
patient died (reported as dropped dead). The cause of death was not reported.
Patient's lab data and corrective treatment were not reported. The events outcome
was reported as fatal. It was unknown whether autopsy was performed or not. List of
documents held by sender: none.; Sender's Comments: Patient was vaccinated with flu
shot had fever and died. Case is poorly documented, latency post vaccination is not
provided, detailed medical history, past vaccination history and concomitant
medication are unknown. Results of laboratory analysis and autopsy report are not
provided. Additional information is required to fully assess role of the vaccine in
reported event.; Reported Cause(s) of Death: Fever." "No lab data for this event."
 "689235-1" "689235-1" "My son was extremely tired after getting shots I had
to wake him to feed him the next morning he passed away." "No lab data for this
event."
"690587-1" "690587-1" "Information has been received from a physician
referring to a patient of unknown age and gender. The patient's concurrent
condition, medical history and concomitant therapy were not provided. On an unknown
date, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and
expiration date unknown) for prophylaxis. On an unknown date, a few weeks later,
the patient was diagnosed with an aggressive lymphoma and developed a severe
hepatitis, It was reported that severe hepatitis led to his demise. The outcome of
the event aggressive lymphoma was not reported. There were no specimens from the
patient. Autopsy was not performed. The causal relationship between the events and
ZOSTAVAX was not provided. Upon internal review, aggressive lymphoma and severe
hepatitis were determined to be medically significant. Additional information has
been requested. Reported Cause(s) of Death: a severe hepatitis." "No lab data for
this event."
"690601-1" "690601-1" "Initial unsolicited report received from the
literature on 31 March 2017. This case involves a 25-year-old male patient who was
vaccinated with a dose of INFLUENZA VACCINE and was also received a dose
ACETAMINOPHEN WITH CODEINE, HYDROCORTISONE, a dose of DOBUTAMINE, a dose of
NOREPINEPHRINE and a dose of EPINEPHRINE (batch number, expiration date, dose ,
site and route of administration was not reported) on an unknown date. Patient had
medical history of intermittent headache and multiple ER visits for weakness,
vomiting, diarrhea and a syncopal episodes was found to have massive
hepatosplenomegaly and eosinophilia. Concomitant medications included Dalteparin
subcutaneously for DVT prophylaxis. On an unknown date, following the vaccination,
the patient developed temperature 102 degree Fahrenheit with stable hemodynamics.
On an unknown date, evening of his second hospital day he acutely developed
respiratory distress, hypotension and tachycardia 130/min with skin flushing. On an
unknown date patient developed severely depressed left ventricle (echocardiogram
showed). On an unknown date following the vaccination, within 5 hours of admission
to the Medical Intensive Care Unit (MICU) patient developed refractory shock and
asystole. On an unknown date following the vaccination, patient developed a rapidly
progressive course of shock with multisystem organ failure, pulmonary leukostasis-
associated right ventricular failure, severe anaphylactoid reaction, multiorgan
failure and overwhelming anaphylactic shock. On an unknown date patient was
hospitalized. Patient was intubated and transferred to the Medical Intensive Care
Unit. It was reported that drop in hemoglobin was related to fluid resuscitation.
On an unknown date patient died. It was also a case of Drug ineffective as
hydrocortisone. Relevant laboratory test results included WBC (white blood cell
count) 13,500 cells/?L with 72 percentage neutrophils, 5 percentage bands, 5
percentage lymphocytes, 11.7 percentage eosinophils, hemoglobin was 8.5 g/dL, Mean
corpuscular volume (MCV) 86.3, platelet count: 110,000/?L. Venous lactate was 0.9
mmol/L. Ferritin was 391 ng/ml. Reticulocyte count, LDH (Lactate dehydrogenase),
thyroid stimulating hormone (TSH), ANA (Anti Nuclear Antibodies) and RF (rheumatoid
factor) were normal. Chest x-ray showed no abnormalities. Abdomen was benign with
marked hepatosplenomegaly. Blood cultures were negative. On an unknown date Repeat
CBC (complete blood count) showed hemoglobin 5.9g/dl, and white blood cell count
42,000/mcl with 30percentage degranulating mast cells. Patient received corrective
treatment with adequate fluid resuscitation, hydrocortisone, broad-spectrum
antibiotics, dobutamine, norepinephrine, epinephrine and vasopressin infusion.
Outcome of temperature 102 Fahrenheit was not recovered and was fatal for other
event. On an unspecified date autopsy was performed with following details: the
bone marrow, spleen and liver were diffusely infiltrated by sheets of hypogranular,
atypical, CD117+mast cells with large or double nuclei, open chromatin, and
irregular nuclear membranes. These filled the pulmonary and coronary vessels and
infiltrated cardiac and pulmonary parenchyma. Documents held by sender: none.
Sender's Comments: Reported symptoms and time to onset are consistent with the
diagnosis of anaphylactic reaction. Time to onset is compatible with INFLUENZA
VACCINE of unknown manufacturer, but additional information including but not
limited to the patient's immunization history (i.e., previous immunizations and any
adverse events following immunization), allergic history, detail autopsy report and
allergy testing to identify the culprit allergen are needed to further assess this
case. In this case patient has history of mast cell leukemia with on and off
symptoms, as mast cell leukemia can cause sudden release of histamine which could
present with above reaction and also in autopsy it has been mentioned that there is
infiltration of mast cells in bone marrow, liver and spleen. Based on available
information the role of vaccine is unlikely. And also there is lack of efficacy for
HYDROCORTISONE, DOBUTAMINE, NOREPINEPHRINE and EPINEPHRINE as patient experienced
asystole and refractory shock even after administration of these drugs. Reported
Cause(s) of Death: Severe anaphylactoid reaction; Autopsy-determined Cause(s) of
Death: Severe anaphylactoid reaction." "Test Name: Body temperature; Result
Unstructured Data: 38.88 Celsius temperature; Test Name: white blood cell count;
Result Unstructured Data: 13,500; Test Name: neutrophils; Test Result: 72 %; Test
Name: lymphocytes; Test Result: 5 %; Test Name: eosinophils; Test Result: 11.7 %;
Test Name: hemoglobin; Result Unstructured Data: 8.5 gram(s)/decilitre; Test Name:
Mean corpuscular volume; Result Unstructured Data: 86.3; Test Name: platelet count;
Result Unstructured Data: 110,000; Test Name: Ferritin; Result Unstructured Data:
391 nanogram(s)/millilitre; Test Name: hemoglobin; Result Unstructured Data: 5.9
gram(s)/decilitre; Test Name: white blood cell count; Result Unstructured Data:
42,000"
"691092-1" "691092-1" "Screaming and crying starting immediately post-vac,
including arched back and stiff limbs. Did not sleep until 0200 06/21/1994, found
dead by mother 1000." "autopsy/SIDS"
"691264-1" "691264-1" "Anti-NMDA receptor encephalitis after
anthrax/typhoid vaccines." "died from Toxic Epidermal Necrolysis related to
treatment of the anti-NMDA receptor encephalitis"
"691319-1" "691319-1" "First Grand Mal Tonic-Clonic Seizure (3/28/2016).
Second Grand Mal Tonic-Clonic Seizure 1/20/2017. Third/Fourth Grand Mal Tonic-
Clonic Seizure 3/10/2017. Fifth/Final Grand Mal Tonic-Clonic Seizure leading to
death: 4/8/2017." "No lab data for this event."
"691409-1" "691409-1" "Patient was put to bed by his parents the previous
night. His Mother discovered him deceased in his bed the next morning."
"Patient didn't feel well a few days after receiving the immunization, Dtap.
He was very fussy and just not himself. He cried uncontrollably for approximately 1
hour before falling asleep. Patient's speech regressed following the Dtap
immunization. He also began staring at things."
"691836-1" "691836-1" "Layed down to take a nap and never woke up."
"autopsy determined unknown cause of death"
"692183-1" "692183-1" "This spontaneous report was received from a nurse
via a company representative and refers to a patient of unknown demographics. No
information regarding the patient's medical history, concomitant medications,
concurrent conditions and drug reactions or allergies was provided. On an unknown
date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, lot
number and expiration date were not reported). Other suspect therapies included
sterile diluent (dose, lot number an expiration date were not reported). On an
unknown date, after receiving ZOSTAVAX the patient died. The cause of death was not
reported. It was unknown, whether the autopsy had been performed. The relatedness
between the event and ZOSTAVAX was not reported. Upon internal review, the event of
death was considered to be medically significant. Additional information is not
expected as there was no consent for further contact with the reporter." "No
lab data for this event."
"692864-1" "692864-1" "Hemodialysis Patient receiving hemodialysis at
approx 0934 pre BP 143/70, pulse 65. At approx 1204 BP 102/43, pulse 65. Patient
was administered first dose of MIRCERA 100mcg IVP at 1158, Pneumococcal vaccine 23
IM 0.5ml at 1200, RECOMBIVAX 40mcg IM at 1201. At approx 1205 patient reported
tingling in his ears and complained of shortness of breath, and then became
unresponsive. CPR was initiated at 1205, 911 called, EMS arrived and transported
patient at approx 1245 to hospital ER. Patient expired in ER." "No lab data for
this event."
"693530-1" "693530-1" "Death CPR administered and taken to the hospital."
"death ruled as SIDS"
"693670-1" "693670-1" ""This spontaneous report was received from an
unspecified source, concerning teenagers from unknown genders and ages, posted in
an online article. The patients' concurrent conditions, pertinent medical history
and concomitant medications were not provided. On an unknown date, the patients
were vaccinated with GARDASIL (dose number, anatomical location, lot # and
expiration date were not known) for prophylaxis. Furthermore, it was reported that
on unspecified dates, an unknown number of patients died due to unknown causes,
after vaccination with GARDASIL, reported as ""parents and women must know that
deaths occurred"". It was unknown if autopsies were done. No further information
was cited. The relatedness between deaths and vaccination with GARDASIL was not
provided. This is one of several reports received from the same source. Additional
information is not expected as no contact details were given. Sender's Comments:
US-009507513-1705USA002408: US-009507513-1705USA002409: US-009507513-1705USA002410:
US-009507513-1705USA002411: US-009507513-1705USA002412: US-009507513-1705USA002413:
US-009507513-1705USA002414: US-009507513-1705USA002415: US-009507513-1705USA002416:
US-009507513-1705USA002393: US-009507513-1705USA003214: ZA-009507513-1507ZAF012830:
Reported Cause(s) of Death."" "No lab data for this event."
"694117-1" "694117-1" ""This spontaneous report was received from a
physician via a company representative and refers to a male child patient. The
patient's concurrent conditions, medical history and concomitant therapies were not
reported. Approximately in 1997 (reported as ""about 20 years""), the patient was
vaccinated with a dose of M-M-R II frequency reported as ""one injection"",
parenteral route reported as ""injection"" (anatomical place of vaccination was not
provided), for Measles, Mumps, and Rubella prophylaxis. Approximately in 1997
(reported as ""two weeks after the vaccine was administered""), the patient
experienced seizures and for an unspecified reason and the child passed away
(death), subsequently on an unspecified date, the child passed away for an
unspecified reason. At the time of reporting, the outcome of seizure was unknown.
The reporter did not provide a causality assessment between M-M-R II, seizures and
death. Upon internal review, seizures and the death were determined to be medically
significant. Additional information is not expected, as the reporter did not
provide consent to follow up."" "No lab data for this event."
"694251-1" "694251-1" "Information had been received on 10-MAY-2017 from a
lawyer and the daughter of the deceased female regarding a case in litigation. It
was alleged in litigation that a female patient (decedent) of unknown age was
inoculated with ZOSTAVAX vaccine (Date, dose, route, site of administration, lot #
and expiration date were not provided) at a pharmacy, as recommended for routine
adult health maintenance for the prevention of shingles. The patient's medical
history, concurrent conditions and concomitant medication were not provided. The
lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but
rather caused the patient to contract a persistent strain of Herpes Zoster. On or
about 05-JUL-2016, the patient was treated in the emergency room, and later by
urologist (as reported)(also reported as family nurse practitioner (FNP)) for an
excruciating rash that spread to the female patient's genitalia and inside her
body. The female was diagnosed with severe shingles. On or about 06-JUL-2016, the
female patient was treated at a family medicine facility, by a physician assistant
(PA) for an ongoing and exceptionally severe outbreak of shingles. The patient was
prescribed gabapentin to manage her symptoms. On or about 09-JUL-2016, the female
died at her home due to unknown causes, which her estate believes was attributable
to the unmanageable pain of her atypical shingles outbreak. At the time of death,
the female was actively suffering from an active outbreak of Herpes Zoster on her
body. As a direct and proximate result of these malfunctions, patient suffered
painful injuries and damages, and required extensive medical care and treatment. As
a further proximate result, patient has suffered and will continue to suffer
significant medical expenses and pain and suffering and other damages. The event of
died at her home due to unknown causes was determined to be a medically significant
event. Additional information has been requested.; Reported Cause(s) of Death: died
at her home due to unknown causes." "No lab data for this event."
"694999-1" "694999-1" ""I belive this injection caused my daughter's death;
This spontaneous report was received from the patient's father via social media,
referring to a female patient of unknown age. The patient's medical history and
concurrent conditions were not provided. On an unknown date, the patient was
vaccinated with unspecified human papillomavirus (HPV) vaccine (manufacturer
unknown), dosage, route, lot# and expiration date were not provided. Concomitant
therapies were not reported. The patient's father stated that ""he believed this
injection caused his daughter death, the date of the patient's death was not
provided, It was unknown if an autopsy was done. The outcome of the event was
fatal. Additional information has been requested."" "No lab data for this event."
"695378-1" "695378-1" "As soon as received GARDASIL vaccine, had burning
thru entire body. Felt different after that. Balance issues, concentration issues.
Said her brain felt different. Soon after that, had a virus that was thought to be
flu. Treated with antibiotics. Had a headache that would not go away for 45 days.
Went from being a 115 lb athlete, to a 155 lbs and could not eat. Hospitalized at
two hospitals. Also hospitalized other times and other places afterwards. She never
got better--had terrible pain. Had multiple tests and saw many doctors and all
tests were normal. They could never find the cause of the headaches, but she did
have 2 surgeries to improve the headaches-decompression surgery in 2015 and removal
of nerves in forehead in 2016. She was diagnosed with POTS and with polycystic
ovarian syndrome after vaccination. Had possible seizures-saw over 200 doctors.
Died in the bathtub due to drowning." "No lab data for this event."
"695677-1" "695677-1" ""This spontaneous report as received from a
healthcare worker also reported as a corporate executive via a company
representative refers to a patient of unknown age and gender. There was no
information about the patient's concurrent conditions, medical history or
concomitant medication. On an unknown date, the patient was vaccinated with
ZOSTAVAX, for prophylaxis (dose, route of administration, lot number and expiration
date were not reported). The reporter stated that according to some
pharmacist, the patient ""died from getting ZOSTAVAX"" on an unknown date. The
cause of patient's death was not reported. It was also unknown whether an autopsy
has been performed. No further details were noted on the after-hours adverse event
voicemail. Additional information has been requested."" "No lab data for this
event."
"695907-1" "695907-1" ""This case was reported in a literature article and
described the occurrence of vaccination failure in a child subject who received Flu
seasonal TIV Dresden. On an unknown date, unknown after receiving Flu seasonal TIV
Dresden, the subject developed vaccination failure. Serious criteria included death
and GSK medically significant. Additional event(s) included influenza with serious
criteria of death. The outcome of vaccination failure was fatal. The outcome(s) of
the additional event(s) included influenza (fatal). The reported cause of death was
influenza. The investigator considered that there was a reasonable possibility that
the vaccination failure and influenza may have been caused by Flu seasonal TIV
Dresden. Relevant Tests: Lab test performed on unspecified date during influenza
season 2011-2012. In this study, among the 27 Influenza-Associated Paediatric
Deaths without any high-risk medical conditions, influenza A virus was found in 18
patients and influenza B found in 9 patients. Diagnostic results (unless otherwise
stated, normal values were not provided): On an unknown date, Influenza virus test
result was positive unknown. Additional information was provided. This case was
reported in a literature article and described the occurrence of suspected
vaccination failure in a patient aged between 6-month and 17-years who was
vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). The
patient was a part of the study that used case cohort approach comparing influenza
vaccination rates among influenza associated paediatric deaths from July 2010
through June 2014 with vaccination coverage estimated for cohorts of children to
estimate the effectiveness of influenza vaccination against laboratory-confirmed
influenza-associated death. The patient had no high-risk medical conditions. No
information on patient's family history or concomitant medication was provided. On
an unspecified date during influenza season 2011-2012, the patient received
unspecified seasonal influenza vaccine (administration route and site unspecified;
dosages unknown; batch number not provided). Age at vaccination was not provided.
[In this study children were considered vaccinated (either fully or partially) if
records indicated receipt of equal to or more than 1 doses of current season
influenza vaccine equal to or more than 14 days before onset of illness. Partial
vaccination was defined as receipt of 1 dose when health department personnel
determined that 2 doses were indicated]. On an unspecified date during influenza
season 2011-2012, equal to or more than 14 days after vaccination, the patient
developed laboratory-confirmed influenza. Subsequently, the patient died. (In this
study, among the 27 Influenza-Associated Paediatric Deaths without any high-risk
medical conditions, influenza A virus was found in 18 patients and influenza B
found in 9 patients). This case has been considered as suspected vaccination
failure being the time to onset was unknown. This case has been considered serious
due to death/suspected vaccination failure. Treatment of influenza was unknown. The
authors did not comment on the relationship between influenza and unspecified
seasonal influenza vaccine. The authors concluded, ""Results of this study suggest
that vaccination reduced the risk of influenza-associated death among children and
adolescents and add to the evidence of benefits of influenza vaccination for
children. Annual vaccination is an important strategy to prevent influenza and
influenza-associated complications and deaths. These results support current
recommendations for annual influenza vaccination for all children equal to or more
than months of age""."" "Lab test performed on unspecified date during influenza
season 2011-2012. In this study, among the 27 Influenza-Associated Paediatric
Deaths without any high-risk medical conditions, influenza A virus was found in 18
patients and influenza B found in 9 patients. Influenza virus test, positive"
"696747-1" "696747-1" "Fever the evening after receiving vaccines. Parents
gave TYLENOL. The infant was sleeping-then at 4:30 AM, the child cried out, then
stiff and unresponsive; mother brought directly to ER. She was pale and pulseless
upon arrival. Multiple rounds of CPR/epinephrine/atropine. Brief returns of sinus
bradycardia. CPR discontinued at 07:19." "No lab data for this event."
"696852-1" "696852-1" "This spontaneous case, initially received on 23-Aug-
2016, was reported by a health professional and concerns a female patient. Past
medical history included COPD (chronic obstructive pulmonary disease), peripheral
neuropathy, atrial fibrillation, abdominal aortic aneurysm and anxiety. Drug
history included drug reactions/allergies to cefazolin and diphenhydramine.
Concomitant medication: refer to appropriate report section. Administration of
company suspect drug(s): On an unknown date, the patient received Influenza Virus
Vaccine (INN) for indication not reported. Dose regimen: Not reported, Route of
administration: Not reported. Batch number: Not reported. No additional suspect
drugs. Adverse reactions/events and outcomes: On an unknown date, the patient
experienced drug reactions/allergies (outcome: not reported). On an unspecified
date in July 2015, the patient began therapy with KEYTRUDA injection for advanced
non-small cell lung cancer 'refractory to all prior treatment' and died to
progression of the disease. At the time of death on 11-Mar-2016, the patient was
taking unspecified doses of the following medications: albuterol, alprazolam,
DULCOLAX, SYMBICORT, DIPROLENE, vitamin B-12, COLACE, doxycycline, furosemide,
gabapentin, MUCINEX, hydrocodone, DUONEB, lactobacillus, levothyroxine, magnesium
chloride, metoprolol, morphine, multi-vitamin, prednisone, prochlorperazine and
warfarin." "No lab data for this event."
"699790-1" "699790-1" "Unknown - Notified by subpoena for records from
coroner of child's death on day following vaccinate administration." "Not
available to provider"
"699844-1" "699844-1" "This is a spontaneous report from a contactable
nurse received via a sales representative. A 8-month-old male patient of an
unspecified race/ethnicity was fully vaccinated with PREVNAR 13 on unspecified
date(s), at single dose(s), for immunisation. The reporter stated the patient was
sick but did not provide further details. Concomitant medications were not
reported. The patient died on an unspecified date in 2017 from pneumonia which
developed on an unspecified date, after being fully vaccinated up to 8 months.
Clinical course of event included the following information: the patient was sick
and he had gone to the hospital. He first came to the doctor's office who sent him
to the hospital for an X-ray. He was sent home, then he went to see the doctor for
follow-up and he was blue, he could not breathe. He went back to the hospital and
died that night. It was not reported if an autopsy was performed. Sero-grouping
test to confirm the strain was performed on an unknown date (pending result).;
Sender's Comments: Based on the information currently available, a lack of efficacy
with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely
excluded. Further information like confirmative pathological/serotype results and
vaccination schedule are needed for full medical assessment. The impact of this
report on the benefit/risk profile of the Pfizer product is evaluated as part of
Pfizer procedures for safety evaluation, including the review and analysis of
aggregate data for adverse events. Any safety concern identified as part of this
review, as well as any appropriate action in response, will be promptly notified to
Regulatory Authorities, Ethics Committees and Investigators, as appropriate.;
Reported Cause(s) of Death: died from pneumonia and was fully vaccinated up to 8
months; died from pneumonia and was fully vaccinated up to 8 months." "Test Name:
Serology test; Test Name: X-ray"
"700093-1" "700093-1" "SIDS. Patient died 6-15-17 in sleep." "No lab data
for this event."
"700165-1" "700165-1" "This spontaneous report was received from a
pharmacist via an unspecified person in leadership of the company and field
representative and refers to a patient of unknown age and gender. Information
regarding the patient's pertinent medical history, drug allergies/reactions and
concomitant medications were unknown. The patient was immunocompromised. On an
unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial
(lot and expiry date not reported) reconstituted with sterile diluent (Manufacturer
unknown) injection (lot and expiry date unknown) for prophylaxis. Pharmacist
mentioned that on an unknown date after vaccination, the patient died due to an
unknown cause. Causality assessment was not provided. Upon internal review, death
was considered to be medically significant. Additional information has been
requested.; Reported Cause(s) of Death: unknown cause of death." "No lab data for
this event."
"700432-1" "700432-1" "Found by EMS on back in her crib. Pt was intubated
and given 6 doses of epi in route to ER. Pt had no pulse on arrival. Pt received
a larger ET tube and bicarb. Resucitation unsuccessful, pt expired." "Labs drawn
and a chest AP xray obtained"
"700585-1" "700585-1" "Respiratory failure leading to death." "Bone Survey
6/2/16 multiple rib fractures"
"700592-1" "700592-1" ""This spontaneous report was received from a
physician via a company representative, referring to a male patient, of an unknown
age. The patient was diagnosed with ""cancer"" in an unspecified date. Concomitant
medications were not mentioned. In approximately December 2016 (reported as
""about six months ago""), while the patient was in the hospital, he was vaccinated
with a shot of PNEUMOVAX23, subcutaneously as a standard protocol from the hospital
(dose number, anatomical location, lot # and expiration date were not reported).
Subsequently, the patient was discharged from the hospital. The next day, he passed
away (death), approximately in December 2016. It was unknown if an autopsy was
performed. The cause of death was unknown. The reporting physician stated that he
felt that the patient should not have been vaccinated due to his ""weakened immune
system"" and he was not pleased about the hospital's conduct. He felt the hospital
should have used individual judgment before vaccination. No causal relationship
between therapy with PNEUMOVAX23 and death was provided. Upon internal review,
death was considered medically significant. Additional information has been
requested.; Reported Cause(s) of Death: it was not known what the cause of death
was."" "No lab data for this event."
 "700841-1" "700841-1" "This spontaneous report was received from a social
media via company representative regarding a 144 female patients of unknown age.
There was no information about patient's concomitant medications and pertinent
medical history reported. On an unknown dates, the patients were vaccinated with
GARDASIL, (dose, route, anatomical location, lot number and expiration date were
not reported) for prophylaxis. It was reported that on unspecified date, the
patients died from unknown cause and it was also unknown if autopsy was performed.
Additionally it stated that the pharmaceutical companies which made the GARDASIL,
as well as the Agency which hold patents and earns profits from the GARDASIL said
that they were all coincidence also that the mainstream media denied that these
events were even happened. The relatedness between the event and therapy with
GARDASIL was not reported. Upon internal review, death was determined to be
medically significant event. This is one of several reports from the same source.
Additional information is not expected as follow up information cannot be obtained.
Sender's Comments: US-009507513-1706USA010923: US-009507513-1706USA010924." "No
lab data for this event."
"700974-1" "700974-1" "Stopped breathing, passed away." "No lab data for
this event."
"701173-1" "701173-1" "My son received his 4th DTAP vaccine on 4/25/17 and
within 24 hours developed cold like symptoms...this was very common after almost
all vaccines...but never related it to vaccine injury until now...on 05/07/17 he
developed a fever and was very lethargic...on 05/08/17 he seemed to be completely
back to himself...on 05/12/17 I found him in his crib at 08:30 AM...he passed away
that prior evening..." ""Autopsy and path reports are all negative and termed my
son's death ""Sudden Unexplained Death""""
"702494-1" "702494-1" "Patient was seen in immunization clinic to receive
some vaccination. Patient is from a family and it is common for them to only
receive certain vaccines and limit the amount of vaccines at one time below the
recommended level. Patient received vaccines listed and this was only the second
time she had received any vaccines. According to History and Physicals the patient
was seen by the walk-in clinic for ear pain and not wanting to eat 3 days later but
mom states that the problem started a couple hours after the vaccines were given.
Patient was seen 2 days later by her family doctor which admitted her to the
hospital with dehydration and possible strep, even though the patient was on
antibiotics at this point." "This RN does not have access to all tests and
results that was done on this patient. This RN has tried to contact both hospitals
but has received no response"
"703490-1" "703490-1" "Baby was co-sleeping between parents and was found
unresponsive and already rigid at around 6:30 am. Last known awake time was 3-3:30
am. Resuscitation attempted by unsuccessful. Full autopsy report is not completed
at this time but the latest I heard from the mother of the baby is that there was
no obvious cause on the exam of the baby and internal organs. There are tissue
sample tests pending." "See above. I do not have more information from medical
examiner."
"703833-1" "703833-1" "DEATH." "AUTOPSY"
"704246-1" "704246-1" "This is a spontaneous report from a contactable
consumer who reported for his/her brother, via Pfizer-sponsored program. A male
patient of an unspecified age received his second single dose of PREVNAR, on
unspecified date for immunization. Medical history and concomitant medications were
not reported. Previously, on an unknown date, the patient received the first dose
of the vaccine. The patient died on an unspecified date, 4 months after getting the
second pneumonia shot. It was unknown if autopsy was performed. It was reported
that patient was up to date on all the pneumonia vaccines available at the time
(2009). Reported Cause(s) of Death: patient died 4 months after getting a pneumonia
shot." "No lab data for this event."
"704769-1" "704769-1" "This literature report has been received from the
author of a published literature article. Background: Patients with sickle cell
disease (SCD) were at risk of fatal sepsis with encapsulated bacteria, such as
Streptococcus pneumonia, because of the inherent autosplenectomy that occurred in
SCD. This risk was thwarted with oral penicillin prophylaxis during the first 5
years of life, and with stringent vaccination against S. pneumoniae alongside
routine childhood immunization. But compared with the general specific pediatric
population, the rate of invasive pneumococcal disease (IPD) in patients with SCD
still remained high, resulting in hospitalization and fatality. This study aimed to
investigate IPD in a patient population with SCD that had received standard
pneumococcal prophylaxis. Methods: Patients with SCD who developed IPD from 2004 up
to 2013 were identified using microbiology records. Those records belonging to
patients with SCD between the ages of 0 to 21 years were selected for inclusion in
this retrospective study. Descriptive analysis of presence of risk factors for IPD,
type of SCD, pneumococcal vaccination and prophylaxis status, clinical
presentation, microbiological data, and the outcome of IPD was performed. Results:
8 patients with SCD developed IPD (7 bacteremia and 1 respiratory tract infection).
Three of the 8 isolates underwent serotype analysis (15 C in 2 and 15 A in 1), none
covered with the current vaccination program. One patient had fatal outcome (15 A).
Conclusions: Breakthrough cases of IPD might involve non-vaccine isolates, and
seemed to occur after 5 years of age when oral penicillin prophylaxis had been
terminated. Non-vaccine serotypes could cause IPD in patients with SCD, especially
in older patients who were no longer on oral penicillin prophylaxis and/or those
patients with incomplete immunization status. Prompt institution of antibiotic and
supportive therapy was essential for the survival of these patients. This case
refers to a 5 year old male patient, with smoking exposure and was also on daycare.
The patient had no sibling. Concomitant therapy included oral penicillin
(complete), heptavalent pneumococcal conjugate vaccine (PCV7) (active) and PREVNAR
13 (active) for prophylaxis. On an unknown date, the patient received PNEUMOVAX 23
for prophylaxis. The patient presented from home with fever of 38.8 Celsius degrees
(date unspecified). In 2013, the non-vaccine serotypes patient presented with IPD -
respiratory tract infection/upper respiratory infection, resulting in
hospitalization (date unknown). Focal infection/other culture:
Rhinovirus/Enterovirus upper respiratory infection by polymerase chain reaction
(PCR) (his nasal wash sample was positive for Rhinovirus/Enterovirus), pneumonia
(concurrent radiological findings, which was likely from S. pneumoniae given his
rapid deterioration and S. pneumoniae bacteremia. The concurrent viral infection
might or might not have contributed to the severity of his presentation and was
performed due to the clinical severity of his symptoms). Because of the
deterioration in clinical status, the patient was transferred to the pediatric
intensive care unit (PICU) but he succumbed to the severe infection (date of death
unknown). The Clinical presentation data: heart rate was 0 /min (asystole). White
blood cell count/ absolute neutrophil count (WBC/ANC): 7500/2475 /mm^3. Hemoglobin
was 6.3 g/dL. Absolute reticulocyte count was 196,400 /mm^3. The other clinical
findings at presentation: Unresponsive on arrival to emergency department. The
microbiological and outcome data: Blood culture: S. pneumoniae positive; Time to
culture positive: 27 hrs; S. pneumoniae Serotype analysis: 15 A; S. pneumoniae
susceptibility: penicillin and ceftriaxone; PICU stay: Yes; outcome of the event:
Died. The reporter considered the event to be related to PNEUMOVAX 23. Upon
internal review, IPD - respiratory tract infection/upper respiratory infection was
determined to be medically significant. This is one of several reports from the
same literature. Sender's Comments: US-009507513-1707USA005890. Reported Cause(s)
of Death: invasive pneumococcal disease/respiratory tract infection/upper
respiratory infection." "Test Name: Body temperature; Result Unstructured Data: Lab
result: 38.8 �C; Test Name: Haemoglobin; Result Unstructured Data: Lab result: 6.3
g/dL; Test Name: Heart rate; Result Unstructured Data: Lab result: 0 /min; Test
Name: Neutrophil count; Result Unstructured Data: Lab result: 2475 /mm3; Test Name:
Reticulocyte count; Result Unstructured Data: Lab result: 196,400 /mm3; Test Name:
White blood cell count; Result Unstructured Data: Lab result: 7500 /mm3"
"706869-1" "706869-1" "This spontaneous report as received from a physician
via field representative refers to a female patient of unknown age. The patient's
medical history, concurrent condition and concomitant medications were not
reported. The physician reported that an unspecified patient stated that daughter
of a friend, on an unknown date, vaccinated with either GARDASIL 9 or GARDASIL
(dose, route, batch/Lot # unknown) for prophylaxis. Subsequently, on an unknown
date the patient died. The cause of death was not reported. It was unknown if an
autopsy was performed. Causality assessment was not provided. No PQC filed. The
physician was not able to provide any further details. Reported Cause(s) of Death:
unknown cause of death." "No lab data for this event."
"708434-1" "708434-1" ""This spontaneous report was received from a
physician via a company representative concerning a 12 year old female patient.
Medical history and concurrent conditions were not provided. On an unknown date,
the patient was vaccinated with a dose GARDASIL 9 (dose, route, lot# and the
expiration date were not reported) for prophylaxis. There was no concomitant
medication provided. The primary reporter stated one parent of one unspecified
patient presented physician with media article stating that "" a twelve year old
girl died a couple hours after receiving GARDASIL 9, a separate patient was said to
have entered premature menopause according to a Pediatrician, and a former company
doctor reported that this vaccine was dangerous (unevaluable event)."" The cause
of death was not provided by the reporter and it was unknown if the autopsy was
performed at the reporting time. The outcome of premature menopause and unevaluable
event was unknown. The reporter did not provide the causality between the events:
premature menopause and unevaluable event and the suspect therapy. Upon internal
review, death was determined to be medically significant.; Reported Cause(s) of
Death: unknown cause of death."" "No lab data for this event."
"708450-1" "708450-1" "PATIENT RECEIVED FLUAD SHOT AT APPROX. 4PM ON
8/11/2017. PATIENT LEFT PHARMACY APPROX 10 MINUTES AFTER RECEIVING SHOT. I WAS
CONTACTED BY FAMILY MEMBER ON 8/12/2017 THAT PATIENT HAD PASSED AWAY SOMETIME
DURING THE NIGHT. IT IS UNCLEAR IF THE SHOT CAUSED THE DEATH NOR IS THE FAMILY
STATING THAT THEY BELIEVE IT DID. I WAS ADVISED TO FILL OUT THIS FORM AS A
PRECAUTION. AGAIN- IT IS UNCLEAR IF SHOT WAS THE CAUSE." "NONE KNOWN"
"709187-1" "709187-1" "This spontaneous report was received from a Nurse
concerning a female patient of unknown age. Information on the patient's medical
history, concurrent conditions and concomitant medications were not reported. It
was unknown if the patient had any drug reactions or allergies. On an unknown date,
the patient was vaccinated with ZOSTAVAX 19400 PFU (route: unspecified injection)
(dose number, dose, unit, lot# and expiration date were not reported) for
prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE
DILUENT) (indication, route, dose, frequency, lot# and expiration date were not
reported). On an unknown date, several days after vaccination, one vesicle appeared
at the patient's injection site and resolved on an unknown date. Later, the patient
was diagnosed with oral cancer (death and medically significant). It was unknown if
the patient received treatment. It was unknown if the patient sought medical
attention. Approximately on an unspecified date in 2007 (10 years ago) the patient
died. The cause of the death was oral cancer. It was unknown if autopsy was done.
No product quality complaint was involved. Causality for the events was not
reported. Upon internal review, the event oral cancer was determined to be
medically significant.; Reported Cause(s) of Death: Oral cancer." "No lab data
for this event."
"709438-1" "709438-1" "Death reported by physician 8/23/17." "No lab data
for this event."
"710135-1" "710135-1" "This case was reported by a consumer and described
the occurrence of vaccination failure in a male patient who received BEXSERO. On an
unknown date, the patient received BEXSERO at an unknown dose. On an unknown date,
unknown after receiving BEXSERO, the patient experienced vaccination failure
(serious criteria GSK medically significant) and meningitis (serious criteria death
and GSK medically significant). On an unknown date, the outcome of the vaccination
failure was unknown and the outcome of the meningitis was fatal. The reported cause
of death was meningitis. It was unknown if the reporter considered the vaccination
failure and meningitis to be related to BEXSERO. Additional details were provided
as follows: The reporter reported this case for his/her friend's boyfriend. The age
at vaccination was not reported. The patient had contracted meningitis from after
receiving BEXSERO and died. This case was considered as suspected vaccination
failure since the completion of vaccination schedule, time to onset of event and
confirmatory laboratory test were unknown." "No lab data for this event."
"710759-1" "710759-1" "Patient received vaccines in office 8/30/17. Patient
was found unresponsive by parents at home 8/31/17 and was unable to resuscitate and
resulted in death." "No lab data for this event."
"712091-1" "712091-1" "This is a spontaneous report from a Pfizer sponsored
program received from a contactable consumer (patient's parent). A male patient of
unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of
administration, on an unspecified date, at single dose, for immunisation. Relevant
medical history and concomitant medications were not reported. The patient
experienced Streptococcus pneumoniae serotype 35B. On an unspecified date the
patient underwent lab tests and procedures which included serology test: serotype
35B. The patient died due to the event on 05May2017, he was almost 9 months old. It
was unknown if an autopsy was performed. Reported Cause(s) of Death: Streptococcus
pneumoniae serotype 35B." "Test Name: Serology test; Result Unstructured Data:
Test Result: Serotype 35B"
"712158-1" "712158-1" "Started with diarrhea the day after her vaccination.
Daughter was fussy and seemed to be in pain and not eating much. Patient died at
hospital on 04/06/2017. Hospital 1: Medical Center ER, transferred to another city
via helicopter. Hospital 2: Hospital." "No lab data for this event."
"712391-1" "712391-1" "She passed away." "No lab data for this event."
"712764-1" "712764-1" "Immediately during and after the shots, she was
crying. Right after, she was very tired and drowsy. She fell asleep in the car on
the way home. Napped for a very short time during the evening and was kind of fussy
which was not normal for her. She was fed at around 9:30 PM that evening and fell
asleep right after so she was laid down on her back in her crib. She was checked on
at 11:30 and 12, still sleeping on her side. She was checked on at 6 the following
morning and was face down. When she was flipped over she was all blue/discolored
with fluids coming out of her nose. When EMS arrived, no resuscitation attempts
were made." "No lab data for this event."
"713218-1" "713218-1" "My baby quit breathing, was not able to be revived
through CPR and passed away. Irritability in the weeks prior." "No lab data for
this event."
"713612-1" "713612-1" ""This initial spontaneous report was received from a
physician via a company field representative referring to a male patient in his
60's. Medical history, concurrent conditions and concomitant medications were
unknown by the reporter. On unspecified Wednesday, the patient received PNEUMOVAX
23 (dose, route and lot # not provided). The patient developed Guillain-Barre
syndrome five days later (also reported as ""about two weeks ago"" on 18-SEP-2017).
The patient was hospitalized and passed away within the week after receiving
unspecified treatment. The cause of death was Guillain-Barre syndrome. Causality
assessment was not provided. The field representative found out that there may be
legal action taken. Upon internal review, Guillain-Barre syndrome was considered
medically significant. The physician felt Guillain-Barre syndrome was life-
threatening. Additional information will not be requested as the reporter did not
provide consent to be contacted. Reported Cause(s) of Death: Guillain-Barre
syndrome."" "No lab data for this event."
"713718-1" "713718-1" "Patient seen in our office on 9/19/2017 at 2:15 pm
for a routine child health examination and weight check. Patient's 4 month vaccines
given, as listed above. On 9/20/2017, patient was found infant unresponsive by
parents. EMS called and arrived to find parents performing CPR. Patient transferred
via EMS to ED. CPR unsuccessful. Time of death called at 7:34am in the ED." "NA"
"714035-1" "714035-1" "Initial unsolicited report received from the
literature on 18-Sep-2017. This case is linked with: 2017SA173133. Verbatim of the
article: This is the second phase 1 study of a respiratory syncytial virus (RSV)
vaccine containing RSV fusion protein (sF) adjuvanted with glucopyranosyl lipid A
(GLA) in a squalene-based 2% stable emulsion (GLA-SE). In this randomized, double
blind study, 261 subjects aged _60 years received inactivated influenza vaccine
(IIV), a vaccine containing 120 _g sF with escalating doses of GLA (1, 2.5, or 5
_g) in SE, or a vaccine containing 80 _g sF with 2.5 _g GLA in SE. Subjects
receiving 120 _g sF with 2.5 or 5 _g GLA were also randomized to receive IIV or
placebo. Immunity to RSV was assessed by detection of microneutralizing, anti-F
immunoglobulin G, and palivizumab-competitive antibodies and F-specific gamma
interferon enzyme linked immunosorbent spot assay T-cell responses. Higher adjuvant
doses increased injection site discomfort, but at the highest dose, the
reactogenicity was similar to that of IIV. Significant humoral and cellular immune
responses were observed. The 120 _g sF plus 5.0 _g GLA formulation resulted in the
highest responses in all subjects and in older subjects. These results confirm
previous observations of vaccine tolerability, safety, and immunogenicity and were
used to select the 120 _g sF plus 5.0g GLA formulation for phase 2 evaluation.
Ethics statement. The study was carried out in accordance with the Declaration and
good clinical practice guidelines. The study protocol and amendments and the
subject informed consent document were approved by the Independent Review Board and
the Review Board. All subjects provided written informed consent. Study design. In
this phase 1b, double-blind, controlled, adjuvant-escalation (1.0, 2.5, and 5 _g of
GLA) study conducted in adults _60 years of age, 264 subjects (healthy subjects or
subjects with stable chronic illnesses) were to be enrolled at 5 centers in 2015.
They were randomized by cohort, as described, using an Internet-based interactive
response system. Subjects received 1 vaccine in cohorts 1 and 4. For cohorts 2 and
3, in which the subjects received an RSV vaccine and either IIV or placebo to
assess the safety and immunogenicity of concurrently administered IIV and RSV
vaccines, the vaccines were randomly assigned to be administered in the right or
the left arm. The dose of 80 _g of sF plus 2.5 _g of GLA was included to bridge to
phase 1a study data. In a preplanned interim analysis, some investigators were made
unblind to the treatments after the subjects had completed 90 days of safety
follow-up, but site staff and subjects remained blind to the treatments until the
end of the study (day 361).Subjects. Subjects were required to be _60 years of age,
to be not institutionalized or homebound, to weigh _40.9 kg, and to have met a
gender-specific hemoglobin requirement. Major exclusions included an unstable
medical condition or a recent change in therapy, receipt of influenza vaccine
within the previous 60 days, receipt of products that could include exogenous
antibodies, clinically significant abnormalities in screening tests, viral
hepatitis, a history of or current autoimmune disorder other than hypothyroidism,
immunosuppression, a body mass index of _40 kg/m2, or the taking of medications or
the existence of conditions that could cause injection site bleeding. Study
vaccines. sF in the postfusion conformation derived and modified from the sequence
of an RSV A strain was expressed in a hamster ovary cell line. GLA-SE was provided
by and licensed from Corporation pursuant to an existing agreement. RSV sF was from
the same lot used in the phase 1a study; GLA-SE was remanufactured to use non-egg-
derived phosphatidylcholine. FLUZONE was purchased commercially and provided to the
study sites. To prepare vaccine on-site, lyophilized RSV sF was reconstituted with
sterile water and combined with liquid diluent, GLA-SE, and SE in a mixing vial to
reach the concentrations of sF, GLA, and SE specified for each cohort. For all
vaccines, a single 0.5-ml dose was drawn into a covered syringe to maintain the
blind and administered into the deltoid muscle with a needle of the gauge and
length described in previously published guidelines. Study assessments. Specified
solicited symptoms were recorded using a diary card between days 1 (dosing) and 7;
AEs were recorded between day 1 and the day 29 visit; and serious AEs, new-onset
chronic diseases, and AESIs, including events of potential autoimmune etiology,
were recorded from days 1 to 361. Visits occurred on (approximately) days 1, 8, 29,
61, 91, 181, 271, and 361. Subjects were contacted by telephone at least monthly
for safety follow-up. Toxicity grading was generally consistent with that on a
standard table. This case involves 79-year-old male patient, who was vaccinated
with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series
site and route of administration were not reported) on an unknown date. The
patient's medical history was not reported. Patient concomitantly received placebo
as part of trial procedure. On an unknown date, 320 days following the vaccination
patient had cardiac arrest. Other laboratory test and corrective treatment were not
reported. On an unknown date, patient died. It was not reported whether autopsy was
performed or not. As per the reporter relationship to study dosing was reported as
not related. List of documents held by sender: none. Sender's Comments: This case
concerns a 79 year old male who died due to cardiac arrest on 320 days post
vaccination with Inactivated Influenza vaccine (MFR unknown). Time to onset is too
long to be compatible with the role of vaccine. More details regarding patient's
medical history (concurrent illness), previous vaccination history, time of death
and autopsy report are needed for complete assessment of the case. Based on the
available information no conclusion can be drawn. Reported Cause(s) of Death:
cardiac arrest." "No lab data for this event."
"715873-1" "715873-1" "This serious initial spontaneous case, was received
from other non-health professional via Merck on 25-Sep-2017, concerning a 23-year-
old male patient. On an unspecified date, the patient was administered with
influenza vaccine (dose, batch number, manufacturer, trade name, route of
administration, anatomical location and expiry date: not reported). On an
unspecified date, the patient became sick. The outcome of the event sick was not
reported. It was reported that the patient had died due to auto accident on an
unspecified date. It was unknown, whether autopsy was done." "No lab data for
this event."
"716263-1" "716263-1" "Patient passed away on 9/2/17. Cause was apparent
SIDS but autopsy results are still pending." "None"
"716526-1" "716526-1" "This spontaneous report as received from social
media via other and refers to a patient of unknown age and gender. The patient's
medical history, concurrent conditions and concomitant medications were not
reported. On an unknown date, the patient was vaccinated with GARDASIL (lot#,
expiry date and dosing details were not reported) for prophylaxis. Later, on an
unknown date, the patient died and the cause of death was unknown. It was unknown
if an autopsy was performed. It was reported that, 63 reports on GARDASIL lot
recalled, including one death (product quality issue). And the reports in vax from
same lot given after recall. Causality assessment was not provided. Upon internal
review, death was determined to be medically significant.; Reported Cause(s) of
Death: unknown cause of death." "No lab data for this event."
"719492-1" "719492-1" "This spontaneous report was received from a
physician via an online article, referring to a female patient of unknown age. The
patient's medical history, concurrent conditions, concomitant medications, and
historical drugs were not reported. On an unknown date, the patient was vaccinated
by her mother who was a nurse, with GARDASIL (route, dose, frequency, anatomical
location, lot # and expiration date were unknown) for prophylaxis. The article
reported that the girl on an unspecified date developed leukemia and died. I was
unknown if an autopsy was done to the patient. The reported did not mention the
causality assessment between the events of leukemia and death with GARDASIL. Upon
internal review, leukemia and death were determined to be medically significant.;
Sender's Comments: US-009507513-1710USA004070:" "No lab data for this event."
"719758-1" "719758-1" "This spontaneous report has been received from a
newspaper article concerning a 10 year old patient of unknown gender. The patient's
medical history, drug allergies, concurrent conditions and concomitant therapies
were not reported. On an unknown date the patient was vaccinated with a human
papillomavirus vaccine (manufacturer unknown) (dose, dose number, route of
administration, anatomical location, lot number and expiration date were not
provided), for prophylaxis. It was reported that on an unknown date the human
papillomavirus vaccine (manufacturer unknown) might have caused the death of the
patient. It was unknown if an autopsy was done. The causal relationship between
human papillomavirus vaccine (manufacturer unknown) and the event was considered as
related. Upon internal review, death was determined to be medically significant."
"No lab data for this event."
"720413-1" "720413-1" "Patient was brought to ED at Hospital by family
member and was DOA. Patient was intubated and CPR was performed for 25 minutes
until patient was pronounced dead at 16:18 on 10/5/17." "No lab data for this
event."
"721311-1" "721311-1" "No adverse reactions noted at clinic visit 8/9/17.
Patient found unresponsive; deceased on 8/11/17." "None"
"721793-1" "721793-1" "Apnea and Bradycardia, seizure, Hypoxic brain
injury, Death. Full Resuscitation. Ventilator support. Epinephrine, Dopamine,
Insulin, hydrocortisone, Antibiotics. VERSED x1 dose, Phenobarbital Loading dose."
"Blood gas at 1810 (10/16) after event PH 6.62/PCo2 46/HCO3 5.1/ Base deficit
-31.5; EEG: abnormal Video EEG study to diffuse attenuation and undifferentiated
activity signifying diffuse cerebral dysfunction."
"723801-1" "723801-1" "This is a spontaneous report from a contactable
consumer via a Pfizer sales representative. An 84-year-old male patient of unknown
race/ethnicity received in Mar2016 (during 6 month home visit) a single dose of
PREVNAR 13 for immunization. Medical history included dementia. Concomitant
medications were not reported. On an unspecified date in 2016, the patient reported
initially pain at injection site then became sick within couple of days and fever
and chills and stiff neck and pain in joints also reported balance problems.
Patient was visited at the emergency room where they really couldn't find anything
wrong with him. Symptoms persisted, may be got little better over time. In Jul2016
patient died. No autopsy was performed. Reported Cause(s) of Death: unknown cause
of death." "No lab data for this event."
"723815-1" "723815-1" ""Friday- complained of leg cramps and the sensation
of ""not being able to move""; Saturday- tired, complained of pain in legs, ""feet
were tingly"" and ""calves were tight""; Monday- worked, but Dr could not see until
Tuesday afternoon; Tuesday- collapsed in bathroom, crawled to wall and pulled self
up, went home from work at noon; Wednesday- MRI no new symptoms; Thursday-
complained of arms tingling; ""legs were like noodles"" and ""couldn't stand"";
Friday- no strength in arms or legs, had trouble breathing, called ambulance at
1:09 pm; died at 2 pm."" "10/18/2017- with results on 10/20 in am- MRI- showed
Congested Disc Disease in back"
"723895-1" "723895-1" "Found apneic and unresponsive. CPR was run x 2h but
patient never revived. Cause of death was determined to be SIDS. No other SIDS risk
factors were present. Baby was asleep on back in proper bed without blankets or
pillows." "blood gas"
"724443-1" "724443-1" "Patient received influenza vaccine on 10/9/2017. On
10/11/2017 patient suffered a myocardial infarction and passed away." "None
reported by patient's family"
"725534-1" "725534-1" "Patient presented to primary care office on Oct. 23,
2017 for 2 month well child check and received routine vaccines PEDIARIX, ACTHIB,
Pneumococcal and ROTATEQ. Manager received a phone call for County Department of
Health that the child passed away on Nov. 4, 2017." "No lab data for this event."
"726353-1" "726353-1" "Lethargy, substantial decreased eating - especially
when trying to get her to eat, very pale in color. Eventually leading to breathing
difficulties and death (one week from vaccinations). Starting the same afternoon of
her vaccines, patient was very lethargic but fussy when awake. The next day and
days to follow her eating substantially decreased and she was very pale in color.
On February 2nd I noticed breathing changes, so I took her to the ER. She passed
away at 68 days old on February 3rd. Now that I have done substantial research on
adverse effects of vaccines, I know these vaccines had to do with her death."
"We found out that our daughter had MPS I, 4 months after she passed away.
However, she should not have died from this condition at a mere 68 days old. Many
doctors agreed that the vaccinations exacerbated the situation greatly. Until the
vaccines she was total healthy and normal. Though photos and even complete autopsy
couldn't find a cause. It was myself who decided to have myself and my husband
screened for genetic issues and even after it was discovered patient had the
genetic issue, the doctors at the Hospital couldn't believe the MPS I would have
killed a baby that young. I have never found another case of a baby dying so young
from MPS I."
"726791-1" "726791-1" "Patient passed away on 4/25/2017. Did not talk to
parents of child. Request for medical records came from Forensic Center on
4/25/2017 at 2:45 pm and that is when we found out the baby had died." "Not known"
"727653-1" "727653-1" "Information has been received on 16-NOV-2017 from a
lawyer and the executor of the estate of a deceased consumer (date of death and
cause of death was not reported.) The patient was reported to be a male patient of
unknown age. The patient's prior concurrent conditions, medical history and
concomitant medications are unknown. On or about On 26-JUN-2015, the patient
received ZOSTAVAX(lot number and expiration unknown), subcutaneous for its intended
purpose: the prevention of shingles. As a direct result of the vaccine, the patient
suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to
various parts of his body. The patient did not have a Shingles outbreak until 11-
NOV-2016. As a direct result of the vaccine, the patient suffered mental and
emotional distress due to resulting physical limitations and seriousness of his
condition. As a result of ZOSTAVAX, the patient sustained severe and permanent
personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient
suffered serious, progressive, permanent, and incurable injuries, as well as
significant conscious pain and suffering, mental anguish, emotional distress, loss
of enjoyment of life, physical impairment and injury. The patient has incurred
medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As
a direct and proximate consequence of ZOSTAVAX, the patient sustained serious
personal injuries and related losses including, but not limited to, mental anguish,
physical pain and suffering, diminished capacity for the enjoyment of life, a
diminished quality of life, medical and related expenses, and other losses and
damages. Upon internal review, deceased was considered to be medically significant.
Additional information has been requested. Reported Cause(s) of Death: deceased."
"No lab data for this event."
"728254-1" "728254-1" "Two days after the flu shot, my mother developed a
headache that became so bad that she went to the hospital. It was determined that
she *might* have meningitis. There was nothing ever definitive. SED rates and CRP
were extremely high. Very low WBC in spinal tap. After weeks of being in and out of
the hospital, she came home. She never regained her strength. Towards the end of
October, she was taken by ambulance yet again for a headache. However, while she
was in the ambulance it was noted that her O2 level was at 80%. They treated her in
the hospital for the headache, but after I pointed it out to them, the doctor
became concerned at her O2 levels as well. X-ray showed nothing substantial, but at
my insistence, she had a CT scan of her lungs. Bilateral pneumonia with ground
glass appearance. Diagnosed with atypical pneumonia. Started in the general
admission ward. Then was moved to step down unit. And was eventually moved to the
CCU and passed away on November 7, 2017, her 74th birthday. Immediate COD was
ARDS." "Contact Winchester Medical Center. There were an extreme number of
tests that were done."
"728520-1" "728520-1" "Received call from ER physician that infant had
died. Mom reported child was a little fussy yesterday due to teething. She swaddled
him and put him to bed. When she went in to check on him in the middle of the night
he had expired." "NONE KNOWN"
"728584-1" "728584-1" "This is a spontaneous report from a contactable
consumer (patient's husband) and from the patient's daughter. A 90-year-old male
patient received PREVNAR 13 (NDC number 00005197105, lot R56671, exp.date
30Apr2018) and first dose of FLUZONE (lot UI845AA, exp.date 13Apr2019, NDC number
49281040188) both via intramuscular route in the arm for immunization on 17Oct2017
14:00 at 0,5ml single dose at the doctor's office. Concomitant medications included
Carbidopa Levodopa since 09Apr2015 at 25/100mg one tablet by mouth three times a
day, FLOMAX since Feb2017 at 0.4mg one capsule by mouth once a day, finasteride
since 26Apr2017 at 5mg one tablet by mouth daily and temazepam at 15mg two capsule
every night at bedtime. Relevant medical history included Enlarged prostate since
Jan2017, Flu since 2016, essential tremors of Parkinson's disease, Parkinson's
started in Jan2017 and Sleep disorder. On 11Nov2017 the patient experienced fever
and difficulty breathing. He was taken to the emergency room via an ambulance at
09:00 on 11Nov2017 because of these events. He was admitted into the hospital on
11Nov2017. Later that day of 11Nov2017, he was diagnosed with pneumonia. She
mentioned as treatment of the pneumonia, he was given heavy antibiotics:
Piperacillin, tazobactam, ZOSYN and vancomycin and he stated a list of side effects
on these antibiotics nausea, vomiting and diarrhea. A Chest x-ray showed Pneumonia
and blood test showed Pneumonia bacteria in the blood stream. She also mentioned
that after the doctor told them that the staff could not do anything else for him,
and the patient was near the end of his life, on 16Nov2017 he was transferred to
Hospice and given Morphine. Again, this was given as part of his treatment for the
end of life. The patient passed away on 18Nov2017 for pneumonia. No autopsy was
done. Reported Cause(s) of Death: drug ineffective; Pneumonia." "Test Date:
20171111; Test Name: Blood test; Result Unstructured Data: Test Result: Pneumonia
bacteria in the blood stream. Septic.; Test Date: 20171111; Test Name: Chest X-ray;
Result Unstructured Data: Test Result: Pneumonia"
"728993-1" "728993-1" "Decedent was in his usual state of health on a 4
month wellness check on 10/12/2017, at which time he received the ROTATEQ
vaccination (among others). Decedent presented to pediatrician on 10/16/2017 for
fussiness, irritability, and nausea. He continued to have nausea, vomiting, and
diarrhea and his parents transported him to the hospital that evening. He arrived
to the hospital in critical condition. He died shortly thereafter on 10/17/2017 at
0100 following an emergent bedside exploratory laparotomy that revealed diffuse
intestinal necrosis without an identified cause." ""Autopsy revealed diffuse
intestinal necrosis (majority of small bowel and proximal portion of large bowel)
without evidence of anatomic abnormality. There was no evidence of trauma; also no
evidence of volvulus, intussusception, malrotation, or vascular abnormality.
Postmortem bacterial cultures of CSF, blood, and lungs grew Enterococcus faecalis.
Viral studies of the stool identified ROTATEQ vaccine strain. Postmortem vitreous
electrolytes revealed evidence of dehydration. No definitive cause for the
intestinal necrosis was determined. Cause of death was attributed to ""Intestinal
necrosis of undetermined etiology.""""
"730194-1" "730194-1" "Child found apneic, unresponsive, brought to
hospital by EMS with CPR in progress, child expired." "No lab data for this event."
"731865-1" "731865-1" "This case was reported by a pharmacist via call
center representative and described the occurrence of multi-organ failure in a
elderly female patient who received FLULAVAL QUADRIVALENT. Co-suspect products
included VALTREX unknown for shingles. On an unknown date, the patient received
FLULAVAL QUADRIVALENT at an unknown dose. On 17th October 2017, the patient started
VALTREX 1000 mg 3 times daily (3000 mg daily). On an unknown date, less than a year
after receiving FLULAVAL QUADRIVALENT and VALTREX, the patient experienced multi-
organ failure (serious criteria death and GSK medically significant) and shingles.
The action taken with VALTREX was unknown. On an unknown date, the outcome of the
multi-organ failure was fatal and the outcome of the shingles was unknown. The
reported cause of death was multi-organ failure. It was unknown if the reporter
considered the multi-organ failure and shingles to be related to FLULAVAL
QUADRIVALENT. It was unknown if the reporter considered the multi-organ failure to
be related to VALTREX. Additional details were reported as follows: The age at
vaccination was not reported. The healthcare professional reported that a patient
in a skilled nursing home facility was given FLULAVAL QUADRIVALENT and then
developed shingles. The patient started VALTREX and went into multi-organ failure
which resulted in her death. The pharmacist did not have information regarding
timing of the FLULAVAL QUADRIVALENT dose given and development of shingles. The
reporter had no information on batch number or expiration dates of the FLULAVAL
QUADRIVALENT. The healthcare professional did not know patient's date of death."
"No lab data for this event."
"732139-1" "732139-1" "Began with nausea vomiting on 12/19/17- 12/20/17. He
died of Sepsis per hospital on 12/27/17." "These would be at the hospital"
"732872-1" "732872-1" ""This case was reported in a literature article and
described the occurrence of vaccination failure in a 16-year-old female subject who
received Meningococcal ACWY vaccine. Co-suspect products included SOLIRIS for
paroxysmal nocturnal hemoglobinuria. Concurrent medical conditions included
paroxysmal nocturnal hemoglobinuria. On an unknown date, 183 days after receiving
Meningococcal ACWY vaccine and Meningococcal B Recom vaccine + AIOH + OMV, the
subject developed vaccination failure. Serious criteria included death and GSK
medically significant. Additional event(s) included meningococcal infection with
serious criteria of death and GSK medically significant. The outcome of vaccination
failure was fatal. The outcome(s) of the additional event(s) included meningococcal
infection (fatal). The reported cause of death was meningococcal infection. The
investigator considered that there was a reasonable possibility that the
vaccination failure and meningococcal infection may have been caused by
Meningococcal ACWY and Meningococcal B Recom vaccine + AIOH + OMV. Relevant Tests:
Lab tests were performed on an unspecified date. The isolate initially was reported
to be serogroup B, but subsequent testing at the Centers for Disease Control
and Prevention (CDC) revealed that the strain actually was non-groupable. The
isolate sequence type (ST-2578) was associated more commonly with asymptomatic
carriage rather than invasive disease. Additional information was provided. This
case was reported in a literature article and described suspected vaccination
failure in a 16-year-old female patient who was vaccinated with unspecified
meningococcal ACWY (MenACWY) vaccine and unspecified meningococcal serogroup B
(MenB-4C) vaccine (manufacturers unknown for both). This case corresponds to the
meningococcal vaccines section of the article. The patient was a part of the study
that provided data from the manufacturer who reported 16 cases of meningococcal
disease (including 1 death) in 5207 person-years of eculizumab exposure between
2007 and 2014; the age range was 17 to 45 years, and all of them had received
meningococcal vaccination. The patient had paroxysmal nocturnal hemoglobinuria. No
information on patient's family history or concomitant medications was provided. On
an unspecified date, the patient received unspecified meningococcal ACWY
(MenACWY) and unspecified meningococcal serogroup B (MenB-4C) vaccines
(administration route and site unspecified; dosage unknown; batch number not
provided for both). The patient had started SOLIRIS. Age of vaccinations was not
provided. On an unspecified date, approximately 6 months after vaccinations and 1
month after eculizumab therapy, the patient developed meningococcal disease. The
isolate initially was reported to be serogroup B, but subsequent testing at the
Centers for Disease Control and Prevention (CDC) revealed that the strain actually
was non-groupable. The isolate sequence type (ST-2578) was associated more commonly
with asymptomatic carriage rather than invasive disease. On an unspecified date,
the patient died despite apparently strong memory antibody response to the strain.
Thus, a normally non-pathogenic strain led to fatal illness despite vaccination. It
was unknown if an autopsy was performed. This case has been considered as suspected
vaccination failure being full schedule was unknown. This case has been considered
serious due to death/suspected vaccination failure. Treatment was unknown. The
authors stated, ""The CDC concluded that vaccination provides incomplete protection
to eculizumab recipients"". Additionally, the authors mentioned ""FDA approved
prescribing information includes a black-box warning for increased risk of
meningococcal disease in recipients who take eculizumab""."" "Lab tests were
performed on an unspecified date. The isolate initially was reported to be
serogroup B, but subsequent testing at the Centers for Disease Control and
Prevention (CDC) revealed that the strain actually was non-groupable. The isolate
sequence type (ST-2578) was associated more commonly with asymptomatic carriage
rather than invasive disease."
"732984-1" "732984-1" "Information has been received on 04-JAN-2018
regarding a case in litigation from a lawyer and an estate administrator regarding
a male patient of unknown age. The patient's prior concurrent conditions, medical
history and concomitant medications are unknown. The patient was inoculated with
ZOSTAVAX (lot number and expiration unknown) subcutaneous on or about 05-MAR-2014,
as recommended for routine adult health maintenance and for the prevention of
shingles. The vaccine did not prevent shingles as intended, but rather caused the
patient to contract a persistent strain of herpes zoster. On or about 09-JUL-2015,
the patient was treated at a medical center for the onset of a severe vesicular
rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes
zoster, or shingles. The patient was prescribed VALTREX for management of his
painful and persistent symptoms. On 24-FEB-2016, the patient succumbed to death
with post-herpetic neuralgia listed a significant factor causing his death. Post-
herpetic neuralgia is a chronic condition of intense pain and nerve damage
secondary to herpes zoster infections. As a direct and proximate result of these
malfunctions, the patient suffered painful injuries and damages, and required
extensive medical care and treatment, with monetary damages. As a further proximate
result, the patient has suffered and suffered significant medical expenses, and
pain and suffering, and other damages, including his eventual death due to
complications of his injuries. Additional information has been requested. Reported
Cause(s) of Death: post-herpetic neuralgia." "No lab data for this event."
"733221-1" "733221-1" "INFANT DECEASED." "AUTOPSY 01/15/2018"
"733241-1" "733241-1" "Initial unsolicited report received from the
literature on 04-Jan-2018. The following is verbatim from the article: The Advisory
Committee on Immunization Practices (ACIP), a group of medical and public health
experts, meets 3 times per year to develop recommendations for vaccine use. The
group has 15 voting members, and each member's term is 4 years. ACIP members and
Centers for Disease Control and Prevention (CDC) staff discuss the epidemiology of
vaccine-preventable diseases and vaccine research, effectiveness, safety data, and
clinical trial results. Representatives from multiple agencies are present as
liaisons to the ACIP. The ACIP met on June 21 to 22, 2017, to discuss catch-up
vaccination for hepatitis A vaccine, influenza surveillance, influenza vaccine
effectiveness, herpes zoster vaccine, the effect of varicella vaccination on the
incidence of herpes zoster, meningococcal disease in patients taking eculizumab,
and considerations for a potential third dose of MMR vaccine to combat ongoing
mumps outbreaks. Updates on dengue virus epidemiology, Zika virus vaccines, anthrax
vaccine, yellow fever vaccine, and the Vaccine Adverse Event Reporting System were
given also. This case involves a 16-year-old female patient who was vaccinated with
doses of MENACWY VACCINE and MENB-4C VACCINES (batch number, expiry date, dose,
dose in series, route and site of administration were not reported for both the
vaccines) on an unspecified date. The patient had medical history of paroxysmal
nocturnal hemoglobinuria. Concomitant medication includes eculizumab for paroxysmal
nocturnal hemoglobinuria which started on an unknown date approximately one month
earlier. On an unspecified date, six months following the vaccinations, the patient
experienced fatal meningococcal disease and vaccination failure. Laboratory
investigation and corrective treatment were not reported. On an unknown date, the
patient died despite apparently strong memory antibody response to the strain. It
was unknown if autopsy was performed or not. List of the documents held by sender:
none. Sender's Comments: Vaccination failure may be expected with any vaccine, as
no vaccine protects all vaccinated individuals. Concomitant medication in this
report of fatal meningococcal disease included eculizumab for paroxysmal nocturnal
hemoglobinuria. Eculizumab is a terminal complement inhibitor and therefore
increases patient risk for meningococcal infections. Patients treated with
eculizumab and without a history of prior vaccination are recommended to receive a
meningococcal vaccine at least 2 weeks prior to receiving the first dose of
eculizumab and be revaccinated according to current medical guidelines for vaccine
use. In this case, vaccination with MenACWY and MenB meningococcal vaccines
occurred prior to initiating treatment with eculizumab. Importantly, this case does
not represent a confirmed vaccine failure to MenACWY because information on the
specific serogroup involved was not available. The isolate initially was reported
to be serogroup B, but subsequent testing revealed that the strain actually was
nongroupable. Reported Cause(s) of Death: Fatal meningococcal disease." "No
lab data for this event."
"733369-1" "733369-1" ""Information has been received from the authors of
the published literature article. The authors used Social Media's Public Streams
Application Programming Interface (API) to collect live data. Between November of
2014 and January 2015, they systematically endeavored to select an optimal set of
terms that would be parsimonious enough to be feasible yet broad enough to capture
sufficient relevant information. Of the 2,000 comments, 1,887 (94.4%) were relevant
to human papillomavirus (HPV). Thus, these 1,887 comments composed their final
data-set. The vast majority of comments (n=1,668, 88.4%) originated from unique
user accounts. Two hundred and four comments (10.8%) were from users who posted
between two and five times, and 30 (1.6%) were from users who posted 10 or more
times. Ninety-five (5.0%) comments were coded as having negative sentiment. These
comments generally discouraged GARDASIL or GARDASIL 9 vaccination or expressed a
particularly negative view toward it. Specific terms characteristic of these
comments included ""beware,"" ""destroys lives,"" and ""mystery illness."" While
sentiments were nearly always directly incorporated in to the comments themselves,
negative sentiment could also often be inferred by the hashtags at the end of the
comment. 78 (4.1%) comments explicitly claimed lack of safety. Examples of phrases
included in comments describing lack of safety included ""GARDASIL or GARDASIL 9
ruins live [sic]"" and ""girl dies shortly after receiving HPV vaccine."" This case
concerns to a healthy 12-year-old girl who died shortly after receiving HPV
vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered
death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was
considered to be a medically significant event. This is one of 2 reports derived
from the same literature source, linked to case # 1801USA003508. Sender's Comments:
US-009507513-1801USA003508."" "No lab data for this event."
"733389-1" "733389-1" ""Information has been received from the authors of
the published literature article. The authors used a Public Streams Application
Programming Interface (API) to collect live data. Between November of 2014 and
January 2015, they systematically endeavored to select an optimal set of terms that
would be parsimonious enough to be feasible yet broad enough to capture sufficient
relevant information. Of the 2,000 responses, 1,887 (94.4%) were relevant to human
papillomavirus (HPV). Thus, these 1,887 composed their final data-set. The vast
majority (n=1,668, 88.4%) originated from unique user accounts. Two hundred and
four tweets (10.8%) were from users who posted between two and five times, and 30
(1.6%) were from users who posted 10 or more times. Ninety-five (5.0%) were coded
as having negative sentiment. These generally discouraged GARDASIL or GARDASIL 9
vaccination or expressed a particularly negative view toward it. Specific terms
characteristic of these tweets included ""beware,"" ""destroys lives,"" and
""mystery illness."" While sentiments were nearly always directly incorporated in
to the responses themselves, negative sentiment could also often be inferred by the
hashtags at the end. 78 (4.1%) explicitly claimed lack of safety. Examples of
phrases included in tweets describing lack of safety included ""GARDASIL or
GARDASIL 9 ruins live [sic]"" and ""girl dies shortly after receiving HPV
vaccine."" This case concerns to a girl who died shortly after receiving HPV
vaccine. The case was coded as lack of safety 77 (4.1%). The reporter considered
death to be related to GARDASIL 9 and/or GARDASIL. Upon internal review death was
considered to be a medically significant event. This is one of 2 reports derived
from the same literature source, linked to case # 1801USA001975. Sender's Comments:
US-009507513-1801USA001975:"" "No lab data for this event."
"733960-1" "733960-1" "Infant Death." "Toxicology labs are still being
completed"
"734042-1" "734042-1" "Initial unsolicited report received from a nurse on
10-Jan-2018. This case involves a six-month-old patient (gender not reported), who
was vaccinated with first dose of 0.25 ml FLUZONE QIV via intramuscular route
(batch number: UT5949KA; expiry date, route and site of administration not
reported) and PEDIARIX (manufacturer: GSK) (batch number, expiry date, dose, route
and site of administration not reported) and ROTAVIRUS VACCINE (batch number,
expiry date, dose, route and site of administration not reported) and PNEUMOCOCCAL
CONJUGATE VACCINE (PCV12) (manufacturer: Pfizer) (batch number, expiry date, dose,
route and site of administration not reported) on 20-Dec-2017. Patient had a mild
cough at time of vaccination. No fever. Concomitant medications were not reported.
On 26-Dec-2017 in morning, six days following the vaccination, patient was found
dead. Patient was previously vaccinated with all vaccines other than FLUZONE QIV
twice. Lab test and corrective treatment was not reported. Reporter stated an
autopsy was being performed to determine cause of death and rule out SIDS (sudden
infant death syndrome). Patient's mother felt it was the flu shot (Fluzone QIV)
that caused her child's demise. Documents held by sender: none.; Sender's Comments:
Time to onset is compatible. The patient already had mild cough at the time of
vaccination. No other medical history was reported. The patient also received
Pediarix and Rotavirus vaccine on the same day as Fluzone QIV. Autopsy was being
performed at the time of reporting to determine the cause of death and rule out
SIDS. Considering that several different vaccines had been co-administered at the
same time it is difficult to elicit role of each vaccine in reported event. Result
of autopsy, patient medical history, past surgical history, and state of health at
the time of vaccination would be helpful with identifying role of each vaccine in
reported event.; Reported Cause(s) of Death: found dead the morning; Autopsy-
determined Cause(s) of Death: found dead the morning" "No lab data for this event."
"734494-1" "734494-1" "Child found unresponsive at 6:30 am on 1/13/2018,
transported to ER via rescue squad, failed CPR, pronounced dead in ER. Mother last
saw him alive at 1:30 am on 1/13/2018. Found unresponsive. This occurred several
hours. Pt's parents found patient (3moM unresponsive at approx 630 am. Last seen at
130am. Arrives in full arrest with CPR in progress. Pt is cyanotic, unresponsive.
No lividity but stiffness noted. Cool to touch, emesis noted. Pink froth noted in
OP. Emesis pink indicating recent tx w/ PO TYLENOL (confirmed by Mother). Pt saw
PCP earlier in the day for routine vaccinations. No sx/sx of acute
allergic/hypersensitivity rxn. The patient was found unresponsive. Down time before
CPR (Unknown - likely hours given hx.). Paramedics findings: The patient was apneic
and pulseless. Prehospital treatment: Compressions performed." "No lab data for
this event."
"734518-1" "734518-1" "PATIENT DECEASED ON 01/16/18 (POSSIBLE SIDS) UNDER
INVESTIGATION." "NONE"
"734553-1" "734553-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU.
On an unknown date, the patient received Influenza vaccine Quadrivalent. On an
unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine Quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that, 8 patients died from flu
of which 7 patients had flu shot and all eight patient's were on THERAFLU. This
case was considered as suspected vaccination failure since time to onset and the
lab test confirmation for the event was unknown. No further details provided about
the product." "No lab data for this event."
"734557-1" "734557-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown
date, unknown after receiving Influenza vaccine Quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine Quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that, 8 patients died from flu
of which 7 patients had flu shot and all eight patients were on THERAFLU. This case
was considered as suspected vaccination failure since time to onset and the lab
test confirmation for the event was unknown. No further details provided about the
product. This case was one of the 7 cases, reported by the same reporter." "No
lab data for this event."
"734560-1" "734560-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown
date, unknown after receiving Influenza vaccine Quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine Quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that 8 patients died from flu
of which 7 patients had flu shot and all eight patients were on THERAFLU. This case
was considered as suspected vaccination failure since time to onset and the lab
test confirmation for the event was unknown. No further details provided about the
product. This case was one of the 7 cases, reported by the same reporter." "No
lab data for this event."
"734562-1" "734562-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown
date, unknown after receiving Influenza vaccine Quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine Quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that, 8 patients died from flu
of which 7 patients had flu shot and all eight patients were on THERAFLU. This case
was considered as suspected vaccination failure since time to onset and the lab
test confirmation for the event was unknown. No further details provided about the
product." "No lab data for this event."
"734563-1" "734563-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown
date, unknown after receiving Influenza vaccine Quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine Quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that, 8 patients died from flu
of which 7 patients had flu shot and all eight patients were on THERAFLU. This case
was considered as suspected vaccination failure since time to onset and the lab
test confirmation for the event was unknown. No further details provided about the
product. This case was one of the 7 cases, reported by the same reporter." "No
lab data for this event."
"734564-1" "734564-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine quadrivalent. On an unknown
date, unknown after receiving Influenza vaccine quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that, 8 patients died from flu
of which 7 patients had flu shot and all eight patients were on THERAFLU. This case
was considered as suspected vaccination failure since time to onset and the lab
test confirmation for the event was unknown. No further details provided about the
product. This case was one of the 7 cases, reported by the same reporter." "No
lab data for this event."
"734569-1" "734569-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown
date, unknown after receiving Influenza vaccine Quadrivalent, the patient
experienced vaccination failure (serious criteria GSK medically significant) and
influenza (serious criteria death and GSK medically significant). On an unknown
date, the outcome of the vaccination failure was unknown and the outcome of the
influenza was fatal. The reported cause of death was influenza. It was unknown if
the reporter considered the vaccination failure and influenza to be related to
Influenza vaccine Quadrivalent. Additional details were reported as follows: The
age at vaccination was not reported. It was reported that, 8 patients died from flu
of which 7 patients had flu shot and all eight patients were on THERAFLU. This case
was considered as suspected vaccination failure since time to onset and the lab
test confirmation for the event was unknown. No further details provided about the
product. This case was one of the 7 cases, reported by the same reporter." "No
lab data for this event."
"734798-1" "734798-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown
dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent,
the patient experienced vaccination failure (serious criteria GSK medically
significant) and influenza (serious criteria death). On an unknown date, the
outcome of the vaccination failure was unknown and the outcome of the influenza was
fatal. The reported cause of death was influenza. It was unknown if the reporter
considered the vaccination failure and influenza to be related to Influenza vaccine
Quadrivalent. Additional details were reported as follows: The age at vaccination
was not reported. The consumer posted on the internet about 8 flu deaths of which,
7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on
who is to blame? It was unknown if an autopsy was performed or not. This case was
considered as suspected vaccination failure since time to onset and the lab test
confirmation for the event was unknown. This case is one of the 7 cases, reported
by the same reporter for same event." "No lab data for this event."
"734942-1" "734942-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown
dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent,
the patient experienced vaccination failure (serious criteria GSK medically
significant) and influenza (serious criteria death). On an unknown date, the
outcome of the vaccination failure was unknown and the outcome of the influenza was
fatal. The reported cause of death was influenza. It was unknown if the reporter
considered the vaccination failure and influenza to be related to Influenza vaccine
Quadrivalent unspecified season. Additional details were reported as follows: The
age at vaccination was not reported. The consumer posted on social media about 8
flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked
what's your take on who is to blame? This case was considered as suspected
vaccination failure since time to onset and the lab test confirmation for the event
was unknown. This case is one of the 7 cases, reported by the same reporter for
same event." "No lab data for this event."
"734951-1" "734951-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Flu seasonal QIV Dresden. Concomitant products included THERAFLU. On an
unknown date, the patient received Influenza vaccine quadrivalent unspecified
season at an unknown dose. On an unknown date, unknown after receiving influenza
vaccine quadrivalent unspecified season, the patient experienced vaccination
failure (serious criteria GSK medically significant) and influenza (serious
criteria death). On an unknown date, the outcome of the vaccination failure was
unknown and the outcome of the influenza was fatal. The reported cause of death was
influenza. It was unknown if the reporter considered the vaccination failure and
influenza to be related to influenza vaccine quadrivalent unspecified season.
Additional details were reported as follows: The age at vaccination was not
reported. The consumer posted on social media about 8 flu deaths of which, 7 had
the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is
to blame? It was unknown if an autopsy was performed or not. This case was
considered as suspected vaccination failure since time to onset and the lab test
confirmation for the event was unknown. This case is one of the 7 cases, reported
by the same reporter for same event." "No lab data for this event."
"734964-1" "734964-1" "This case was reported by a consumer via interactive
digital media and described the occurrence of vaccination failure in a patient who
received Influenza vaccine Quadrivalent. Concomitant products included THERAFLU. On
an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown
dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent,
the patient experienced vaccination failure (serious criteria GSK medically
significant) and influenza (serious criteria death). On an unknown date, the
outcome of the vaccination failure was unknown and the outcome of the influenza was
fatal. The reported cause of death was influenza. It was unknown if the reporter
considered the vaccination failure and influenza to be related to Influenza vaccine
Quadrivalent. Additional details were reported as follows: The age at vaccination
was not reported. The consumer posted about 8 flu deaths of which, 7 had the flu
shot and all 8 took THERAFLU. The consumer asked what's your take on who is to
blame? It was unknown if an autopsy was performed or not. This case was considered
as suspected vaccination failure since time to onset and the lab test confirmation
for the event was unknown. This case is one of the 7 cases, reported by the same
reporter for same event." "No lab data for this event."
"735234-1" "735234-1" "18 yo woman with a history of asthma was seen at ER
for asthma exacerbation on 1/14/18 at 10 AM. She was treated with DUONEB and
steroids with improvement of symptoms and was discharged on a course of prednisone.
On 1/24/18 patient was seen for well visit with Dr. during which no complaints or
abnormal exam findings were documented. A flu vaccine was administered at 3 pm. On
1/26/18 the patient was brought into hospital at 8:21 in cardiorespiratory arrest.
After 60 minutes of resuscitation efforts, the patient was pronounced dead." "No
lab data for this event."
"735308-1" "735308-1" "Approximately 8 hours after the injection, patient
suffered a massive right cerebral hemisphere stroke. He was unconscious when taken
to emergency room. He did not regain full consciousness and died on 11/17/2017."
"CAT scan 11/15/17 Massive cerebral hemorrhage (right side); Partial MRI
11/16/17 As above"
"736883-1" "736883-1" "Patient received vaccine at an on-site flu clinic
and experienced no symptoms at the time. Two months after the immunization, the
patient passed away." "No lab data for this event."
"737284-1" "737284-1" "This case was reported by a non-health professional
via local affiliate and described the occurrence of speech loss in a 4-month-old
patient who received DTaP vaccine. Co-suspect products included Rotavirus vaccine,
Hepatitis B vaccine, Poliomyelitis vaccine (IPV) and Pneumococcal vaccine. On an
unknown date, the patient received DTaP vaccine at an unknown dose, Rotavirus
vaccine at an unknown dose, Hepatitis B vaccine at an unknown dose, IPV at an
unknown dose and Pneumococcal Vaccine at an unknown dose. On an unknown date, less
than a day after receiving DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine,
the patient experienced speech loss (serious criteria death), movements reduced
(serious criteria death) and withdrawn (serious criteria death). On an unknown
date, the outcome of the speech loss, movements reduced and withdrawn were fatal.
The reported cause of death was speech loss, movements reduced and withdrawn. The
reporter considered the speech loss, movements reduced and withdrawn to be related
to DTaP vaccine, Rotavirus vaccine and Hepatitis B vaccine. Additional details were
reported as follows: This report was found in a debate article published in a
newspaper (there was no information about the source of the information and no
contact information to the author of the debate article). The Vaccination Court
believed it was proven that the patient died of vaccines. The parents visited their
pediatrician with their baby vaccinated with five different vaccines. According to
the court documents, the patient's physician described in his journal at the
physician's visit that, the patient was healthy, cooperative, well-fed and
babbling. After the physician's visit, in the afternoon, the parents noticed that
the patient was no longer babbling, the patient was instead withdrawn, silent and
moved less than before. Less than 24 hours later, the patient died. It was unknown
if an autopsy was performed or not. The reporter considered the speech loss,
movements reduced and withdrawn to be related to Poliomyelitis vaccine (IPV) and
Pneumococcal vaccine as well." "No lab data for this event."
"738249-1" "738249-1" "This case was reported in a literature article and
described the occurrence of suspected vaccination failure in a subject who received
Meningococcal ACWY-CRM vaccine. On an unknown date, less than a year after
receiving Meningococcal ACWY-CRM vaccine, the subject developed vaccination
failure. Serious criteria included death and GSK medically significant. Additional
event(s) included neisseria meningitides meningitis with serious criteria of death
and GSK medically significant and central nervous system infection with serious
criteria of death and GSK medically significant. The outcome of vaccination failure
was fatal. The outcome(s) of the additional event(s) included neisseria
meningitides meningitis (fatal) and central nervous system infection (fatal). The
reported cause of death was neisseria meningitides meningitis and central nervous
system infection. The investigator considered that there was a reasonable
possibility that the vaccination failure, neisseria meningitides meningitis and
central nervous system infection may have been cause by Meningococcal ACWY-CRM
vaccine. Additional information was provided. This case was reported in a
literature article and described the suspected vaccination failure in a patient of
unspecified age and gender who was vaccinated with unspecified quadrivalent
meningococcal (groups A, C, W, and Y) vaccine (manufacturer unknown). The patient
was the part of active surveillance for primary infectious disease deaths in a
specific group over 16 years (1998 - 2013), identified 217 deaths. This study
probably presented nearly complete capture of all specific group infectious disease
deaths resulting from: the established reporting of deaths through specific
administrative systems and aggressive follow-up of deaths by The Mortality
Surveillance Division (MSD) staff. No information on medical or family history or
concurrent condition or concomitant medication was provided. On an unspecified
date, the patient received unspecified quadrivalent meningococcal (groups A, C, W,
and Y) vaccine (administration route and site unspecified; dosages unknown; batch
number not provided). Age of vaccination was not provided. On an unspecified date,
an unknown period after vaccination, the patient had blood-borne infection. The
patient developed Neisseria meningitis infection. 2 months after vaccination, the
patient had central nervous system (CNS) death from Neisseria meningitis infection.
Typing of the isolate associated with death was not performed. It was not reported
if the autopsy was performed. This case has been considered as suspected
vaccination failure being full schedule and confirmed lab serotype was unknown.
This case has been considered serious due to death/suspected vaccination failure.
The author did not comment on the relationship between Neisseria meningitis
infection and unspecified quadrivalent meningococcal (groups A, C, W, and Y)
vaccine. The author concluded, 'The time lag between death and notification of the
MSD at the start of this surveillance program was 24 to 48 hours. The lag at the
end of the reported surveillance period was 8 to 24 hours. The MSD surveillance
system identified an agent in 140 of 217 (64.5%) uniformed deaths. In a similar
program by the Centers for Disease Control and Prevention, in 122 cases with
specimens, an agent could be identified in 34 (28%). Medical Mortality Registry
(MMR) data and information provided strong support for re-establishing the specific
group adenovirus vaccination program, which ceased in 1999 and was finally re-
established in 2011. MMR data and information also assisted in monitoring the
specific group meningococcal vaccine program, helped to describe the virulence of
circulating influenza viruses, and identified areas where deadly malaria infections
were not being prevented.'" "No lab data for this event."
"738637-1" "738637-1" "This spontaneous report was received from a medical
assistant (patient's mother) refers to 16 years old female patient. Pertinent
medical history and concomitant medication were not reported. On an unknown date in
October 2006, the patient was vaccinated with first dose of GARDASIL for
prophylaxis, lot# 0668F, expiry date 21-NOV-2008 (strength, dose were unknown) in
the office. After the first dose of GARDASIL the patient always felt tired. The
patient also complained all the time that her legs ached. It was hard for her to
get across campus because she felt very winded all the time. On an unknown date in
November 2006, the patient was vaccinated with second dose of GARDASIL in her arm.
After second vaccination, her arm would not stop bleeding and the reporter had to
hold it until it stopped bleeding. The patient became very puffy, lethargic and on
and off she'd have a sore throat. The patient had not received the third dose of
GARDASIL. It was reported that, the patient experienced 104-105 fever at home and
she kept going through ibuprofen. Her body was aching and she didn't know, her
period too that would just be prolonged, she had a sore throat and some swollen
lymph nodes. The physician thought it was tonsillitis, hence she was prescribed of
amoxicillin. After two-week round of antibiotics, the patient came back because she
hadn't gotten any better. She looked white as a ghost, very weak. The reporter had
to almost carry her into the doctor's office. The patient was very pale, she looks
anemic. The hemoglobin was 4. She had bruising on her legs and petechiae. The
patient was hospitalized. On an unknown date in March 2007, the patient was
diagnosed with leukemia. The patient received blood transfusion. The reporter
stayed in the hospital for 10 months pretty much straight. They weren't allowed to
leave because of her white blood cell count and her contacting other viruses. So,
they were allowed to leave if her blood count was high enough. On an unknown date
in October 2007, the patient experienced first coma and was supported with life
support. On 03-JAN-2008, in the morning, the reporter was informed that, her
daughter was having trouble breathing and experienced second coma. The patient's
condition got deteriorated and they couldn't tell if there was any brain function.
As of 03-JAN-2008, the patient had meningitis and sepsis. The patient died on 03-
JAN-2008 due to deterioration of leukemia. It was unknown if the autopsy was
performed. The outcome of leukemia was reported as fatal. The causality was not
reported. The reporter considered the event leukemia as serious due to
hospitalization and medically significant. Reported Cause(s) of Death: Leukemia
deteriorated." "No lab data for this event."
"739780-1" "739780-1" ""Based on information received on 15 Nov 2017, the
following information has been amended: vaccine preferred name changed from
""INFLUENZA QUADRIVALENT RECOMBINANT VACCINE"" to ""INFLUENZA VACCINE"". Initial
unsolicited case received from a consumer (patient wife) via other company Astellas
Pharma under the MFR control number: 2016US015482 on 15 Nov 2017. This case
involves 67-year-old male patient who was vaccinated with a dose of INFLUENZA
VACCINE and a dose of PNEUMOCOCCAL VACCINE (Batch numbers, expiry date, dose, dose
in series, route and site of administration were not reported for both the
vaccines) on 07 Nov 2016. The patient also started treatment with 160 mg and 120 mg
dose of XTANDI (Manufacturer: Astellas Pharma) (Batch numbers reported as 1539683PC
and 1543982PC, expiry date not reported) daily once orally from an unknown dates
for prostate cancer with metastasis and metastatic castrate resistant prostate
cancer. (It was reported as patient had no changes after starting the drug and
patient was enrolled in patient support program). Patient current condition was
reported as pain. Other medical history was not reported. Concomitant medications
were not reported. On an unknown date, after receiving the treatment with XTANDI,
patient developed first episode of fatigue. On an unknown date in Jul 2016 and Oct
2016, after receiving the treatment with XTANDI, patient developed fatigue (second
and third episode). On an unknown date in Nov 2016, following the vaccination and
after the administration of XTANDI patient developed soreness in the arm and
achiness at injection sites. On an unknown date, following the vaccination and
after the administration of XTANDI, patient developed bruising, depression, hot
flashes, loss of appetite, joint aches and headache. On an unknown date, following
the vaccination and after the administration of XTANDI, patient died due to unknown
cause. Patient relevant lab tests and corrective treatment were not reported. The
outcome of the events fatigue, Hot flashes, soreness in the arm and achiness at
injection sites were reported as not recovered and the outcome of all the other
events were not reported. It was not known, whether autopsy was performed to the
patient. The patient wife assessed the causal relationship between the suspect drug
XTANDI and with the event soreness in arm as not related. List of documents held by
sender: none. Sender's Comments: The patient died post vaccination with influenza
vaccine (Mfr Unk) and Pneumococcal vaccine. Time to onset was not reported. Patient
had an ongoing medical condition of prostate cancer with metastasis and metastatic
castrate resistant prostate cancer for which he was being treated with XTANDI. No
autopsy results were available. Reported events may be related to preexisting
medical condition which could have as well resulted in death. Based upon reported
information the role of the vaccine cannot be established. Autopsy report
confirming the cause of death is required to further assess the case. Reported
Cause(s) of Death: Deceased."" "No lab data for this event."
"740050-1" "740050-1" "Patient died at 5:15 the same day--- his wife
performed cpr on patient until medical help arrived." "We have none available to
us"
"740671-1" "740671-1" ""This case was reported in a literature article and
described the occurrence of acute appendicitis in a 18-day-old male patient who
received Hepatitis B vaccine. Concurrent medical conditions included thrush (at ten
days old and was managed with nystatin). Concomitant products included nystatin. On
an unknown date, the patient received Hepatitis B vaccine at an unknown dose. On an
unknown date, 18 days after receiving Hepatitis B vaccine, the patient experienced
acute appendicitis (serious criteria death, hospitalization and GSK medically
significant), appendicitis perforated (serious criteria death, hospitalization and
GSK medically significant), serositis (serious criteria death and hospitalization),
megacolon (serious criteria death, hospitalization and GSK medically significant),
fever neonatal (serious criteria hospitalization and GSK medically significant),
pulseless electrical activity (serious criteria hospitalization and GSK medically
significant), hypokalemia (serious criteria hospitalization and GSK medically
significant), obtundation (serious criteria hospitalization and GSK medically
significant), hypoxia (serious criteria hospitalization and GSK medically
significant), metabolic acidosis (serious criteria hospitalization), feeding
disorder (serious criteria hospitalization), abdominal tenderness (serious criteria
hospitalization), leukocytosis (serious criteria hospitalization), abdominal
distension (serious criteria hospitalization), edema (serious criteria
hospitalization), anisocoria (serious criteria hospitalization), contusion of trunk
(serious criteria hospitalization), absent reflex (serious criteria
hospitalization), movements reduced (serious criteria hospitalization), distended
bowel (serious criteria hospitalization), hypoglycemia (serious criteria
hospitalization), wide complex tachycardia (serious criteria hospitalization),
irritability (serious criteria hospitalization) and hypotension (serious criteria
hospitalization). The patient was treated with antibiotics NOS. On an unknown date,
the outcome of the acute appendicitis, appendicitis perforated, serositis and
megacolon were fatal and the outcome of the fever neonatal, pulseless electrical
activity, hypokalemia, obtundation, hypoxia, metabolic acidosis, feeding disorder,
abdominal tenderness, leukocytosis, abdominal distension, edema, anisocoria,
contusion of trunk, absent reflex, movements reduced, distended bowel,
hypoglycemia, wide complex tachycardia, irritability and hypotension were unknown.
The reported cause of death was appendicitis. An autopsy was performed. The autopsy
determined cause of death was serositis, megacolon and appendicitis perforated. The
reporter considered the acute appendicitis, appendicitis perforated, serositis,
megacolon, fever neonatal, pulseless electrical activity, hypokalemia, obtundation,
hypoxia, metabolic acidosis, feeding disorder, abdominal tenderness, leukocytosis,
abdominal distension, edema, anisocoria, contusion of trunk, absent reflex,
movements reduced, distended bowel, hypoglycemia, wide complex tachycardia,
irritability and hypotension to be related to Hepatitis B vaccine. Additional
information was provided. This case was reported in a literature article and
described the occurrence of acute neonatal appendicitis in a 18-day-old male
patient who was vaccinated with unspecified hepatitis-B virus vaccine (manufacturer
unknown). The patient was born at full term via spontaneous vaginal delivery
following an unremarkable pregnancy. No information on patient's medical history or
family history was provided. On an unspecified date shortly after birth, the
patient received unspecified hepatitis-B virus vaccine (administration route and
site unspecified; dosages unknown; batch number not provided). The patient stayed
in the newborn nursery for two days prior to discharge. At 10 days old, the patient
was diagnosed with thrush and was managed with nystatin. On an unspecified date, 19
days after vaccination, the patient presented at an emergency department with 1-day
complaints of increased fussiness and difficulty feeding and was noted to have
slightly distended and tender abdomen (a clinical picture of a possible small bowel
obstruction). A septic workup was performed and included a complete blood count
(CBC) (revealed leukocytosis of 28.5k/UL), a negative blood culture, a lumbar
puncture (clear fluid with a negative Gram stain), urinalysis (25mg/dL protein with
negative nitrite and leukocyte esterase), and elevated C-Reactive Protein (CRP)
(194.6mg/L). The patient was subsequently started on antibiotics for neonatal
fever. During his three days of hospitalization, the clinic team requested a
transfer to the paediatric Intensive Care Unit (ICU) due to worsening of abdominal
distension, increasing white count to 43.81k/UL, and suspicions of small bowel
obstruction. The patient further deteriorated during transfer and was significantly
obtunded on arrival to the paediatric ICU. He was grossly oedematous, with
abdominal distension, anisocoria, bruising along the right flank, absence of
reflexes, and minimal spontaneous movement. Radiographic studies performed included
a Kidneys, Ureter, and Bladder (KUB) (showed absence of air in the rectum, oedema
of the bowel walls, but no free air on cross table film), an abdominal X-ray
(showed a mild-to-moderate degree of gaseous distension of the bowel), and a chest
X-ray (showed bilateral pulmonary opacities). The patient was acutely managed for
hypoxia associated with severe metabolic acidosis, hypokalaemia, hypotension, and
hypoglycemia. He subsequently had several episodes of recurrent wide complex
tachycardia and pulseless electrical activity. After multiple resuscitations, the
patient was pronounced dead several hours after the transfer. An autopsy was
performed and the most significant findings were gangrenous appendicitis with
evidence of rupture and marked acute serositis identified in the rectal serosa and
focally in the mesenteric peritoneum. There was dilation of the transverse colon
and proximal descending colon but no obstruction of the bowel was identified. This
case has been considered serious due to death/hospitalisation. The author did not
comment on the relationship between the event of acute neonatal appendicitis and
unspecified hepatitis-B virus vaccine. The authors stated, ""Acute neonatal
appendicitis is more common in males, with up to a half of all reported cases
involving premature infants. The different factors attributing to the low incidence
include funnel-shaped appendix with a wide opening into the cecum, soft liquid
diet, lack of faecalith, recumbent posture, and the presumed infrequent occurrence
of viral-induced lymphatic hyperplasia in the periappendiceal region. Perforation
plays a significant role in determining the prognosis. Due to the delayed diagnosis
and management, the incidence of perforation and subsequent peritonitis is high in
neonatal appendicitis. Other factors con" "Lab tests performed on unspecified
dates. Radiographic studies performed included a Kidneys, Ureter, and Bladder (KUB)
(showed absence of air in the rectum, oedema of the bowel walls, but no free air on
cross table film. Abdominal X-ray, Distended bowel; Blood culture, negative; C-
reactive protein, 194.6 mg/L, elevated; Chest X-ray, bilateral pulmonary opacities;
Full blood count, leukocytosis; Gram stain, negative; Lumbar puncture, clear fluid
with a negative Gram stain; Nitrite urine, negative; Protein urine, 25 mg/dL; Urine
leukocyte esterase, negative; White blood cell count, 43800/uL, elevated; White
blood cell count, 28500/uL"
"740847-1" "740847-1" "On 03/13/2018 this patient expired with SIDS. This
report is being generated because do not know if vaccines were a contributing
factor. There was smoking around child, and child had been sleeping with mother at
checkup visit." "none"
"741848-1" "741848-1" "Patient expired." "No lab data for this event."
"742230-1" "742230-1" ""This initial spontaneous report was received from
the mother of a ""college aged"" female patient via a company representative.
Concurrent conditions included an unspecified heart condition. Concomitant
medications were not provided. On unspecified dates, the patient received her
first, second and third doses of the human papilloma virus (HPV) vaccine
(manufacturer not specified). The company representative stated she had heard of a
mother (gave mother's first name) who was telling people that her daughter died
after receiving the third dose of a series of HPV vaccine. It was not stated which
HPV vaccine the patient received. The mother has already filed a federal lawsuit.
The cause of death was not specified. Upon internal review, death was considered
medically significant. Additional information is not expected as there was no
contact information."" "No lab data for this event."
"742777-1" "742777-1" "24-48 hours after patient received vaccines, Patient
was found dead in crib, no clearly identifiable cause of death." "No lab data for
this event."
"743048-1" "743048-1" "AE reported to pharmacy team member on 3-28-18 that
patient is deceased as of 3-16-18. No additional details provided." "Unknown"
"743123-1" "743123-1" "Patient received immunizations on 2/8/18. She
presented to ED on 2/11/18 in respiratory distress/ septic shock and passed away
the same day, presumably from Influenza B." "No lab data for this event."
"743156-1" "743156-1" "Found unresponsive the next morning face down in
bassinet. Survived unresponsive ~ 1 week." "No lab data for this event."
"743343-1" "743343-1" "Patient's granddaughter stated that the evening that
the vaccine was received (4/3), the patient was having difficulty breathing with
cough and sinus inflammation. The patient had no other symptoms the next morning
(4/4), but she took a nap later in the morning and didn't wake up." "No lab data
for this event."
"743378-1" "743378-1" "This case was reported by a pharmacist via call
center representative and described the occurrence of heart disease, unspecified in
a 62-year-old male patient who received SHINGRIX (batch number XC534, expiry date
4th July 2020). The patient's past medical history included hypertension and
diabetes. On 27th March 2018 11:30, the patient received SHINGRIX. On 27th March
2018 18:00, 6 hrs 30 min after receiving SHINGRIX, the patient experienced heart
disease, unspecified (serious criteria death). On 27th March 2018 18:00, the
outcome of the heart disease, unspecified was fatal. The patient died on 27th March
2018. The reported cause of death was heart disease, unspecified. It was unknown if
the reporter considered the heart disease, unspecified to be related to SHINGRIX.
Additional details were provided as follows: At 6 pm, the patient passed away. The
healthcare professional explained that the coroner reported that the patient passed
away due to heart issues etc. The pharmacist was sure that the patient also passed
away due to heart issues. The pharmacist called into medical information to confirm
that other patients had not passed away due to the SHINGRIX vaccine." "No lab data
for this event."
"743431-1" "743431-1" "This spontaneous report was received from a non-
healthcare professional via Pfizer refers to a 17 years old female patient.
Patient's medical history and concomitant medications were not reported. On an
unknown date, the patient was vaccinated with GARDASIL (dosing information was not
provided) for prophylaxis. On an unknown date, the patient died. It was unknown if
the autopsy was performed. The cause of death was unknown. Reporter considered the
event to be related to GARDASIL. Upon internal review, death was determined to be
medically significant. This is one of the two reports received from the same
reporter.; Reported Cause(s) of Death: unknown cause of death." "No lab data for
this event."
"743447-1" "743447-1" "Patient's daughter came to the pharmacy at 5:30PM
on 4/5/2018 and informed us patient died." "Don' t know the cause of death.
Tried calling family and unable to reach them."
"743633-1" "743633-1" "This is a spontaneous report from a Pfizer-sponsored
program comScore Quant Concept Testing. A contactable consumer reported for a
female patient (his/her mother) of an unspecified age and race who received PREVNAR
13 at single dose on unknown date for immunization via unspecified route. Relevant
medical history and concomitant medication were unknown. The patient died of
pneumonia. No follow-up attempts are possible; information about batch number
cannot be obtained. No further information is expected. Reported Cause(s) of Death:
Died of pneumonia." "No lab data for this event."
"744185-1" "744185-1" "Extreme congestion (runny nose, etc) starting about
a week after birth/vaccination and up until his death on 10/28/17." "N/A"
"744430-1" "744430-1" ""This spontaneous report has been received from a
physician via a company representative referring to a male patient of unknown age
reported as ""in his 80's or 90's"". Information regarding the patient's medical
history, drug reactions or allergies, concurrent conditions and concomitant
medications was not reported. On an unknown dates ""for five consecutive years"",
the patient was vaccinated with one dose of PNEUMOVAX 23 (strength, dose, route,
anatomical location, lot # and expiration date were not provided) for prophylaxis.
On an unknown dates ""for five consecutive years"", the patient was hospitalized
for pneumonia and while he was still sick, received a dose of PNEUMOVAX 23 every
time he was hospitalized. It was also mentioned, that the PNEUMOVAX 23 was
ineffective in preventing pneumonia for the patient (drug ineffective).
Subsequently, on an unknown date, the patient died from an unknown cause. It was
not known if an autopsy was performed. At the reporting time, the outcome of
pneumonia, drug ineffective and malaise were unknown. The causality assessment
between therapy with PNEUMOVAX 23 and the events was not reported. Upon internal
review, pneumonia was determined to be medically significant. This is one of two
cases from the same reporter. Sender's Comments: US-009507513-1804USA004352:
Reported Cause(s) of Death: Cause of death unknown."" "No lab data for this event."
"744493-1" "744493-1" ""This case was reported in a literature article and
described the occurrence of unknown cause of death in a adult subject who received
Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B
vaccine, the subject developed unknown cause of death. Serious criteria included
death and GSK medically significant. The outcome of unknown cause of death was
fatal. The reported cause of death was unknown cause of death. It was unknown if
the investigator considered the unknown cause of death to be related to Hepatitis B
vaccine. Additional information was provided. This case was reported in a
literature and described death not otherwise specified (NOS) in a patient aged
between 18 and 70 years of unspecified gender who was vaccinated with ENGERIX
(GlaxoSmithKline). The patient was part of a post hoc analysis that compared the
safety of HBsAg-1018 with ENGERIX-B, in 3 randomised, observer-blinded, active-
controlled, multi-center phase 3 trials in adults. Eligible participants in HBV-10
and HBV-16 were generally healthy volunteers but HBV-23 did not specify that
participants must be generally healthy. Subjects in all three pivotal trials were
serum negative for HBsAg, anti-HBs, and anti-HBc; had no history of HBV infection;
had no history of prior immunization with any hepatitis B vaccine; did not have
human immunodeficiency virus infection; had no autoimmune disease; and were not
pregnant. No information on patient's family history or concomitant medication was
provided. On an unspecified date, the patient received ENGERIX intramuscularly
(administration site unspecified, dosage unknown; batch number not provided). [In
this study, ENGERIX-B (GlaxoSmithKline Biologicals) consists of 20 mcg of
recombinant HBsAg combined with 0.5 mg of aluminum hydroxide adjuvant per 1.0 mL
dose. Participants in the ENGERIX-B group received the Food and Drug Administration
(FDA) approved regimen of intramuscular injections at weeks 0, 4, and 24]. The age
at vaccination was not provided. On an unspecified date, and unknown period after
vaccination, the patient died. It was reported that the patient died due to illicit
or therapeutic drug overdose. It was unknown if an autopsy was performed. This case
has been considered serious due to death. The authors commented ""Most deaths
occurred in participants with significant pre-existing disease, comorbidities, or
contributory social circumstances. The only imbalance in causes of death between
the vaccine groups was in deaths due to illicit or therapeutic drug overdose
(HBsAg-1018: n: 6 HBsAg-Eng: n:1"". The authors concluded ""the safety profile of
HBsAg-1018 is similar to that of ENGERIX-B with vaccine-associated adverse events
limited to mild to moderate local and systemic post-injection reactions. There is
no evidence for a causal association between HBsAg-1018 and autoimmune or
cardiovascular events. Although current hepatitis B vaccines have addressed a
medical need in infants and adolescents, there remains a large unmet need in
adults. A two dose hepatitis B vaccine with an acceptable safety profile should
provide improved seroprotection and a significant public health benefit to adults
18 years of age or older"". This is 1 of the 4 valid cases reported in the same
literature article."" "No lab data for this event."
"744725-1" "744725-1" "The following is verbatim from the article:
BACKGROUND: Influenza-associated pediatric deaths became a notifiable condition in
2004. METHODS: We analyzed deaths in children aged less than 18 years with
laboratory-confirmed influenza virus infection reported to the Centers for Disease
Control and Prevention during the 2010-2011 to 2015-2016 influenza seasons. Data
were collected with a standard case report form that included demographics, medical
conditions, and clinical diagnoses. RESULTS: Overall, 675 deaths were reported. The
median age was 6 years (interquartile range: 2-12). The average annual incidence
was 0.15 per 100 000 children (95% confidence interval: 0.14-0.16) and was highest
among children aged less than 6 months (incidence: 0.66; 95% confidence interval:
0.53-0.82), followed by children aged 6-23 months (incidence: 0.33; 95% confidence
interval: 0.27-0.39). Only 31% (n = 149 of 477) of children aged 6 months had
received any influenza vaccination. Overall, 65% (n = 410 of 628) of children died
within 7 days after symptom onset. Half of the children (n = 327 of 654) had no
preexisting medical conditions. Compared with children with preexisting medical
conditions, children with none were younger (median: 5 vs 8 years old), less
vaccinated (27% vs 36%), more likely to die before hospital admission (77% vs 48%),
and had a shorter illness duration (4 vs 7 days; P less than .05 for
all).CONCLUSIONS: Each year, influenza-associated pediatric deaths are reported.
Young children have the highest death rates, especially infants aged less than 6
months. Increasing vaccination among children, pregnant women, and caregivers of
infants may reduce influenza associated pediatric deaths. This case involves a two
patients (age reported as less than seven months) who were partially vaccinated
with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, route and site
of administration were not reported) on an unknown date. The patient's medical
history and concomitant medications were not reported. On an unspecified date, post
vaccination, the patient died due to influenza. The patients were less than 7
months of age and therefore did not have time for full vaccination before death.
The median time from symptom onset to death was 5 days (IQR: 2-11 days). Relevant
lab investigations and corrective treatment were not reported. It was not reported
if the autopsy was performed or not. List of documents held by sender: none.
Sender's Comments: This literature article describes two patients (less than 7
months of age, other details unknown) who died in association with Influenza
infection. These patients were partially immunized with Influenza vaccine (unknown
manufacturer). It is not a case of vaccination failure as complete immunization
schedule was not followed. Time to onset, type and serotype of influenza infection
are not reported. Based upon the reported information, the role of vaccine cannot
be assessed. Reported Cause(s) of Death: Influenza." "No lab data for this event."
"745519-1" "745519-1" "He was normal. He went to sleep and never woke up.
11 days after his vaccines." "Unknown"
"747685-1" "747685-1" "Death on 05/04/2018 from unknown causes at this
time. Vaccines given on 05/03/2018 in office." "Unknown at this time."
 "748549-1" "748549-1" "Diarrhea, nausea, dehydration, loss of weight,
weakness, loss of appetite. On May 31, 2017, my husband went to the hospital for
his annual checkup. At that time his primary care doctor commented that he was in
very good shape for an 83 year old man. Then he gave him a pneumonia shot, PREVNAR
13. He said that it might make him a little sick but that would go away. Within a
day or so he began feeling bad, threw up every thing he ate, got severe diarrhea
and got very weak. Started getting dehydrated, and lost weight. We took him to the
doctor again and he ran tests. The doctor was very surprised at how he looked. Even
commented that he looked awful. Sent him home with some medication. But within a
few days we took him back to the Emergency Room. They sent him home with
medication. A few days later we took him to the emergency room again. And then to
an other Emergency room. Still no results. Back to the hospital, and they were
required to admit him They ran many tests. CT scan, MRI. Then one night he
developed a heart problem (he never had any heart issues up till then). They moved
him to another hospital. Cardiac ward. They did more tests and found that he had 2
massive strokes. He died on July 15, 2017. Up until the time he got that PREVNAR 13
shot he was a very healthy man. At 83 years old he could outwork a man 40 years
old. He never had any heart issues. The most health problem he had was a prostate
problem. Which he was being treated for. None of the doctors could find a reason
for him being so sick. It all started with the shot that he was given on May 31. I
would like some answers. What killed him? Was it the shot?""MRI; CT scan; many
blood tests"
"749388-1" "749388-1" ""This spontaneous report was received from a
physician via a company representative. The physician heard about this shingles
case study which was presented during a meeting, referring a male patient of an
unknown age. The patient was considered ""immunosuppressed"" and he had a
transplant surgery in an unspecified date for an unspecified cause/reason.
Information regarding drug reactions, allergies or concomitant medications was not
mentioned. In an unspecified date in 2012, the patient was vaccinated with ZOSTAVAX
(dose, anatomical location and patient route of administration, lot # and
expiration date were not reported). On an unmentioned date, after getting
vaccinated the patient experienced disseminated shingles virus. It was unknown
which the outcome of shingles was. Furthermore, on an unspecified date due to an
unspecified cause the patient died. It was not known if an autopsy was performed.
The causal relationship between shingles and death, with vaccination with ZOSTAVAX
was not reported. Upon internal review, the event Herpes zoster disseminated was
considered to be medically significant.; Reported Cause(s) of Death: died due to an
unspecified cause."" "No lab data for this event."
"749562-1" "749562-1" "My two month old daughter passed a week after
receiving shots." "don't have"
"750873-1" "750873-1" "Patient was seen for WCC on 5-17-2018 vaccines
administered. Returned to clinic on 5-18-2018 triaged had a temp of 101.4 assessed
by an FNP reassurance given along with the 24 hour triage line. Family traveled he
was given IV fluids and subsequently transferred to an ED, received one dose of
ceftriaxone 50mg/kg then transferred to another ED for a higher level of care. An
LP was performed which showed findings consistent with meningitis WBC 62, RBC 75,
Protein greater than 600, Glucose less than 2, culture positive fror gram-positive
cocci in pairs. Given one dose of Vanco and transferred to PICU where he stayed for
2 days he passed away 05-22-2018 at 1842." "LP was performed which showed
findings consistent with meningitis WBC 62, RBC 75, Protein greater than 600,
Glucose less than 2"
"751362-1" "751362-1" "This case was reported by a physician via call
center representative and described the occurrence of death NOS in a 3-month-old
male patient who received HIBERIX (batch number 73T35, expiry date 9th June 2019).
The patient's past medical history included prematurity. On 17th May 2018, the
patient received the 1st dose of HIBERIX (intramuscular) .5 ml. On 19th May 2018, 2
days after receiving HIBERIX, the patient experienced death NOS (serious criteria
death and GSK medically significant). On 19th May 2018, the outcome of the death
NOS was fatal. The reported cause of death was death. It was unknown if the
reporter considered the death NOS to be related to HIBERIX. Additional details were
provided as follows: The patient was born prematurely. The estimated delivery due
date was 8th April 2018 and his birth weight was 1.440 kg. At 12:00 the patient
received HIBERIX in the right thigh. There was no cause of death known. The patient
was taken to the emergency room where he was pronounced dead." "No lab data for
this event."
"752841-1" "752841-1" "By October 8th patient felt extreme shoulder pain.
On 10/23/17 appt. with Dr. - given 10-23-17 appt. with Dr.-given complete physical.
Diagnosis: frozen shoulder. Five additional appointments - condition appointments-
condition worsened. Twelve appointments with PT - no Therapist-no improvement. Pain
spread throughout body, limb weakness, weight loss, could not hold eating utensils.
Doctor and Physical Therapist Providers both recommended neurology group/no appt.
until 02-03-18 apt until 2-03-18 died waiting. My husband was an active active,
robust man until this vaccine shot. He weighed 175 pounds on October 1st, 2017, and
at his last appointment on January 3rd, 2018, he registered 150 pounds. He could
not hold a fork or juice glass. Both Dr. and Therapist said they could no longer
help him and recommended the Neurologist Neurologists the first week in January.
His appointment was set for February 3rd and he called every day to see if there
was a cancellation; but he died 10 ten days before. He awakened at 1:00 to use the
bathroom. When his legs gave out, I called 911 and did chest thrusts. The ambulance
took him to the Hospital hospital where he died within one hour. Therapist said
from his first appointment, on November 15th, that the cause was the flu shot. All
symptoms point to Chronic Inflammatory Demyelinating Polyneuropathy. Here is a
strong man who had never been hospitalized since a tonsillectomy at age 5 who dies
from a vaccination designed to keep him healthy. What are the statistics of death
from a flu shot? What compensation for wrongful death is covered by the FDA?
Pharmacy certainly shuns responsibility for having an inexperienced girl administer
the shot. I think there should be a precise warning given at the time of the shot,
shot as opposed to the generic list of possible side effects. We wasted months
treating a frozen should shoulder rather than see seeing a neurologist. I have
saved all receipts and reports in my file. And you are welcome to verify husband's
patient's physical condition from any of the 136 units in our condo who saw him
walking daily, fishing, playing tennis, etc. You can also check with our neighbors
who saw him boating, cycling, gardening, etc. etc.. One week before the vaccination
he drove 1600 miles (with overnight stops along the way, of course). I will, and
do, miss my loving husband of fifty three years-as years - as do our children and
his twin sister. It is a difficult time for all of us." "Blood work-normal 10-
23-17; Complete physical-normal 10-23-17; MRI 10-25-17 mild arthropathy"
"753090-1" "753090-1" "This initial Literature serious spontaneous case,
was received from health professional (Physician) on 25-Sep-2017, concerning a 09-
year-old male child patient. On an unspecified date, the patient was administered
with influenza vaccine, (dose, route of administration, anatomical location, batch
number, expiry date, manufacture and trade name was not provided). A 9-year-old
otherwise healthy male presented to the emergency department (ED) with 3 weeks of
decreased energy, decreased appetite, and a 2-week history of persistent cough. The
patient was initially seen at an outside hospital ED 2 weeks before this most
recent ED visit, predominantly for cough, and was discharged home with albuterol
without a specific diagnosis. Two days after his initial ED visit, he went to see
his primary care physician, was diagnosed with croup, and prescribed a 5-day course
of dexamethasone. On an unspecified date, after the administration of vaccine, the
patient started coughing again, predominantly at night. Three days prior, he was
seen again by his primary care physician and was diagnosed with mycoplasma
pneumonia. On the same day, a rapid strep was sent and it was negative. The patient
was started on a 5-day course of azithromycin but had persistent and worsening
cough. The morning of his visit to the ED, the patient was seen by his primary care
physician and was given an albuterol treatment, which helped his cough. He was
noted to be febrile to 101-degree F at his physician's office. This was the first
time during his course of illness that he had a fever. His cough was now also
associated with rhinorrhea and mild sore throat. On an unspecified date, chest x-
ray (CXR) was performed, which showed right lower lobe pleural effusion. On review
of systems, he denied any chest pain, abdominal pain, nausea, vomiting, diarrhea,
constipation, rashes, myalgia, arthralgia, weight loss, or night sweats. He had no
recent travel or sick contacts, and there was no known human immunodeficiency virus
or tuberculosis exposure. He was living with his mother who did not know his
complete past medical history, but she stated that he was healthy, his
immunizations were up to date, and he did not have any known allergies. His family
history was unknown. He was taking albuterol as needed for cough and was on day 3
of 5 of azithromycin when he presented to ED for further evaluation. On an
unspecified date in initial examination, he was well appearing and active but noted
to be coughing frequently. His vital signs revealed a temperature of 37.20 degrees
C, a heart rate of 106 beats per minute, a respiratory rate of 32 breaths per
minute, a blood pressure of 95/62 mmHg, and an oxygen saturation of 97% on room
air. His weight was 36.9 kg. His head and neck exam was notable only for mild
rhinorrhea. He had full range of motion at the neck with no evidence of cervical
lymphadenopathy. On an unspecified date, cardiac examination was performed, which
showed a regular rate and rhythm, a harsh 2/6 systolic murmur at the left lower
sternal border with no evidence of rubs or gallops, and normal central and
peripheral pulses. It was reported that, the patient's family was not aware that he
had a heart murmur. On an unspecified date, on pulmonary examination, the patient
had coarse breath sounds bilaterally with intermittent crackles and decreased
breath sounds in the right lower lobe, without increased work of breathing or
tachypnea. He had a persistent dry cough, worse when supine, with significant
orthopnea. No axillary lymphadenopathy was noted. His abdomen was soft, non tender,
and with normal bowels sounds. There was no hepatosplenomegaly, but slight
generalized voluntary guarding was noted. On an unspecified date, genito-urinary
examination was performed which was unremarkable, and there was no noted inguinal
lymphadenopathy. On an unspecified date, musculoskeletal examination was performed,
where the patient had a normal gait, full range of motion at all joints, and no
evidence of edema or swelling. On an unspecified date, neurological examination was
performed, where the patient had no focal neurological deficits and his cranial
nerves were intact laboratory evaluation was significant for a white blood cell
count of 14,600 (with 66% segmented neutrophils, 22.7% lymphocytes, and 9.5%
monocytes). His hemoglobin was 12 g/dL, and his hematocrit was 34%. Platelets are
within normal limits at 312,000 per micro liter. Inflammatory markers were elevated
with a C-reactive protein of 6.2 mg/dL and an erythrocyte sedimentation rate of 108
mm/h. Coagulation studies were within normal limits: prothrombin time, 11.8
seconds, international normalized ratio, 1.8; and partial prothrombin time, 26
seconds. Lactic dehydrogenase was elevated at 1078 U/L, and uric acid was within
upper limits of normal at 5.4 mg/dL. Electrolytes were within normal limits, as
were his bilirubin and liver transaminase. His previously obtained CXR was solely
an anterior/posterior view. On an unspecified date, CXR (X ray) with both
anterior/posterior and lateral was performed again noted the right lower lobe
pleural effusion as well as the right round paratracheal/anterior mediastinal mass
with a slight leftward shift of mediastinal structures. On an unspecified date,
computed tomography (CT) scan of the chest, abdomen, and pelvis was performed,
which showed a heterogeneous anterior mediastinal mass causing significant tracheal
narrowing and deviation. The left innominate and subclavian veins were not seen,
likely owing to mass effect. A moderate size right pleural effusion and a small
pericardial effusion were also noted. In addition, there was narrowing of the
superior vena cava. No abdominal or pelvic abnormalities were noted. This
constellation of findings was consistent with malignant neoplasm with lymphoma the
most likely etiology. During his ED course, the patient had episodes of unrelenting
cough, stating that he was unable to catch his breath. During these episodes, he
would be tachycardic to the 150 seconds and his saturation would decrease to 90% on
room air. He was extremely anxious and agitated. Oxygen was administered via a non-
rebreather mask, subsequent to which the patient calmed down and had improved vital
signs. Once calm, he was weaned back to room air and maintained oxygen saturations
around 93% to 95%. He was given nebulized saline and racemic epinephrine
treatments, which seemed to alleviate his symptoms. He was transitioned to 1 L of
oxygen via nasal cannula, and his oxygen saturation rose to 98%. Oncology was
consulted, and at that time, there was discussion about pursuing emergent radiation
versus observing the patient after initiating high dose steroids. Given his
inability to tolerate the supine position, he was admitted to the pediatric
intensive care unit on high-dose steroids. Allopurinol and rasburicase were given
before steroids to reduce the risks of tumor lysis syndrome and major electrolyte
instability. At the time" "On an unspecified date, rapid test was performed
which showed negative results. On an unspecified date, Chest X ray was performed
which revealed a right lower lobe pleural effusion. On an unspecified date, the
patient's head and neck examinations were performed which showed mild rhinorrhea.
He had full range of motion at the neck with no evidence of cervical
lymphadenopathy. On an unspecified date, cardiac examination was performed, which
showed a harsh 2/6 systolic murmur at the left lower sternal border with no
evidence of rubs or gallops, and normal central and peripheral pulses. On an
unspecified date, pulmonary examination showed coarse breath sounds bilaterally
with intermittent crackles and decreased breath sounds in the right lower lobe,
without increased work of breathing or tachypnea. On an unspecified date, Physical
examination was performed, which showed that the patient's abdomen was soft,
nontender with normal bowels sound. There was no hepatosplenomegaly, but slight
generalized and no axillary "
"754900-1" "754900-1" "This case was reported by a physician via call
center representative and described the occurrence of death nos in a adult patient
who received SHINGRIX for prophylaxis. On an unknown date, the patient received
Shingrix at an unknown dose. On an unknown date, less than a year after receiving
SHINGRIX, the patient experienced death nos (serious criteria death,
hospitalization and GSK medically significant). On an unknown date, the outcome of
the death nos was fatal. The reported cause of death was unknown cause of death.
The reporter considered the death nos to be related to SHINGRIX. Additional details
were provided as follows: The age at vaccination was not reported. The physician
reported that, one of his patient told him that she did not want to get the 2nd
shot of SHINGRIX because of what the patient overheard beauty parlor talk that
someone was admitted to the hospital and died from the SHINGRIX vaccine. The
physician did not have any additional information regarding the patient who died
from the SHINGRIX.; Reported Cause(s) of Death: Unknown cause of death." "No
lab data for this event."
"755074-1" "755074-1" "Both my identical twin daughters received an oral
liquid vaccination as well as 3 shots to both their upper thighs on Friday, June 1,
23018 around 3 pm. Later that evening, approx 4 hours later, my daughter was having
what I would now consider being neurological issues, flailing of the arms and legs
and twitching. I kept an eye on her and it seemed to calm down some. I was informed
that the emergency room doesn't really do much for infants so I did not take her to
the hospital. Saturday, June 2, 2018, around 10 am both my girls were running
ridiculously high fevers, I called their Pediatrician and informed her about what
was happening to them. and she made the comment that they had been switching around
the vaccinations because they were causing infants to have high fevers. She
informed me to give them Tylenol. I did and the fevers did go down. Around 2 am
Sunday, June 3, 2018, I rechecked their temperature for the 3rd or 4th time and I
was happy to see they both had low-grade fevers of 99.2 and 99.1, Patient's being
99.2. I Fed both girls again around 5:30 a.m. they went back to sleep. I went back
into their room to check on them because they were being fussy so i put them on
their bellies and that seemed to calm them down and they went back to sleep. I
awoke around 7:30 a.m. to my baby dead in her crib. She was still on her stomach, I
believe she was face down but cannot remember 100%. When I flipped her over she had
blood coming out of her nose and she was dead. She was still warm as if she were
sleeping, her sister is just fine. We attempted CPR while waiting on the ambulance.
She was rushed to the emergency room where they were unable to revive her. I cannot
accept that it was caused by anything other than those vaccinations. We are
currently waiting for the Autopsy Report to come back. We had her sister checked
out by their Pediatrician the same day and she is just fine." "She had an
Autopsy done but I have yet to receive the results."
"755211-1" "755211-1" "This spontaneous report was received from a
Registered Nurse via a company representative referring to a 15 month old female
patient. The patient's concurrent conditions included hypertrophic cardiomyopathy.
There was no concomitant medications reported. On 14-JUN-2018, the patient was
vaccinated with VAQTA 25/0.5 (dose, route, lot number and expiration date were not
reported) for prophylaxis. Other suspect therapies administered on that same date
included VARIVAX (dose, route, lot number and expiration date were not reported)
and another unspecified vaccine, both administered for prophylaxis. On 15-JUN-2018,
the patient was lethargic and was taken to the office, later she was taken to the
hospital and was admitted. The nurse reported that patient died next day (16-JUN-
2018). It was also informed that an autopsy was done, but the results were not
available at the reporting time. The nurse reported that patient was a twin and
that the other unspecified 15 month old twin also received the same vaccinations
(no further information was provided). The causality assessment between the events
and the suspect therapies was not provided. The event lethargy was considered as
disability and life threatening as serious criteria by the reporter.; Reported
Cause(s) of Death: death." "No lab data for this event."
"756119-1" "756119-1" "Immediately following the SHINGRIX injection,
patient complained of pain at the injection site. Patient was advised to take
TYLENOL to relieve symptoms. Six days following the injection on 5-29-18, the
patient's daughter came to the pharmacy to explain her mother was experiencing
continued pain, fever, loss of appetite, nausea, lethargy, and malaise. The
pharmacist advised the patient to supplement her hydration with extra electrolytes
to prevent dehydration and for the patient to seek further evaluation/treatment at
urgent care. Two days later on 5-31-18 the patient's daughter returned to pharmacy
again to report patient was feeling better. On June 17, 2018, a different daughter
called the pharmacy to inform the staff that patient unfortunately passed away
following a fall. The daughter did not give details to her mother's death, and she
did not disclose to the pharmacist that the SHINGRIX vaccine contributed to her
death." "Medical tests/lab results were not available to pharmacist. Patient
was evaluated at an urgent care."
"756227-1" "756227-1" "Death, ruled SIDS." "Autopsy"
"757414-1" "757414-1" "This spontaneous report was received from a
physician via field representative refers to a 15 year old female patient. The
patient's pertinent medical history, drug reactions/allergies and concomitant
medications were unknown. On an unknown date in 2011 (at her age of 11), the
patient was vaccinated with first dose of GARDASIL 9 (anatomical location, dose,
route, frequency, expiration date and lot number were not specified) as
prophylaxis. Thereafter, the patient received her second and third dose on an
unknown date in 2015 (reported as 4 years later) and in November 2015 respectively
(inappropriate schedule of drug administration). In January 2016, the patient died
(death) when she was 15 years old. It was unknown, if any lab diagnostics/studies
were performed. The cause of death was unknown. It was unknown, if an autopsy was
performed. The reporter did not assess the causality of the event death with
GARDASIL 9. Product quality complaint was not involved.; Reported Cause(s) of
Death: Unknown." "No lab data for this event."
"757651-1" "757651-1" "Diahrrea immediately following vaccines. Leg
couldn't be touched for three days due to extreme pain in injection site. Patient
died 5 weeks after vaccines were given." "Toxicology report at the morgue.
Autopsied following death of the patient. Death certificate states natural causes
with vaccines listed by name as factors involved. The doctors called it a rare form
of toddler SIDS. Patient's Mother asked for a copy of the patient's shot records
and was given only part of the record by the family doctor."
"758500-1" "758500-1" "Information has been received from a lawyer
regarding a case in litigation concerning a male patient (age unknown). The
patient's medical history, concurrent conditions and concomitant medication use
were not provided. On or about July 2015, the patient was inoculated with ZOSTAVAX,
(lot number and route unknown) as recommended for routine adult health maintenance
and for the prevention of shingles. The vaccine did not prevent shingles but caused
the patient to contract a persistent strain of herpes zoster. Shortly after
receiving ZOSTAVAX the patient was admitted to an intensive care unit for a
transient ischemic attack, viral encephalitis, pneumonia and herpes zoster.
Thereafter, the patient was diagnosed with transient ischemic attack, viral
encephalitis, pneumonia and herpes zoster. As a direct and proximate result of
these injuries, the patient suffered painful injuries and damages, and required
extensive medical care and treatment. As a further proximate result, the patient
suffered significant medical expenses, severe pain and suffering, other damages,
and ultimately death on 05-JUL-2016. The patient sustained severe and permanent
personal injuries. Further, as a tragic consequence the patient suffered serious,
progressive, permanent, and incurable injuries, as well as significant conscious
pain and suffering, mental anguish, emotional distress, loss of enjoyment of life,
physical impairment and ultimately death. Upon internal review transient ischemic
attack, viral encephalitis, pneumonia and death were considered medically
significant events. Transient ischemic attack, viral encephalitis, pneumonia and
herpes zoster were reported to be disabling. Additional information has been
requested. Reported Cause(s) of Death: death." "No lab data for this event."
"758807-1" "758807-1" "Information has been received regarding a case in
litigation from a lawyer and the spouse of a female patient of unknown age. No
information was received regarding the patient's past medical history, concurrent
conditions, or concomitant medication. On an unknown date in 2015, the patient was
inoculated with the ZOSTAVAX (lot number, dosage and route of administration not
provided) at a health department, as recommended for routine adult health
maintenance for the long-term prevention of shingles. The ZOSTAVAX did not prevent
shingles as intended, and the patient subsequently contracted a persistent strain
condition of herpes zoster. On an unknown date in 2016, the patient was treated at
a hospital for a blistering vesicular outbreak, which was diagnosed as herpes
zoster or shingles. The outcome of persistent strain condition of herpes
zoster/shingles and ZOSTAVAX did not prevent shingles as intended is unknown. As a
direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving
ZOSTAVAX for long-term prevention of shingles, the patient suffered painful
injuries and damages, and required extensive medical care and treatment. As a
further proximate result, the patient has suffered significant medical expenses,
and pain and suffering, and other damages. The patient died on 07-JAN-2017; cause
of death not provided. It is unknown if an autopsy was performed. Upon internal
review, death was determined to be medically significant. Additional information
has been requested. Reported Cause(s) of Death: Death." "No lab data for this
event."
"760416-1" "760416-1" "Information has been received on 18-JUL-2018
regarding a case in litigation from a lawyer and the spouse of a deceased male
consumer. The patient's prior concurrent conditions, medical history and
concomitant medications are unknown. On or about 27-JAN-2012, the patient was
inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a
county health district as recommended for routine adult health maintenance for the
long-term prevention of shingles. The vaccine did not prevent shingles as intended,
and the patient subsequently contracted a persistent strain condition of herpes
zoster. On or about 19-JAN-2015, the patient was treated by a physician for a
blistering vesicular outbreak, which was diagnosed as shingles. The patient was
prescribed FAMVIR, acetaminophen, NORCO and NEURONTIN for management of his painful
symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX
and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the
patient suffered painful injuries and damages, and required extensive medical care
and treatment. As a further proximate result, the patient has suffered significant
medical expenses and pain and suffering and other damages. On 24-FEB-2017, the
patient passed away. The cause of death was not reported. Upon internal review,
passed away was considered to be medically significant. Additional information has
been requested. Reported Cause(s) of Death: passed away." "No lab data for this
event."
"761392-1" "761392-1" ""Patient first evaluated by Clinic 3/2018. Reports
in January 2018 reported some low back pain after working with a snow blower. A few
weeks after this, noted some rectal and bladder burning and 'urgency' - lasted 4-5
days and then resolved. Toward the end of Jan, flew to and back and had trouble
getting out the airplane seat. In February 2018 went snowshoeing and fell, noted
legs aching. Noted decreased power in the quads bilaterally and this progressed to
a feeling 'like my legs are disconnected from me, like my quads are weak.' Early
March 2018, symptoms progressed and more noticeable. Felt like knees might give out
when getting up and down. Went to the ED - had cardiac/syncope r/o on telemetry.
Didn't mention his lower extremity concerns during that visit. Symptoms continued.
In April, patient reported legs ""feeling buzzy"", some numbness in upper
extremities, particularly bilat pinky fingers, pins and needles from biceps to tips
of fingers. Towards end of April, some abdominal pain reported, intermittently,
decreased appetite. Some SOB, had panic attack, situational anxiety. Patient seen
again in May, continued progression of paresthesias in upper extremities. Reports
having ""fogginess"" worse in AM, feeling jittery, sometimes has the sense that
""brain is on fire."" Reported feeling anxious, ongoing. Frontal HA and neck pain
reported. Situational anxiety ongoing. Passive suicidal thoughts with no plan or
intent. End of May reported arms and legs feeling worse, losing strength despite
exercise; unintended weight loss, GI cramps; twitching in arms, legs, hands, L>R;
headaches; mild cognitive foggy feeling; anxiety. Seen by office in early June,
reported legs still feeling numb and ""on fire"", but overall better; HA and neck
pain. Late June reported feeling jittery, anxious, with sense of doom. Again
reported passive suicidality with no plan or intent; continued weight loss, bowel
movements every 3-4 days with abdominal cramping, nausea. Discussed seeing a
psychiatrist for ongoing anxiety. Seen multiple times between March and July with
ongoing symptoms; saw several specialists for workup during this time. Most
recently seen by our office 7/2/2018, plan to return to work discussed. Ongoing
HAs, constipation, situational anxiety. Called office 7/9 feeling jittery and with
mental fogginess and forgetfulness, SOB with exercise. Plan to see gastroenterology
7/10 for further testing. 7/10/18 self inflicted gunshot wound, patient deceased.""
"*3/10/18 MRI brain, cervical, thoracic, and lumbar spine Brain: symmetric
bilateral periventricular signal hyperintensity as well as seen in a pericallosal
distribution suggestive of a demyelinating process. This might be confirmed with
evaluation of CSF. Vascular structures as covered demonstrate a normal flow void.
Spine: foraminal narrowing at C4, C5 but no cord signal abnormality or suggestion
of cervical stenosis. Of note on T spine was predominantly erythropoietic red
marrow suggestive of anemia and 1.3cm hyperintense cyst R kidney *3/17/18 MRI
brain, cervical and thoracic spine: Brain: small focal and more patchy regions of
T2 and T2 FLAIR signal hyperintensity within the supratentorial periventricular,
centrum semiovale, and to lesser extent subcortical white matter appear entirely
unchanged when compared to the 3/10/2018 exam. Although the possibility of a
demyelinating process was raised on the report from the previous brain MRI and that
such process cannot with certainty be excluded, I favor that t"
"763518-1" "763518-1" "This spontaneous report was received from a
registered pharmacist via a company representative, who refers to an adult female
patient between 20 and 21 years old. The patient's concomitant medications,
pertinent medical history, drug reactions or allergies were not reported. On an
unknown date in 2013 (reported as approximately 5 years ago), the patient received
the complete vaccination series of three doses of GARDASIL 9 (lot #, expiration
date, dose, and route of administration were not provided for all) for prevention
of human papilloma virus (HPV). On an unknown date in 2013 (reported as
approximately 5 years ago after complete series of vaccination), the patient
developed liver failure. The outcome of the event was unknown. On an unspecified
date, after developing liver failure the patient died. Cause of death was not
provided. It was unknown if autopsy was performed. The causal relationship between
the events and therapy with GARDASIL 9 was not provided by the reporter. Upon
internal review, the event of liver failure was determined to be medically
significant. Reported Cause(s) of Death: Unknown by reporter." "No lab data for
this event."
"763575-1" "763575-1" "This literature report, initially received on 23-
Jul-2018, was reported by other health professional and concerns a 65-year-old,
elderly, male patient. The patient's current conditions included human
immunodeficiency virus (HIV) infection (CD4 count 533/uL), hypertension, diabetes
mellitus type II and blindness (since an unspecified date). On an unspecified date,
the patient was administered Influenza Vaccine (dose, route of administration,
batch number, anatomical location and expiry date, manufacturer and trade name: not
reported). On an unspecified date, 03 days after vaccination, the patient was
admitted to the hospital for acute weakness of all extremities. Initial laboratory
workup was performed and showed elevated protein in cerebrospinal fluid and no
evidence of infection was noted. Anti-nuclear, anti-VGCC (voltage-gated calcium
channel), anti-MUSK and anti-GQ1b antibodies were found to be negative. The patient
was treated with intravenous immunoglobulin and steroids for possible Guillan-Barre
Syndrome, however his condition deteriorated, and he developed respiratory failure
which required mechanical ventilation. The patient also experienced complete
quadriplegia, nystagmus and multilobar pneumonia. Electromyography (EMG) showed a
severe diffuse demyelinating pattern. On 16th day of hospitalization, magnetic
resonance imaging (MRI) of brain showed innumerable foci of T2 flair hyperintensity
involving brain and spinal cord. On 17th day of hospitalization, the patient died
and permission for autopsy was granted. The autopsy was performed and
neuropathologic examination showed multiple soft lesions with tan discoloration
throughout the brain and spinal cord, predominantly involving periventricular white
matter, bilateral basal ganglia, corpus callosum, cerebellar white matter, pons,
medulla and upper cervical spinal cord. Microscopic examination showed discrete
areas of demyelination surrounding vessels, with patchy macrophage aggregation,
sparse CD8+ lymphocyte infiltration and mild reactive gliosis at the periphery. In
a few of the lesions, the infiltrate was composed of neutrophils. Inflammation was
perivascular or in the brain parenchyma and did not involve the vessel wall. No
hemorrhage or viral inclusions were identified. Luxol fast blue stain demonstrated
loss of myelin within the lesions. Neurofilament Immunohistochemical stain
highlighted relative preservation of axons, although spheroids and axonal
disruption were also present. The findings were more consistent with diagnosis of
acute disseminated encephalomyelitis (ADEM). The outcome of the events respiratory
failure, multilobar pneumonia and symptoms of ADEM (acute weakness of all
extremities, complete quadriplegia, nystagmus, elevated protein in cerebrospinal
fluid and severe diffuse demyelinating pattern) was not reported. The reporter
assessed this case as serious (death and hospitalization).""On an unspecified date:
Anti-nuclear, anti-VGCC (voltage-gated calcium channel), anti-MUSK and anti-GQ1b
antibodies were found to be negative. On an unspecified date: On 16th day of
hospitalization, magnetic resonance imaging (MRI) of brain showed innumerable foci
of T2 flair hyperintensity involving brain and spinal cord. On an unspecified date:
Electromyography (EMG) demonstrated a severe diffuse demyelinating pattern. CSF
protein, elevated"
"763777-1" "763777-1" "This literature marketed report has been received
from the authors of the published article, and refers to an adult patient with a
chronic autoimmune disease. The authors obtained data on varicella deaths for 2012-
2016 using the Mortality Multiple Cause of Death public use records from the
Center. A death from varicella was defined as one for which varicella diagnosis was
listed on the death certificate. On an unknown date, the patient was vaccinated
with a 1 dose of varicella virus vaccine live (Oka/Merck) (manufacturer unknown)
injection (exact dose, vaccination site, route of administration, lot# and
expiration date were not provided). On an unknown date, the patient died and
varicella was listed as the underlying cause. The patient was vaccinated with
varicella virus vaccine live (Oka/Merck) (manufacturer unknown) within 1 month
prior to death. Varicella-zoster virus (VZV) specimens were unavailable for
laboratory testing. It was unknown if an autopsy was performed. The authors
considered varicella post vaccine to be related to varicella virus vaccine live
(Oka/Merck) (manufacturer unknown). This is one of several reports derived from the
same literature article (linked with MARRS # 1808USA000251 and 1402USA010964).
Sender's Comments: US-009507513-1402USA010964: US-009507513-1808USA000251: Reported
Cause(s) of Death: varicella listed as the underlying cause of death." "No lab data
for this event."
"763778-1" "763778-1" "This literature marketed report has been received
from the authors of the published article, titled as stated above and refers to an
adult patient with a chronic renal failure on immunosuppressive treatment. The
authors obtained data on varicella deaths for 2012-2016 using the Mortality
Multiple Cause of Death public use records from the Center for Health Statistics. A
death from varicella was defined as one for which varicella diagnosis was listed on
the death certificate. On an unknown date, the patient was vaccinated with 1 dose
of varicella virus vaccine live (oka/merck) (manufacturer unknown) injection (exact
dose, site of administration, route of administration, lot# and expiration date
were not provided). On an unknown date, the patient died and varicella was listed
as the underlying cause. The patient was vaccinated with varicella virus vaccine
live (oka/merck) (manufacturer unknown) within 1 month prior to death. The patient
was confirmed to have vaccine-strain varicella-zoster virus (VZV). It was unknown
if an autopsy was performed. The authors considered varicella post vaccine to be
related to varicella virus vaccine live (Oka/Merck) (manufacturer unknown). A copy
of the published article is attached as further documentation of the patient's
experience. This is one of several reports derived from the same literature article
(linked with MARRS # 1807USA012959 and 1402USA010964). Sender's Comments: US-
009507513-1402USA010964: US-009507513-1807USA012959. Reported Cause(s) of Death:
varicella listed as the underlying cause of death." "No lab data for this event."
"764964-1" "764964-1" "Our daughter was healthy with no issues whatsoever
until after her four month shots. She had them and she changed. From the day she
was born she slept through the night and always woke up at 6am which was so
different from our son who was up multiple times in the night. But after her four
month shots. We noticed that she would wake up through night a lot more. She
wouldn't want to eat through the night. She would cry and scream like she was in
pain. But there was never anything wrong. She was always a happy baby and so
healthy. I also had a normal pregnancy. It was unlike her. However she had her
bottom teeth and was chewing a lot on things so my husband and I thought it was
just teething. About a month after her vaccinations she passed away. On August 6th
of 2017 She had stopped breathing and was having issues August 5th late ate night
and was pronounced dead on August 6th around 1 am." "There was an autopsy done
that where they confirmed SIDS. At this point I started looking into other things
due to the fact I wasn't going to accept that my healthy happy beautiful baby girl
went to sleep and never woke up. I had been on the phone with the autopsy guy and
the moment I had asked if he would be able to tell if vaccinations killed my
daughter he was quick to ignore the question and get off the phone. It also took me
almost a whole year to finally get the doctor office to give me the correct papers
I needed to do this. Some of them got rude with me over this vaccination deal."
"765023-1" "765023-1" "Infant found about 5AM 4-27-18, in its bed,
deceased. Coroner states autopsy suspects death about 2AM 4-27-2018."
"Coroner/pathologist"
"765844-1" "765844-1" "On June 8th 2018 death occurred." "No lab data for
this event."
"767019-1" "767019-1" "This case was reported by a physician via sales rep
and described the occurrence of cardiac arrest in a 37-year-old male patient who
received BOOSTRIX for prophylaxis. Co-suspect products included PNEUMOVAX for
prophylaxis. Concurrent medical conditions included HIV positive. In August 2018,
the patient received BOOSTRIX and PNEUMOVAX. In August 2018, 10 hrs after receiving
BOOSTRIX, the patient experienced cardiac arrest (serious criteria death and GSK
medically significant). In August 2018, the outcome of the cardiac arrest was
fatal. The patient died in August 2018. The reported cause of death was cardiac
arrest. The reporter considered the cardiac arrest to be unrelated to BOOSTRIX.
Additional information was received as follows: The reporter said that the event
occurred about a week before the reporting date. Ten hours after vaccination, the
patient was brought to the hospital in full cardiac arrest and he died. The
reporter did not think to call GlaxoSmithKline. He did not think that either
vaccine caused the death of the patient. The reporter agreed to be followed up and
said the best way to contact was via email. Reported Cause(s) of Death: Cardiac
arrest." "No lab data for this event."
"767323-1" "767323-1" "This spontaneous report was received from a
pediatric nurse practitioner and a nurse via a company representative and refers to
a 14 year old male patient. The patient's concurrent condition, medical history and
concomitants medications were not reported. On unknown date 5 to 6 weeks prior to
the patient's death (also reported as ''last Wednesday''), the patient was
vaccinated with GARDASIL 9 (lot #, expiration date, dose, route and site of
administration were not reported) for immunisation (also reported as vaccination).
On unknown date, the patient complained of a headache after received GARDASIL 9 but
the patient was not seen for this initial headache. On unspecified date, the
patient developed a severe headache and went to hospital emergency room, from there
he was transferred to the hospital, where he later passed away of acute
disseminated encephalomyelitis on unknown date. It was unknown if an autopsy was
performed. The causality between the event and GARDASIL 9 was not provided by the
reporters. However, an unspecified physician from the hospital reported that, the
patient's death was related to the GARDASIL 9. Upon internal review, the event of
acute disseminated encephalomyelitis was considered to be medically significant.
Reported Cause(s) of Death: Acute Disseminated Encephalomyelitis." "No lab data
for this event."
"767664-1" "767664-1" "Baby had increased episodes of apnea, bradycardia,
requiring intubation and support for hypotension (Dopamine, hydrocortisone). She
expired within." "No lab data for this event."
"768094-1" "768094-1" ""This spontaneous report was received from a
pharmacist via a company representative and refers to a elderly male patient of
unknown age. Information regarding the patient's pertinent medical history,
concurrent conditions, concomitant and historical drugs was not provided. On an
unknown date in 2017, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose,
route, lot # and expiration date were not provided) for prophylaxis. At the same
time, the patient received also a dose of influenza virus vaccine (unspecified)
(reported as ""Flu vaccine"") (dose, route, lot # and expiration date were not
provided) for an unknown indication. The pharmacist stated that, on an unknown date
in 2017 (reported as ""next day""), the elderly patient got sick and was
hospitalized. The pharmacist reported that, shortly after that, the patient passed
away on an unknown date in 2017. The cause of date was not reported. It was unknown
if autopsy was done. The outcome of malaise was not reported. The causality between
the events and PNEUMOVAX 23 was not reported. Reported Cause(s) of Death:
Pharmacist reported the ""elderly man passed away shortly after""."" "No lab data
for this event."
"768177-1" "768177-1" ""This spontaneous report as received from a
physician, who read in an article that was published recently about a female
patient of unknown age. The patient's concurrent conditions included an allergy to
meat called ""alpha-gal allergy"" that was transmitted via tick bite. There was no
information about the patient's medical history or concomitant medication. On an
unknown date, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming units
(PFU) for prevention of shingles (dose, route of administration, anatomical
location, lot number and expiration date were not reported). On an unspecified date
in 2006, the patient died after resuscitation attempts in an unspecified emergency
room, due to an anaphylactic reaction to the porcine gelatin content of ZOSTAVAX.
The reporter considered the aphylactic reaction to be a life threatening event that
required intervention to prevent serious criteria. It was unknown if an autopsy was
performed. The reporter considered anaphylactic reaction to be related to ZOSTAVAX.
Upon internal review, the event anaphylactic reaction was considered to be
medically significant. This is one of two reports received from the same reporter.
Sender's Comments: US-009507513-1808USA009391: Reported Cause(s) of Death:
Anaphylactic reaction to the porcine gelatin content of ZOSTAVAX."" "No lab data
for this event."
"769676-1" "769676-1" "This spontaneous report was received from a consumer
who saw a video on the internet referring to a female patient of unknown age. No
information was provided regarding the patient's medical history, concurrent
conditions or concomitant medications. On an unknown date, the patient was
vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration,
anatomical location, lot number and expiration date were not reported). On an
unknown date, the patient experienced reactions after the vaccination and
subsequently died due to an unspecified reason; it was unknown whether an autopsy
was performed. The reporter did not provided causality assessment between the
adverse reaction and vaccination with GARDASIL 9. Upon internal review the
patient's death was determined to be medically significant. This is one of several
cases received from the same reporter. Sender's Comments: US-009507513-
1809USA001815: Reported Cause(s) of Death: Unknown cause of death." "No lab data
for this event."
"769678-1" "769678-1" "This spontaneous report was received from a consumer
who saw a video on the internet referring to several female kids of unknown age. No
information was provided regarding the patient's medical history, concurrent
conditions or concomitant medications. On an unknown date, the patients were
vaccinated with GARDASIL 9 for prophylaxis (dose, route of administration,
anatomical location, lot number and expiration date were not reported). On unknown
dates, the patients died after the vaccination due to an unspecified reason; it was
unknown whether an autopsy was performed. The reporter did not provided causality
assessment between the patients' deaths and vaccination with GARDASIL 9. Upon
internal review the patient's death was determined to be medically significant.
This is one of several cases received from the same reporter. Sender's Comments:
US-009507513-1809USA000416: Reported Cause(s) of Death: Unknown cause of death."
"No lab data for this event."
"770068-1" "770068-1" "The patient received both vaccines on Tuesday
afternoon. On Wednesday evening, she felt 'achy' and 'had chills'. She passed away
in her sleep on Thursday evening/Friday morning after 2:00am. The family said that
she had a 'weak heart' and that they don't think her death was caused by the
vaccines, but they also wanted us to report her death 'just in case' because of the
close proximity of her death to the vaccines." "No lab data for this event."
"---"
"Dataset: The Vaccine Adverse Event Reporting System (VAERS)"
"Query Parameters:"
"Title: death"
"Adverse Event Description: All"
"Adverse Events After Prior Vaccinations: All"
"Age: All"
"Current Illness: All"
"Date Died: All, Before 1980 to Sep., 2018"
"Date of Onset: All, Before 1980 to Sep., 2018"
"Date Report Completed: All, Before 1990 to Sep., 2018"
"Date Report Received: All, Jul., 1990 to Sep., 2018"
"Date Vaccinated: All, Before 1980 to Sep., 2018"
"Days In Hospital: All"
"Event Category: Death"
"Grantee: All"
"History/Allergies: All"
"Lab Data: All"
"Medications At Time Of Vaccination: All"
"Mfr/Imm Project Number: All"
"Onset Interval: All"
"Recovered: All"
"Report Form Version: All"
"Serious: All"
"Sex: All"
"State / Territory: The United States/Territories/Unknown"
"Symptoms: DEATH"
"Vaccine Administered By: All"
"Vaccine Dose: All"
"Vaccine Lot: All"
"Vaccine Manufacturer: All"
"Vaccine Products: All"
"Vaccine Purchased By: All"
"VAERS ID: All"
"Group By: VAERS ID"
"Show Totals: False"
"Show Zero Values: False"
"---"
"Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information."
"---"
"Query Date: Nov 22, 2018 7:34:03 AM"
"---"
"Suggested Citation: United States Department of Health and Human Services (DHHS),
Public Health Service (PHS), Centers for"
"Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event
Reporting System (VAERS) 1990 - last month,"
"CDC WONDER On-line Database. Accessed at http://wonder.cdc.gov/vaers.html on Nov
22, 2018 7:34:03 AM"
"---"
Messages:
"1. These results are for 1,399 total events."
"2. When grouped by VAERS ID, results initially don't show Events Reported,
Percent, or totals. Use Quick or More Options to"
"restore them, if you wish."
"3. Click on a VAERS ID to see a report containing detailed information for the
event."
"---"
Footnotes:
"1. Submitting a report to VAERS does not mean that healthcare personnel or the
vaccine caused or contributed to the adverse"
"event (possible side effect)."
"---"
Caveats:
"1. DISCLAIMER: VAERS staff at CDC and the Food and Drug Administration (FDA)
follow up on all serious adverse event reports to"
"obtain additional medical, laboratory, and/or autopsy records to help understand
the circumstances. However, VAERS public data"
"do not generally change based on the information obtained during the follow-up
process. There are limitations to VAERS data. A"
"report to VAERS does not mean that the vaccine caused the adverse event, only that
the adverse event occurred sometime after"
"vaccination. Read more about interpreting VAERS data: More information:
http://wonder.cdc.gov/wonder/help/vaers.html#Additional."
"2. Some items may have more than 1 occurrence in any single event report, such as
Symptoms, Vaccine Products, Manufacturers, and"
"Event Categories. If data are grouped by any of these items, then the number in
the Events Reported column may exceed the total"
"number of unique events. If percentages are shown, then the associated percentage
of total unique event reports will exceed 100%"
"in such cases. For example, the number of Symptoms mentioned is likely to exceed
the number of events reported, because many"
"reports include more than 1 Symptom. When more then 1 Symptom occurs in a single
report, then the percentage of Symptoms to"
"unique events is more than 100%. More information:
http://wonder.cdc.gov/wonder/help/vaers.html#Suppress."
"3. Data contains VAERS reports processed as of 9/14/2018. The VAERS data in WONDER
are updated monthly, yet the VAERS system"
"receives continuous updates including revisions and new reports for preceding time
periods. More information:"
"http://wonder.cdc.gov/wonder/help/vaers.html#Reporting."
"4. Values of Event Category field vary in their availability over time due to
changes in the reporting form. The ""Emergency"
"Room/Office Visit"" value was avaliable only for events reported using the VAERS-1
form, active 07/01/1990 to 06/29/2017. The"
"""Congenital Anomaly/Birth Defect"", ""Emergency Room"", and ""Office Visit""
values are available only for events reported"
"using the VAERS 2.0 form, active 06/30/2017 to present. These changes must be
considered when evaluating count of events for"
"these categories."