Adverse Events Following

Immunization (AEFI)

9 February 2021
 Topics to cover during the Training

• What is AEFI and classification

• Reporting of AEFIs

• Management of AEFIs

• Anaphylaxis- identification and management

• AEFI Committees at different level
• Crisis Communication
Topics to cover during the Training

• What is AEFI and classification

• Reporting of AEFIs

• Management of AEFIs
• Anaphylaxis- identification and management

• AEFI Committees at different level

• Crisis Communication
 What is an AEFI?

An ADVERSE EVENT FOLLOWING IMMUNIZATION (AEFI) is any

untoward medical occurrence which:
• follows immunization;
• does not necessarily have a causal relationship with vaccine
usage;
• may be an unfavourable symptom about which a vaccine
recipient complains; and
• may be abnormal laboratory finding, sign or disease found by
medical staff.
 Classification of AEFI

1. Vaccine product-related reaction

2. Vaccine quality defect-related reaction
3. Immunization error-related reaction
4. Immunization anxiety-related reaction
5. Coincidental
 Cause-specific definitions of AEFI
1. Vaccine product-related reaction
An AEFI that is caused or precipitated by a vaccine due to one or more of the inherent
properties of the vaccine product
2. Vaccine quality defect-related reaction
An AEFI that is caused or precipitated by a vaccine that is due to one or more quality defects
of the vaccine product including its administration device as provided by the manufacturer.
3. Immunization error-related reaction
An AEFI that is caused by inappropriate vaccine handling, prescribing or administration and
thus by its nature is preventable.
4. Immunization anxiety-related reaction
An AEFI arising from anxiety about the immunization and fear of injection.
5. Coincidental
An event that happens after vaccination but is not caused by vaccine or vaccination process
 AEFI classification by seriousness
AEFI can be classified by seriousness as:
 Serious AEFI – results in death, is life-threatening, requires
hospitalization or prolongation of existing hospitalization, results in
persistent or significant disability, or is a congenital anomaly/birth
defect

 Non-serious AEFI – does not pose a potential risk to the health of the
recipient.

Both serious and non-serious events should be carefully monitored.

AEFI after COVID-19 vaccines from clinical trials

 Known minor AEFI from COVID-19 vaccines are similar to other

injectable vaccines and include injection site pain, headache,
fatigue, muscle pain.
 Other minor AEFI include fever, chills, nausea, arthralgia (pain in a
joint).

 No serious safety concerns have been reported to date.

 General precaution/contraindication for any vaccine is possible

allergic reaction, including anaphylaxis, to a vaccine component.
How can immunization error-related AEFI prevented?

Do not store and/or pack other diluents or medications together with
the COVID-19 vaccine.
Always check the labels of vaccines and diluents before
reconstitution – vaccines and diluents should be from the same
manufacturer.
Follow manufacturer’s recommendations on storage, vaccine
preparation, route and technique of administration, and
contraindications and precautions.
Draw the auto-disable (AD) syringe just before vaccination.
Do not touch the needle.
How can immunization error-related AEFI prevented ? (2)

Do not touch the rubber cap of the vaccine vial.

Never carry partially used vaccine vial from one session to
other session
Discard the vaccine after 6 hours of opening or at the end of
the session, whichever comes first (COVID-19 vaccine)
If reconstituted, never carry vaccines from one session to
another.

Discard the vaccine if it was reconstituted before the

maximum recommended time or at the end of the session,
whichever comes first.
 Cluster
Cluster – two or more cases of the same or similar events related in time,
place/geography, and/or vaccine administered.
• Coincidental events can occur as clusters.
• Immunization anxiety related events can occur in clusters.
• Clusters should be reported.

Clusters can be usually associated within

a particular provider a vial/vials of vaccine
/health facility that has/have been

In appropriately stored
Inappropriately
prepared Contaminated (e.g. freezing vaccine
during transport).
AEFI Reporting: COVID-19 Vaccine
 What cases of AEFI to be reported and how ?
Report all AEFI serious and non serious AEFIs including minors AEFIs

Use the COVID-19 vaccine reporting form

Complete the reporting forms and send them to respective manager at

upazila/ municipality/ zone level within 24hours of notification

In case of serious AEFI, inform respective supervisors/managers / AEFI focal

person immediately (over telephone) and complete the reporting form within
24 hours.
Online AEFI Reporting
AEFI Management for COVID -19 Vaccine
COVISHIELD Vaccine (Serum Institute of India)

https://www.seruminstitute.com/pdf/covishield_fact_sheet.pdf
 Vaccinators : Key points to remember

 Inform the beneficiaries about the possible

minor adverse events following COVID-19
vaccination
 Ask beneficiaries to wait at vaccination
sites for 30 minutes after vaccination
 Beyond 30 minutes ensure beneficiaries
are aware where to go or whom to contact
in case required
 Preparation for AEFI Management

AEFI management team at all vaccination centre for COVID-19 vaccine

with a focal person for AEFI.
AEFI management team be ready for any emergency round the clock
AEFI Kit be available with each AEFI management team at the
vaccination centres/hospitals.
Label on AEFI kit should also display emergency phone numbers of
AEFI focal persons and ambulance driver
All vaccination centre should have a sucker machine, Ambu bag, BP
instrument, Stethoscope, Oxygen cylinder and Nebulizer
 Preparation for AEFI Management
There should be a separate room (AEFI management room )with 1-2 beds for AEFI
patient close to the waiting area of the AEFI vaccination centre. All necessary
equipments should be in this room.
Ambulance/vehicles be available for emergency. If required patient to be referred to
tertiary or specialized hospital
All the vaccination team should have the phone number of the AEFI focal person of
the AEFI management team to contact in case of any emergency. It should be
included in the microplan
The name and contact number of AEFI focal person of the AEFI management team
should be available at a visible place at the emergency dept of all the hospitals.
 Vaccinator remain in touch with AEFI focal person of the AEFI management Team
(before , during and close of vaccination)

Before starting vaccination

• Vaccinator : Good morning doctor , I am vaccinator Rukhsana calling from vaccination session no 5 ,
Health facility upazila sadar. I am about to begin vaccination , may I start ?
• AEFI management doctor : Yes please go ahead.

During vaccination session

• Vaccinator : Sir we have vaccinated around XX person so far . Status all ok.
• AEFI management doctor Thankyou . Good . Call me when you finish the session
Close of session
• Vaccinator : Sir we have vaccinated total XX person. Status all ok.
• AEFI management doctor : Good , thankyou.
Identification of Anaphylaxis
 Anaphylaxis : Extremely rare adverse events

In general anaphylaxis is a very rare (estimated as < 1 per 1 million)

but severe and potentially fatal reaction. Proper diagnosis and urgent
treatment and management are essential.

When sudden loss of consciousness occurs >5–10 minutes after

immunization, anaphylaxis should be considered as a possible
diagnosis, in addition to fainting (vasovagal syncope)
 Anaphylaxis: Clinical features
Clinical Progression Signs and symptoms of anaphylaxis

Itching of the skin, rash and swelling around injection site,

Mild, early warning signs
dizziness, general feeling of warmth

Painless swelling in part of the body e.g. face or mouth. Flushed,

itching skin, nasal congestion, sneezing, tears

Hoarseness, nausea, vomiting

Swelling in the throat, difficulty in breathing, abdominal pain

Late, life-threatening Wheezing, noisy, difficulty in breathing, collapse, low blood

Symptoms pressure, irregular weak pulse
 Distinguishing Vasovagal Syncope and Anaphylaxis
Vasovagal syncope (VVS) Anaphylaxis
Seconds to minutes after
VVS : occurs suddenly, before, at time of or
At onset exposure, almost all cases
soon after injection
within 1 hour
Red, raised itchy rash, swollen
Skin VVS : pale, cold, sweaty/clammy eyes and face, generalized
rash
Noisy breathing, wheeze or
Respiratory VVS: normal to deep breaths
stridor, persistent cough
Heart VVS: slow pulse, transient hypotension Fast pulse, hypotension
Abdominal cramps, vomiting,
Gastro-intestinal VVS: nausea, vomiting
nausea
VVS: transient loss of consciousness reversed
May develop loss of
by supine position,dizziness, numbness,
Neurologic consciousness not relieved by
weakness, tingling around lips, spasms in
supine position
hands and feet
Management of Anaphylaxis
 Steps in management of Anaphylaxis
Keep the patient lying flat on back (supine position) with foot end raised. If patient
vomits then put the patient in lateral position
If patient is unconscious, keep in left lateral position

Keep the airway clear

Give Injection Adrenaline 1:1000 solution (1mg/1ml) IM immediately

To relief respiratory distress, itching and hives, antihistamine and bronchodilator
may be used. But these should be administered after injection Adrenaline.

Monitor the patient for several hours even after complete resolution of signs and
symptoms .
If required arrange for ambulance/vehicle to transport the patient to the secondary or
tertiary level hospital .
Injection Adrenaline Ampoule

Adrenaline is also supplied in ampoules labelled as Epinephrine.

 Treatment of Anaphylaxis

Drug, site and route of

administration
• Adrenaline (epinephrine) 1:1000,
immediate intramuscular injection to the
midpoint of anterolateral aspect of the
middle third of the thigh
 What is the dose of adrenaline In adults ?

WHO Recommended Adrenaline Dose in

Adults
0.2 ml to 0.5 ml
(Max is 0.5 ml)
Based on response , repeat every 5–15 minutes as needed until
resolution of anaphylaxis
Treating doctor to decide on how much dose to be used based on the condition of the
patient. Factors affecting : Age / gen condition of body / weight of the patient
3 ML Disposable Syringe- Markings
For Adrenaline injection
 Needles Gauges

A standard needle (25mm and 23G) should be used to inject

intramuscular adrenaline.

The best Gauge

Needle site for an intramuscular injection of adrenaline for the
size
treatment of an anaphylactic reaction is the anterolateral aspect of the
middle third of the thigh.
Which of the
figure is correct
route for
Adrenaline?

Fig 1 fig 2
fig 3 fig 4
 AEFI Kit
Inj. adrenaline 1:1000 solution (1mg/1ml) This should be
– 3 ampoules accompanied with the
Inj. Hydrocortisone (100 mg) – 2 vials following information
AD syringe (0.5 ml) - 3 Drug dosage for Inj.
Disposable Syringe (3 ml)- 7 Adrenaline
Butterfly needle – 2 sets ( 23 gauge) Label showing: Expiry
I/V fluids (Normal Saline): 1 unit
date of Inj.
Adrenaline
I/V fluids (5% Dextrose): 1 unit
At hospital setting,
I/V saline set: 1 set intubation facility &
Cotton and adhesive tape : 1 each oxygen should be
available.
Tab Paracetamol (500 mg) - 10 tabs
Syrup Paracetamol – 1 bottle 1-2 separate bed
should be assigned
AEFI reporting form: 2 forms
for AEFI
AEFI KIT
Labelling of AEFI Kit
 AEFI management center
Remember
• AEFI management area should be clearly marked out in the health facility

• This area should have bed/s ready for handling any adverse event

• Oxygen , stethoscope , BP apparatus, ambu bag, sucker machine and

other important equipment should be ready. Before vaccination starts the
Facility in charge/ AEFI focal person should personally ensure all
equipment is functional.

• AEFI kit, should be checked by the AEFI focal person/facility in charge

before vaccination starts
AEFI Management Team during COVID-19 Vaccination
AEFI Management Team : Medical College Hospital & Other
Hospitals
Team members ( not as per seniority)

1. Director/ Deputy Director/ Hospital Superintendent

2. Head of the dept, Medicine
3. Resident Physician ( Medicine)
4. Resident Surgeon ( casualty)
5. Indoor Medical Officer ( Medicine)
6. Emergency Medical Officer

A member need to be assigned as AEFI Focal person by Director/DD/Superintendent

hospital
Nursing Superintendent will assist the team
District Level including District Hospital: AEFI Management Team
Team members ( not as per seniority)
1. Civil Surgeon
2. Hospital Superintendent
3. Deputy Civil Surgeon
4. Consultant Medicine
5. RMO of district hospital
6. Medical Officer-CS
7. Medical Officer (DC)
8. EMO
A member need to be assigned as AEFI Focal person by Civil Surgeon
District PHN, Nursing-in-charge and EPI Superintendent will assist the
AEFI management team
 City Corporation level: AEFI Management Team

Team members ( not as per seniority)

1. Chief Health Officer
2. Medicine Specialist of the hospital of respective zone
3. Health Officer
4. Zonal Medical Officer/AHO/Medical Officer-City Corporation

A member need to be assigned as AEFI Focal person by CHO

EPI Supervisor/ Vaccinator Supervisor will assist the AEFI management team
 Upazila Level : AEFI Management Team
Team members ( not as per seniority)
1. UHFPO
2. Medicine Consultant
3. RMO
4. Medical Officer- Disease Control
5. EMO
A member need to be assigned as AEFI Focal person by UH&FPO
The following staff will assist the AEFI management team
1. Sr. Staff Nurse
2. Medical Technologist EPI ( MT-EPI)
AEFI Committees at different levels
 District AEFI Committee for COVID-19 Vaccine

Composition of the Committee

Civil Surgeon ( Chairperson) Medical Officer- Disease Control (MO-DC)

Medicine Specialist Asst. Director/Superintendent of Drugs ,

DGDA
Upazila Health & Family Planning EPI Superintendent
Officer (UHFPO of concerned upazila)
Deputy Civil Surgeon/Medical Officer-
RMO ( District Sadar Hospital) Civil Surgeon Office
( Member Secretary )
City Corporation AEFI Committee for COVID-19 Vaccine

Composition of the Committee

Chief Health Officer ( CHO) Zonal Medical Officer/Assistant Health
(Chairperson) Officer ( of concerned zone)

Medicine Specialist EPI Supervisor

Local Asst. Director/Superintendent Health Officer/ Medical Officer- City

of Drugs, DGDA Corporation
( Member Secretary )
 Divisional AEFI Causality Assessment Committee
for COVID-19 Vaccine
Composition of the committee
Director of Govt Medical College Endocrinologist
Hospital (Chairperson) at Divisional
HQ
Divisional Director Health, DGHS ( Pharmacologist
Co-Chairperson)
Medicine Specialist Gynecologist
Epidemiologist/ public health specialist Nephrologist

Microbiologist/ Virologist Cardiologist

Respiratory disease specialist Dermatologist
Neurologist Civil Surgeon ( Member Secretary)
National AEFI Committee for COVID-19 Vaccine

Composition
DG, DGDA (Chairperson) Dermatologist
Director, IEDCR Pharmacologist
Medicine Specialist Gynecologist
Paediatrician Nephrologist
Microbiologist/ Virologist Cardiologist
Epidemiologist/ public health Respiratory disease expert
specialist
Endocrinologist Deputy Director , DGDA (Member
Secretary)
Neurologist
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