Work Instruction for Management of Adverse Event Following

Immunization (AEFI)
Document No :
Date of Issue : 16/10/2023
AEFI/HWC-SC/…../…
Version/Issue No: 01 Effective Date: 21/10/2023

Work Instruction
For
Management Of
Adverse Event Following Immunization (AEFI)

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 The signatures below certify that this procedure has been reviewed and approved, and
demonstrate that the Signatories are aware of all the requirements contained herein and are
committed to ensuring their provision.

Name Position Signature

Prepared By Ritu Baghel CHO

Approved By Dr. Amrit lakra BMO

Amendment Note:

Page Context Revision Date

No

Note: Prior to use, ensure this document is the most recent issued
This procedure is reviewed to ensure its continuing relevance to the systems and process that
it describes. A record of contextual additions or omissions is given below:

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S.No. Content
1. Purpose, Scope, Responsibility

2. Basic Definitions

3. Service Delivery Frame Work

4. Management of AEFI

5. Common AEFI & Their Management

6. Initial management of Anaphylaxis by ANM

7. Anaphylaxis Kit
8. Reporting of AEFI
9. References

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 1. Purpose:
a. To ensure that immunization services are provided at Health and Wellness Centre safely,
in a consistent manner without compromising the quality of services.
b. To ensure that HWCs staff should Identify common adverse events, manage an adverse
event when it occurs.
c. List the responsibilities of health service providers in minimizing AEFIs
2. Scope:
The document provides basic and necessary information to provide adverse events following
Immunization (AEFIs), Types of AEFIs, managing AEFI when it occurs, described
responsibilities of health service providers in minimizing AEFIs, reporting of AEFI.

3. Responsibility:

Sl. Staff Responsibility

1 ASHA 1. Awareness generation and community mobilization
2. Ensure follow-up visits to beneficiaries to identify minor vaccine
reactions or AEFIs
2 MPW-F/M 1. Planning for Immunization
2. Managing the Cold chain
3. Receiving the vaccine carrier and logistics
4. Preparing and conducting the immunization session
5. Communicating with caregivers
6. If any AEFI occurs following use of any vial, do not use that vial;
mark it and retain safely for AEFI investigation.
7. Primarily Management & ensure recording of all AEFIs in the Block
AEFI register
8. Capacity building of ASHAs and AWWs to perform their roles in
AEFI
3 CHO Overall supervision of all the processes related to immunization and manage
and report AEFI to appropriate level.
1. Planning for Immunization
2. Managing the Cold chain
3. Communicating with caregivers
4. Recording, Reporting and tracking of AEFI cases
5. Capacity building of ANM, ASHAs and AWWs to perform their roles
in AEFI

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Definitions: -
What is AEFI: -
 Adverse event following immunization (AEFI) is defined as any untoward medical
occurrence which follows immunization and which does not necessarily have a causal
relationship with the usage of the vaccine.
 The adverse event may be any unfavourable or unintended sign, abnormal laboratory
finding, symptom or disease.
 Majority of the adverse event are coincidental i.e. unrelated to vaccine or vaccination
process but have to be reported as the symptoms or signs have occurred after
vaccination
Types of AEFI: -
For purpose of reporting, AEFIs can be minor, severe and serious
Type of AEFI Definition
Minor Common, self-limiting reactions, usually occur within a few hours of
injection and resolve after short period of time and pose little danger.
Examples: pain, swelling at injection site, fever, irritability, malaise
etc.
Severe AEFIs that are not minor but do not result in death, hospitalization or
disability are categorized as severe. Eg. Non-hospitalized cases of
seizures, hypotonic hyporesponsive episodes (HHEs), persistent
screaming, anaphylaxis, severe local reaction, injection site
abscesses, intussusception, etc.
Serious An AEFI will be considered serious if it results in death, requires
hospitalization, results in persistent or significant
disability/incapacity or a cluster (two or more cases) of AEFIs occur
in a geographical area.
Cause specific type of AEFI
Type of AEFI Definition
Vaccine product-related An AEFI that is caused or precipitated by a vaccine due to one or
reaction more of the inherent properties of the vaccine product
Vaccine quality defect-related An AEFI that is caused or precipitated by a vaccine that is due to
reaction (Both 1 & 2 were one or more quality defects of the vaccine product, including its
earlier categorised in Vaccine administration device as provided by the manufacturer
Reaction)
Immunization error-related An AEFI that is caused by inappropriate vaccine handling,
reaction (formerly prescribing or administration and thus by its nature is
“programme error”) preventable
Immunization anxiety-related An AEFI arising from anxiety about the immunization
reaction (formerly “injection
reaction”)
Coincidental event An AEFI that is caused by something other than the vaccine
product, immunization error immunization anxiety
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Service Delivery framework: -
Following are the role and responsibilities of staff to minimize the AEFI cases at Community
and HWCs: -
At Community level by ASHA: -
1. Follow up with beneficiaries to identify AEFIs after the vaccination session, using the
beneficiaries’ list provided by the ANM.
2. Inform the adverse event immediately by telephone to concerned ANM, MO, etc.
3. Assist in referral of any suspected cases
4. Assist the team investigating the event
5. Support in building community confidence
At Sub Centre Level: -
By ANM: -
1. Screen each beneficiary for contraindications to avoid serious reactions. For example,
vaccines are contraindicated if there is a possibility of serious allergy to a vaccine or
its components. Live vaccines should not be given to immune deficient children.
2. Follow best immunization practices. Prior to starting vaccination at the RI site, the
ANM must note down (in vaccinator’s logistics diary) the following particulars. This
will help mitigate AEFIs at session site level:
a. Manufacturer’s name
b. Expiry date
c. Batch number
d. VVM status (for new and partially used vaccines)
e. Date on the label of partially used vaccine (in case of OVP)
f. In case of reconstituted vaccines, date and time on the label.
3. Ensure that vaccine vial septum has not been submerged in water or contaminated in
any way.
4. Use Measles, BCG and JE vaccine within 4 hours of reconstitution.
5. Never carry and use reconstituted vaccine from one session site to another.
6. Do not store other drugs or substances in the ILR. These refrigerators are only meant
for vaccines.
7. After injection, do not attempt to re-cap or bend the needle.
8. Ask the beneficiaries to wait for half an hour after vaccination to observe for any
AEFI.
9. Provide a list of children vaccinated during the session to the AWW/ASHA and
request them to be alert, follow up and report AEFIs (if any) to her, CHO and the
concerned MO.
10. Ensure reasons for dropouts are entered in the immunization card counterfoils.
11. Share details of all AEFIs (serious/severe and minor) with the CHO and MOIC in the
weekly block level meeting. Ensure details of all serious/severe and minor cases are
entered in the AEFI case register maintained at the block PHC (see Figure 1 for
suggested format for AEFI Case Register).
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 12. Assist in investigation of AEFIs and take corrective action in response to the guidance
from the MO (PHC)
By Community Health Officer (CHO):-
1. Supervise and provide hands-on training to the ANMs/vaccinators in the field. This
includes provision of information on referral transport and concerned officials in case
of crisis.
2. Monitor the community for adverse events during supervisory visits to immunization
sites or SCs. Also monitor and ensure follow-up of beneficiaries by HWs. Ensure
reasons for dropouts are entered in the counterfoils.
3. Encourage the HWs to report AEFIs. Serious/severe AEFIs should be notified
immediately by the fastest means possible.
4. Analyse the reported AEFIs in the SC monthly reports and keep track of HWs who
have not reported any AEFI over a period of time.
5. Assist the investigation team in conducting the investigation.

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Management of AEFI: -
 When a serious or severe adverse event occurs, ANM should immediately:
 Provide immediate first aid: lay child flat; ensure airway is clear. If child is
unconscious, put in semi-prone position.
 Refer to the MO (PHC) or nearest AEFI management centre for prompt treatment.
Accompany the patient if needed.
 Inform the CHO and MO (PHC) at the health centre immediately by the fastest means
possible e.g. telephonically.
 Report and assist in investigation of AEFIs.
 Treat minor/non-serious AEFIs symptomatically as per following: -
Minor vaccine reactions Treatment When to report
Local reaction (pain, swelling,  Cold cloth at injection site  In case of an abscess
redness)  Give Paracetamol
Fever > 38.5o C  Give extra fluids  When accompanied by
 Give tepid sponging other symptoms
 Give Paracetamol
Irritability, malaise and systemic  Give extra fluids  When severe or unusual
symptoms  Give Paracetamol

Figure 1- Minor Reactions due to vaccines

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COMMON AEFI & THEIR MANAGEMENT
Adverse event Signs & symptoms, reporting Treatment Vaccines
involved
Fever Fever below 102o F/<39o C Symptomatic: Any Vaccine
(low/medium grade) may be listed in
AEFI register as minor AEFI if Paracetamol
medical care was sought
Several local Redness and/or swelling around the Symptomatic Any Vaccine
reactions injection site and one or more of the treatment with
following: analgesics.
 Swelling beyond the nearest joint
 Pain, redness and swelling of Antibiotic is
more than 3 days duration inappropriate.
 Require hospitalization

Local reactions of lesser intensity

occur commonly and are trivial and
do not need to be reported. Settles
spontaneously within a few days to
a week.
Infection site Fluctuant or draining fluid-filled Incise and drain Any vaccine
abscess lesion at the site of injection (e.g., anti-inflammatory
purulent, inflammatory signs, fever, (e.g., Syp.
culture), sterile abscess if not reported Ibuprofen)
and investigated as serious, if Antibiotics if
hospitalized for treatment. bacterial
Seizures Occurrence of generalized Supportive care All especially
convulsions that are not accompanied Paracetamol and pertussis
by focal neurological signs or cooling if febrile containing
symptoms. rarely vaccine (DPT,
Febrile seizures; if temperature anticonvulsants Penta), measles
elevated >100.4o F/ >38oC (rectal)
Afebrile seizures: if temperature
normal self-limiting.
Persistent Inconsolable continuous crying Settles within a day DPT, penta
inconsolable lasting 3 hours of longer accompanied or so
screaming by high-pitched screaming
Analgesics may
help
Hypotonic Event of sudden onset occurring Episode is transient Mainly DPT,
Hypo- within 48 (usually less than 12) hours and self-limiting Penta rarely
responsive of vaccination and lasting from one others
Episode (HHE) minute to several hours, in children Does not require
or shock younger than 10 years of age. All of specific treatment
collapse the following must be present:
 Limpness (hypotonic) Not a
 Reduced responsiveness (hypo contraindication for
responsive) further doses of the
 Pallor or cyanosis vaccine

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Differential diagnosis for Breath holding spell, Convulsion and
Anaphylaxis
Breath holding spell Convulsion Anaphylaxis
Triggering factor Triggered by sudden Illness, fever, Any drug including
fright/ pain / injury to medication, or injury vaccine, food, insect
head; occur in young bite etc.
children
Clinical Features Child becomes pale, Child cries. groans Urticaria, swollen
loses, consciousness, loudly. Tonic phase – eyes, face, generalized
develops facial
body is rigid, with rash; noisy breathing
flushing & cyanosis, clenched teeth. Lips from airways
may become sweaty, may turn blue. obstruction;
or stiffen, have a few Clonic phase – Tachycardia; weak
body jerks or loose resumes shallow carotids;
bladder control breathing; arms and
legs jerk quickly and Loss of consciousness;
rhythmically; pupils’ little response in prone
contract and dilate position
Duration Episodes are brief and Generally, lasts 1 -3 With early and
lasts less than minute minutes, Seizure appropriate
lasting more than five intervention,
minutes requires anaphylaxis can pass
emergency medical within a few hours. If
help progresses to a serious
stage, recovery may
take a few days. May
cause death within
minutes or hours after
onset if appropriate
steps are not taken
Recovery Chill will regain Child relaxes, may Potential fatal if not
consciousness, lose control of bowel recognised and treated
recognises people but or bladder. Regains appropriately soon
may seem sleepy consciousness slowly. after onset. Recovery
May appear drowsy, may take days.
confused, anxious, or
depressed.

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Differential diagnosis for Mild and Severe allergic reactions
Mild allergic reactions Severe allergic reactions / Anaphylazis
Onset and Fast onset immediately Quick onset, progresses quickly in severity
progression following vaccination, does
not progress in severity not
life threatening
Signs and Itching, redness, mucosal In addition to dermatological involvement
symptoms involvement (swelling of lips, as in mild allergic reactions, the case may
face, eyes) tingling sensation progress quickly to involve other systems
in mouth, abdominal pain such as cardiac (persistent dizziness, pale
appearance, sudden collapse) or respiratory
system (difficulty / noisy breathing,
swelling / tightness of throat, difficulty in
talking / hoarse voice, wheeze).
Requires symptomatic ANM can safely administer single dose of
treatment and refer to medical adrenaline intramuscularly before referring
officer for further the case immediately to appropriate health
management safety
Management
Many of the initial symptoms and signs are similar in both mild allergic
reactions and severe allergic reactions/anaphylaxis. ANM may administer a
single dose of adrenaline injection at the first sign or symptoms suggestive of
allergy or anaphylaxis

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Initial management of Anaphylaxis by ANM
AFTER IMMUNIZATION LET THE PARENTS OR GUARDIANS WAIT FOR 30
MINUTES.
Suspect* Anaphylaxis in a case with following symptoms and signs.

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Anaphylaxis Kit
The ANM will ensure to maintain an anaphylaxis kit at session site. The contents of
anaphylaxis kit will be as follows: -
Sl. Contents Quantity
1 Job aid for recognizing anaphylaxis; dose chart for adrenaline 1 Nos
as per age
2 1 ml ampoule of adrenaline (1:1000 aqueous solution) 3 nos
(adrenaline ampoules may also label as epinephrine)
3 Tuberculin syringes (1ml) or insulin syringe (without fixed 3 nos
needle of 40 units)
4 24G/25G needles (1 inch) 3 nos.
5 Swabs 3 nos.
6 Updated contact information of DIO, Medical Officer(s) of -
PHC/CHC, referral centre and local ambulance services
7 Adrenaline administration record slips -

Reporting of AEFI
1. Immediately inform all serious/severe AEFIs by telephone / in person.
2. Provide details of all AEFIs in your area on a weekly basis. Submit weekly NIL report
only after making efforts to look for these events in the children recently vaccinated.
3. Notify detailed information of all serious, severe and minor AEFIs to be recorded in
the block AEFI register (Figure-1)
4. Communicate and share the results of investigation with the community whenever
instructed by the medical officer

Figure 2- Block AEFI Register

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 CASE REPORTING FORM (CRF)
To be filled by doctor and sent to District Immunization Officer within 24 hours
AEFI Case ID: IND (AEFI) / S T / D S T / Y R / N U M (from SAFE-VAC) *Mandatory Fields
AEFI Case ID: IND (CO-AEFI) / S T / D S T / Y R / N U M (from Co-WIN - SAFE-VAC, for COVID-19 vaccines)
Section A: Reporter and notifier details

Name of doctor reporting / filling this form*: Reporting Date: / /

Contact phone number*:
E mail*:
Place of present posting*:
Address of present posting:
(date when this form is prepared)
Date case visited and examined / interviewed:
Designation*: / /
(date when the case visited or interviewed)

Notified by (Name)*: Designation of notifier (please circle): ASHA / AWW / Health worker / Government
doctor / Private practitioner or hospital / Parent / Community / Media / Others
Date notified: / /
(date when the case informed to reporting doctor) Specify:

Address of session site*:

Place of Vaccination*: Govt Health Facility / Outreach / Private Health Facility /
Village or Urban area: Others (specify): _
Block Name:
Source of vaccine: Government supply / Privately purchased / Others (specify):
District:
State:
Vaccination in*: Routine Immunization / Campaign (MI, Pulse Polio, MR, JE, COVID
Date of Vaccination*: / /
19) / Others (specify):
Time of Vaccination: : AM/PM Type of Session Site: Fixed / outreach / mobile / others (specify):

Section B : Patient details

Patient Name*

Date of Birth * DD/MM/YYYY Age: years Months days Sex* Male Female

Mother’s Name

Spouse/Father’s Name*
Complete Address* with landmarks (Street name, house number, village, block, Tehsil, PIN No., Telephone No. etc.)

P I N - P H O N E* -
Section C : Details of vaccine(s) and diluent(s) administered to the AEFI case during this session (to be filled by MO incharge or DIO of area where
vaccination took place)
Name of vaccines Date & Time of No. of OTHER
Dose no. (birth / zero
administered to this Name of vaccine beneficiaries who
/1 /2 /3 /
st nd rd Batch / Lot Mfg. Expiry
case (write vaccine & Manufacturer / reconstitution / received vaccine
booster 1 / booster 2 No.* date date
diluent details in Brand Name* opening vaccine from SAME vial in
/ campaign)*
separate rows)* vial this session

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Section D : Details of adverse event(s)
1. Type of Adverse Event: Serious / Severe
2. If serious AEFI specify: Death / Hospitalization / Cluster / Persistent or significant disability / Congenital anomaly or birth defect / Media,
community/ parental concern

If this is a part of a cluster*: Yes / No / Unknown

If yes number of other cases in the cluster Cluster ID (as generated by SAFE-VAC):
Adverse event(s) - clinical* (TICK AS MANY AS APPLICABLE):
Severe local reaction Fever Seizures Injection site abscess
Sepsis Encephalopathy Toxic shock syndrome Thrombocytopenia
Allergic reaction Anaphylaxis Intussusception Lymphadenitis
Acute Flaccid Paralysis Hypotonic Hypo-responsive Episode (HHE) Unexplained Death Anxiety reaction
Additional for COVID vaccine
Joint pain/swelling of recent onset Painful single limb swelling Chest pain/ fainting/ palpitation
Recent ECG/Echo/angiography changes Breathlessness/ difficulty in breathing/ worsening of existing respiratory problem
Altered sensorium/ Loss of consciousness Acute disseminated encephalomyelitis Guillain-Barre syndrome
Meningoencephalitis Mono-neuropathy/Poly-neuropathy Rashes
Loss of taste/smell Acute liver injury/Acute Liver Failure Chilblain-like lesions /vasculitis
Acute kidney injury / Acute Renal Failure / Hematuria/Oliguria/ Edema of legs/Hypertension Lymphadenopathy
Coagulation / bleeding disorder (Thromboembolism, Hemorrhage)
Worsening of existing disease (Cardiac/Respiratory/Liver/Kidney/Diabetes etc.) Others (specify)………………………..……………
Pregnancy related events-
Maternal death Fetal loss (abortion) Premature delivery Still birth Neonatal mortality Congenital anomaly in newborn

Date & Time of first symptom*: DD / MM / YYYY at : AM/ PM Hospitalization*: Yes / No

Name and address of hospital:

Date & Time of hospitalization*: DD / MM / YYYY at : AM / PM Hospital Reg. No. (OPD/Admission/Bed Head Ticket):

If hospitalized, outcome (encircle)*: Discharged / Still Hospitalized / Left Against Medical Advice (LAMA) / Absconded / Referred / brought dead

Current status of patient*: Recovered completely / recovered with sequalae / still under treatment / death / unknown

Date & Time of Death*: DD / MM / YYYY (if died) at : AM / PM Post mortem done: YES / NO / Unknown
Place of death: Home / Hospital / On the way to hospital / Others Date of Post mortem: DD / MM / YYYY

Describe AEFI (sequence of events, signs and symptoms after vaccination) *:

Signature and name of Reporting Medical Officer:

Section E: Decision making details

District Immunization Officer to complete and submit in SAFE-VAC / Co-WIN SAFE-VAC (for COVID-19 vaccines) within 24 hours of receiving the above
information. SAFE-VAC: https://safevac.nhp.gov.in; Co-WIN - SAFE-VAC:
Date report received at District level: / /
Date investigation planned: / /
DIO/ District Nodal Person (Officer forwarding this report)
Name ……………………………………………………………..…………. Designation……………………………………………..… Mobile No*: …………………….………….
Email id*: …………………………………………………………………….. Signature……………………………..……………….. Date/ Seal: ……………………………………
Complete Office address (with Pin code) …………………………………………………………………………………..……………………………………………………………………………………..
…………………………………………………………………………………………………………………………………………………………………………………………………………

For any support or help, write to: aefiindia@gmail.com; safevac.chi@gmail.com

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References
1. Immunization Handbook for Health Workers (2018)
2. Operational Guidelines Initial management of Anaphylaxis using Injection Adrenaline by
ANMs
3. AEFI Surveillance Processes- A Guidance Document for States
4. Implementing Guidebook of Quality Management System for AEFI Surveillance in States
And Districts

End of the Document

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