Update in April

1. A.E.F.I.
Adverse Event Following
Immunization

2. A.E.F.I.
Why “event” – not “effect”?
Event -vs- Effect (outcome of RI)
Not desired desired /expected
Unwanted wanted
Eventful uneventful
Warrants does not
actions warrant actions
More players Less players
(people gets involved) (only beneficiary involved)

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4. Types of AEFIs
• Program Errors
• Vaccine reactions
• Coincidental
• Injection reaction
• Unknown

5. Types of AEFI
1. Programmatic Error
• Due to error in vaccine preparation, handling or administration.
• Majority of AEFIs occur due to programmatic errors
– and preventable
Non-sterile needle
Suppurative Lymphadenitis
following BCG Vaccination

6. Common programmatic errors
which can lead to AEFIs
Non-sterile injection
 Contact of needle with unsterile surface
e.g. finger, swab, table etc.
Infection can manifest as:
 Administering injection over clothes
Local reactionvaccine or diluent abscess
 Contaminated – suppuration,
 Use of reconstituted vaccines beyond
Systemic effecthours
the stipulated 4
– sepsis, toxic shock syndrome
Blood borne virus infection at HIV, HBV, HCV
 Reuse of reconstituted vaccine –
subsequent sessions
 Reuse of disposable syringe & needle
Time ??

7. Common programmatic errors
which can lead to AEFIs
Reconstitution error/ Wrong vaccine preparation
 Reconstitution with incorrect diluent
- less vaccine effectiveness
 Drug substituted for diluent – drug reaction, death
 Inadequate shaking of T-series vaccines
– local abscess
Injection at incorrect site/route
 Injection into gluteal region (buttocks)
– sciatic nerve damage
 BCG /T series vaccine given subcutaneously
– local reaction or abscess

8. Common programmatic errors
which can lead to AEFIs
Vaccine transportation/storage incorrect
 Administration of frozen and thawed
freeze-sensitive vaccine -local reaction
such as sterile abscess
Contraindications ignored
 DPT2 given after H/O convulsions with DPT1
- convulsions

9. Common program errors can be prevented by :-
• training of H.W.
• regular supervision
• adequate supply / availability of logistics

10. …Types of AEFI
2. Vaccine Reaction
An event caused or precipitated by the active component or
one of the other components of the vaccine (e.g. adjuvant,
preservative or stabilizer).
This is due to the inherent properties of the vaccine.
A. Common, minor vaccine reactions
– local reaction (e.g. pain, swelling and/or redness, fever).
- Local reactions and fever should be anticipated in only 10% of the vaccine
recipients, except in the case of whole cell DPT which produces fever in
nearly half of those vaccinated.

11. …Types of AEFI
2. Vaccine Reaction
- Fever and minor local and systemic reactions usually occur within a day or
two of immunization (except for those produced by measles/MMR vaccine
which occurs 6 to 12 days after immunization) and only last for few days.
- Fever and minor local reactions can usually be treated symptomatically with
paracetamol.
- systemic symptoms (e.g. vomiting, diarrhoea, malaise)
B. Rare serious vaccine reactions
High (39-40.4oC / 102-104.7oF) to extreme fevers (>40.5oC/105 oF)
indicate the possibility of:
Anaphylaxis - potentially fatal allergic reaction, but treatable

12. …Types of AEFI
3. Coincidental Event
An event that occurs after immunization but is not caused by the vaccine.
This is due to a chance temporal association
Example: pneumonia after oral polio vaccine administration
4. Injection Reaction
Event caused by anxiety about, or pain from the injection
itself rather than the vaccine
Example: fainting spell in a teenager after vaccination
5. Unknown
Any event due to undetermined cause.

13. Interval No. of
AEFI Vaccine Definition between events / Treatment
vaccn. & million
onset doses
Heals spontaneously
Either at least one lymph 2 to 6 over months and best
nodes enlarged to >1.5 cm in months not to treat. If lesion is
size (one adult finger width) or after sticking to skin or
a draining sinus over a lymph receipt of already draining,
Suppurative BCG node. BCG 100-1000 surgical drainage and
lymphadenitis vaccine
Almost exclusively caused by local instillation of anti-
BCG - same side as tuberculosis drug.
inoculation (mostly axillary). Systemic treatment with
anti-tuberculous drugs is
ineffective
Acute onset of major illness
characterized by any two of Within 48
the following three conditions: hours of No specific treatment
seizures DPT or available;
Encephalopath Measles, -
severe alteration in level of from 7 to supportive care.
y Pertussis
consciousness lasting for 12 days
after
one day or more
measles
Distinct change in behavior vaccine
lasting one day or more..
Persistent DPT, Inconsolable continuous 0-48 1,000- Settles within a day or
inconsolable Pertussis crying lasting 3 hours or hours 60,000 so; analgesics may help.
longer accompanied by high-
screaming
pitched screaming.

14. Interval No. of
AEFI Vaccine Definition between events / Treatment
vaccn. & million
onset doses
Seizures Occurrence of generalized
are mostly convulsions that are not
febrile in origin, accompanied by focal
the rate All, neurological signs or Self-limiting; supportive
depends on symptoms.
especially care; paracetamol and
past history, Febrile seizures: if cooling if febrile; rarely
family history Pertussis, 0-3 days 600
temperature elevated anticonvulsants.
and age, much Measles >100.4 0F or 38 0C (rectal)
lower risk in
infants < age of Afebrile seizures: if
4 mns. temperature is normal

15. AEFIs following ALL injectible vaccines
AEFI Definition Treatment
The fever can be classified (based on rectal Symptomatic; paracetamol.
temperature) such as Give extra oral fluids.
Mild fever: 100.4 0F to 102 0F (38 to 38.9 0C), Tepid sponge or bath.
Fever High fever: 102 0F to 104.7 0F (39 to 40.40C) and In cases of high and extreme fever, other
Extreme fever: 104.7 0F or higher (>40.50C). signs and symptoms should be sought
and reported /managed as appropriate.
Fluctuant or draining fluid-filled lesion at injection.
Injection Bacterial if evidence of infection (e.g. purulent,
site inflammatory signs, fever, culture), Sterile abscess if Incise and drain; Antibiotics if bacterial.
abscess no evidence of bacterial infection on culture. Sterile
abscesses are usually due to the inherent properties
of the vaccine.
Acute onset of severe generalized illness due to Critical to recognize and treat early.
Sepsis bacterial infection and confirmed (if possible) by Urgent hospitalization
positive blood culture. Needs to be reported as for intravenous antibiotics and fluids
possible indicator of program error.
Redness and/or swelling centered at the site of
Severe injection and one or more of the following: Settles spontaneously within a few days
local Swelling beyond the nearest joint to a week. Symptomatic treatment with
reaction Pain, redness, and swelling of more than 3 days analgesics.
Requires hospitalization. Antibiotics are inappropriate.
Local reactions of lesser intensity occur commonly
and are trivial and do not need to be reported.

16. AEFIs following ALL injectible vaccines
AEFI Definition Treatment
Toxic shock Abrupt onset of fever, vomiting and watery diarrhoea Critical to recognize and treat early.
syndrome within a few hours of immunization. Often leading to Urgent hospitalization for intravenous
(TSS) death within 24 to 48 hours. Report as a possible antibiotics and fluids
indicator of program error.
Anaphylactoid Exaggerated acute allergic reaction, occurring Self-limiting
reaction (acute within 2 hours after immunization, characterized by Anti-histamines may be useful
one or more of the following:
hypersensitivity
reaction) wheezing and shortness of breath due to
bronchospasm
Laryngospasm / laryngeal oedema
One or more skin manifestations, e.g. hives, facial
oedema, or generalized oedema.
Do not report less severe allergic reactions
Severe immediate (within 5-30 minutes) allergic Most life-threatening reactions begin
reaction leading to circulatory failure with or without within 10 minutes of immunization.
bronchospasm and / or laryngospasm / laryngeal Keep the vaccinee under
oedema observation
The early signs of anaphylaxis are generalized for at least 20 minutes after the
erythema and urticaria with upper and/or lower injection.
Anaphylaxis respiratory tract obstruction. Transfer the patient swiftly to
In more severe cases, limpness, pallor, loss of hospital
consciousness and hypotension become evident in Make sure the details accompany the
addition. patient when he is transferred. Mark
A strong central pulse (e.g. carotid) is maintained the immunization card clearly so the
during a faint, but not in anaphylaxis. individual never gets a repeat dose
of the offending vaccine

17. Treatment of Anaphylaxis
Adrenaline (epinephrine) counters anaphylaxis.
Keep emergency kit ready with adrenaline. kit should be checked three or four times a year. Adrenaline
that has a brown tinge must be discarded.
Ensure the airway is clear. If appropriate, begin cardiopulmonary resuscitation.
Give 1:1000 adrenaline at a dose of 0.01ml/kg up to a maximum of 0.5 ml by deep intramuscular
injection into the opposite limb to that in which the vaccine was given. (Subcutaneous administration is
acceptable in mild cases).
If the weight of the patient is unknown, an approximate guide is:
Less than 2 years 2-5 years 6-11 years 11+ years
0.0625 ml (1/16th of a ml) 0.125 ml (1/8th of a ml) 0.25 ml (1/4 of a ml) 0.5 ml (1/2 of a ml)
And give an additional half dose around the injection site (to delay antigen absorption).
If the patient is conscious after the adrenaline is given, place his/her head lower than the feet and keep the
patient warm.
Give oxygen by face mask.
Call an ambulance (or arrange other means of transport, after the first injection of adrenaline. If there is no
improvement within 10-20 minutes, of the first injection, repeat the dose of adrenaline up to a maximum of
three doses in total. Recovery from anaphylactic shock is usually rapid after adrenaline.
At a suitable moment, explain to parents or relatives the importance of avoiding the vaccine in the future.

18. Reporting AEFIs
Why report AEFIs ?
• Effective means of monitoring immunization
safety
• Contributes to quality & credibility of program
• Helps in clinical management of case
• Identify gaps in program implementation (if any)
• Helps identify actual rate of occurrence.
• Avoids false rumors
• Build confidence of public in program

19. Cluster of AEFIs
A cluster is defined as two or more cases of the same or
similar events, which are related in time, and have occurred
within specific geographical area, or associated with the
same vaccine, the same batch number or the same
vaccinator.
e.g. two or more cases of abscess occur in a village following an
immunization session
Or
multiple abscess cases following immunization by the same vaccinator or
the same batch of the vaccine, but in different villages.

20. Reporting of AEFIs
What to report How to report Who reports to Whom When to report
For Immediate Reporting Telephone or HWs MO DIO/CMO Immediately
and Investigation – any other quick SIO
SERIOUS AEFIs means of
communication
Death FIR (First Information Report) Within 24 hrs
Hospitalization (anaphylaxis, to District &
anaphylactoid reaction, TSS, 48 hrs to State
Encephalopathy, Sepsis) PIR and GOI
Any event where vaccine (Preliminary Investigation
quality is suspected Report) Within 7 days
Events occurring in a cluster
DIR
Within 90 days
(Detailed Investigation report)
For Routine Monthly reporting
Deaths
Injection site abscesses
Persistent (> 3hrs) screaming
HHE
UIP Report HWs MO DIO/CMO
Severe local reaction
Seizures including febrile seizures SIO Monthly
Brachial neuritis
Thrombocytopenia
Lymphadenitis All reported cases that are not
Disseminated BCG infection serious are recorded as minor
Osteitis / Osteomyelitis AEFIs
Events occurring in cluster

21. Channels and Timeline Sub Center / Outreach
for Reporting Serious
AEFI cases
Private District
PHC/CHC
Practitioner Hospital,
Med college
FIR to Distt HQ within 24 hrs or Other
Institutions
District
FIR forwarded within next 24 hrs
PIR with available med record within 7 days
State DIR & all med records within 3 months
MOHFW
Govt of India
State drug controller) State EPI officer
Vaccine
Asst Comm (UIP) DCG (India)
Manufacturer

22. Pending Documents - AEFI - West Bengal
Serial Post
N Mortem Vaccine
o EPID No District Patient's name FIR PIR DIR report Samples
1 WB-SPG-11-001 South 24 PGS Harun AL Rashid Yes Yes Pending
Paschim
2 WB-MNP-11-003 Midnapore SK Riyazul Yes Pending Pending Pending
3 Sofiya Mondal Yes Pending Pending
4 Antara Siddya Yes Pending Yes
5 Anisha Khatoon Yes Yes Pending
6 WB-MLD-11-001 Malda Puja Chowdhury Yes Yes Pending
7 Tisha Roy Yes Pending Pending
8 WB-MLD-11-002 Malda Saheb SK Yes Pending Pending
9 WB-MLD-11-003 Malda Tahasina Khatoon Yes Yes Pending Pending
10 WB-PRL-11-001 Purulia Prabin Mahato Yes Yes Pending Pending
11 WB-SPG-11-004 South 24 PGS Nurnabi Purkait Yes Yes Pending
12 WB-SPG-11-005 South 24 PGS Mamoni Laskar Yes Yes Pending
13 WB-SPG-11-006 South 24 PGS Alamin Laskar Yes Yes Pending
14 WB_SPG-11-003 South 24 PGS Ajmira Khatoon Yes Yes Pending
15 WB-SPG-11-007 South 24 PGS Habibul SK Yes Yes Pending
16 WB-SPG-11-008 South 24 PGS Raihan Yes Yes Pending
17 SK Irfan Yes Yes Pending

23. Pending Documents - AEFI - West Bengal
Post
Mortem Vaccine
Serial No EPID No District Patient's name FIR PIR DIR report Samples
18 WB-SPG-11-012 South 24 PGS Puja Sarder Yes Pending Pending
19 WB-SPG-11-011 South 24 PGS Amit Mondal Yes Pending Pending
20 WB-HGL-11- Hooghly Raju Saha Yes Pending Pending
21 WB-HGL-11- Hooghly Joy Bag Yes Pending Pending
22 Asmina Khatoon Yes Yes Pending Pending
23 WB-SPG-11-013 South 24 PGS Masud Rahaman Molla Yes Pending Pending
24 WB-MLD-11--004 Malda Hasina Yasmin Yes Yes Pending
25 Tania sardar Yes Pending Pending
26 WB-SPG-11-014 South 24 PGS Sounem Mondal Yes Pending Pending
27 WB-SPG-11-016 South 24 PGS Sasadhar Mondal Yes Pending Pending
28 WB-PRL-11-002 Purulia Nagesh Gorai Yes Yes Pending
29 WB-PRL-11-003 Purulia Shibam Choubey Yes Pending Pending
30 jayashree Ray Yes Pending Pending
31 WB-MLD-11-001 Malda Pabitra Mudi Yes Yes Pending
32 WB-PRL-12-001 Purulia Laxmi Kalindi Yes Pending Pending
33 WB-PRL-12-002 Purulia Sudip mahato Yes Pending Pending Pending
34 Tamim Molla Yes Pending Pending

24. FIR

25. PIR

26. DETAILIR
DIR

27. Investigating AEFIs
• The focus of the investigation should be to confirm the working hypothesis.
• Request laboratory testing only on a clear suspicion and not as routine, and
never before the working hypothesis has been formulated
• Laboratory testing may sometimes confirm or rule out the suspected cause.
• The vaccine and diluent may be tested for sterility and chemical composition;
and the needles and syringe for sterility.
• Send unopened vaccine vials and matching diluent of the same batch for
testing
• Send vaccine samples for testing to the National Control Laboratory (NCL),
Central Research Institute, Kasauli accompanied with a completed Lab
Requisition Form (LRF) along with a copy of the available FIR/PIR. Send the
samples in cold chain (+20C to +80C) and by fastest means.

28. AEFI SAMPLES RECEIVED BY CDL
Commissioner/
Deputy Drug Inspectors
Commissioner /
Assistant
Commissioner
AEFI
State Drug
CMO/DHO Controller/ADC
28

29. Labeling of Vaccine Samples
• Vaccine samples are packed properly
along with “Seal”.
• Same “Seal” is put on the forwarding
letter and on the Thermocol Box.
29

30. Minimum Quantity of AEFI
Samples Required for Testing
• DTP Group of Vaccines - 10 dose x 10 vials or
- 01 dose x 30 vials
• BCG Vaccine -10/20 dose x 40 vials
• Oral Polio Vaccine -20 dose x 10 vials
• Measles/MMR Group -01 dose x 20 vials or
-05 doses x 15 vials or
-10 Dose x 10 Vials
• J.E & Hepatitis vaccines -01 Dose x 30 Vials or
-05 Dose x 15 Vials or
-10 Dose x 10 Vials
30

31. Duration of Time required for
Testing of Vaccines
31

32. Shipment of Vaccine Samples
• Samples of Vaccines involved in AEFI Cases must be
transported
• With a Formal Letter stating the purpose/Form as per Drug
Act
• In properly Sealed and Addressed containers
• Under Adequate COLD CHAIN (No Freezing, except for
vaccines which are stored at < -20C e.g. Oral Polio Vaccine)
• Preferably by COURIER (On Dot, DTDC)/ In Person
• In Appropriate Quantity (Refer previous text)
• With Relevant Documents enclosed
32

33. Kindly Check
• The labels must never be wrapped with adhesive tape.
• The samples must be so packed that the vials do not get
wet and labels are not peeled off
• Most of the times due to either inadequate number of
samples or no response to NCL’s (National Control
Laboratory) queries the cases are considered as closed.
• Please ensure that the appropriate diluents accompany
the freeze dried vaccines
33

34. Kasauli Lab contact details
Head, Central Drugs Lab.
Central Research Institute
Kasauli – 173204.
Himachal Pradesh.
Email : nclkasauli@bsnl.in
Phone: 0179-2272046, 2272060
Fax: 0179-2272049, 2272016
34

35. CDL Kolkata Lab
The Director
3, KYD Street
Kolkata-700016
Phone: 033-22299021, 22870513
Email: cdlkol@gmail.com
35

36. Where to send samples for testing
used / unused batch of National control lab
vaccine/diluents Kasauli
used / unused batch of CDL Kolkata
syringes/Vit A
Biological products Labs approved
(blood, CSF etc) by State/ Distt
Autopsy (post mortem)
State Forensic Labs
samples
As per information from FDA office

37. Key reasons for under reporting
• Fear/ apprehension to report.
• Unaware about reporting system & process.
• No technical committee to respond.
• Not considering the event as related to
immunization
• Guilt about having caused harm and being
responsible
• Media fear
• A nil report is also important.

38. AEFIs
• Encourage Field workers to report AEFIs without
fear of penalty.
• The aim is to improve systems to prevent /
minimize further AEFI and not to blame
individuals.

39. Roles and Responsibilities
ANMs should:
• Ask the beneficiaries to wait for half an hour after vaccination to
observe for any AEFI.
• Leave the list of children vaccinated in a session with the AWW/ASHA
and request them to be alert and report AEFIs. Share contact details of
self and PHC.
• Treat mild symptoms like fever, pain
• Report deaths, injection site abscesses and other complications in the
monthly UIP report. A nil report is also important.
• Refer serious cases to MO (PHC) or to appropriate health facility for
prompt treatment.
• Report serious events/ cluster of events immediately to the supervisor/
MO (PHC)/ DIO
• Record the time of opening/ reconstitution of vial on the vial label.
• Communicate with parents and other members of the community
• Assist in investigation of AEFIs

40. Roles and Responsibilities
Health Supervisors should:
• Collect and review reports of AEFIs during their
supervisory visits to immunization session sites/ SC.
• Provide on-the-job training to the field staff on safe
injection practices and reporting.
• Assist the MO in conducting the investigation.

41. Roles and Responsibilities
MO PHC/ CHC should: ANMs should:
• Improve/arrange logistics to prevent AEFI due to program errors.
• Train staff in detecting, managing and reporting of AEFIs
• Manage AEFIs and refer to the higher level, if required.
• Initiate investigation, when required
• Complete case report forms (FIR, PIR and DIR) and inform the DIO
immediately for serious cases and deaths
• Report deaths, injection site abscesses and other complications in
the monthly UIP report. A nil report is also important.
• Supervise all reported AEFI through site visits and give immediate
feedback to health workers.
• Communicate with and share the conclusions and results of
investigation with health workers and the community.

42. Roles and Responsibilities
AT DISTRICT LEVEL:
• Establish district AEFI committee
• Train field staff in managing, investigating and reporting
AEFIs.
• Identify a focal person for investigations.
• Identify a designated spokesperson to address the media
if required
• Coordinate AEFI case management
• Report ALL AEFIs - a nil report is also important.
• Investigate serious AEFIs and deaths with State-level
Investigation Teams
• Send FIR, PIR and DIR of serious AEFIs

43. District AEFI Committee
• CMOH
• DIO
• DFWO
• Dy.CMOH-II (Epidemiologist)
• Microbiologist / Pathologist
• Paediatrician / Physician
• DPHNO
• IAP/IMA Representative
• Assistant Drug Controller

44. State AEFI Committee
• SEPIO
• SRTL-NPSP (East)
• Representative from WBSISC
• Microbiologist / Pathologist
• Paediatrician / Physician
• IAP/IMA Representative
• Representative of Director, Drug Control

45. Media hunts for sensational news
Stick to basic messages
when dealing with media

46. Media Management -AEFI
• Verification of FIR / PIR
• Guessing / speculation to be avoided
• Attempt to cover up to be avoided
• Designated responsible spokesperson (block / district / state) should
talk to media
• Provide a complete / simple account of events
• Compassionate & caring attitude is needed
• Avoid off-hand & disparaging remarks
• Try to convince that despite AEFI, the benefit of vaccination
outweighs the risks