A.E.F.I.

Adverse Event Following Immunization

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 deaths following Vaccination:

Probe teams for Aurangabad

Special Correspondent NEW DELHI: The Central government has deputed a high-level te

am under

a Special Director-General to

investigate the death of four in

fants following measles vaccination in

Aurangabad district of Maharashtra last week. Four in

fants had died and six taken ill at a measles

vaccination camp organised at the Judean prim

ary health centre in Phulambri tehsil on Friday last

AEFI is defined as: A medical event that takes place

after an immunization, causes concern and is believed to be caused by immunization

It is important that AEFIs are detected,investigated, monitored and promptly responded to for corrective interventions.

Types of AEFIs

• Program Errors • Vaccine reactions • Coincidental • Injection reaction• Unknown

Types of AEFI

• Due to error in vaccine preparation, handling or administration.

• Majority of AEFIs occur due to programmatic errors

– and preventable

Suppurative Lymphadenitis following BCG Vaccination

1. Programmatic Error

Non-sterile needle

Time ??

Non-sterile injection

Contact of needle with unsterile surface e.g. finger, swab, table etc.

Administering injection over clothes Contaminated vaccine or diluent Use of reconstituted vaccines beyond

the stipulated 4 hours Reuse of reconstituted vaccine at

subsequent sessions Reuse of disposable syringe & needle

Common programmatic errors which can lead to AEFIs

Infection can manifest as:Local reaction – suppuration, abscessSystemic effect – sepsis, toxic shock syndrome Blood borne virus infection – HIV, HBV, HCV

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

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

Common programmatic errors which can lead to AEFIs

Common program errors can be prevented by :-

• training of H.W.

• regular supervision • adequate supply / availability of logistics

…Types of AEFI

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.

2. Vaccine Reaction

…Types of AEFI

- 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

2. Vaccine Reaction

…Types of AEFI

Event caused by anxiety about, or pain from the injection itself rather than the vaccineExample: fainting spell in a teenager after vaccination

Any event due to undetermined cause.

4. Injection Reaction

5. Unknown

An event that occurs after immunization but is not caused by the vaccine. This is due to a chance temporal associationExample: pneumonia after oral polio vaccine administration

3. Coincidental Event

AEFI Vaccine Definition Interval between vaccn. &

onset

No. of events /million doses

Treatment

Suppurative lymphadenitis

BCG

Either at least one lymph nodes enlarged to >1.5 cm in size (one adult finger width) or a draining sinus over a lymph node.Almost exclusively caused by BCG - same side as inoculation (mostly axillary).

2 to 6 months

after receipt of

BCG vaccine

100-1000

Heals spontaneously over months and best not to treat. If lesion is sticking to skin or already draining, surgical drainage and local instillation of anti-tuberculosis drug.Systemic treatment with anti-tuberculous drugs is ineffective

Encephalopathy

Measles,Pertussis

Acute onset of major illness characterized by any two of the following three conditions:seizuressevere alteration in level of consciousness lasting forone day or moreDistinct change in behavior lasting one day or more..

Within 48 hours of DPT or from 7 to 12 days after measles vaccine

-

No specific treatment available; supportive care.

Persistentinconsolablescreaming

DPT,Pertussis

Inconsolable continuous crying lasting 3 hours or longer accompanied by high-pitched screaming.

0-48 hours

1,000-60,000

Settles within a day or so; analgesics may help.

AEFI Vaccine Definition Interval between vaccn. &

onset

No. of events /million doses

Treatment

Seizuresare mostly febrile in origin, the rate depends on past history, family history and age, much lower risk in infants < age of 4 mns.

All,especiallyPertussis,Measles

Occurrence of generalized convulsions that are notaccompanied by focal neurological signs or symptoms.Febrile seizures: if temperature elevated >100.4 0F or 38 0C (rectal)Afebrile seizures: if temperature is normal

0-3 days 600

Self-limiting; supportive care; paracetamol and cooling if febrile; rarely anticonvulsants.

AEFI Definition Treatment

Fever

The fever can be classified (based on rectal temperature) such asMild fever: 100.4 0F to 102 0F (38 to 38.9 0C),High fever: 102 0F to 104.7 0F (39 to 40.40C) andExtreme fever: 104.7 0F or higher (>40.50C).

Symptomatic; paracetamol.Give extra oral fluids.Tepid sponge or bath.In cases of high and extreme fever, other signs and symptoms should be sought and reported /managed as appropriate.

Injection siteabscess

Fluctuant or draining fluid-filled lesion at injection.Bacterial if evidence of infection (e.g. purulent,inflammatory signs, fever, culture), Sterile abscess if no evidence of bacterial infection on culture. Sterileabscesses are usually due to the inherent properties of the vaccine.

Incise and drain; Antibiotics if bacterial.

SepsisAcute onset of severe generalized illness due to bacterial infection and confirmed (if possible) by positive blood culture. Needs to be reported as possible indicator of program error.

Critical to recognize and treat early. Urgent hospitalizationfor intravenous antibiotics and fluids

Severe local reaction

Redness and/or swelling centered at the site of injection and one or more of the following:Swelling beyond the nearest jointPain, redness, and swelling of more than 3 daysRequires 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. Symptomatic treatment withanalgesics. Antibiotics are inappropriate.

AEFIs following ALL injectible vaccines

AEFI Definition Treatment

Toxic shocksyndrome (TSS)

Abrupt onset of fever, vomiting and watery diarrhoea within a few hours of immunization. Often leading to death within 24 to 48 hours. Report as a possible indicator of program error.

Critical to recognize and treat early. Urgent hospitalization for intravenous antibiotics and fluids

Anaphylactoidreaction (acutehypersensitivityreaction)

Exaggerated acute allergic reaction, occurring within 2 hours after immunization, characterized by one or more of the following:wheezing and shortness of breath due to bronchospasmLaryngospasm / laryngeal oedemaOne or more skin manifestations, e.g. hives, facial oedema, or generalized oedema.Do not report less severe allergic reactions

Self-limitingAnti-histamines may be useful

Anaphylaxis

Severe immediate (within 5-30 minutes) allergic reaction leading to circulatory failure with or without bronchospasm and / or laryngospasm / laryngeal oedema The early signs of anaphylaxis are generalized erythema and urticaria with upper and/or lower respiratory tract obstruction. In more severe cases, limpness, pallor, loss of consciousness and hypotension become evident in addition.A strong central pulse (e.g. carotid) is maintained during a faint, but not in anaphylaxis.

Most life-threatening reactions begin within 10 minutes of immunization. Keep the vaccinee under observationfor at least 20 minutes after the injection.Transfer the patient swiftly to hospitalMake sure the details accompany the patient when he is transferred. Mark the immunization card clearly so the individual never gets a repeat dose of the offending vaccine

AEFIs following ALL injectible vaccines

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.

Reporting 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

Why report 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.

Cluster of AEFIs

What to report How to report Who reports to Whom When to report

For Immediate Reporting and Investigation –SERIOUS AEFIs

DeathHospitalization (anaphylaxis,anaphylactoid reaction, TSS, Encephalopathy, Sepsis)Any event where vaccine quality is suspectedEvents occurring in a cluster

Telephone or any other quick means of communication

HWs MO DIO/CMOSIO

FIR (First Information Report)

PIR (Preliminary Investigation Report)

DIR (Detailed Investigation report)

Immediately

Within 24 hrsto District & 48 hrs to State and GOI

Within 7 days

Within 90 days

For Routine Monthly reporting Deaths Injection site abscesses Persistent (> 3hrs) screaming HHE Severe local reaction Seizures including febrile seizures Brachial neuritis Thrombocytopenia Lymphadenitis Disseminated BCG infection Osteitis / Osteomyelitis Events occurring in cluster

UIP Report HWs MO DIO/CMOSIO

All reported cases that are not serious are recorded as minor AEFIs

Monthly

Reporting of AEFIs

District

Private Practitioner PHC/CHC

Sub Center / Outreach

District Hospital,

Med college or Other

InstitutionsFIR to Distt HQ within 24 hrs

State MOHFW

Govt of India

FIR forwarded within next 24 hrs

PIR with available med record within 7 days

DIR & all med records within 3 months

Channels and Timeline for Reporting Serious

AEFI cases

Asst Comm (UIP) DCG (India) Vaccine Manufacturer

State drug controller) State EPI officer

Pending Documents - AEFI - West Bengal

Serial No EPID No District Patient's name FIR PIR DIR

PostMortemreport

VaccineSamples

1 WB-SPG-11-001 South 24 PGS Harun AL Rashid Yes Yes Pending    

2 WB-MNP-11-003Paschim

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    

Pending Documents - AEFI - West Bengal

Serial No EPID No District Patient's name FIR PIR DIR

Post Mortem report

Vaccine 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    

FIR

PIR

DETAILIR

DIR

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.

2828

AEFI SAMPLES RECEIVED BY CDL

AEFI

CMO/DHO

Commissioner/Deputy Commissioner / Assistant Commissioner

Drug Inspectors

State Drug Controller/ADC

2929

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.

3030

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

3131

Duration of Time required for Testing of Vaccines

3232

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

3333

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

34

Kasauli Lab contact detailsHead, Central Drugs Lab.Central Research Institute

Kasauli – 173204.Himachal Pradesh.

Email : nclkasauli@bsnl.in

Phone: 0179-2272046, 2272060Fax: 0179-2272049, 2272016

35

CDL Kolkata Lab

The Director3, KYD Street

Kolkata-700016Phone: 033-22299021, 22870513

Email: cdlkol@gmail.com

Where to send samples for testingused / unused batch of vaccine/diluents

National control lab Kasauli

used / unused batch of syringes/Vit A

CDL Kolkata

Biological products (blood, CSF etc)

Labs approved by State/ Distt

Autopsy (post mortem) samples State Forensic Labs

As per information from FDA office

• 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.

Key reasons for under reporting

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.

Roles and Responsibilities

• 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

ANMs should:

Roles and Responsibilities

• 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.

Health Supervisors 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.

MO PHC/ CHC should:

Roles and Responsibilities

ANMs should:

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

District AEFI Committee

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

State AEFI Committee

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

Media hunts for sensational news

Stick to basic messages when dealing with media

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