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)
AEFI is defined as: | nt s A medical event that takes place ka s er g | K | En | me ala age after an immunization, causes h| rn ataneou Ka cella es | Mis er nd n concern and is believed to be ra d rt u i r pe hr a P| Spo am tion es pa nd ess l te a l e ws A in ve ccin eas last e a m y lN u| s h- l v caused by immunization l o na ad | Bu iona hig sles ll at aFrida at i il N n at a a i N am pinio y | N ted me ken sil on ias |T pu g a nd 008 ersio n al al | O itua r de owin six t ri teh fI on b as l l d b n o30, 2DA V ati ations | O t h t s fo d an l am io dit ep le/P |N n b en n e u e S i g e I n t e r | Jo a | o n: nm infa d di in Ph r r ati ne , e nli sday | Mo b tP ds ov u h a eO e Fr on tates sifie in l g of foants centr r Tu ape al r | er S Clas cc tr a f e th | a en eathur in alth It is important that AEFIs are detected, eP tion Pap O us a s: e hi | l Pl N w e l ai e D et n wi anga g V bad I: e C d o he Th e theek. F ary LH tigat t we prim lo r DE s fol or Au N ew : R s n W invetra laudea investigated, monitored and promptly N vts Ad ath ams s f NE to h J nt eral aras the 4 obde e te de on -Gen Mahed a t responded to for corrective interventions. Pr lC esp or of is orr irect trict rgan is o e cia cial D d d mp Sp Spe gaba n ca a ran atio u in
Types of AEFIs• Program Errors• Vaccine reactions• Coincidental• Injection reaction• Unknown
Types of AEFI1. 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
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 clothesLocal reactionvaccine or diluent abscess Contaminated – suppuration, Use of reconstituted vaccines beyondSystemic effecthours the stipulated 4 – sepsis, toxic shock syndromeBlood borne virus infection at HIV, HBV, HCV Reuse of reconstituted vaccine – subsequent sessions Reuse of disposable syringe & needle Time ??
Common programmatic errors which can lead to AEFIsReconstitution 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 abscessInjection 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 AEFIsVaccine transportation/storage incorrect Administration of frozen and thawed freeze-sensitive vaccine -local reaction such as sterile abscessContraindications ignored DPT2 given after H/O convulsions with DPT1 - convulsions
Common program errors can be prevented by :-• training of H.W.• regular supervision• adequate supply / availability of logistics
…Types of AEFI2. Vaccine ReactionAn event caused or precipitated by the active component orone 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.
…Types of AEFI2. 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
…Types of AEFI3. Coincidental EventAn 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 4. Injection ReactionEvent caused by anxiety about, or pain from the injectionitself rather than the vaccineExample: fainting spell in a teenager after vaccination 5. Unknown Any event due to undetermined cause.
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 orinconsolable Pertussis crying lasting 3 hours or hours 60,000 so; analgesics may help. longer accompanied by high-screaming pitched screaming.
Interval No. of AEFI Vaccine Definition between events / Treatment vaccn. & million onset dosesSeizures Occurrence of generalizedare mostly convulsions that are notfebrile in origin, accompanied by focalthe rate All, neurological signs or Self-limiting; supportivedepends on symptoms. especially care; paracetamol andpast history, Febrile seizures: if cooling if febrile; rarelyfamily history Pertussis, 0-3 days 600 temperature elevated anticonvulsants.and age, much Measles >100.4 0F or 38 0C (rectal)lower risk ininfants < age of Afebrile seizures: if4 mns. temperature is normal
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 ofSevere injection and one or more of the following: Settles spontaneously within a few dayslocal Swelling beyond the nearest joint to a week. Symptomatic treatment withreaction 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.
AEFIs following ALL injectible vaccines AEFI Definition TreatmentToxic 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-limitingreaction (acute within 2 hours after immunization, characterized by Anti-histamines may be useful one or more of the following:hypersensitivityreaction) 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
Treatment of AnaphylaxisAdrenaline (epinephrine) counters anaphylaxis.Keep emergency kit ready with adrenaline. kit should be checked three or four times a year. Adrenalinethat 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 intramuscularinjection into the opposite limb to that in which the vaccine was given. (Subcutaneous administration isacceptable 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 thepatient warm.Give oxygen by face mask.Call an ambulance (or arrange other means of transport, after the first injection of adrenaline. If there is noimprovement within 10-20 minutes, of the first injection, repeat the dose of adrenaline up to a maximum ofthree 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 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
Cluster of AEFIsA cluster is defined as two or more cases of the same orsimilar events, which are related in time, and have occurredwithin specific geographical area, or associated with thesame vaccine, the same batch number or the samevaccinator.e.g. two or more cases of abscess occur in a village following animmunization session Ormultiple abscess cases following immunization by the same vaccinator orthe same batch of the vaccine, but in different villages.
Reporting of AEFIs What to report How to report Who reports to Whom When to reportFor Immediate Reporting Telephone or HWs MO DIO/CMO Immediatelyand Investigation – any other quick SIOSERIOUS AEFIs means of communicationDeath FIR (First Information Report) Within 24 hrsHospitalization (anaphylaxis, to District &anaphylactoid reaction, TSS, 48 hrs to StateEncephalopathy, Sepsis) PIR and GOIAny event where vaccine (Preliminary Investigationquality is suspected Report) Within 7 daysEvents 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
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 IndiaState drug controller) State EPI officer Vaccine Asst Comm (UIP) DCG (India) Manufacturer
Pending Documents - AEFI - West BengalSerial Post N Mortem Vaccine o EPID No District Patients 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
Pending Documents - AEFI - West Bengal Post Mortem VaccineSerial No EPID No District Patients 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
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.
AEFI SAMPLES RECEIVED BY CDLCommissioner/Deputy Drug InspectorsCommissioner /AssistantCommissioner AEFI State Drug CMO/DHO Controller/ADC 28
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
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 Vials30
Duration of Time required for Testing of Vaccines31
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 enclosed32
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 vaccines33
Kasauli Lab contact details Head, Central Drugs Lab. Central Research Institute Kasauli – 173204. Himachal Pradesh. Email : firstname.lastname@example.org Phone: 0179-2272046, 2272060 Fax: 0179-2272049, 227201634
CDL Kolkata Lab The Director 3, KYD Street Kolkata-700016 Phone: 033-22299021, 22870513 Email: email@example.com
Where to send samples for testingused / unused batch of National control labvaccine/diluents Kasauliused / unused batch of CDL Kolkatasyringes/Vit ABiological products Labs approved(blood, CSF etc) by State/ DisttAutopsy (post mortem) State Forensic Labssamples As per information from FDA office
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.
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 ResponsibilitiesANMs 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
Roles and ResponsibilitiesHealth 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.
Roles and ResponsibilitiesMO 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.
Roles and ResponsibilitiesAT 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
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