Module 11 · Annexures 1–25
Annexures — forms, charts, schedules and terms of reference
Every annexure summarised with the details you are expected to know: dose charts, form sections, autopsy protocol, committee ToRs, communication templates, the National Immunization Schedule and adult vaccine indications.
Annexure 1 · Types of vaccines
UIP vaccines
| Vaccine | Strain | Type |
|---|---|---|
| BCG | Mycobacterium bovis | Live attenuated |
| Hepatitis B | HBs antigen | Subunit protein |
| OPV | Polio virus types 1 and 3 | Live attenuated |
| IPV | Polio virus types 1, 2 and 3 | Killed |
| Diphtheria | Diphtheria toxoid | Toxoid |
| Whole-cell pertussis | Bordetella pertussis | Killed |
| Tetanus | Tetanus toxoid | Toxoid |
| Hib-PRP-TT | H. influenzae b | Conjugate |
| Rotavirus | G9P11 (Rotavac); five serotypes G1, G2, G3, G4, G9 (Rotasiil) | Live attenuated |
| Measles | Edmonston-Zagreb | Live attenuated |
| Rubella | Wistar RA27/3 | Live attenuated |
| Pneumococcal | 10-valent | Conjugate |
| Japanese encephalitis | SA-14-14-2; Kolar-821564XY | Killed (as listed) |
Non-UIP vaccines
| Vaccine | Strain | Type |
|---|---|---|
| Acellular pertussis | B. pertussis | Subunit protein |
| Rabies | Rabies virus | Cell cultured |
| Mumps | Jeryl Lynn | Live attenuated |
| Varicella zoster | Oka/Merck | Live attenuated |
| HPV | Types 16, 18, 6, 11 | Subunit protein |
| Typhoid | Vi polysaccharide of S. typhi Ty2 | Conjugated, killed, polysaccharide |
| Influenza | H1N1, H3N2, Yamagata, Victoria | Killed, live attenuated |
| Yellow fever | YF 17D | Live attenuated |
| Meningococcal | Groups A, C, W135, Y | Conjugate |
| Hepatitis A | H2 strain · HAV antigen (TZ84) | Killed · inactivated |
| Cholera | V. cholerae O1, O139 | Killed, live attenuated |
NoteAnnexure 1 lists OPV as types 1 and 3 (bivalent) and JE (SA-14-14-2) as “killed”, while Ch 3 Table 3.4 treats SA14-14-2 as live attenuated. Know both statements as written.
Annexure 2 · Brighton Collaboration AEFI case definitions (64 listed)
Each entry cites the published case definition (mostly in the journal Vaccine); several have companion guides (anaphylaxis, aseptic meningitis, facial nerve palsy, ADEM/encephalitis/myelitis, seizure, GBS, thrombocytopenia). The anaphylaxis definition (2007) was revised in 2023.
- Abscess at injection site
- Acute aseptic arthritis / arthralgia
- Antenatal bleeding
- Anosmia
- Anaphylaxis
- Acute respiratory distress syndrome
- Aseptic meningitis
- Bell’s palsy
- Cellulitis
- Chorioamnionitis
- Congenital anomalies
- Congenital microcephaly
- Diarrhoea
- Dysfunctional labour
- Encephalitis / myelitis / ADEM
- Encephalopathy (neonatal)
- Facial nerve palsy
- Failure to thrive
- Fatigue
- Fetal growth restriction
- Non-reassuring fetal status
- Fever
- Generalized convulsive seizure
- Gestational diabetes
- Guillain-Barré and Fisher syndrome
- Henoch-Schönlein purpura
- Hypertensive disorders of pregnancy
- Hypotonic hypo-responsive episode
- Immunization site pain
- Inadvertent inoculation (vaccinia)
- Induration at/near injection site
- (Neonatal) infections
- Intussusception
- Kawasaki disease
- Local reaction at/near injection site
- Low birth weight
- MIS-C/A
- Myocarditis and pericarditis
- Narcolepsy
- Neonatal seizures
- Neurodevelopmental delay
- Nodule at injection site
- Pathways to preterm birth
- Peripheral (vasculitic) neuropathy
- Persistent crying
- Postpartum endometritis
- Postpartum haemorrhage
- Preterm birth
- Rash
- Respiratory distress in a neonate
- Sensorineural hearing loss
- Single organ cutaneous vasculitis
- Small for gestational age
- Spontaneous abortion and ectopic pregnancy
- Swelling at/near injection site
- Systemic lupus erythematosus
- Thrombocytopenia
- Thrombosis and thromboembolism
- Thrombosis with thrombocytopenia syndrome
- Unexplained sudden death incl. SIDS
- Vaccine-associated enhanced disease (VAED)
- Vasculitis (IgA)
- Viscerotropic disease
- Wheeze
Annexure 3 · Biopsychosocial conceptualisation of ISRR
Immunization Stress-Related Response arises from interplay of biological, psychological and social factors (WHO 2019). Acute stress responses (incl. vasovagal: dizziness, syncope, heart racing, nausea, blurred vision, sweating, hyperventilation) and, later, dissociative neurological symptom reactions.
| Phase | Biological | Psychological | Social |
|---|---|---|---|
| Before vaccination (predisposing) | Age; genetics (vulnerability to anxiety, vasovagal, acute stress response); low body mass | Previous negative needle experiences; anxiety about vaccination/medical situations; history of acute stress response | Negative information from family, friends, media; witnessing others’ reactions; cultural beliefs |
| Peri-vaccination (precipitating) — individual | Prolonged standing; vasovagal response; pain | Expectations; fear; pain | Behaviour/attitude of clinicians and caregivers; expressing pain |
| Peri-vaccination — mass | – | Concern about evaluation by peers/authority | Witnessing peers’ reactions; others’ behaviour in the same context; expressing pain in front of peers |
| Post-vaccination (perpetuating) | Cascade of stress response; hypothalamic–pituitary axis sensitisation | Catastrophic interpretations; fear; hypervigilance to body experiences | Behaviour, confidence, attitudes of clinicians, authorities, family, peers, community; media |
Annexure 4 · Syrup paracetamol after vaccination
Fever within 24 h is most frequent after pentavalent, DPT and IPV. Give syrup paracetamol after vaccination at 1½, 2½, 3½ months (pentavalent 1–3) and 1½ years and 5–6 years (DPT boosters). For children 6 weeks–6 years use 125 mg/5 ml for uniformity and fewer dosing errors (10–15 mg/kg).
| Age | Dose (125 mg/5 ml) | When |
|---|---|---|
| 6 weeks – 6 months | 2.5 ml | Only if fever* after vaccination; then every 4–6 h if needed# |
| 6 – 24 months | 5 ml | |
| 2 – 4 years | 7.5 ml | |
| 4 – 6 years | 10 ml |
*Axillary temperature ≥38°C/100.4°F or child feels hot to touch. #Maximum four doses in 24 h, at least four hours apart.
Instructions for health workers
- COUNT bottles at session start — 10% more than expected pentavalent + DPT doses.
- DISPENSE one bottle only to children given pentavalent or DPT.
- READ the label (contents, strength, expiry).
- REFER the dosage chart by age.
- INSTRUCT to give only if fever — not if no fever.
- TELL the dose and SHOW the cap markings.
- USE only the measuring cap supplied.
- INSTRUCT max 4 doses/24 h, ≥4 h apart.
- DEMONSTRATE shaking for 10 seconds if a suspension is supplied.
- ADVISE seeing a doctor if any danger sign or fever >2 days despite paracetamol.
- USE the referral protocol for post-vaccination fever.
Non-drug comfort: breastfeeding before, during and after immunization; sponging, skin-to-skin contact, holding the infant.
Annexure 5 · Initial anaphylaxis management with injection adrenaline
RememberOne IM dose of adrenaline for any suspected anaphylaxis is completely safe even if it later proves not to be anaphylaxis.
A. Suspect anaphylaxis
Early onset (minutes to 6 hours) and rapid progression, with at least one sign/symptom from at least two of three systems:
| System | Signs/symptoms |
|---|---|
| Respiratory | Swelling of tongue, lip, throat, uvula or larynx; difficulty breathing; stridor; wheezing; cyanosis; grunting |
| Cardiovascular | Decreased level/loss of consciousness (fainting, dizziness); low (measured) blood pressure; tachycardia/palpitation |
| Dermatological/mucosal | Generalised urticaria; generalised erythema; local/generalised angioedema (eyelids, lips, tongue, face); generalised pruritus with rash |
| Others | Anxiety, diarrhoea, abdominal cramps, nausea, vomiting, sneezing, rhinorrhoea |
Initial features of mild allergy and anaphylaxis overlap — the ANM may give one dose at the first sign suggestive of allergy/anaphylaxis.
B. Steps
- Do not panic; reassure.
- Conscious: supine with lower limbs raised above head. Unconscious: left lateral position.
- Immediately give one dose of adrenaline by deep IM injection.
C. Giving adrenaline (1:1000)
| Age | Dose in ml (1 ml tuberculin syringe) | Units on 40-unit insulin syringe |
|---|---|---|
| 0–1 year | 0.05 | 2 |
| 1–6 years | 0.1 | 4 |
| 6–12 years | 0.2 | 8 |
| 12–18 years | 0.3 | 12 |
| Adults | 0.5 | 20 |
Check name, dilution and expiry; use a 24G/25G one-inch needle; clean and inject at 90° into the middle third of the anterolateral thigh of the opposite limb to the vaccinated one.
D. Transport, inform, document
- Ambulance to the nearest facility equipped for anaphylaxis (PHC/CHC/DH).
- Inform the MO en route — name, age, date, time, site, route, dose of adrenaline.
- Record the reaction on the immunization card in BLOCK letters.
- Record in the PHC AEFI register.
Annexures 6–9 · Reporting and investigation forms
| Form | Who / when | Contents |
|---|---|---|
| 6 · Case Reporting Form (CRF) | Doctor fills; to DIO within 24 h; DIO completes Section E and submits in SAFE-VAC/Co-WIN SAFE-VAC within 24 h of receipt | Case ID IND (AEFI)/ST/DST/YR/NUM (COVID: IND (CO-AEFI)). A reporter/notifier (designation of notifier: ASHA, AWW, HW, govt doctor, private, parent, community, media), dates notified/visited, session site, place of vaccination, vaccine source, RI vs campaign (MI, Pulse Polio, MR, JE, COVID-19), session type. B patient (DOB, age, sex, parents/spouse, address, pregnancy and lactation status). C vaccines and diluents (dose number, manufacturer/brand, batch/lot, mfg/expiry, time of reconstitution/opening, number of others vaccinated from the same vial). D event — serious/severe; serious type; cluster (Cluster ID); clinical events (severe local reaction, fever, seizures, abscess, sepsis, encephalopathy, TSS, thrombocytopenia, allergic reaction, anaphylaxis, intussusception, lymphadenitis, AFP, HHE, unexplained death, anxiety reaction); extra COVID items (joint pain, painful single-limb swelling, chest pain/fainting/palpitation, ECG/echo changes, breathlessness, altered sensorium, ADEM, GBS, meningoencephalitis, neuropathy, rash, loss of taste/smell, liver injury, kidney injury, lymphadenopathy, coagulation/bleeding disorders, worsening of existing disease); pregnancy events (maternal death, fetal loss, premature delivery, stillbirth, neonatal death, congenital anomaly); onset, hospitalisation, outcome, death, post-mortem; narrative. E DIO decision details. Help: aefiindia@gmail.com, safevac.chi@gmail.com |
| 7 · AEFI Register | Filled by ANMs weekly at PHC/cold-chain point/block/facility; MO I/C verifies weekly; monthly assessment to DIO | Columns: date of entry, facility, name, parent name and mobile, sex, DOB, date/time of vaccination, vaccines with manufacturer and batch, date/time of onset, sign/symptom/diagnosis, type (minor/serious/severe), CRF reported (date or “No”). All entries go into HMIS monthly; “No case reported” certified if none. Monthly assessment format: counts per planning unit — minor (injection-site reaction, fever <39°C, irritability/malaise/fatigue/loss of appetite) and serious/severe (abscess, seizures, fever >39°C, allergic reaction, other); aggregation/clustering (A antigen- and batch-wise vs expected rates; B sub-centre/vaccinator-wise; C other unusual), possible reason, action proposed; shared with DIO in the first week of each month |
| 8 · Case Investigation Form (CIF) | Within 21 days in SAFE-VAC/Co-WIN SAFE-VAC; six pages | A basic details (lead investigator) · B patient · C vaccines/diluents · D pre-immunization history (similar past events, prior AEFI, allergies, concomitant medicines, pre-existing illness, acute illness/hospitalisation within 30 days, family history, COVID-19 test/contact/symptoms; birth details for infants/babies of vaccinated mothers) · E clinical assessment, investigations, treatment, provisional/final diagnosis, sources of information, post-vaccination COVID tests · F vaccination site — sequence of the patient in session and in vial (first/last half), multidose vial use, cluster details; immunization practices (AD syringes, reconstitution syringe reuse, correct diluent, errors in selection, sterility, physical condition, reconstitution, opening date, handling, administration) · G cold chain (ILR temperature 2–8°C, other items in fridge, unusable vaccines/diluents, carrier type 4/2 ice packs, conditioned ice packs, same-day return) · H community investigation (vaccinated vs unvaccinated affected) · I DAC review (provisional diagnosis, biological samples — for AEFI within 28 days of JE send CSF/serum to NIV Pune, Gorakhpur or Mumbai; vaccine and syringe samples sent to CDL Kasauli/Kolkata; questions A–H on quality defect, prescribing, sterility, physical condition, reconstitution, handling, administration, stress response) · J attached documents checklist · K DIO details; DAC signatures |
| 9 · Case Notification Form (CNF) | ADR Monitoring Centre for serious AEFIs | ICSR no.; AMC name; patient details; date of vaccination and facility address; vaccines and doses; first symptom, hospitalisation, current status, death; description; AMC coordinator and pharmacovigilance associate. Notify the DIO of the district where the vaccine was given; scan and email simultaneously to DIO, SEPIO, PvPI and AEFI Secretariat |
Annexures 10–11 · Verbal autopsy forms
Filled in every death reported as an AEFI, whether or not a post-mortem was done, after explaining that some questions may seem unrelated.
10 · Children 0–18 years
- Basic details — identifiers (EPID), respondents and relation, whether respondent lived with child, date/time/place of death; family history (household, siblings and their health, consanguinity, recent illness, parents’ occupations, similar illness/death in family, adverse family circumstances); current vaccination (who gave, vaccine, route, site — body diagram); past history (vaccines received, previous reactions, allergy, seizures/breath-holding/cyanosis, pre-existing illness, hospitalisation in 30 days, medications); nutritional status (weight or appearance).
- Children 0–5 years — birth details (weight, size, place, type of delivery, multiple births, prematurity, malformations, complications, hospitalisation in first month); feeding history and last 24 h feeds (breast milk, animal milk, water, other liquids, solids; mode); development; events after vaccination (fever, diarrhoea, sweating, stool changes, lethargy, fast breathing, excessive crying, apnoea, poor feeding, cyanosis, vomiting, seizures, rash, choking); death at home — place/position/clothing/face position at last-alive, put-to-bed and found-dead times, room temperature, co-sleepers, items near the child, heating devices, appearance (discolouration, secretions, pressure marks, petechiae, marks), feel on touch, resuscitation.
- Treatment for this event (mandatory) — where, medicines, referral, contact with services in the previous month, cause told, prescriptions/discharge notes, death certificate.
- Respondent/witness account verbatim; injection-site appearance; bystander information.
- Interviewer’s case summary — exact chronology from vaccination to event (translate local-language notes).
- Final diagnosis; attach documents; up to three interviewers sign.
11 · Adults >18 years
- Basic details, respondents, date/place of death
- Respondent’s account and perceived cause
- Known conditions — hypertension, diabetes, asthma, chronic lung disease, stroke, cancer, CAD, epilepsy, allergy, psychiatric illness/suicidal thoughts, TB, COVID-19, HIV, malnutrition, early sudden death in first-degree relatives, others
- Injuries/accidents (RTA, fall, drowning, poisoning, burns, violence, suicide, bites, lightning)
- Women — breast, menstrual, discharge, post-menopausal bleeding, recent hysterectomy
- Pregnancy, labour, delivery, abortion, neuro symptoms in pregnancy, single-limb swelling
- Final-illness symptoms by system — general, respiratory, cardiovascular, GI, CNS, genitourinary, other (rash, bleeding, weight loss, swellings, lumps, jaundice, pallor, ulcers)
- Treatment and health-service use, operations
- Risk factors — alcohol, tobacco, other addictions, pesticides, indoor air pollution
- Death certificate causes (lines 1–4)
- Other health records (post-mortem, MCH/ANC card, prescriptions, discharge summary, lab, cremation/burial)
- Miscellaneous — facts and circumstances of the body
- Bystander information
- Interviewer observations and final diagnosis
Annexure 12 · Conducting autopsies in AEFI deaths
- Perform as soon as possible — within 72 hours — to avoid tissue damage, artefacts and adrenal lysis; because autolysis is early and anaphylaxis cytokines have very short half-lives, begin within two hours of death where possible.
- An autopsy should ideally be done in every AEFI death; consider it mandatory when earlier similar deaths went uninvestigated, the public is losing faith, litigation is possible, or such deaths have been attributed to vaccination elsewhere.
- Roles of autopsy: establish pre-existing natural disease (incl. congenital/metabolic); infection; trauma/accident; other contributing changes; anaphylaxis (the most likely cause of immediate vaccine-attributed death — usually a diagnosis of exclusion).
- Location with trained staff and sample-handling facilities; proper consent (complete autopsy, blood, fluids, tissues) — or inform family where autopsy is mandated; ideally a pathologist or forensic medicine specialist.
Biological samples
Tissues/organs for histopathology; blood and fluids for microbiology, immunology/metabolic, haematology and toxicology; tissues for genetics, electron microscopy and toxicology.
Conditions to look for in infants
| System | Conditions |
|---|---|
| General | Malnutrition; sepsis; DIC; poisoning, drowning, scalding; hyperthermia (cystic fibrosis, congenital adrenal hyperplasia); inborn errors of metabolism (fatty-acid oxidation defects) |
| Cardiovascular | Congenital heart disease; myocarditis; trauma; coronary arteritis (Kawasaki); anomalous arterial/venous drainage; cardiac tumours (rhabdomyoma) |
| Respiratory | Epiglottitis; laryngotracheobronchitis; laryngeal oedema; bronchiolitis; pneumonia; pulmonary hypertension; pulmonary haemorrhage; atelectasis; bronchopulmonary dysplasia; foreign body |
| GI · liver · pancreas · kidney | Enterocolitis; obstruction (volvulus, hernia); perforation/peritonitis; appendicitis; ruptured viscera · hepatitis, fatty liver, cholestasis, rupture · acute pancreatitis · pyelonephritis, tubular necrosis, ischaemic injury |
| Brain · musculoskeletal | Trauma; intracranial haemorrhage; AV malformation; meningoencephalitis; hypoxia · skin, soft-tissue, bone injury; soft-tissue inflammation |
| Specific | SIDS — tracheitis without pathogens; found dead in cot. SUDI — mild focal pulmonary haemorrhage; 2–5-month-old found dead in cot. Injury — fractures; cranial injury (abuse, fall from cot, overlaying). Anaphylaxis — often little or no findings (death by asphyxia or shock); laryngeal and pulmonary oedema; myocardial infarction even without coronary disease; widespread congestion; raised mast cell tryptase (may persist 3 days after death; also raised in trauma); raised total or specific IgE |
Before autopsy — history to document
- All records (clinical, past, malformations, family history, drugs, immunization, allergies, CRF).
- Sleeping environment — asphyxia mechanisms: overlaying, wedging, choking, obstruction of nose/mouth, rebreathing, neck compression, immersion; sleep-surface sharing (adults, children, pets); recent changes in position (important within 24 h), location, surface; unsafe surfaces (soft, lumpy, concave, broken/mismatched, worn/wet bedding).
- Hyper/hypothermia (wrapping, environment); environmental hazards (carbon monoxide, chemicals/sprays, electricity, drugs, cigarette/beedi smoke, cords/strings).
Facilities and fixatives
- Lit, ventilated autopsy room (night use possible); instruments to restore the body with dignity; sterile 10 ml and 5 ml syringes with 21/22 SWG needles; camera (preferably video); lidded containers; on-site freezing; centrifuge for plasma.
- 10% neutral buffered formalin per litre: 100 ml formalin (40% v/v / 37% w/v), 900 ml tap water, 4.0 g NaH₂PO₄·H₂O, 6.5 g Na₂HPO₄ (scales ×5, ×50). Alternative 10% neutral sodium acetate formalin: 100 ml formalin, 900 ml water, 20 g sodium acetate per litre.
- Blood tubes: yellow — bacteriological culture; red — plain; purple — EDTA; green — heparin; grey — fluoride.
Performing the autopsy
- External: anthropometry; rigor mortis; pallor, cyanosis, icterus; petechiae, bruises, injury; vaccination site; photographs prone and supine; radiograph where possible.
- Incisions: midline thoraco-abdominal; intermastoid for skull; midline spinal if cord examined; evisceration by the Rokitansky technique after collecting blood, fluids and culture samples.
- Anaphylaxis histology: upper airway mucosal oedema, lung hyperinflation, organ congestion, eosinophil infiltration; many mast cells in laryngeal mucosa — special stains (toluidine blue, Giemsa) underestimate because of degranulation; IHC for CD117 and mast cell tryptase helps. A study showed significantly more splenic eosinophils (26.6 ± 17.8 vs 7.0 ± 10.5) and mast cells (3.2 ± 2.0 vs 0.9 ± 1.1) in anaphylactic deaths — needs evaluation in Indian subjects.
Laboratory tests for suspected anaphylaxis
| Test | Specimen / handling | Stability | Reference / notes |
|---|---|---|---|
| Plasma IgE (immunofluorescence/RAST) | Heparin or EDTA; separate plasma within 2 h; refrigerated transport | Ambient 48 h; fridge 2 weeks; frozen 1 year | 2–13 IU/ml (0–5 months) to 2–215 IU/ml (>18 y). Corroborates allergy; also raised in AML, MDS, mastocytosis, hypereosinophilic syndrome |
| Plasma tryptase (total) | Heparin/EDTA; femoral vein; separate immediately; frozen transport | Ambient 48 h; fridge 72 h; frozen 1 month | 0.5–10.0 µg/L. Collect 15 min–3 h after the event; half-life 2 h — unreliable after 3 h |
| Whole-blood histamine | Heparin; frozen (critical) | Ambient 2 h; fridge 6 h; frozen 6 months | 180–1800 nmol/L; must be drawn near the event — not practical post-mortem |
| Plasma histamine | EDTA; separate within 20 min; upper two-thirds of plasma; frozen | Ambient 1 h; fridge 6 h; frozen 6 months | 0–8 nmol/L |
| Urine histamine | Ideally 24 h (not possible post-mortem); freeze immediately | Ambient unacceptable; fridge 24 h; frozen 6 months | 0–450 nmol/g creatinine; 0–60 µg/day. Better than blood, but a low level does not rule out anaphylaxis |
Post-mortem samples
- Label and date; request form with history, clinical presentation, duration of illness, date of death, tests and provisional diagnosis; contact lab first for special tests.
- Histopathology — all major organs in 10% formal saline (or dry ice for frozen section). Brain: fix in 20% formal saline for two weeks; sections from middle frontal gyrus, hippocampus, basal ganglia + insular cortex, mamillary bodies, thalamus, left cerebellum, dentate nucleus, midbrain, pons, medulla. Heart: LV, RV, RA, LA, septum, valves, coronaries, conduction system. Respiratory: epiglottis, tonsils, larynx, trachea, bronchi, lungs (each lobe, hilum and periphery), hilar nodes. Liver, pancreas, kidneys (cortex and medulla), spleen, thymus, bone marrow, adrenal, pituitary, thyroid, injection sites incl. control.
- Bacteriology — collect early (before morgue if possible) and before dissection; clean skin with 70% alcohol; 3–5 ml blood into a culture bottle with 30–40 ml BHI; CSF/fluids in sterile screw-capped containers at room temperature; tissues in sterile saline; pus/swabs; plain blood for serology.
- Immunology — serum tryptase from femoral vessels, not heart blood; separate and refrigerate (4°C) or freeze. Tryptase also rises after MI, trauma, amniotic fluid embolism and SIDS; rises in anaphylaxis with shock, insect stings or parenteral allergen, but usually not after food-allergen ingestion. Ask about food allergies (beef, pork, milk, gelatine) and prior vaccination; send blood for allergen-specific IgE.
- Mycology — 5–10 ml blood into BHI (1–5 ml paediatric bottles); bone marrow 2–3 ml with 0.5 ml 1:1000 heparin within 24 h; CSF 3–5 ml; fluids; respiratory tissue in saline (and formal saline for histology); 1–2 ml plain blood for serology.
- Virology — haemolysed post-mortem blood unsuitable for antigen/antibody tests → take blood (and CSF, lung) just before/after death; pleural/peritoneal/pericardial fluids of limited value; tissues, swabs and secretions into virus transport medium (keep at 4°C for a few weeks; discard if colour changes from yellowish-orange to pink); separate sterile instruments per site.
- Electron microscopy — 3 mm myocardium in glutaraldehyde to look for mast-cell degranulation around coronaries (distinguish from myocarditis).
Annexures 13–14 · Laboratory request and causality forms
| Form | Key contents |
|---|---|
| 13 · Laboratory Request Form (LRF) | Completed by drug inspector/DIO; accompanies vaccine/logistics samples. AEFI category (death, hospitalised, cluster, disability, other); Case ID; DI/DIO contacts; case details; dates of vaccination, onset, collection; vaccine/diluent samples (reverse cold chain) and logistics (AD, reconstitution, disposable syringes) with quantity, manufacturer, batch, mfg/expiry; biological samples; tests requested; DAC preliminary diagnosis; addresses for results — State Drug Controller, SEPIO, State Cold Chain Officer, DIO, Immunization Division; lab section — receipt date, receiver, condition (good = sent as per guidelines / poor / unknown), comments, dispatch date |
| 14A · Causality Assessment Form (State) | Case header (state, district, ID, age/sex, vaccines, outcome, dates of birth, vaccination, onset, hospitalisation, discharge, death; verbal autopsy, first and final post-mortem reports); forms and documents received; key findings for valid diagnosis. Step 1 vaccines, valid diagnosis, case definition met?, Brighton level of certainty, causality question, eligible? (else missing information). Step 2 checklist (Y/N/UK/NA + remarks). Step 3 algorithm with notes. Step 4 classification (A1–A4, B1*, B2, C; unclassifiable with missing information; *B1 = potential signal). Summarise logic (“we could conclude … because” / “could NOT classify because”); feedback to district; expert signatures. Notes: all documents before meeting; quorum complete; all columns filled; write N.A. where not applicable |
| 14B · Causality Assessment Form (National) | National ID; reason for reporting; routine/campaign; document availability (CRF, CIF, hospital records, post-mortem, verbal autopsy, state CA, others) checked by name/date; screening status; cluster (reported/identified, number); final case status F0/F1 with reason; case summary; valid diagnosis and classification by state vs CA sub-committee, consistency with the state and reasons, quality-review feedback to state; status tracking through CA sub-committee (F2/F3) and NAC meeting (F4/F6); Steps 1–4 as in 14A; reasons for unclassifiable: (1) supporting documents (hospital records, post-mortem HPE/chemical, verbal autopsy) unavailable; (2) documents available but inadequate; (3) standard formats (CRF/PCIF/FCIF) unavailable; Brighton level of certainty with reason; feedback; expert signatures |
Annexures 15–17 · Committee terms of reference and meetings
15 · District AEFI Committee ToR
DIO = member secretary; chair = paediatrician/epidemiologist/public health specialist (govt or medical college). Block MOs and the investigating/treating MO invited case-by-case. Meets at least quarterly; membership reviewed yearly; quorum 5 (2 independent + 3 liaison incl. chair, paediatrician, PHS).
- Review status — reporting ≥10 serious/severe AEFIs per 100,000 live infants/year; meet even if no cases to find reasons; include private/public secondary and tertiary facilities; QMS progress; trainings; silent blocks; AEFI registers; one-year trends in registers and HMIS.
- Investigation — support DIO esp. deaths and clusters; field visits; interviews; recommendations to prevent recurrence.
- Document completion — desk review of CRF, CIF and documents; analyse similar/clustered cases; act on state causality results (esp. immunization errors).
- Other — support the spokesperson; share minutes with members, SEPIO and sub-district within a fortnight.
16 · State AEFI Committee ToR
SEPIO = member secretary; chair preferably paediatrician/community medicine/medical epidemiologist (government medical college or DH); medical-college specialists preferred. Concerned DIOs/DAC members may be special invitees. New membership notified; new members trained in causality and may attend national CA meetings. At least one-third of members rotated at least once in 3 years. Meets at least quarterly; quorum 7 (3 + 4).
- Review state and districts — ≥10 per 100,000 live infants/year; meet even if no cases; DACs meet quarterly; private/public inclusion; QMS; trainings; silent districts; registers; trends; pending documents.
- Investigation — guide DACs; field visits; interviews; recommendations.
- Causality assessment — desk review; cluster analysis; assess and share results nationally.
- Other — support spokesperson; share minutes with Immunization Division/AEFI Secretariat within a fortnight; share action points with districts.
17 · Steps for an effective State AEFI Committee meeting
| Stage | Steps |
|---|---|
| Preparatory | Approval and draft agenda ≥2 weeks before; notice with agenda to members ≥1 week before; action-taken report from last minutes; presentation on district status, QMS, DAC meetings; screening of cases and case summaries (with the state TCC). Checklist: agenda, approved minutes, declaration and non-disclosure agreement forms, TA/DA forms (15–20 copies); attendance sheets; surveillance status report; pending-documents report; blank CA formats; one photocopy set of cases; causality assessment tool kit (suitcase); stationery; audio-visual equipment; computer and internet for literature search |
| During — surveillance update | Action-taken report; silent districts and trainings; performance indicators; QMS progress; AEFI registers; DAC meeting frequency (tracking tool); case completion, HMIS vs line-list mismatches (esp. deaths), AMC and private-sector involvement |
| During — causality | Present cases; decide by consensus; fill CA forms; expert signatures — paediatrician’s signature mandatory |
| After | Minutes approved by chair and circulated; verify CA forms and upload scanned copies on SAFE-VAC for the national level |
Annexures 18–23 · Communication tools
18 · District communication plan for RI
| Area | Activity and frequency |
|---|---|
| Advocacy | District Task Force for Immunization (DTFI) — one per month; sensitise professional bodies (IMA, IAP) — twice a year; orient religious leaders/influencers — twice a year; district media orientation workshops — twice a year; others |
| Capacity building | Training block health officers on communication planning and monitoring — twice a year; orientation of ANMs/ASHAs/AWWs on communication planning — twice a year; IPC orientation for ANMs, ASHAs, AWWs |
| Social media | Focal person; creatives; WhatsApp groups (number, members, frequency) |
| Block level | Block Task Force (BTFI) — one per quarter; key religious leaders — twice a year |
| Social mobilisation | Mothers’ meetings — one per quarter per village; community meetings (VHSNC, SHGs, Mahila mandals) — one per quarter per village; rallies — one per block per quarter; religious announcements (mosque, temple); household visits to left-out/drop-out families for IPC |
| Mid-media | Posters — 5 per village per year; banner — 1 per session site per year; hoardings — 3 per block per year; leaflets as needed; wall paintings/slogans — 1 per village; miking — twice a year per block |
Completed by the District MEIO/IEC officer/consultant (else the DIO, consulting block MOIC/BEE/IEC consultant) and submitted to the DTFI for approval.
19 · Media rating tool
- Source of the story stated?
- Conflict of interest declared?
- Issue adequately described?
- Evidence reported?
- Economic aspects reported?
- Benefits and harms explained?
- Alternative options described?
- Goes beyond the press release?
- Independent experts consulted?
- Disease/scare-mongering avoided?
- Readable for a broad audience?
- Relevant to local settings?
Situation messages: benefits are well proven; unimmunised children at greater risk; VPDs cause millions of deaths/disabilities — continued vaccination is the only solution; reactions are rarely serious (have data ready); surveillance detects even minor problems; the AEFI is being investigated but immunization must continue. Stay calm with provocative journalists; acknowledge concern; stick to facts.
20 · District/State AEFI response template
States: number of children vaccinated (and against which diseases) in a period; coverage achieved; doses of the vaccine in question; number of AEFIs reported (e.g. deaths, hospitalisations); the surveillance system records minor events and investigates serious ones; the DAC is investigating with state support (records, samples, post-mortems); reporting an AEFI does not mean the vaccine caused it; vaccination is the most effective child-health intervention; local disease burden; manufacturing is tightly monitored and every batch is tested before release.
21 · Key messages format
Three key messages × three supporting messages (1a–3c).
22 · Means of media communication
- Press statement — reaction to an event: full account, actions taken/planned (investigation), cause, assurance of corrective action, 5 Ws and 1 H, more than one opinion, references, contacts.
- Press release — new information/update answering who, what, when, where, why, how; contacts of DIO/SIO, committee experts, IAP/IMA; end with “for more information, contact…”.
- Press conference — use judiciously when an AEFI is widely reported; everyone gets the same facts; one or two speakers; statement ≤10 minutes; rehearse; prepare 30-second answers and quotable lines; speaker available after.
- Press interview — only the designated spokesperson; know the interviewer, organisation, possible bias and scientific background; emphasise key messages.
Details: Communication Guidelines for Building Vaccine Confidence around AEFI (ITSU).
23 · Sample press release (PIB, Prime Minister’s Office, 3 July 2014)Four new vaccines in the UIP: rotavirus (indigenous), rubella, injectable polio vaccine, and adult JE vaccine in high-priority districts (179 endemic districts in 9 states). Expected to prevent at least 1 lakh infant and working-age adult deaths and up to 10 lakh hospitalisations a year; UIP to protect against 13 life-threatening diseases for 27 million children annually. Rotavirus diarrhoea kills ~80,000 children a year, up to 10 lakh hospitalisations, economic burden >₹300 crore; rubella → ~2 lakh babies with congenital defects a year; IPV introduced with 125 countries (India certified polio-free March 2014); recommendations by NTAGI. Backgrounder: world’s largest programme, 27 million children, 7 VPDs (plus JE and Hib where introduced); free vaccines and syringes; 27,000 cold-chain points; ~9 million sessions a year.
Annexure 24 · National Immunization Schedule (as on 2023)
| Vaccine | When | Dose | Route | Site |
|---|---|---|---|---|
| Pregnant women | ||||
| Td-1 | Early in pregnancy | 0.5 ml | IM | Upper arm |
| Td-2 | 4 weeks after Td-1* | 0.5 ml | IM | Upper arm |
| Td-Booster | If 2 Td doses received in a pregnancy within the last 3 years* | 0.5 ml | IM | Upper arm |
| Infants | ||||
| BCG | At birth or as early as possible till 1 year | 0.1 ml (0.05 ml until 1 month) | Intradermal | Left upper arm |
| Hepatitis B birth dose | At birth or as early as possible within 24 h | 0.5 ml | IM | Anterolateral left mid-thigh |
| OPV-0 | At birth or within the first 15 days | 2 drops | Oral | Oral |
| OPV 1, 2, 3 | 6, 10, 14 weeks (till 5 years) | 2 drops | Oral | Oral |
| Pentavalent 1, 2, 3 | 6, 10, 14 weeks (till 1 year) | 0.5 ml | IM | Anterolateral left mid-thigh |
| fIPV 1, 2 | Two fractional doses at 6 and 14 weeks | 0.1 ml | Intradermal | Right upper arm |
| Rotavirus | 6, 10, 14 weeks (till 1 year) | 5 drops | Oral | Oral |
| PCV | 6 weeks, 14 weeks and booster at 9 completed months | 0.5 ml | IM | Anterolateral right mid-thigh (booster on left mid-thigh where JE is given) |
| IPV-3 | At 9 months | 0.1 ml | Intradermal | Left upper arm |
| MR-1 | 9 completed–12 months (till 5 years) | 0.5 ml | Subcutaneous | Right upper arm |
| JE-1** | 9 completed–12 months | 0.5 ml | IM | Anterolateral right mid-thigh |
| Vitamin A (1st) | 9 completed months with MR | 1 ml (1 lakh IU) | Oral | Oral |
| Children | ||||
| DPT booster-1 | 16–24 months | 0.5 ml | IM | Anterolateral left mid-thigh |
| MR-2 | 16–24 months | 0.5 ml | Subcutaneous | Right upper arm |
| OPV booster | 16–24 months | 2 drops | Oral | Oral |
| JE-2 | 16–24 months | 0.5 ml | IM | Anterolateral right mid-thigh |
| Vitamin A (2nd–9th)*** | 16–18 months, then every 6 months up to 5 years | 2 ml (2 lakh IU) | Oral | Oral |
| DPT booster-2 | 5–6 years | 0.5 ml | IM | Left upper arm |
| Td | 10 years and 16 years | 0.5 ml | IM | Upper arm |
*Give Td-2 or booster before 36 weeks — but give even after 36 weeks; give Td to a woman in labour if never vaccinated. **JE in select endemic districts after the campaign. ***Vitamin A 2nd–9th doses for 1–5-year-olds in biannual rounds with ICDS.
Annexure 25 · Indications for adult vaccinations
| Vaccine | Dosing | Indications | Precautions / contraindications | Undesirable effects |
|---|---|---|---|---|
| Hepatitis A (inactivated) | 2 doses, 1 ml IM; booster 6–12 months after primary | HIV or chronic liver disease | Hypersensitivity to a component or previous dose | Very common pain, redness; common swelling, malaise, fever >37.5°C |
| Japanese encephalitis (inactivated) | 2 doses, 0.5 ml IM, ≥1 month apart | Travel to/living in endemic areas (≥1 month), lab workers | Severe allergy to a previous dose | Fever, body ache, injection-site pain, tenderness |
| Hepatitis B (subunit) | 3 doses (20 µg) at 0, 1, 6 months; 4 doses (40 µg) at 0, 1, 2, 6 months on haemodialysis | 19–59 y unvaccinated; ≥60 y with risk factors (may if none): chronic liver disease, HIV, sexual exposure risk, injection drug use, blood exposure (household contacts, health/public-safety workers, dialysis, diabetes), incarceration, travel to endemic countries | Hypersensitivity | Pain, redness |
| Hib (conjugate) | 1 dose; 3 doses after HSCT | Anatomical/functional asplenia incl. sickle cell; haematopoietic stem cell transplant | Hypersensitivity | Pain, redness, swelling, fever |
| HPV (protein subunit) | 3 doses at 0, 2, 6 months | All females up to 26 y; 27–45 y by shared clinical decision | Hypersensitivity incl. severe yeast allergy or previous dose | Pain, headache |
| Influenza (inactivated split virion) | 1 dose 0.5 ml IM annually | Any adult | Severe allergy to any component incl. egg protein, or prior influenza vaccine | Pain, headache, fever, cold, vertigo, nausea, body ache, myalgia, fatigue, vomiting |
| Rubella (live) | 1 dose 0.5 ml SC (two doses ≥1 month apart for some) | Health workers, outbreaks, recent exposure, women who could become pregnant, college students | Pregnancy; immunocompromise | Fever, lymphadenopathy, arthralgia |
| Meningococcal (A, C, Y, W-135) | 1 or more doses by indication | Asplenia, HIV, complement deficiency, complement inhibitors (eculizumab, ravulizumab) — booster every 5 years if risk persists; travel to hyperendemic areas; microbiologists | Severe allergy; prior GBS may increase GBS risk | Pain, headache, fatigue |
| Pneumococcal conjugate | Single 0.5 ml IM | ≥65 y; 19–64 y with alcoholism, chronic heart/liver/lung disease, CRF, smoking, cochlear implant, asplenia, CSF leak, diabetes, malignancy, HIV, Hodgkin’s, immunodeficiency/suppression, leukaemia, lymphoma, myeloma, nephrotic syndrome, transplants, sickle cell | Hypersensitivity incl. diphtheria toxoid | Fever, erythema, induration, pain |
| Pneumococcal polysaccharide (PPSV23) | 1–3 doses, 0.5 ml IM by age/indication | 19–64 y chronic conditions, alcoholism, smoking; immunocompromised/asplenia: PCV13 then PPSV23 ≥8 weeks later, another PPSV23 ≥5 years later; at ≥65 y one PPSV23 ≥5 years after the last (only one dose at ≥65) | Hypersensitivity | Fever, local reactions, decreased limb mobility, peripheral oedema |
| IPV | Single booster | Travellers to countries with polio risk | Hypersensitivity | Local pain, fever, poor appetite, diarrhoea, vomiting |
| Tdap/Td | 3 primary doses (0, 1–2 months, 6–12 months), boosters every 10 years; pregnancy: 2 doses (early, 4 weeks later; 1 dose if within 3 years of last pregnancy) | Long-term protection; whole-cell pertussis not recommended for adolescents/adults | Hypersensitivity | Fever, malaise, local pain |
| Typhoid conjugate (Vi-TT) | Single 0.5 ml IM | Food handlers in endemic areas, travellers to endemic areas, microbiology lab staff | Hypersensitivity; pregnant and lactating women; fever or severe infection | Fever, pain, swelling |
| Varicella (live) | 2 doses 0.5 ml SC, ≥6 weeks apart (never <4 weeks) | Susceptible adolescents/adults, esp. high risk of getting/spreading | Immunodeficiency; hypersensitivity incl. neomycin; avoid pregnancy for 1 month after | Redness, pain, swelling, fever, skin eruptions |
| Yellow fever (live) | 1 dose 0.5 ml SC | Travellers to risk areas | Egg allergy; immunodeficiency; symptomatic HIV; prior hypersensitivity; pregnancy | Rarely encephalitis in the very young; hepatic failure; rare deaths from organ failure |
| Recombinant zoster (RZV) | 2 doses 0.5 ml IM, 2–6 months apart | ≥50 y; >19 y with immunocompromise incl. HIV | Severe allergy; current shingles; pregnancy | Local reactions; GBS very rarely |
| Kyasanur Forest Disease | 2 doses 1 month apart, boosters after 6–9 months | People in or travelling to at-risk areas — 5-km aerial radius of infected zone | Allergy to gentamicin, penicillin, egg; fever, jaundice; pregnancy | Brief burning at site; mild giddiness for 2–3 minutes |
| Rabies (cell culture: HDCV, PCECV, PVRV, PDEV) | PEP IM: days 0, 3, 7, 14, 28; PEP ID: 0.1 ml at two sites on days 0, 3, 7, 28; PrEP: days 0, 7 and 21 or 28 | All Category II and III bites, same dose regardless of age/weight | No absolute contraindication (100% fatal) | Headache, malaise, nausea, fever; transient local reactions esp. after ID |
Use clinical judgement, availability and current guidelines; references include CDC adult schedule, NCDC CD Alert, IMA Life Course Immunization Guidebook, WHO typhoid position paper, MoHFW yellow fever and KFD manuals, CDSCO SmPCs and NCDC rabies guidelines.
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