Module 4 · Chapter 4
Recording and Reporting AEFIs
Who notifies whom, the two reporting channels, SAFE-VAC, HMIS rows, the CRF → CIF pipeline with timelines, clusters, cross-notification and non-government reporters.
4.1 Who can inform about an AEFI case
The UIP is the main provider of childhood immunization; sessions are held in government centres at primary, secondary and tertiary levels on fixed days (varying by state) at least once a week, mostly as outreach sessions. The private sector also provides routine and non-UIP vaccines.
Patients or family are often first to suspect an AEFI and inform the vaccination or health-care provider. With death, hospitalization, clusters or inaction, they may go to local people’s representatives or the media. Any health-care provider (public or private) who comes across an AEFI must inform the district health authorities (District Immunization/RCH Officer) directly or through a government MO.
Rural — first to know
- Frontline workers: ASHA, anganwadi workers (AWW)
- Vaccinators: ANM, male multipurpose health workers and supervisors (LHV, Health Supervisors)
- MOs and paramedics of HWCs, PHCs, CHCs
- Doctors and staff nurses in private clinics, dispensaries, nursing homes, hospitals
- Media, lay public, community mobilisers
Urban — first to know
- Dispensaries, urban health centres, MCH centres under urban local bodies
- Government sub-divisional, divisional and district hospitals
- Government and private medical colleges (incl. ADR Monitoring Centre staff under PvPI)
- Central government / PSU facilities — CGHS, Railways, Defence, ESI, airport authorities (travel vaccination), industry, autonomous bodies
- Private providers — practitioners, paediatricians, obstetrician-gynaecologists, physicians, neonatologists, other specialists
- DIO’s responsibility: sensitise all these cadres (public and private) to suspect, identify, notify and report AEFIs — special focus on secondary/tertiary hospitals, medical colleges and large (super-)speciality hospitals.
- DIO ensures AEFIs after any licensed vaccine are reported — UIP, outside UIP (TT, rabies, yellow fever) or private (influenza, chickenpox, mumps).
4.1.1 Who should be informed?
Serious/severe AEFIs are notified immediately to the MO of the nearest government PHC/CHC and/or the DIO by the quickest means (telephone, SMS, WhatsApp, email, messenger). The most important reason for immediate notification is to ensure the case gets treatment on priority; reporting and investigation follow once treatment starts. Minor events are recorded in AEFI registers.
4.2 Reporting of AEFIs — two channels
1. Immediate reporting
Serious and severe AEFIs.
2. Routine reporting
All types — minor, severe and serious.
4.2.1 Immediate reporting of serious and severe AEFIs
Reported immediately to the MO or DIO because of clinical severity and potential threat to public confidence. A two-step process:
- Step 1: report to the appropriate authority — DIO or MO in charge (urban); DIO or MO I/C of the health centre (rural).
- Step 2: district-level investigation.
All notified serious/severe AEFIs are documented on a Case Reporting Form (CRF, Annexure 6) and submitted to SAFE-VAC as soon as possible. Cases are entered by the DIO (Co-WIN SAFE-VAC for COVID-19 vaccines) and are visible at state and national level.
SAFE-VAC — Surveillance and Action for Events Following Vaccination
A web-based application conceptualised by MoHFW to digitise AEFI surveillance (https://safevac.mohfw.gov.in). Data can be entered by DIOs, SEPIOs and the national level, who monitor progress and take corrective action.
Objectives
- Speed up recording/reporting → shorter response time
- Reduce data loss and transmission time
- Support timely investigation and causality assessment
- Improve timely evidence-based feedback and action
Benefits
- Better timeliness and completeness
- Less information loss to higher levels
- Allows cross-notification district to district
- No data loss when DIO/data handler changes
- Empowers district and state monitoring
- Easy, secure access for managers
- Facilitates early causality assessment
- Promotes evidence-based action for vaccine acceptance
For COVID-19, another version of SAFE-VAC was integrated into Co-WIN; collated data and in-built analysis serve state/national AEFI committees and programme managers.
Table 4.1 · Adverse events known to be associated with vaccines (reportable — indicative, not exhaustive)
All serious and severe AEFIs are a medical emergency: management first, then reporting and investigation in standard formats.
| Vaccine | Reactions |
|---|---|
| BCG | Local: abscess, keloid, cutaneous lesions, lymphadenitis, suppuration. Systemic: osteitis, osteomyelitis, disseminated BCG disease, immune reconstitution syndrome (HIV) |
| OPV | VAPP |
| DTwP / Pentavalent | Fever >38°C, irritability, drowsiness; prolonged inconsolable crying (>1 h); high fever >40.5°C; acute encephalopathy/encephalitis, HHE, seizure, anaphylaxis/shock |
| DTaP / DTaP+Hib+HBV | Fever >38°C and irritability, drowsiness; prolonged crying; high fever >40.5°C; HHE, seizures, anaphylaxis |
| Hepatitis B | Anaphylaxis |
| Measles / MR | Fever >39.4°C, rash, febrile seizure; thrombocytopenia, anaphylaxis, encephalopathy/encephalitis/encephalomyelitis |
| Rubella · Mumps · MMR | Arthralgia/arthritis/arthropathy · aseptic meningitis · febrile seizure |
| Tetanus / Td | Brachial neuritis, anaphylaxis |
| Rotavirus | Intussusception |
| Japanese encephalitis | Serious allergic reactions, seizures, encephalopathy, neuropathy, myelitis, aseptic meningitis |
| Influenza (inactivated) | Anaphylaxis, GBS, oculo-respiratory syndrome |
| Influenza (live) | Seizures, anaphylaxis, wheeze, GBS |
| Varicella zoster | Febrile seizures |
| HPV | Myalgia, arthralgia, anaphylaxis |
| Rabies | Local: pain, redness, swelling, induration. Systemic: fever, headache, dizziness, GI symptoms. Hypersensitivity (arthralgia, angioedema): anaphylaxis, GBS |
| Yellow fever | Headache, myalgia, malaise, fever, injection-site pain, swelling; viscerotropic disease; neurotropic disease (encephalitis, meningitis, GBS) |
| Typhoid | Oral: GI, fever. Injectable: injection-site pain, erythema, induration, headache |
| COVID-19 vaccines | Anaphylaxis |
| Covishield | Thrombotic thrombocytopenia syndrome (TTS), thrombocytopenia |
4.2.2 Routine reporting
1. AEFI registers (facility / block / planning unit)
- All ANMs of a block/planning unit record all AEFIs (serious, severe, minor) from their areas weekly in the AEFI register (Annexure 7) at the centre.
- Registers also kept at private and public facilities — nursing homes, district hospitals, medical colleges — under a nodal MO; vaccinators, nurses, paramedics and doctors can enter AEFIs.
- The MO I/C verifies the register every week, analyses it for patterns or preventable programme errors using the assessment format (part of Annexure 7) and submits it to the DIO every month. Sub-centre-wise analysis may trigger more cold-chain or session monitoring, training, etc., depending on AEFI types and clustering.
2. Monthly Progress Reports (HMIS)
Existing monthly formats (NRHM, HMIS etc.). Sub-centre data are entered at the PHC; data from PHCs, CHCs, SDHs, DHs and medical colleges are visible at district then state level.
| Sub-centre (HWC-SC) row | PHC/CHC/SDH/DH/MC row | Content |
|---|---|---|
| 8.6.1 | 9.6.1 | AEFI – Minor (e.g. fever, rash, pain) |
| 8.6.2 | 9.6.2 | AEFI – Severe (e.g. anaphylaxis, fever >39°C, not requiring hospitalization) |
| 8.6.3 | 9.6.3 | AEFI – Serious (e.g. hospitalization, death, disability, cluster) |
| 8.6.3.a | 9.6.3a | Of serious AEFIs, total number of deaths |
- Deaths in 8.6.3a are also counted in 8.6.3.
- ANMs enter 0 if no AEFI was reported.
- Enter separately for “In facility” and “Outreach”.
- Reconcile HMIS figures with AEFI registers; medical colleges may need initial handholding.
Figure 4.1 data flow: Sub-centre → PHC/CHC/HWC → District HQ (+ referral hospitals, depending on location) → State HQ (+ urban centres, depending on location) → National. Monthly reports from referral hospitals/urban centres go to the district or state HQ through the Immunization Officer I/C.
4.3 Reporting and investigating serious AEFIs — process, forms, timelines
Notification
Health worker/FLW informs the MO of the PHC; a private practitioner or doctor in a hospital/medical college informs the DIO. Any means — phone, SMS, WhatsApp, email.
Reporting
Sending AEFI information to the district and documenting it in the CRF. MO fills a hard copy and sends it to the DIO; large hospitals/medical colleges fill it via their AEFI Nodal Officer.
Case Reporting Form (CRF) — only for serious/severe AEFIs
Sections: A reporter · B patient · C vaccine and diluent · D event · E decision making.
- Gives basic information for decisions at all levels — therefore urgent.
- Fill with as much detail as possible — the investigation is planned from it.
- A good CRF helps identify potential signals early, without waiting for investigation and causality.
- First reference point for quality assurance and programme performance — reflects health-system quality.
CRF process (Figure 4.3)
4.3.1 Planning for investigations
- DIO convenes the District AEFI Committee to decide on a time-bound investigation.
- MO + DIO list items useful for the team — registers, ANM diaries, session tally sheets, indent records, used and unused vials, diluents, syringes.
- Ensure these are preserved and available when the district team fills the CIF.
- Share CRF copies with: the District AEFI Committee; the Drug Inspector (a committee member); in death, the post-mortem panel and verbal-autopsy team; the testing laboratory (with the LRF) if samples are to be sent.
State Immunization Officer: on receiving the CRF via SAFE-VAC, judges gravity — gives immediate support through the state/regional AEFI committee (incl. State Drug Controller) or waits for the CIF.
Immunization Division, MoHFW: the National AEFI Secretariat reviews, collates and gives feedback; may involve DCG(I)/CDSCO and the National AEFI Committee.
Case Investigation Form (CIF, Annexure 8)
In-depth information on the case and circumstances: (a) basic details; (b) patient health and socio-demographic information before immunization; (c) first examination of severe/serious case; (d) medical care and treatment; (e) vaccines provided at the site; (f) immunization practices where the vaccine was used; (g) cold chain and transport; (h) community investigation; (i) other key findings; (j) District AEFI Committee review and investigation report; (k) any other information supporting causality.
Purpose: guides the team to collect what is needed for causality assessment — be as detailed as possible. The CIF is not “set in stone”: add information from non-conventional sources (e.g. suspicion of suicide or homicide from neighbours/relatives, drug use, alcoholism).
CIF process (Figure 4.4)
In urban areas the DIO’s counterpart is the MO Health in charge of immunization (Corporation Immunization Officer, Municipal Health Officer) with the same roles.
4.4 AEFI records and databases
- District and state: DIO and SIO review the database and line list in SAFE-VAC; quarterly review of all serious/severe AEFIs by district and state AEFI committees; feedback to all stakeholders.
- National: the National AEFI Secretariat maintains the national database manually and digitally (SAFE-VAC) at MoHFW.
Periodic analysis at district, state and national levels covers: number of AEFIs; geographic and temporal distribution (look for clustering); number and type of events by antigen (abscess, seizures, HHE…); geographic distribution of possible programme-related events (e.g. abscess); clustering by vaccine, batch etc.; timeliness and completeness; silent blocks/corporations/districts/states not reporting.
4.5 Cluster AEFI cases · 4.6 Cross-notified cases
- Each case in a cluster gets its own CRF and CIF in SAFE-VAC.
- Prepare a summary (sequence of events, common factors) describing any deaths well.
- A line list of all cases is mandatory: age, gender, vaccines received, sequence of vaccination (if known), onset of symptoms, date/time of hospitalization and death, signs and symptoms.
- During mass campaigns MoHFW may issue a revised protocol for anxiety clusters — valid only for that campaign.
4.6 Cross-notification
- An AEFI belongs to the place of vaccination — not residence, place of treatment or place of reporting.
- The reporting district fills the CRF with available information, generates a Case ID using the “cross-notification” function in SAFE-VAC, enters details and uploads the CRF.
- The parent district fills gaps (vaccines given, exact session site, similar cases) and does the final submission — only the parent district can submit.
- The reporting district supports with medical records, post-mortem report etc.; the parent district investigates (vaccines, batches, session, technique, cold-chain points).
4.7–4.11 Other reporters, minor AEFIs and encouraging reporting
4.7 Private facility/practitioner
- State/district authorities (DIO/CMO/Block MO) identify and sensitise nodal persons in private facilities.
- Report AEFIs after all vaccines used in the private sector, including new vaccines — same formats, channels, investigation processes and timelines.
- Private providers notify the government MO/DIO; district health authorities investigate; give appreciation and feedback (investigation and causality results).
- Professional bodies (IAP, IMA, IPHA) and partners (WHO-NPSN, UNICEF, UNDP, USAID, PATH) should support. The National AEFI Committee will explore more options; MoHFW will provide a feasible, easy, secure channel and coordinate with IAP, API, IMA.
4.8 Other health systems
CGHS, ESI, Railways, Defence, Airport Authority, PSUs — integrated into the national system. DIO identifies them; each designates a nodal person reporting to the DIO/MO I/C; same forms; maintain AEFI registers; DIO holds refresher/sensitisation meetings.
4.9 ADR Monitoring Centres (AMCs) of PvPI
AMCs must know MO/DIO contacts and assist reporting and investigation. They report serious AEFIs using the Case Notification Form (CNF, Annexure 9); on receiving a CNF the DIO immediately starts reporting and investigation. Appreciation and coordination by state/district.
4.10 Minor AEFIs
Currently name-based in AEFI registers; aggregate numbers go to HMIS via the PHC Monthly Progress Report. During COVID-19, CoWIN-SAFE-VAC captured minor, serious and severe AEFIs by vaccinators and DIOs. A similar system for routine immunization (electronic reporting by vaccinators, MOs, DIOs and others) is proposed — software reporting enables early, automated analysis for programme errors and signals.
4.11 Encouraging reporting
Staff should report without fear of penalty. Enhance by: sensitisation and refresher training; regular feedback on investigation status, causality and corrective actions; adequate support at all levels; confidence-building; commendation of districts/facilities for better reporting (quality and quantity). Private sector: engage IAP and IMA chapters at district and state level.
Table 4.2 · Channels and frequency
| Channel | Frequency | Categories |
|---|---|---|
| AEFI reporting and investigation formats (CRF & CIF) | Immediate notification and reporting | Serious and severe |
| AEFI registers | Weekly | Serious, severe and minor |
| SAFE-VAC (Co-WIN SAFE-VAC for COVID-19) | Immediate | Serious, severe and minor |
| Monthly Progress Report (HMIS) | Monthly | Serious, severe and minor |
Chapter summary
- Anyone — any provider, ICDS worker, ASHA, community member — can notify the PHC MO or district authority by the quickest means.
- Report AEFIs after any licensed vaccine, UIP or non-UIP, public or private.
- Serious/severe cases: immediate medical care first, then reporting.
- All AEFIs go into AEFI registers and their numbers into HMIS.
- CRF: MO → DIO within 24 h; DIO verifies and submits on SAFE-VAC within another 24 h; SAFE-VAC generates the case ID.
- DIO leads investigation with the DAC and submits the CIF within 21 days.
- Private practitioners, facilities and AMCs notify the MO/DIO; district authorities investigate.
- Clusters: separate CRF/CIF per case + summary + single line list.
- Minor AEFIs via registers and MPRs; electronic minor-AEFI reporting proposed.
Quick recall
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Self-test · Chapter 4
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