This document outlines India's guidelines for monitoring adverse events following immunization (AEFI). It discusses the importance of AEFI surveillance for ensuring vaccine safety and public confidence. It describes the steps for detecting, reporting, investigating, and responding to AEFIs at various levels of the healthcare system. All serious or unexpected health issues post-vaccination should be reported and investigated to determine the cause and prevent future occurrences. The goal is to quickly respond to AEFIs to strengthen immunization programs and ensure safe vaccination practices.

1. Adverse Events Following Immunization Current Status & National Guidelines State EPI Officers Meeting 8 July 2005

2. INDIA (1999-2005) Serious AEFI Case(s) 72 Cases 1 Dot= 1 Case

3. INDIA

4. Why monitor AEFI? No vaccines are 100% safe and without any risks It is important to know the risks and how to handle such an event when it occurs Informing people correctly on AEFI helps keep public’s confidence in the immunization programmes Monitoring AEFI also helps improve the quality of service

5. Steps in AEFI surveillance Detection and reporting Investigation Data analysis Corrective and other actions Evaluation

6. AEFI Detection and reporting Every individual that administers an immunization injection should know about AEFI The following are events need to be reported and investigated immediately (Serious Events) All deaths suspected to be related to immunization All hospitalisation suspected to be related to immunization Any other event in which vaccine quality is suspected

7. AEFI Detection and reporting The above basic categories act as “ trigger ” mechanisms for further course of action Minor events Sudden, unexplained deaths or large scale hospitalisation or a cluster of events reported following immunisation warrants immediate investigation

8. HOW , WHOM & WHEN TO REPORT PHC level Minor Events By ANM to MO PHC In Monthly Report By MO PHC to DIO in Monthly Report District Level By DIO to SEPIO in Monthly Report State level By SEPIO to GoI in Monthly Report

9. HOW , WHOM & WHEN TO REPORT Serious events PHC level ANM to the MO (PHC) immediately by telephone. The MO (PHC) First Information Report (FIR): to DIO in 24 hrs

10. HOW , WHOM & WHEN TO REPORT Serious events District Level DIO informs AC (UIP), GoI & SEPIO within next 24 hrs. Preliminary Investigation (PIR) PIR to AC (UIP) & SEPIO within 7 days of the AE. This report will include the probable cause of death and also mention the further investigation planned for the case

11. HOW , WHOM & WHEN TO REPORT Detailed Investigation (DIR) The DIO with team/ Regional investigation team/ State investigation team Prepare & Forward DIR, Post mortem report, vaccine test report, medical documents etc of the case to the AC (UIP) within 90 days Field workers are encouraged to report AEFIs

13. AEFI Investigation AEFI investigation will attempt to confirm or propose alternative diagnosis of the reported event identify the specifications of the vaccine incriminated examine the operational aspects of the programme identify whether it was an isolated event or a cluster of events and, if a cluster, where the immunization was given and what vaccines were used Preliminary investigation may be carried out by the local health worker, but serious AEFIs or clusters of AEFIs should be investigated from district or state/central level

14. AEFI Investigation Data on the patient(s) Vaccine (lot number, expiry, manufacturer, lab results if any), storage, reconstitution practice, diluent used, General disease information Similar disease episodes Collect samples of vaccines and diluents used (make sure vaccine sample collected are kept in the cold chain)

15. FORMS USED FOR INVESTIGATION The reporting of the minor events is done on monthly basis in the form 6-9 of RCH The reporting for severe cases is done using First Information report (FIR) in 48 hrs Followed by Preliminary investigation report (PIR) within 7 days And a Final report in form of Detailed investigation report (DIR) within 90 days

16. AEFI Data analysis Quickly to determine whether the AEFI is Programme related (incorrect dose of vaccine, wrong site, wrong diluent, improper storage & handling, use of other medicines as diluent, etc.) Vaccine induced AEFI Coincidental AEFIs (caused by something other than vaccine or programme errors) Unknown

17. Laboratory support If patient hospitalised, tests may confirm diagnosis Testing vaccines Send Vaccine & Diluents in reverse cold chain to CRI Kasauli Send case investigation report with vaccine for test

18. AEFI Corrective and other actions Action must not wait for investigation to be completed Treat Communicate Publicise the results Take corrective actions, where necessary Training of health workers & supervision to prevent avoidable AEFIs in future

19. AEFI Avoiding Programme Errors Use sterile needle & syringe for every injection Reconstitute only with specific diluent Discard reconstituted vaccines after Four hours Do not store drugs & other medicines in the same fridge as the vaccines and diluents Train & supervise health workers to ensure safe injection practices Monitor, Investigate and Act when AEFIs occur

20. AEFI Evaluation Periodically to examine its usefulness and to modify it if necessary Issues to consider when evaluating a surveillance system are timeliness, completeness, accuracy of the system swiftness with which response was effected when a trigger event was reported appropriateness of actions taken potential for strengthening of immunization system