Definition And Objectives
- Any untoward medical occurrence following immunization.
- Not necessarily causally related to vaccine usage.
- Includes unfavorable signs, abnormal laboratory findings, symptoms, or diseases.
- Identifies new safety signals after product marketing.
- Monitors adverse event rates and trends nationwide.
- Detects problems with vaccine manufacturing, storage, delivery, or administration.
Criteria For Notification
- All serious adverse events.
- Signals and events associated with newly introduced vaccines.
- Events potentially caused by immunization errors.
- Significant unexplained events occurring within 30 days post-vaccination.
- Events causing significant community or parental concern.
Classification Of Adverse Events
- Vaccine product-related reactions.
- Vaccine quality defect-related reactions.
- Immunization error-related reactions.
- Immunization-triggered stress responses.
- Coincidental events.
Reporting Channels And Process
- Indicated for serious and severe events due to clinical severity and potential threat to public confidence.
- Notification to Medical Officer or District Immunization Officer within 24 hours.
- District-level investigation initiated immediately.
Routine Reporting
- Captures all events including minor, severe, and serious.
- Recorded weekly in facility-level registers by healthcare staff.
- Verified by Medical Officer In-charge weekly.
- Submitted monthly to District Immunization Officer via Monthly Progress Reports.
Reporting Timelines
| Action | Timeline |
|---|
| Notification of serious/severe event | Within 24 hours of occurrence. |
| Case Reporting Form submission | Within 24 hours of notification. |
| Case Investigation Form submission | Within 21 days of notification. |
| Final Case Investigation Form submission | Within 100 days of notification. |
- Documents serious and severe adverse events.
- Completed by Medical Officer following patient examination.
- Reviewed by District Immunization Officer within 24 hours.
Surveillance And Action For Events Following Vaccination
- Web-based application for recording and reporting serious/severe cases.
- Improves timeliness and completeness of reporting.
- Reduces data loss during transmission.
- Facilitates early causality assessment and evidence-based action.
- Integrated into application systems for coronavirus disease 2019 vaccines.
Private Sector Reporting
- Private practitioners utilize Case Reporting Form for serious cases.
- Notify Medical Officer In-charge of nearest primary health center or District Immunization Officer.
- May utilize infectious disease surveillance and reporting systems developed by pediatric associations for real-time notification.
