Definition of adverse events after vaccination
- This refers to all unintended symptoms that occur after vaccination; causality is not necessarily required. Most adverse events are mild, but severe adverse events can occur in rare cases when a large number of people are vaccinated (WHO).
- Any symptoms or diseases that may occur as a result of the vaccination, which are temporally related to the vaccination (Infectious Disease Control and Prevention Act)
How to report adverse events
Reported by doctors, dentists, and Oriental medicine practitioners.
- When to report: Report to the head of the health center with jurisdiction over the location of the affected individual at the time of diagnosis or examination.
- How to report: Report adverse events by submitting a web report through the Disease and Health Integrated Management System, or by completing the adverse event reporting form at the local health center and sending it via fax.
- Reporting form: Form No. 2 of the Enforcement Rules of the Act on the Prevention and Management of Infectious Diseases
- Details to report: Personal information, vaccination date and vaccination institution name, details of the vaccine administered, vaccination history, unusual circumstances before vaccination, date of adverse reaction occurrence after vaccination, type of adverse event, and progress
Report by the vaccinated individual or their guardian
- When to report: Report without delay if an adverse reaction is suspected after vaccination.
- How to report: Report via the vaccination assistant website or by phone to the health center with jurisdiction over your address.
- Details to report: Details of the vaccinated individual/guardian, name of the vaccine administered, vaccination date and institution name, date of occurrence of adverse reaction after vaccination, type of adverse reaction, and progress
Adverse event reporting and surveillance system after vaccination
이 이미지는 예방접종 후 이상반응 발생 시 신고와 감시가 이루어지는 절차를 나타낸 흐름도이다.
- 신고 주체: 환자 또는 보호자, 의사·치과의사·한의사.
- 신고 경로:
- 인터넷 신고: 예방접종도우미 누리집(nip.kdca.go.kr)
- 팩스 신고
- 정보시스템 신고: 질병보건 통합관리시스템(is.kdca.go.kr)
- 처리 절차:
- 보건소 접수 → 시·도 보고 → 질병관리청 예방접종정책과 보고
- 각 단계에서 유선 신고와 확인 과정 포함
의미: 예방접종 후 이상반응은 다양한 주체가 신고할 수 있으며, 보건소·시도·질병관리청을 거쳐 단계적으로 확인·관리되는 구조임을 보여준다.