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Guideline for submission of vaccine ICSRs in Switzerland
Q: What scenarios of vaccine Adverse reactions to be reported to Switzerland?
A: Suspected serious unlabelled and non-serious unlabelled AEFI are to be reported to Swissmedic according to Swiss legal requirements. Additionally, reporting of non-serious – labelled AEFI is strongly recommended by Swissmedic
Q: What is structure and what is included in AEFI report as per Switzerland?
A: Each AEFI report forwarded to SMC shall contain
- In structured data reporting fields
- Dose number (if series) and dates of vaccinations
- Vaccine batch number (this information can be repeated in free-text)
- Most vaccines are a dose series. If an AEFI occurs for each dose in a series:
- Enter the vaccine each time as a suspected drug for each dose with different Start Date/End Date
- If the AEFI is the same as with the earlier exposure to the vaccine, check yes under the field Rechallenge for the second vaccine dose.
- . Include in the Case Narrative free-text
- Side of administration: left or right
- Body site of administration (e.g. thigh muscle, deltoid muscle)
- Latency: time from exposure to onset of symptoms and signs
- Vaccination history if relevant or unusual (e.g. delayed schedule, missed childhood immunisations)
- Severity and course/outcome of AEFI
- Results of relevant laboratory, radiological, surgical, pathological, etc. investigations
- Batch Number: request always and if not available, state clearly in case narrative. e.g. batch number requested but unavailable
- New identified safety signals(not in form of Individual Case Safety Reports (ICSR) but as concise, critical evaluation of the issue) identified on Swiss or international level:
- Not later than 15 calendar days for a new potential risk identified by the MAH on Swiss or international level in relation with immunisation (e.g. new potential risk, vaccine use or prescribing problem, increase of abnormal outcomes frequency).
- This should be considered as an identified safety signal for which an evaluation report including available data, risk assessment and planned measures must be submitted.
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