Quote from VigiServe Admin on December 28, 2020, 11:32 AM

General instructions / recommendations for submission of adverse events following immunisation (AEFI)

Suspected «serious» 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.
Each AEFI report forwarded to SMC shall contain:
1. 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:
1. Enter the vaccine each time as a suspected drug for each dose with different
«StartDate/EndDate»
2. 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.
2. 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 immunizations)
- 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».

3. 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.