Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient had rash on the neck and trunk; Case reference number US-BN-2024-002739 is a spontaneous case initially received from other health care professional via Bavarian Nordic (reference number: BN_2024_03049) on 04-Nov-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication. On an unspecified date, unknown amount of time after vaccination with Vivotif, the patient had rash on neck and trunk. At the time of initial report, it was unknown if the patient recovered from event of 'rash'. The reporter did not provide seriousness and causality assessment for event of 'rash'. No further information was provided.; Reporter's Comments: A female patient of unknown age experienced a non-serious event of rash on neck and trunk an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Rash is listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age experienced a non-serious event of rash on neck and trunk an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Rash is listed and expected for Vivotif per CCDS v8 and USPI. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and known vaccine safety profile, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Comments: None