Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | Unknown | — |
Clay colored stools; Discomfort from stomach; Abdominal pain; Case reference number US-BN-2024-002542 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: BN_2024_02980) on 24-Sep-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of typhoid vaccine (brand name: unknown, batch number: unknown), at dose of one capsule, via unknown route and for unknown indication. On an unspecified date, unknown amount of time after taking the typhoid vaccine, the patient experienced abdominal pain, clay colored stools and discomfort from stomach. At the time of the initial report, the outcome for the events of abdominal pain, clay colored stools and discomfort from stomach was unknown. The reporter did not provide seriousness and causality assessment for the events of abdominal pain, clay colored stools and discomfort from stomach. Additional information received from Bavarian Nordic on 25-Sep-2024 included confirmation of county of occurrence.; Reporter's Comments: A patient of unknown age and gender experienced non-serious events of abdominal pain, clay colored stools and discomfort from stomach on an unspecified date, unknown amount of time after the patient took a dose of typhoid vaccine for unknown indication. Abdominal pain is listed and expected for Typhoid vaccine per CCDS v8 and USPI, whilst faeces discoloured and abdominal discomfort are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Typhoid vaccine. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender experienced non-serious events of abdominal pain, clay colored stools and discomfort from stomach on an unspecified date, unknown amount of time after the patient took a dose of typhoid vaccine for unknown indication. Abdominal pain is listed and expected for Typhoid vaccine per CCDS v8 and USPI, whilst faeces discoloured and abdominal discomfort are unlisted and unexpected. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported events have been considered as related to Typhoid vaccine. This case is considered as non-serious.
Comments: None.