Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004338 | PO / MO |
The patient experienced explosive diarrhea after taking Vivotif; Case reference number US-BN-2025-001587 is a spontaneous case initially received from a nurse via Communications (reference number: USBAV25-2365) on 23-Sep-2025 and concerns a female patient of an unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: 3004338), orally, at an unknown dose, for the indication of protection against typhoid fever. On an unspecified date, an unknown amount of time after the first dose, the patient took the second dose of Vivotif (batch number: 3004338) orally, at an unknown dose. On an unspecified date, an unknown amount of time after the first dose, the patient experienced explosive diarrhea. Per the nurse, the patient described the diarrhea as "a pretty nasty and controllable bout of diarrhea". It was reported that no laboratory tests had been performed, and no treatment was given due to the event. At the time of the initial report, it was unknown whether the patient recovered from the event of 'explosive diarrhea'. The reporter assessed the event of 'explosive diarrhea' as non-serious and possibly related to Vivotif. No further information was provided.; Reporter's Comments: A female patient of an unknown age experienced a non-serious event of diarrhea on an unspecified date, an unknown amount of time after the patient took two doses of Vivotif for the indication of protection against typhoid fever. Diarrhoea 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, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A female patient of an unknown age experienced a non-serious event of diarrhea on an unspecified date, an unknown amount of time after the patient took two doses of Vivotif for the indication of protection against typhoid fever. Diarrhoea 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, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.