Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | unknown | PO / MO |
stomach cramping, pain and diarrhoea; stomach cramping, pain and diarrhoea; stomach cramping, pain and diarrhoea; Case reference number US-BN-2025-001528 is a spontaneous case initially received from a consumer via Med Communication (reference number: USBAV25-2261) on 10-Sep-2025 and concerns a 28-year-old male patient. The patient's medical history included polyps and anemia in the past, and gastrointestinal (GI) issues in the past, but not recently. As reported, the patient was not on any concomitant medications. On 03-Sep-2025, the patient received the first dose of Vivotif (batch number: unknown), orally, at an unknown dose for typhoid immunization. On 05-Sep-2025, two days after the first dose, the patient received the second dose of Vivotif (batch number: unknown), orally, at an unknown dose for typhoid immunization On 07-Sep-2025, two days after the second dose, the patient received the third dose of Vivotif (batch number: unknown), orally, at an unknown dose for typhoid immunization On 09-Sep-2025, two days after the third dose, the patient received the fourth dose of Vivotif (batch number: unknown), orally, at an unknown dose for typhoid immunization On an unspecified date, an unknown amount of time after Vivotif, the patient experienced stomach cramping, pain and diarrhoea. At the time of initial report, the outcome of the events of 'stomach cramps', 'pain', and 'diarrhoea' was unknown. The reporter assessed the events of 'stomach cramps', 'pain' and 'diarrhoea' as non-serious and possibly related to Vivotif. No further information was provided.; Reporter's Comments: A 28-year-old male patient experienced stomach cramping, pain and diarrhoea on an unspecified date, an unknown amount of time after the patient received four doses of Vivotif for typhoid immunization. Abdominal pain upper and diarrhoea are considered as listed and expected for Vivotif per CCDS v8 and USPI, whilst pain is unlisted and unexpected. The patient's medical history included polyps and anemia in the past, and gastrointestinal (GI) issues in the past, but not recently, and the patient was not on any concomitant medications. 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 Vivotif. This case is considered as non-serious.; Sender's Comments: A 28-year-old male patient experienced stomach cramping, pain and diarrhoea on an unspecified date, an unknown amount of time after the patient received four doses of Vivotif for typhoid immunization. Abdominal pain upper and diarrhoea are considered as listed and expected for Vivotif per CCDS v8 and USPI, whilst pain is unlisted and unexpected. The patient's medical history included polyps and anemia in the past, and gastrointestinal (GI) issues in the past, but not recently, and the patient was not on any concomitant medications. 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 Vivotif. This case is considered as non-serious.
Medical History/Concurrent Conditions: Anaemia; Gastrointestinal disorder NOS; Polyps