Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
Patient experienced mild stomach upset for a day; Patient was fatigued; Patient experienced some diarrhea on the first day of taking the Vivotif capsule; Patient experienced headache; Case reference number US-BN-2025-001970 is a spontaneous case initially received from other health professional via Bavarian Nordic on 15-Dec-2025 and concerns a *male* patient of an unspecified age. Patient medical history included Typhoid fever. No concomitant medications details were provided. On an unspecified date in March 2024, the patient took dose of Vivotif (batch number: unknown) at an unknown dose, orally for prophylaxis. On an unspecified date, the patient experienced mild stomach upset for a day and headache, and fatigue. Patient also experienced diarrhea on the first day of taking Vivotif capsule, At the time of *follow-up* report, it was unknown if the patient was recovered from the events of diarrhea, headache, fatigue. The reporter did not provide seriousness and causality assessment for events abdominal discomfort, diarrhea, headache, fatigue. Additional information was received from other health professional on 16-Dec-2025, include confirmation of country of occurrence. Additional information was received from other health professional on 18-Dec-2025 included date of administration of Vivotif and confirmation of adverse events. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*) Follow-up information was received from other health professional on 17-Jan-2026. New information included patient's initials, gender and contact information.; Reporter's Comments: This case report concerns a male patient of an unspecified age, who had developed non-serious events of abdominal discomfort, fatigue, diarrhoea and headache, on unspecified date and time after patient receiving the dose Vivotif, for an indication of prophylaxis. Diarrhoea and headache are listed as per CCDS v9 and expected per USPI, whilst abdominal discomfort is unlisted and unexpected. Fatigue is listed and unexpected. Patient's medical history included Typhoid fever and concomitant medications details were not provided. Outcome is unknown. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events, is assessed as possibly related to suspect. This case is considered as non-serious.; Sender's Comments: This case report concerns a male patient of an unspecified age, who had developed non-serious events of abdominal discomfort, fatigue, diarrhoea and headache, on unspecified date and time after patient receiving the dose Vivotif, for an indication of prophylaxis. Diarrhoea and headache are listed as per CCDS v9 and expected per USPI, whilst abdominal discomfort is unlisted and unexpected. Fatigue is listed and unexpected. Patient's medical history included Typhoid fever and concomitant medications details were not provided. Outcome is unknown. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported events, is assessed as possibly related to suspect. This case is considered as non-serious.
Medical History/Concurrent Conditions: Typhoid
Test Name: Salmonella test positive; Result Unstructured Data: positive