Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient on two separate occasions left Vivotif out overnight, 14 hours, and still took the dose the next morning; The patient on two separate occasions left Vivotif out overnight, 14 hours, and still took the dose the next morning; The patient on two separate occasions left Vivotif out overnight, 14 hours, and still took the dose the next morning; Case reference number US-BN-2025-001993 is a spontaneous case report initially received from other health care professional via Bavarain Nordic (reference number: CASE-001333) on 22-Dec-2025 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, the patient on two separate occasions left Vivotif out overnight, 14 hours, and (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too high'). On unspecified dates, still took the dose the next morning the patient took a first dose of Vivotif (batch number: unknown), at an unknown dose, route and site of administration, for unknown indication (explicitly coded as 'product administration error'). On unspecified dates, the patient took the second dose of Vivotif (batch number: unknown), at an unknown dose, route and site of administration (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from other health care professional on 23-Dec-2025 included reporter's information.; Reporter's Comments: A male patient of unknown age took the first and the second dose of affected Vivotif for unknown indication, after the patient on two separate occasions left Vivotif out overnight, 14 hours, which is considered as product temperature excursion issue, product storage error temperature too high and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age took the first and the second dose of affected Vivotif for unknown indication, after the patient on two separate occasions left Vivotif out overnight, 14 hours, which is considered as product temperature excursion issue, product storage error temperature too high and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Product temperature excursion issue, product storage error and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product temperature excursion issue, product storage error and product administration error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE.