Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient left the Vivotif vaccine out at room temperature and then took one dose of vaccine; The patient left the Vivotif vaccine out at room temperature and then took one dose of vaccine; The patient left the Vivotif vaccine out at room temperature and then took one dose of vaccine; Case reference number US-BN-2025-000348 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV25-0559) on 12-Mar-2025 and concerns a male patient of unspecified age. The patient's relevant medical history and concomitant medications were not provided. On an unspecified date, the patient was left the Vivoitf vaccine out at room temperature (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On 12-Mar-2025, the patient took first dose of defected Vivotif vaccine (batch number: unknown) at an unknown dose, route or site of administration, for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A male patient of unspecified age left the Vivoitf vaccine out at room temperature, which is considered as product storage error and product temperature excursion issue. The patient took the first dose of defected Vivotif vaccine for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error and product temperature excursion issue 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 unspecified age left the Vivoitf vaccine out at room temperature, which is considered as product storage error and product temperature excursion issue. The patient took the first dose of defected Vivotif vaccine for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.