Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient took one dose of Vivotif vaccine whicih lef out of refrigerator for 48h, temperature assessed 23°C; The patient took one dose of Vivotif vaccine whicih lef out of refrigerator for 48h, temperature assessed 23°C; The patient took one dose of Vivotif vaccine whicih lef out of refrigerator for 48h, temperature assessed 23°C; Case reference number US-BN-2025-001796 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000717) on 12-Nov-2025 and concerns a female patient of an unknown age. The patient's medical history and concomitant medications were not provided. On 07-Nov-2025 the patient picked up Vivotif vaccine (batch number: unknown) but didn't realize until 09-Nov-2025 that vaccine should be refrigerated, on that evening the patient placed them in refrigerator. The Vivotif vaccine was out of the refrigerator for 48h and the temperature was 23°C (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too high'). On 10-Nov-2025, the patient took her first dose of Vivotif (batch number: unknown), at unknown dose, via an unknown route 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. Additional information was received from Bavarian Nordic on 13-Nov-2025 and included the BN reference number: BN-2025-00326. Additional information was received from Bavarian Nordic on 17-Nov-2025 and included the temperature (23°C) and duration of time (48 hours) Vivotif vaccine that was not refrigerated. Additional information was received from Bavarian Nordic on 17-Nov-2025 and included that reported temperature excursion is critical for the stability and efficacy of Vivotif, therefore, the respective product is not acceptable for further use.; Reporter's Comments: A female patient of an unknown age picked up Vivotif vaccine but didn't realize that vaccine should be refrigerated, on that evening the patient placed them in refrigerator. The Vivotif vaccine was out of the refrigerator for 48h, and the temperature was 23°C, which is considered as product temperature excursion issue and product storage error temperature too high. Reportedly, the patient took her first dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medications details were provided. Product temperature excursion issue, product administration error and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of an unknown age picked up Vivotif vaccine but didn't realize that vaccine should be refrigerated, on that evening the patient placed them in refrigerator. The Vivotif vaccine was out of the refrigerator for 48h, and the temperature was 23°C, which is considered as product temperature excursion issue and product storage error temperature too high. Reportedly, the patient took her first dose of Vivotif for unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product administration error and product storage error are considered as listed per company convention. The patient's medical history and concomitant medications details were provided. Product temperature excursion issue, product administration error and product storage error are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE.