Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
Vivotif was left out of refrigerator for several days, maximum temperature was 65°F; Vivotif was left out of refrigerator for several days, maximum temperature was 65°F; Vivotif was left out of refrigerator for several days, maximum temperature was 65°F; Case reference number US-BN-2025-001950 is a spontaneous case initially received from pharmacist via Bavarian Nordic (reference number: CASE-001175) on 13-Dec-2025 and concerns a patient of unknown gender and age. The patient's medical history and concomitant medication details were not provided. On 12-Dec-2025, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose and route of administration for an unknown indication. As reported the Vivotif was left out of refrigerator since 26-Nov-2025, the maximum temperature was 65°F (explicitly coded as 'product temperature excursion issue', 'product storage error, and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to the Vivotif vaccine. No further information was provided.; Reporter's Comments: A patient of unknown gender and age took a dose of Vivotif for an unknown indication. As reported the Vivotif was left out of refrigerator for several days, the maximum temperature was 65°F, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to the 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 patient of unknown gender and age took a dose of Vivotif for an unknown indication. As reported the Vivotif was left out of refrigerator for several days, the maximum temperature was 65°F, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events due to the 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.