Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004338 | — |
The patient took the full course of Vivotif while it was kept at room temperature (72-74 degrees Fahrenheit for eight days); The patient took the full course of Vivotif while it was kept at room temperature (72-74 degrees Fahrenheit for eight days); The patient took the full course of Vivotif while it was kept at room temperature (72-74 degrees Fahrenheit for eight days); Case reference number US-BN-2025-001692 is a spontaneous case report initially received from a pharmacist via Bavarian Nordic (reference number: CASE-000320) on 17-Oct-2025 and concerns a patient of unspecified age and gender. The patient's medical history and concomitant medication details were not reported. On an unspecified date, Vivotif was left at room temperature of 72-74 degrees Fahrenheit for eight days (explicitly coded as 'product temperature excursion issue' and 'product storage error'). On an unspecified dates, an unknown amount of time from the excursion, the patient took the full course of Vivotif (batch number: 3004338), at an unknown dose, route, or site of administration, for an 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. No further information was provided.; Reporter's Comments: This case concerns a patient of unspecified age and gender, who took the full course of Vivotif vaccine for an unknown indication, which was left at room temperature of 72-74 degrees Fahrenheit for eight days, which is considered 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 Vivotif. 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: This case concerns a patient of unspecified age and gender, who took the full course of Vivotif vaccine for an unknown indication, which was left at room temperature of 72-74 degrees Fahrenheit for eight days, which is considered 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 Vivotif. 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.