Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | — |
The patient stored Vivotif inside a cooler bag in the back of his truck inside an insulated cooler bag at -12 F for four hours.; The patient stored Vivotif inside a cooler bag in the back of his truck inside an insulated cooler bag at -12 F for four hours.; The patient took two Vivotif doses that where inside a cooler bag in the back of his truck inside an insulated cooler bag at -12 F for four hours.; Case reference number US-BN-2025-001971 is a spontaneous case initially received from a pharmacist via Bavarian Nordic (reference number: CASE-001229) on 16-Dec-2025 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, four doses of Vivotif vaccine (batch number: unknown) had temperature excursion, with a recorded minimum temperature of 12 °F that lasted for four hours (explicitly coded as 'product temperature excursion issue' and 'product storage error temperature too low'). On an unspecified date, the patient took the first dose of Vivotif vaccine (batch number: unknown) at an unknown dose, route, or site of administration, for an unknown indication (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose, the patient took the second dose of Vivotif vaccine (batch number: unknown) 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. Additional information was provided via Bavarian Nordic on 18-Dec-2025, new information included Bavarian Nordic ID (BN_2025_00376), confirmed Vivotif vaccine details.; Reporter's Comments: A male patient of unspecified age took the first and the second dose of affected Vivotif vaccine for an unknown indication, which had temperature excursion, with a recorded minimum temperature of 12 °F that lasted for four hours, which is considered as product temperature excursion issue, product storage error temperature too low and product administration error. 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: A male patient of unspecified age took the first and the second dose of affected Vivotif vaccine for an unknown indication, which had temperature excursion, with a recorded minimum temperature of 12 °F that lasted for four hours, which is considered as product temperature excursion issue, product storage error temperature too low and product administration error. 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