Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient left Vivotif out of the fridge for 7.5 hours, reaching a maximum temperature of 75 degrees Fahrenheit; The patient left Vivotif out of the fridge for 7.5 hours, reaching a maximum temperature of 75 degrees Fahrenheit; The patient then took the first dose of affected Vivotif vaccine; Case reference number US-BN-2025-001677 is a spontaneous case initially received from a consumer via Bavarian-Nordic (reference number: CASE-000261) on 14-Oct-2025 and concerns a 68-year-old male patient. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif (batch number: unknown) out of the fridge for 7.5 hours, reaching a maximum temperature of 75 degrees Fahrenheit (explicitly coded as 'product temperature excursion error' and 'product administered error'). On an unspecified date, the patient took the first dose of affected Vivotif vaccine (batch number: unknown), at unknown dose, route, or site of administration for an unknown indication (explicitly coded as 'product administration error'). At the time of 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 68-year-old male patient left Vivotif out of the fridge for 7.5 hours, reaching a maximum temperature of 75 degrees Fahrenheit, which is considered as product temperature excursion error and product administered error. On an unspecified date, the patient took the first dose of affected Vivotif vaccine for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to 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 68-year-old male patient left Vivotif out of the fridge for 7.5 hours, reaching a maximum temperature of 75 degrees Fahrenheit, which is considered as product temperature excursion error and product administered error. On an unspecified date, the patient took the first dose of affected Vivotif vaccine for an unknown indication, which is considered as product administration error. It was unknown if the patient experienced any adverse events due to 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.