Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient left Vivotif unrefrigerated overnight for 12 hours at 76 degrees Fahrenheit; The patient left Vivotif unrefrigerated overnight for 12 hours at 76 degrees Fahrenheit; The patient took one dose of Vivotif after the temperature excursion; Case reference number US-BN-2025-001652 is a spontaneous case initially received from a pharmacist via Bavarian-Nordic (reference number: CASE-000116) on 07-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif unrefrigerated overnight for 12 hours at 76 degrees Fahrenheit (explicitly coded as 'product temperature excursion error' and 'product storage error temperature too high'). 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 female patient of unspecified age left Vivotif unrefrigerated overnight for 12 hours at 76 degrees Fahrenheit, which is considered as product temperature excursion error and product storage error temperature too high. 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 female patient of unspecified age left Vivotif unrefrigerated overnight for 12 hours at 76 degrees Fahrenheit, which is considered as product temperature excursion error and product storage error temperature too high. 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.