Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
Patient took first dose of Vivotif after temperature excursion; Patient took first dose of Vivotif after temperature excursion; Patient took first dose of Vivotif after temperature excursion; Case reference number US-BN-2025-001637 is a spontaneous case initially received from consumer via Bavarian-Nordic (reference number: CASE-000080) on 03-Oct-2025 and concerns female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient was unaware the vaccine Vivotif needed to be refrigerated. (explicitly coded as 'product temperature excursion error' and 'product storage error'). On 02-Oct-2025, the patient took first dose of affected Vivotif vaccine (batch number: unknown), at unknown dose, route and for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient of unspecified age took the first dose of affected Vivotif vaccine that was not refrigerated for unknown indication, which is considered as product administration error, product temperature excursion error and product storage error. It was unknown if the patient experienced any adverse event 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 took the first dose of affected Vivotif vaccine that was not refrigerated for unknown indication, which is considered as product administration error, product temperature excursion error and product storage error. It was unknown if the patient experienced any adverse event 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.