Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient took Vivotif vaccine which was not stored refrigirated; The patient took Vivotif vaccine which was not stored refrigirated; The patient took Vivotif vaccine which was not stored refrigirated; Case reference number US-BN-2025-001727 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-000433) on 24-Oct-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, patient stored Vivotif unrefrigerated. (explicitly coded as product storage error', and 'product temperature excursion error'). On an unspecified date, the patient administered Vivotif while unrefrigerated (batch number: unknown; expiration date: unknown), at an unknown dose, site or route 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. Additional information received from Bavarian Nordic on 24-Oct-2025, included country of occurrence confirmation. No further information was provided.; Reporter's Comments: This case concerns a female patient of unspecified age. As reported patient administered Vivotif vaccine, which was unrefrigerated for unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. At the time of 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 female patient of unspecified age. As reported patient administered Vivotif vaccine, which was unrefrigerated for unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. At the time of 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