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 the Vivotif, which stayed at room temperature for about 16 hours and 30 minutes at approximately 20 degrees; The patient took the Vivotif, which stayed at room temperature for about 16 hours and 30 minutes at approximately 20 degrees; The patient took the Vivotif, which stayed at room temperature for about 16 hours and 30 minutes at approximately 20 degrees; Case reference number US-BN-2025-001951 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-001074) on 08-Dec-2025 and concerns a female patient of an unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took a dose of Vivotif vaccine (batch number: unknown), at unknown dose, route or site of administration for unknown indication. As reported, the patient took the Vivotif, which was stayed at room temperature for about 16 hours and 30 minutes approximately at 20 degrees (explicitly coded as 'product temperature excursion issue', 'product storage error', and 'product administration error'). Additional information was received from consumer via Bavarian Nordic on 11-Dec-2025: new information included that the product stayed at room temperature for about 16 hours and 30 minutes approximately. No further information was provided. Non-significant follow up received from Bavarian Nordic on 08-Dec-2025 included: Reference number (BN-2025-00377); Reporter's Comments: A female patient of an unknown age took a dose of Vivotif vaccine for unknown indication. As reported, the patient took the Vivotif, which was stayed at room temperature for about 16 hours and 30 minutes approximately at 20 degrees, which is considered as product temperature excursion issue, product storage error, and product administration error. It was unknown if the patient experienced any adverse events due to the 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 an unknown age took a dose of Vivotif vaccine for unknown indication. As reported, the patient took the Vivotif, which was stayed at room temperature for about 16 hours and 30 minutes approximately at 20 degrees, which is considered as product temperature excursion issue, product storage error, and product administration error. It was unknown if the patient experienced any adverse events due to the 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.