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 after temperature excursion, temperature was around 40-50°F; The patient took Vivotif after temperature excursion, temperature was around 40-50°F; The patient took Vivotif after temperature excursion, temperature was around 40-50°F; Case reference number US-BN-2025-001969 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-001197) on 15-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 one dosage form, at an unknown route or site of administration for unknown indication. As reported the patient left the Vivotif out of the refrigerator, and temperature was around 40-50°F (explicitly coded as 'product temperature excursion issue', 'product storage error' and 'product administration error'). At the time of the initial report, the patient did not experience any adverse events due to Vivotif. Additional information was received from consumer via Bavarian Nordic on 16-Dec-2025 included that the patient took the Vivotif after the temperature excursion. Hence, the event 'product administration error' was added.; Reporter's Comments: A female patient of an unknown age took a dose of Vivotif vaccine for unknown indication. As reported the patient left the Vivotif out of the refrigerator, and temperature was around 40-50°F, which is considered as product temperature excursion issue, product storage error and product administration error. The patient did not experience 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: A female patient of an unknown age took a dose of Vivotif vaccine for unknown indication. As reported the patient left the Vivotif out of the refrigerator, and temperature was around 40-50°F, which is considered as product temperature excursion issue, product storage error and product administration error. The patient did not experience 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.