Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
The patient took all 4 doses of Vivotif but did not refrigerate it; The patient took all 4 doses of Vivotif but did not refrigerate it; The patient took all 4 doses of Vivotif but did not refrigerate it; Case reference number US-BN-2025-001929 is a spontaneous case initially received from a other health professional via Bavarian Nordic (reference number: CASE-001058) on 05-Dec-2025 and concerns a 44-years-old female patient. The patient's medical history and concomitant medications details were not provided. On an unspecified date, the patient took the first dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication. On an unspecified date, unknown amount of time after the first dose, the patient took the second dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication. On an unspecified date, unknown amount of time after the second dose, the patient took the third dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication. On an unspecified date, unknown amount of time after the third dose, the patient took the fourth dose of Vivotif vaccine (batch number: unknown), at an unknown dose, route, and site of administration, for unknown indication. As reported the patient took all the four doses of Vivotif but did not refrigerate it (explicitly coded as product temperature excursion issue', product storage error', product administration error'). At the time of the initial report, the patient did not experience any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A 44-year-old female patient took all the four doses of Vivotif for unknown indication, but did not refrigerate it, 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 medications 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 44-year-old female patient took all the four doses of Vivotif for unknown indication, but did not refrigerate it, 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 medications 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.