Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | UNKNOWN | — |
Patient took two doses of Vivotif, which have not been refrigerated; Patient took two doses of Vivotif, which have not been refrigerated; Patient took two doses of Vivotif, which have not been refrigerated; Case reference number US-BN-2025-000907 is a spontaneous case initially received from a consumer via agency (reference number: USBAV25-1023) on 05-May-2025 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient left Vivotif vaccine out of the fridge (explicitly coded as 'product storage error' and 'product temperature excursion issue'). On an unspecified date, as reported every other day the patient took two doses of Vivotif (batch number unknown) at unknown dose, route or side of administration for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: This case concerns a female patient of unknown age, who left Vivotif vaccine out of the fridge on an unspecified date, which is considered as 'product temperature excursion issue', and 'product storage error'. On unspecified date, as reported every other day, the patient took two doses of Vivotif for unknown indication, which is considered as product administration error'. At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed as per company convention. The patients' 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 unknown age, who left Vivotif vaccine out of the fridge on an unspecified date, which is considered as 'product temperature excursion issue', and 'product storage error'. On unspecified date, as reported every other day, the patient took two doses of Vivotif for unknown indication, which is considered as product administration error'. At the time of the initial report, it was unknown if patient experienced any adverse events due to Vivotif. Product temperature excursion issue, product storage error and product administration error are considered as listed as per company convention. The patients' 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