Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
The patient took Vivotif vaccine which was taken out of the fridge for the first dose back then, it was never placed in the fridge, subsequent doses were not refrigerated; The patient took Vivotif vaccine which was taken out of the fridge for the first dose back then, it was never placed in the fridge, subsequent doses were not refrigerated; The patient took Vivotif vaccine which was taken out of the fridge for the first dose back then, it was never placed in the fridge, subsequent doses were not refrigerated; Case reference number US-BN-2025-000220 is a spontaneous case initially received from a physician via Communication (reference number: USBAV-25-0335) on 13-Feb-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On unspecified date, two and two and a half years ago, the patient took the first dose of Vivotif (batch number: unknown) orally, at unknown dose and for unknown indication. As reported the product was taken out of the fridge for the first dose back then, it was never placed back in the fridged, the subsequent doses were not refrigerated (explicitly coded as 'product storage error' and 'product temperature excursion issue') On an unspecified date, unknown of time after first dose of Vivotif, the patient took an unspecified number of doses of Vivotif (batch number: unknown) at unknown dose, orally (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any of adverse events due Vivotif. No further information was provided.; Reporter's Comments: A female patient of unspecified age took the first dose of Vivotif. orally, at unknown dose and for unknown indication. Reportedly, the product was taken out of the fridge for the first dose back then, it was never placed back in the fridge and the subsequent doses were not refrigerated which is considered as product storage error and product temperature excursion issue. Unknown time after first dose of Vivotif, the patient took an unspecified number of doses of Vivotif at unknown dose, orally which is considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unspecified age took the first dose of Vivotif. orally, at unknown dose and for unknown indication. Reportedly, the product was taken out of the fridge for the first dose back then, it was never placed back in the fridge and the subsequent doses were not refrigerated which is considered as product storage error and product temperature excursion issue. Unknown time after first dose of Vivotif, the patient took an unspecified number of doses of Vivotif at unknown dose, orally which is considered as product administration error. Product administration error, product storage error and product temperature excursion issue are all considered listed per company conventions. At this point, it was unknown if the patient experienced any of adverse events due Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error, product storage error and product temperature excursion issue are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: NONE