Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
Patient took four Vivotif doses which were not refrigerated; Patient took four Vivotif doses which were not refrigerated; Patient took four Vivotif doses which were not refrigerated; Case reference number US-BN-2025-001316 is a spontaneous case initially received from pharmacist via Med Communication (reference number: USBAV25-1821) on 25-Jul-2025 and concerns a female patient of an unspecified age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, route or site of administration for an unknown indication. On an unspecified date, an unknown amount of time from the first dose, the patient took the second dose of Vivotif (batch number: unknown) at an unknown dose, route or site of administration. On an unspecified date, an unknown amount of time from the second dose, the patient took the third dose of Vivotif (batch number: unknown) at an unknown dose, route or site of administration. On an unspecified date, an unknown amount of time from the third dose, the patient took the fourth dose of Vivotif (batch number: unknown) at an unknown dose, route or site of administration. It was reported that the patient did not keep Vivotif in the fridge at all and took all four doses (explicitly coded as 'product temperature excursion issue', 'product storage error' and 'product administration error'). At the time of initial report, it was unknown if patient experienced any adverse event due to Vivotif. No further information was provided.; Reporter's Comments: A female patient of an unspecified age did not keep Vivotif in the fridge at all and took all four doses for an unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if patient experienced any adverse event 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 unspecified age did not keep Vivotif in the fridge at all and took all four doses for an unknown indication, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if patient experienced any adverse event 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.