Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patients took Vivotif vaccine that was never refrigerated; The patients took Vivotif vaccine that was never refrigerated; The patients took Vivotif vaccine that was never refrigerated; Case reference number US-BN-2025-000170 is a spontaneous case initially received from pharmacist via Communication (reference number: USBAV25-0211) on 29-Jan-2025 and concerns a female patient and male patient (MULTI 2). The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patients were never refrigerated Vivotif vaccine (explicitly coded as 'product storage error' and 'product temperature excursion error') On unspecified date, as reported the patients took defected very last dose of Vivotif (batch number: unknown) at unknown dose, route or site of administration for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patients experienced any adverse events due Vivotif. Additional information received from pharmacist via Communication (reference number: USBAV25-0212) on 29-Jan-2025 included demographic information of the second patient (husband).; Reporter's Comments: A female patient and male patient took defected dose of Vivotif for unknown indication, which was never refrigerated, which is considered as product storage error, product temperature excursion error and product administration error. It was unknown if the patients experienced any adverse events due Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue 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 and male patient took defected dose of Vivotif for unknown indication, which was never refrigerated, which is considered as product storage error, product temperature excursion error and product administration error. It was unknown if the patients experienced any adverse events due Vivotif. Product storage error, product temperature excursion issue and product administration error are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Product storage error, product temperature excursion issue 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