Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | — |
The patient took one dose of unrefrigerated Vivotif with the maximum temperature of 70 degrees of Fahrenheit; The patient took one dose of unrefrigerated Vivotif with the maximum temperature of 70 degrees of Fahrenheit; The patient took one dose of unrefrigerated Vivotif with the maximum temperature of 70 degrees of Fahrenheit; Case reference number US-BN-2025-000908 is a spontaneous case initially received from other health care professional via Communication (reference number: USBAV25-1024) on 05-May-2025 and concerns a female patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 02-May-2025 the patient left Vivotif vaccine out of the unrefrigerated, with the maximum temperature of 70 degrees of Fahrenheit (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On unspecified date, the patient took one dose of Vivotif that was unrefrigerated (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 patient experienced any of adverse events due to Vivotif. No further information was provided.; Reporter's Comments: This case concerns a female patient of unspecified age, who left out Vivotif vaccine unrefrigerated, which is considered as product temperature excursion issue', and 'product storage error'. On unspecified date, as reported the patient took one dose of Vivotif that was unrefrigerated which is considered as product administration error'. At the time of initial report, it was unknown if the patient experienced any of 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 unspecified age, who left out Vivotif vaccine unrefrigerated, which is considered as product temperature excursion issue', and 'product storage error'. On unspecified date, as reported the patient took one dose of Vivotif that was unrefrigerated which is considered as product administration error'. At the time of initial report, it was unknown if the patient experienced any of 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