Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004299 | PO / MO |
The patient took the first dose of Vivotif that was left out of refrigeration with maximum temperature 72 Fahrenheits for six hours and Vivotif was taken two hours after a meal; The patient took the first dose of Vivotif that was left out of refrigeration with maximum temperature 72 Fahrenheits for six hours and Vivotif was taken two hours after a meal; The patient took the first dose of Vivotif that was left out of refrigeration with maximum temperature 72 Fahrenheits for six hours and Vivotif was taken two hours after a meal; Case reference number US-BN-2025-001175 is a spontaneous case initially received from a physician via Communication (reference number: USBAV25-1657) on 09-Jul-2025 and concerns a female patient of unspecified age born in 1962. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the Vivotif vaccine was left out of refrigeration with a maximum temperature of 72 Fahrenheit for six hours (explicitly coded as 'product temperature excursion issue', 'product storage error temperature too high'). On 08-Jul-2025, two hours after a meal, the patient took the first dose of Vivotif (batch number: 3004299) orally, at an unknown dose, for an unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. No further information was provided.; Reporter's Comments: A female patient born in 1962 took the first dose of Vivotif for an unknown indication, after the Vivotif vaccine was left out of refrigeration with a maximum temperature of 72 Fahrenheit for six hours, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events 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 born in 1962 took the first dose of Vivotif for an unknown indication, after the Vivotif vaccine was left out of refrigeration with a maximum temperature of 72 Fahrenheit for six hours, which is considered as product temperature excursion issue, product storage error and product administration error. It was unknown if the patient experienced any adverse events 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