Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | unknown | — |
Patient stated that he can feel a difference when he took Vivotif and obviously he had some reaction.; The patient took Vivotif that stayed out of the fridge for a few days, at temperature 65 Fahrenheits; The patient took Vivotif that stayed out of the fridge for a few days, at temperature 65 Fahrenheits; The patient took Vivotif that stayed out of the fridge for a few days, at temperature 65 Fahrenheits; Case reference number US-BN-2025-000371 is a spontaneous case initially received from consumer via Communication (reference number: USBAV25-0582) on 14-Mar-2025 and concerns a 56-year-old, male patient. The patient's medical history and concomitant medication details were not provided. On 11-Mar-2025, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, route or site of administration for unknown indication. On 13-Mar-2025, two days after the patient took first dose, the patient took second dose of Vivotif (batch number: unknown), at unknown dose, route or site of administration for unknown indication. The vaccines were not refrigerated they stayed out for a few days, temperature was like 65 Fahrenheits (explicity coded as 'Product administration error', 'Product storage error temperature too high' and 'Product temperature excursion issue'). On unspecified date, the patient stated that he can feel a difference when he took Vivotif and obviously he had some reaction. At the time of the initial report, it was unknown if the patient recovered from the event 'adverse event NOS'. The reporter assessed the event 'adverse event NOS' as non-serious and related to the Vivotif. No further information was provided.; Reporter's Comments: A 56-year-old male patient took the first and the second dose of Vivotif for unknown indication. Reportedly, the vaccines were not refrigerated as they stayed out for a few days, temperature was like 65 Fahrenheits, which is considered as product administration error, product storage error temperature too high and product temperature excursion issue. On unspecified date, the patient experienced a non-serious adverse event. Adverse event, product administration error, product storage error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product administration error, product storage error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 56-year-old male patient took the first and the second dose of Vivotif for unknown indication. Reportedly, the vaccines were not refrigerated as they stayed out for a few days, temperature was like 65 Fahrenheits, which is considered as product administration error, product storage error temperature too high and product temperature excursion issue. On unspecified date, the patient experienced a non-serious adverse event. Adverse event, product administration error, product storage error and product temperature excursion issue are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The outcome was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product administration error, product storage error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE