Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004298 | — |
little stomach cramping; The patient took Vivotif vaccine which was kept at maximum temperature +26,7°C for seven days; The patient took Vivotif vaccine which was kept at maximum temperature +26,7°C for seven days; The patient took Vivotif vaccine which was kept at maximum temperature +26,7°C for seven days; The patient stated there was no label on packaging to refrigerate upon receipt.,the pharmacist stated there was a label lettered REF on the bag; Case reference number US-BN-2025-001585 is a spontaneous case initially received from a nurse via Communication (reference number: USBAV25-2358) on 23-Sep-2025 and concerns a male patient of unspecified age. The patients' medical history and concomitant medication details were not provided. On an unspecified date, 1 box of Vivotif (batch number: 3004298) (NDC number 50632-016-02, Serial number 57704086588236, GTI number 00350632016024) was left out of the refrigerator on 70 to 80F, +26,7 °C(room temperature) for seven days, also reported as the first temperature excursion (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). As reported, the Vivotif vaccine, no label on the packaging to refrigerate upon receipt and was a label lettered reference (REF) on the bag (explicitly coded 'product label confusion'). On an unspecified date, the patient took the first dose of Vivotif (batch number:3004298), for an unknown dose, route, or site of administration for an unknown indication (explicitly coded as 'product administration error'). On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced little stomach cramping. At the time of initial report, it was unknown if the patient recovered from 'stomach cramps'. The reporter assessed the event 'stomach cramps' as non-serious and did not provide a causality assessment. Additional information was received from a nurse via Bavarian Nordic (reference number: BN_2025_00286) on 26-Sep-2025 and is blended into the case narrative above: Information included batch number and numbers of the vaccine packaging, additional reference number, and exact temperature excursion. Additional information was received from a nurse via Communications (reference number: USBAV25-2397) on 26-Sep-2025 included additional reference number.; Reporter's Comments: A male patient of unspecified age took the first dose of Vivotif for an unknown indication, which was left out of the refrigerator on 70 to 80F, +26,7 °C(room temperature) for seven days, also reported as the first temperature excursion, which is considered as product administration error, product storage error temperature too high and product temperature excursion issue. As reported, the Vivotif vaccine, no label on the packaging to refrigerate upon receipt and was a label lettered reference (REF) on the bag, which is considered as product label confusion. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced a non-serious event of stomach cramping. Abdominal pain upper is considered as listed and expected for Vivotif per CCDS v8 and USPI. Product temperature excursion issue, product storage error, product administration error and product label confusion are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product temperature excursion issue, product storage error, product administration error and product label confusion are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age took the first dose of Vivotif for an unknown indication, which was left out of the refrigerator on 70 to 80F, +26,7 °C(room temperature) for seven days, also reported as the first temperature excursion, which is considered as product administration error, product storage error temperature too high and product temperature excursion issue. As reported, the Vivotif vaccine, no label on the packaging to refrigerate upon receipt and was a label lettered reference (REF) on the bag, which is considered as product label confusion. On an unspecified date, an unknown amount of time after the first dose of Vivotif, the patient experienced a non-serious event of stomach cramping. Abdominal pain upper is considered as listed and expected for Vivotif per CCDS v8 and USPI. Product temperature excursion issue, product storage error, product administration error and product label confusion are considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. The outcome was unknown. Considering implied temporal relationship, known vaccine safety profile and since the contributory role of the suspect vaccine cannot be excluded, the reported event has been considered as related to Vivotif. Product temperature excursion issue, product storage error, product administration error and product label confusion are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.