Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule was administered after excursion; Vivotif was kept at the temperature that got up to 60 degrees (unit not provided), and one capsule was administered after excursion; Case reference number US-BN-2024-002570 is a spontaneous case initially received from a consumer via Med Communications (reference number: USBAV24-2558) on 30-Sep-2024 and concerns one male and one female patient (MULTI2) of unspecified age. The patients' medical history and concomitant medication details were not provided. On an unspecified date, as reported, Vivotif vaccine was stored in a cooler, but it got up to 60 degrees (unit not provided) (explicitly coded as 'product storage error'). On an unspecified date, after temperature excursion, the patients took the first dose of Vivotif (batch number: unknown), at an unknown dose, route, for a trip (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Additional information received from the consumer via Med Communications on 30-Sep-2024 included an additional reference number (USBAV24-2559), the case is crosslinked by same reporter. Additional information received from Bavarian Nordic on 01-Oct-2024 included additional reference number (BN_2024_02995). Non-significant follow-up was downloaded from VAERS on 09-May-2025 included new reference number. Administrative update performed within the case: Worldwide Unique Case Identification Number (WWID) updated from US-20240930-bd7618 to US-BAVARIAN NORDIC A/S-US-BN-2024-002570, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: One male and one female patient of unspecified age took the first dose of Vivotif, which was stored in a cooler, but it got up to 60 degrees, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. 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: One male and one female patient of unspecified age took the first dose of Vivotif, which was stored in a cooler, but it got up to 60 degrees, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse events due to the Vivotif vaccination. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. 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