Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | 3004043 | — |
Patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose of Vivotif; Patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose of Vivotif; Case reference number US-BN-2024-002083 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV24-1443) on 21-Jun-2024 and concerns female patient of unknown age. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: 3004043) at an unknown dose, route for unknown indication. As reported, patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose; three doses exposed to lack of refrigeration (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event Vivotif. Additional information received from a nurse via Communication (reference number: (USBAV24-1444) on 21-Jun-2024: included added reporter details, event verbatim and confirmation on Vivotif dosage information, confirmation on patient gender and additional reference number (USBAV24-1444). Additional information received from a nurse via Communication (reference number: (USBAV24-1442) on 21-Jun-2024: included additional reference number (USBAV24-1442). Additional information received from a health care professional via Communication (reference number: (USBAV24-1449) on 26-Jun-2024: included additional reference number (USBAV24-1449). 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-20240621-17d81d to US-BAVARIAN NORDIC A/S-US-BN-2024-002083, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took the first dose of Vivotif for unknown indication. As reported, patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose; three doses exposed to lack of refrigeration, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event Vivotif. 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 storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took the first dose of Vivotif for unknown indication. As reported, patient left Vivotif out of refrigeration for approximately two and a half to three hours and had taken one dose; three doses exposed to lack of refrigeration, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event Vivotif. 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 storage error and product administration error have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.