Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The Vivotif vaccines were left out of the refrigerator for six hours and was given to five patients; The Vivotif vaccines were left out of the refrigerator for six hours and was given to five patients; Case reference number US-BN-2024-002062 is a spontaneous case initially received from a healthcare professional via Communications (reference number: USBAV24-1401) on 18-Jun-2024 and concerns five patients of unspecified age. The patients' medical history and concomitant medication details were not provided. On an unspecified date, Vivotif vaccines were left out of the refrigerator for six hours (explicitly coded as 'product storage error'). On an unspecified date, five patients took a dose of Vivotif (batch number: unknown), at an unknown dose and route of administration, for an unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if any of the patients experienced adverse event due to Vivotif vaccine. 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-20240618-999e22 to US-BAVARIAN NORDIC A/S-US-BN-2024-002062, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: Five patients of unspecified age took a dose of Vivotif, after Vivotif vaccines were left out of the refrigerator for six hours, for an unknown indication, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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: Five patients of unspecified age took a dose of Vivotif, after Vivotif vaccines were left out of the refrigerator for six hours, for an unknown indication, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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.