Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004044 | PO / MO |
Patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80°F and then 50°F, the vaccine was outside of the refrigerator for four days; Patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80°F and then 50°F, the vaccine was outside of the refrigerator for four days; Case reference number US-BN-2024-002067 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV24-1404) on 18-Jun-2024 and concerns an unknown number of patients of unknown age and gender. The patients' medical history and concomitant medication were not provided. On unspecified dates, the patients took the first and second dose of Vivotif (batch number: 3004044) at an unknown dose, via oral use for unknown indication. As reported, patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80 Fahrenheit degrees and then 50 Fahrenheit degrees, the vaccine was outside of the refrigerator for four days (explicitly coded as 'product storage error' and 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any 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-20240618-806b86 to US-BAVARIAN NORDIC A/S-US-BN-2024-002067, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: An unknown number of patients of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported, patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80 Fahrenheit degrees and then 50 Fahrenheit degrees, the vaccine was outside of the refrigerator for four days, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication 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: An unknown number of patients of unknown age and gender took the first and the second dose of Vivotif for unknown indication. As reported, patients took two doses of Vivotif that haven't been refrigerated at all and the temperature around was 80 Fahrenheit degrees and then 50 Fahrenheit degrees, the vaccine was outside of the refrigerator for four days, which is considered as product storage error and product administration error. It was unknown if the patients experienced any adverse event due to Vivotif vaccine. Product storage error and product administration error are considered as listed per company convention. The patients' medical history and concomitant medication 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.