Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | — |
The patient took the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; The patient took the first dose of Vivotif which was kept on 75 degrees Fahrenheit for five days; Case reference number US-BN-2024-002900 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3313) on 17-Dec-2024 and concerns a patient of unknown age and gender. The patient's medical history and concomitant medication details were not provided. On 16-Dec-2024, the patient took the first dose of Vivotif (batch number: unknown), at unknown dose, route, site of administration for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days (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 due to Vivotif. 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-20241217-5e9542 to US-BAVARIAN NORDIC A/S-US-BN-2024-002900, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown age and gender took the first dose of Vivotif for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A patient of unknown age and gender took the first dose of Vivotif for an unknown indication. As reported, the patient took the Vivotif dose which was kept on 75 degrees Fahrenheit for five days, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse event due to 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.