Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
Patient took Vivotif four doses correctly, but all stored at room temperature range from 71-75 F for more that 24 hours; Patient took Vivotif four doses correctly, but all stored at room temperature range from 71-75 F for more that 24 hours; Case reference number US-BN-2024-002055 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV24-1364) on 13-Jun-2024 and concerns a patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified dates, the patient took first, second, third and fourth dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, patient took all four doses correctly, but all stored at room temperature for more that 24 hours and range was from 71-75 F (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-20240613-102bf2 to US-BAVARIAN NORDIC A/S-US-BN-2024-002055, in accordance with ICH guidance on WWID formatting."; Reporter's Comments: A patient of unknown age took the first, second, third and the fourth dose of Vivotif, but all stored at room temperature for more than 24 hours and range was from 71-75 F, 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 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 patient of unknown age took the first, second, third and the fourth dose of Vivotif, but all stored at room temperature for more than 24 hours and range was from 71-75 F, 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 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.