Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | Unknown | PO / MO |
The patient took two doses of Vivotif vaccine which were left out of the refrigerator at room temperature since 08-Aug-2024 to 13-Aug-2024; The patient took two doses of Vivotif vaccine which were left out of the refrigerator at room temperature since 08-Aug-2024 to 13-Aug-2024; Case reference number US-BN-2024-002345 is a spontaneous case initially received from a pharmacist via agency (reference number USBAV24-1965) on 14-Aug-2024 and concerns a patient of unknown demographics. The patient's medical history and concomitant medication details were not provided. As reported, the doses of Vivotif were left out of the refrigerator at room temperature since 08-Aug-2024 when patient picked up vaccines from the pharmacy until 13-Aug-2024 (explicitly coded as 'product storage error'). On unspecified date, the patient took the first dose of Vivotif (batch number: unknown), at a dose of capsule, orally for typhoid immunization. As reported, the pharmacist think that the patient took the first dose of Vivotif while it was still refrigerated. On unspecified date, unknown amount of time after first dose of Vivotif, the patient took the affected second dose of Vivotif (batch number: unknown), at a dose of capsule, orally (explicitly coded as 'product administration error'). On unspecified date, unknown amount of time after second dose of Vivotif, the patient took the affected third dose of Vivotif (batch number: unknown), at a dose of capsule, orally (explicitly coded as 'product administration error'). As reported, the pharmacist think that the patient took the second and third dose of Vivotif when vaccines were not refrigerated. At the time of the initial report, it was unknown if the patient experienced any adverse events 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-20240814-b3694b to US-BAVARIAN NORDIC A/S-US-BN-2024-002345, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A patient of unknown demographics took the affected second and third dose of Vivotif, which were left out of the refrigerator at room temperature since 08-Aug-2024 when patient picked up vaccines from the pharmacy until 13-Aug-2024, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events 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 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 demographics took the affected second and third dose of Vivotif, which were left out of the refrigerator at room temperature since 08-Aug-2024 when patient picked up vaccines from the pharmacy until 13-Aug-2024, which is considered as product storage error and product administration error. It was unknown if the patient experienced any adverse events 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 are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1965:
Comments: None