Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3004062 | — |
Patient took Vivotif doses which were left at room temperature for a week and the maximum temperature reached 25ºC; Patient took Vivotif doses which were left at room temperature for a week and the maximum temperature reached 25ºC; Case reference number US-BN-2024-002524 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-2440) on 19-Sep-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication details were not provided. On unspecified date, reported as for a week, the patient left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees (explicitly coded as 'product storage error') On unspecified dates, the patient took the unspecified number of doses, as reported did the entire course of Vivotif (batch number: 3004062) at an unknown dose, route for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse events due to Vivotif. Additional information received from a pharmacist via Med Communication (reference number: USBAV24-2446) on 19-Sep-2024: Information included additional reference number (USBAV24-2446) and gender. 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-20240919-e84639 to US-BAVARIAN NORDIC A/S-US-BN-2024-002524, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees which is considered as product storage error. The patient took the unspecified number of doses, as reported did the entire course of Vivotif, at an unknown dose, route for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A female patient of unknown age left one box of Vivotif vaccine at room temperature and the maximum temperature reached 25 Celsius degrees which is considered as product storage error. The patient took the unspecified number of doses, as reported did the entire course of Vivotif, at an unknown dose, route for unknown indication which is considered as product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse events due to Vivotif. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.