Received Mar 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | — |
One patient took three doses of Vivotif with food, other patients took only one dose with food; Case reference number US-BN-2024-002754 is a spontaneous case initially received from other healthcare professional via Med Communications (reference number: USBAV24-2938) on 07-Nov-2024 and concerns three patients of unknown age and gender (MULTI3). The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patients took Vivotif (batch number: unknown), at unknown dose, route, for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals (explicitly coded as drug administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from other healthcare professional via Med Communications (reference USBAV24-2948) on 07-Nov-2024: included reference number. 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-20241107-c8bc63 to US-BAVARIAN NORDIC A/S-US-BN-2024-002754, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: Three patients of unknown age and gender took Vivotif for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals, which is considered as drug administration error. It was unknown if the patients experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Three patients of unknown age and gender took Vivotif for unknown indication. As reported, one patient took three doses of Vivotif with food and then the final dose was done, and two patients (other members of the family) took only one dose with food then became aware it was one hour before meals, which is considered as drug administration error. It was unknown if the patients experienced any adverse event due to Vivotif. Product administration error is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product administration error is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None