Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The patient took all four doses of Vivotif vaccine with food and not on empty stomach; Case reference number US-BN-2024-002413 is a spontaneous case initially received from other health professional via agency (reference number USBAV24-2168) on 29-Aug-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. On unspecified dates, the patient took the first, second, third and fourth dose of Vivotif vaccine (batch number: unknown), at a dose of a capsule, orally, for typhoid immunization. As reported, the patient took all four Vivotif tablets with food and not on empty stomach (explicitly coded as 'Product administration error'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. Additional information received from agency on 29-Aug-2024, included additional reference number, dosage, and patient's and reporter's details. Additional information received from agency on 29-Aug-2024, included additional reference number. Additional information received from agency on 03-Sep-2024, included additional reference number, reporter's detail and confirmation that patient took all four doses of Vivotif with food and not on empty stomach. 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-20240829-cba95c to US-BAVARIAN NORDIC A/S-US-BN-2024-002413, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A female patient of unknown age took all four Vivotif tablets with food and not on empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication were not provided. Causality is 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 took all four Vivotif tablets with food and not on empty stomach which is considered as product administration error. Product administration error is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious. USBAV24-2168:
Comments: None