Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 1 | Unknown | PO / MO |
Patient took first dose of Vivotif on empty stomach, ended up vomiting about an hour after taking it; Case reference number US-BN-2024-002054 is a spontaneous case initially received from a pharmacist via Communication (reference number: USBAV24-1398) on 17-Jun-2024 and concerns a female patient of unknown age. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient took the first dose of Vivotif (batch number: unknown) at an unknown dose, orally for typhoid Immunization. On an unspecified date, reported as about an hour after taking first dose of Vivotif on empty stomach, patient ended up vomiting. As reported, it turned up that patient vomited the full capsule. At the time of the initial report, it was unknown if the patient recovered from vomiting. The reporter assessed the seriousness for the event vomiting as non-serious and assessed the causality as possible for the event vomiting. 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-20240617-ddeacb to US-BAVARIAN NORDIC A/S-US-BN-2024-002054, in accordance with ICH guidance on WWID formatting; Reporter's Comments: A female patient of unknown age ended up vomiting about an hour after taking first dose of Vivotif on empty stomach. Vomiting is listed and expected according to CCDS v8 and USPI. The outcome was unknown. Causality is assessed as related due to suggestive temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.; Sender's Comments: A female patient of unknown age ended up vomiting about an hour after taking first dose of Vivotif on empty stomach. Vomiting is listed and expected according to CCDS v8 and USPI. The outcome was unknown. Causality is assessed as related due to suggestive temporal relationship, known product safety profile and since contributory role of suspect product cannot be excluded. The case is non-serious.
Comments: None.