Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | Unknown | PO / MO |
Sinus infection; Case reference number US-BN-2024-002045 is a spontaneous case initially received from a consumer via Communication (reference number: USBAV24-1331) on 11-Jun-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication were not provided. On an unspecified date, the patient took a dose of Vivotif (batch number: unknown) at an unknown dose, via oral use for unknown indication. As reported, the patient completed the dosing with Vivotif. On an unspecified date, unknown amount of time after the dose of Vivotif, the patient had sinus infection and needs to begin a round of antibiotics for a sinus infection. At the time of the initial report, the outcome of the event sinus infection was unknown. The reporter assessed seriousness for the event sinus infection as non-serious and assessed the causality as possible for the event sinus infection. 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-20240611-2d1f95 to US-BAVARIAN NORDIC A/S-US-BN-2024-002045, in accordance with ICH guidance on WWID formatting; Reporter's Comments: A male patient of unknown age had a non-serious event of sinus infection an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Sinusitis is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication were not provided. The outcome of the event sinus infection was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as non-serious.; Sender's Comments: A male patient of unknown age had a non-serious event of sinus infection an unknown amount of time after the patient took a dose of Vivotif for unknown indication. Sinusitis is unlisted and unexpected for Vivotif according to the CCDS v8 and USPI. The patient's medical history and concomitant medication were not provided. The outcome of the event sinus infection was unknown. Considering implied temporal relationship and since the contributory role of the suspect vaccine cannot be excluded with certainty, the reported event has been considered as related to Vivotif. This case is considered as non-serious.
Comments: None.