Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The patient took two doses of Vivotif capsules which was kept at room temperature; The patient took two doses of Vivotif capsules which was kept at room temperature; The patient took two doses of Vivotif capsules which was kept at room temperature; Case reference number US-BN-2024-002889 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3309) on 16-Dec-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On an unspecified date, the patient didn't know they were supposed to refrigerate four capsules of Vivotif vaccine and was kept at room temperature (explicitly coded as 'product storage error temperature too high' and 'product temperature excursion issue'). On unspecified date, patient received first and second doses of defected Vivotif vaccine (batch number: unknown), at a dose of one capsule, orally, for unknown indication (explicitly coded as 'product administration error'). At the time of initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. 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-20241217-16b285 to US-BAVARIAN NORDIC A/S-US-BN-2024-002889, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient of unknown age didn't know they were supposed to refrigerate four capsules of Vivotif vaccine and was kept at room temperature which is considered as product storage error temperature too high and product temperature excursion issue. On unspecified date, patient received first and second doses of defected Vivotif vaccine, at a dose of one capsule, orally, for unknown indication which is considered as product administration error. Product temperature excursion issue, product storage error and product administration error are all considered listed per company conventions. 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 details were not provided. Product temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age didn't know they were supposed to refrigerate four capsules of Vivotif vaccine and was kept at room temperature which is considered as product storage error temperature too high and product temperature excursion issue. On unspecified date, patient received first and second doses of defected Vivotif vaccine, at a dose of one capsule, orally, for unknown indication which is considered as product administration error. Product temperature excursion issue, product storage error and product administration error are all considered listed per company conventions. 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 details were not provided. Product temperature excursion issue, product storage error and product administration error are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None