Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | unknown | PO / MO |
Vivotif vaccine was out for more than 24 hours before administration, one patient had 4 doses, and second patient had 3 doses that were unfrigerated; Vivotif vaccine was out for more than 24 hours before administration, one patient had 4 doses, and second patient had 3 doses that were unfrigerated; Vivotif vaccine was out for more than 24 hours before administration, one patient had 4 doses, and second patient had 3 doses that were unfrigerated; Case reference number US-BN-2025-000293 is a spontaneous case initially received from other health care professional via Communication (reference number: USBAV25-0450) on 27-Feb-2025 and concerns a two male, child patients with unspecified ages (MULTI 2). The patients' medical history and concomitant medication details were not provided. On an unspecified date, two boxes of the Vivotif vaccine were left out more than 24 hours, before administrated (explicitly coded as 'product storage error' and 'product temperature excursion issue') On unspecified dates, the first one patent took three doses, and second one patient took four doses of Vivotif (batch number: unknown) orally, at unknown dose for unknown indication (explicitly coded as 'product administration error'). At the time of the initial report, it was unknown if the patients experienced any of adverse events due Vivotif. Additional information received from other health care professional via Communication (reference number: USBAV25-0452) on 27-Feb-2025: New information included patient details for second patient.; Reporter's Comments: Two male child patients with unspecified age took doses of Vivotif for unknown indication, which was left out more than 24 hours before administrated, which is considered as product administration error, product storage error and product temperature excursion issue. It was unknown if the patients experienced any of adverse events due Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Two male child patients with unspecified age born took doses of Vivotif for unknown indication, which was left out more than 24 hours before administrated, which is considered as product administration error, product storage error and product temperature excursion issue. It was unknown if the patients experienced any of adverse events due Vivotif. Product storage error, product administration error and product temperature excursion issue are considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Product storage error, product administration error and product temperature excursion issue are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE