Received Mar 18, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | PO / MO |
The female patient took the third dose, and the male patient took the second dose of Vivotif on the following day, without the 48-hour gap; Case reference number US-BN-2025-001455 is a spontaneous case initially received from a pharmacist via agency (reference number: USBAV25-2124) on 25-Aug-2025 and concerns a male and female patients with unspecified ages (MULTI 2). The patients medical history and concomitant medication details were not provided. On an unspecified date, the female patient took the first Vivotif capsule (batch number: unknown) at an unknown dose, orally, for an unknown indication. On an unspecified date, 48 hours after the first dose, the female patient took the second Vivotif capsule (batch number: unknown) at an unknown dose, orally. On an unspecified date, an unknown amount of time from the first dose, reported as the following day from the second dose, without 48-hour gap, a female patient took the third Vivotif capsule (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of product administration'). On an unspecified date, the male patient took the first Vivotif capsule (batch number: unknown) at an unknown dose, orally, for an unknown indication. On an unspecified date, reported as the following day from the first dose, without a 48-hour gap, the male patient took the second Vivotif capsule (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of product administration'). At the time of the initial report, it was unknown if the patients experienced any adverse events due to Vivotif. Additional information received from a pharmacist via agency (reference number: USBAV25-2128) on 25-Aug-25. New information included: dosing information for male patient.; Reporter's Comments: A male and a female patient with unspecified age took a dose of Vivotif for an unknown indication, without 48-hour gap after the previous dose, which is considered as inappropriate schedule of product administration. It was unknown if the patients experienced any adverse events due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male and a female patient with unspecified age took a dose of Vivotif for an unknown indication, without 48-hour gap after the previous dose, which is considered as inappropriate schedule of product administration. It was unknown if the patients experienced any adverse events due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patients' medical history and concomitant medication details were not provided. Inappropriate schedule of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: NONE