Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | Unknown | PO / MO |
The female patient took the third dose nine days after the first dose of VIviotif, and the male patient took the second dose three days after first dose, the fourth dose five days after first dose and the fourth dose nine days after first dose; Case reference number US-BN-2024-002832 is a spontaneous case report initially received from nurse via Med Communication (reference number: USBAV24-3188) on 03-Dec-2024 concerns a female patient born in 1976 and male patient born in 1977. The patients relevant medical history and concomitant medications were not provided. On 22-Nov-2024, both the patients took first dose of Vivotif (batch number: unknown) at an unknown dose, orally, for an unknown indication. On 24-Nov-2024, two days after the first dose, the female patient took second dose of Vivotif (batch number: unknown) at an unknown dose, orally. On 25-Nov-2024, three days after the first dose, the male patient took second dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 27-Nov-2024, five days after the first dose, the male patient took third dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). On 01-Dec-2024, nine days after the first dose, the female patient took the third dose and male patient took the fourth dose of Vivotif (batch number: unknown) at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patients messed up their schedule because of the holidays. At the time of initial report, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. Additional information received from a nurse via Med Communications on 03-Dec-2024 included: reference number (EUBAV24-3190) and demographic information for male patient. 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-20241203-b96f08 to US-BAVARIAN NORDIC A/S-US-BN-2024-002832, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: This case concerns a female patient born in 1976 and male patient born in 1977. Three days after the first dose, the male patient took second dose of Vivotif, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose, the male patient took third dose of Vivotif, at an unknown dose, orally which is also considered as inappropriate schedule of vaccine administered. Nine days after the first dose, the female patient took the third dose and male patient took the fourth dose of Vivotif which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. The patients relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: This case concerns a female patient born in 1976 and male patient born in 1977. Three days after the first dose, the male patient took second dose of Vivotif, at an unknown dose, orally which is considered as inappropriate schedule of vaccine administered. Five days after the first dose, the male patient took third dose of Vivotif, at an unknown dose, orally which is also considered as inappropriate schedule of vaccine administered. Nine days after the first dose, the female patient took the third dose and male patient took the fourth dose of Vivotif which is also considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown if the patients experienced any adverse events due to Vivotif vaccine. The patients relevant medical history and concomitant medications were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None