Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004045 | PO / MO |
The patient received second dose of Vivotif on 25-Aug-2024 and third dose on 26-Aug-2024; Case reference number US-BN-2024-002401 is a spontaneous case initially received from a consumer via agency (reference number: USBAV24-2117) on 26-Aug-2024 and concerns a 48-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 23-Aug-2024, the patient took the first dose of Vivotif (batch number: 3004045), at an unknown dose, orally, for indication reported as protection against typhoid fever. On 25-Aug-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004045), at an unknown dose, orally. On 26-Aug-2024, three days after the first dose, the patient took the third dose of Vivotif (batch number: 3004045), at an unknown dose, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the patient took the Vivotif vaccine two days in a row thinking that the previous dose was administered on Saturday instead of Sunday. At the time of the initial report, it was unknown if the patient experienced any adverse events 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-20240826-bb6aba to US-BAVARIAN NORDIC A/S-US-BN-2024-002401, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 48-year-old female patient took the third dose of Vivotif for indication reported as protection against typhoid fever, on the day 1 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's 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 48-year-old female patient took the third dose of Vivotif for indication reported as protection against typhoid fever, on the day 1 after the second dose, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse events due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's 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.