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 took three doses of Vivotif three days in a row and one dose left; Case reference number US-BN-2024-002351 is a spontaneous case initially received from pharmacist via agency (reference number USBAV24-1977) on 15-Aug-2024 and concerns a male patient of unspecified age. The patient's medical history and concomitant medication details were not provided. On 12-Aug-2024, the patient took the first dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally, for unknown indication. On 13-Aug-2024, one day after the first dose, the patient took the second dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 14-Aug-2024, one day after the second dose, the patient took the third dose of Vivotif (batch number: 3004045), at unknown dose, or site of administration, orally. The patient did not take the fourth dose, reported as the one dose left (explicitly coded as 'Inappropriate schedule of vaccine administered'). At the time of the 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-20240815-454de1 to US-BAVARIAN NORDIC A/S-US-BN-2024-002351, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient of unspecified age took the second dose of Vivotif for unknown indication one day after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, one day after the second dose, the patient took the third dose of Vivotif and the patient did not take the fourth dose, reported as the one dose left, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication was 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 patient of unspecified age took the second dose of Vivotif for unknown indication one day after the first dose, which is considered as inappropriate schedule of vaccine administered. Reportedly, one day after the second dose, the patient took the third dose of Vivotif and the patient did not take the fourth dose, reported as the one dose left, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication was 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. USBAV24-1977:
Comments: None