Received Mar 20, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004007 | PO / MO |
The patient took accidentally took two doses of Vivotif vaccine two days on a row, second dose on day 2, third dose on day 4 and fourth dose on day 6; Case reference number US-BN-2024-002050 is a spontaneous case report initially received from a pharmacist via Communications (reference number USBAV24-1379) on 14-Jun-2024 and concerns an 18-years-old male patient. The patient's medical history and concomitant medication details were not provided. On 07-Jun-2024, the patient took first dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally, for immunization against disease caused by Salmonella typhi. On 08-Jun-2024, one day after the first dose of Vivotif, the patient took second dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally. As reported, the patient accidentally took two doses two days on a row (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 10-Jun-2024, three days after the first dose of Vivotif, the patient took third dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally (explicitly coded as 'Inappropriate schedule of vaccine administered'). On 12-Jun-2024, five days after the first dose of Vivotif, the patient took fourth dose of Vivotif vaccine (batch number: 3004007), at an unknown dose, orally (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. Additional information received from Med Communications on 14-Jun-2024: new information included patient details, Vivotif dosing information for all four doses and additional reference number. 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-20240614-5064ec to US-BAVARIAN NORDIC A/S-US-BN-2024-002050, in accordance with ICH guidance on WWID formatting; Reporter's Comments: An 8-year-old male patient accidentally took two doses of Vivotif vaccine two days in a row, the second dose on the day 2, the third dose on the day 4 and the fourth dose on the day 6, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to the 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: An 8-year-old male patient accidentally took two doses of Vivotif vaccine two days in a row, the second dose on the day 2, the third dose on the day 4 and the fourth dose on the day 6, which is considered as inappropriate schedule of product administration. It was unknown if the patient experienced any adverse event due to the 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious. USBAV24-1380: USBAV24-1379:
Comments: None