Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 4 | 3004007 | PO / MO |
The patient received fourth dose of Vivotif on day 12; Case reference number US-BN-2024-002175 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-1609) on 09-Jul-2024 and concerns a 57-year-old male patient. The patient's medical history and concomitant medication were not provided. On 03-Jul-2024, the patient took the first dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule orally, for immunization against disease caused by salmonella typhi. On 05-Jul-2024, two days after the first dose, the patient took the second dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule, orally. On 07-Jul-2024, four days after the first dose, the patient took the third dose of Vivotif (batch number: 3004007, expiry date: 31-Oct-2024) one capsule, orally. On 15-Jul-2024, 12 days after the first dose, the patient took the fourth dose of Vivotif (batch number: 3004044, expiry date: Nov-2024) one capsule, orally (explicitly coded as 'inappropriate schedule of vaccine administered'). *At the time of follow up report, the patient did not experience any adverse event due to Vivotif*. All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from a nurse on 20-Aug-2024: New information included added patient demographic details (initials), Vivotif dosage information and updated event verbatim. Follow up information received from a nurse on 04-Sep-2024: New information included confirmation on the adverse events during the administration of Vivotif. 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-20240709-5134fc to US-BAVARIAN NORDIC A/S-US-BN-2024-002175, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 57-year-old male patient took fourth dose of Vivotif, one capsule, orally, 12 days after the first dose which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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 57-year-old male patient took fourth dose of Vivotif, one capsule, orally, 12 days after the first dose which is considered as inappropriate schedule of vaccine administered. The patient did not experience any adverse event due to Vivotif. Inappropriate schedule of product administration is considered as listed per company convention. The patient's medical history and concomitant medication 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.