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 patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours.; Case reference number US-BN-2024-002865 is a spontaneous case initially received from a pharmacist via Med Communication (reference number: USBAV24-3251) on 09-Dec-2024 and concerns a 78-year-old female patient. The patient's medical history and concomitant medication details were not provided. On an unspecified dates, the patient received first, second and third dose of Vivotif (batch number: unknown), at a dose of one capsule, orally, for typhoid immunization. On an unknown date, the patient received fourth dose of Vivotif (batch number: unknown), at a dose of one capsule, orally. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours (explicitly coded as 'inappropriate schedule of vaccine administered'). 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-20241209-c13025 to US-BAVARIAN NORDIC A/S-US-BN-2024-002865, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 78-year-old female patient received the first, second and the third dose of Vivotif for typhoid immunization. On an unknown date, the patient received the fourth dose of Vivotif. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours, 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 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 78-year-old female patient received the first, second and the third dose of Vivotif for typhoid immunization. On an unknown date, the patient received the fourth dose of Vivotif. As reported, the patient received the last dose of Vivotif 96 hours after the third dose, instead of 48 hours, 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 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