Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 3 | 3004045 | PO / MO |
The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and felt weird; The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and felt weird; The patient took two doses of Vivotif on the same day (one own dose and one dose of husband) and felt weird; Case reference number US-BN-2024-002548 is a spontaneous case initially received from a nurse via Med Communications (reference number: USBAV24-2513) on 25-Sep-2024 and concerns a 71-year-old female patient. The patient's medical history and concomitant medication details were not provided. On 22-Sep-2024, the patient took the first dose of Vivotif (batch number: 3004045, expiry date: 30-Nov-2024), at a dose of one capsule, orally as, for indication reported as for pre-travel. On 24-Sep-2024, two days after the first dose, the patient took the second and third dose of Vivotif (batch number: 3004045, expiry date: 30-Nov-2024) at an unknown dose, orally. As reported, the patient took own dose and husband's dose of Vivotif, as the patient was worried to get typhoid (explicitly coded as 'vaccine overdose' and 'inappropriate schedule of vaccine administered'). On the same day, the patient felt weird. At the time of the initial report, the patient did not recover from the event of felt weird, reported as ongoing. The reporter assessed the event of felt weird as non-serious and not related to the product 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-20240925-2d0872 to US-BAVARIAN NORDIC A/S-US-BN-2024-002548, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 71-year-old female patient took own dose and husband's dose of Vivotif for indication reported as for pre-travel, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. Reportedly, on the day 0 after the vaccination, the patient felt weird. Feeling abnormal, underdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of feeling abnormal is assessed as related to Vivotif. Underdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 71-year-old female patient took own dose and husband's dose of Vivotif for indication reported as for pre-travel, which is considered as vaccine overdose and inappropriate schedule of vaccine administered. Reportedly, on the day 0 after the vaccination, the patient felt weird. Feeling abnormal, underdose and inappropriate schedule of product administration are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. The patient did not recover from the event. Considering suggestive temporal relationship and since the contributory role of the suspect vaccine cannot be excluded, the event of feeling abnormal is assessed as related to Vivotif. Underdose and inappropriate schedule of product administration are not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.