Received Mar 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | 3004008 | PO / MO |
The patient took the first dose of Vivotif on 24-Jun-2024, and the second dose on 27-Jun-2024; Case reference number US-BN-2024-002114 is a spontaneous case initially received from a nurse via agency (reference number: USBAV24-1514) on 27-Jun-2024 and concerns a 17-year-old male patient. The patient's medical history and concomitant medication details were not provided. On 24-Jun-2024, the patient took the first dose of Vivotif (batch number: 3004008, exp. date: 31-Oct-2024), at an unknown dose, orally, for indication reported as prior to travel. On 27-Jun-2024, three days after the first dose, the patient took the second dose of Vivotif (batch number: 3004008, exp. date: 31-Oct-2024), at an unknown dose, orally. As reported, the patient forgot to take yesterday's dose so was advised to take it as long as it was on an empty stomach and could wait to eat (explicitly coded as 'inappropriate schedule of vaccine administered'). As reported, the third dose was scheduled for 29-Jun-2024, and the fourth dose for 01-Jul-2024. At the time of the initial report, it was unknown if the patient experienced any adverse event due to the 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-20240627-f173d6 to US-BAVARIAN NORDIC A/S-US-BN-2024-002114, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A 17-year-old male patient forgot to take yesterday's third dose of Vivotif on scheduled day, so was advised to take it as long as it was on an empty stomach and could wait to eat, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced 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 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: A 17-year-old male patient forgot to take yesterday's third dose of Vivotif on scheduled day, so was advised to take it as long as it was on an empty stomach and could wait to eat, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced 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 has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None.