Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | UNK | 3003851 | PO / MO |
The patient took one dose of Vivotif vaccine with two different batch numbers and expiration dates on the box and on blister packaging; The patient took one dose of Vivotif vaccine with two different batch numbers and expiration dates on the box and on blister packaging; The patient took the Vivotif vaccine with expired date on Mar-2024 on the blister; Case reference number US-BN-2024-002835 is a spontaneous case initially received from a pharmacist via Med Communications (reference number: USBAV24-3193) on 03-Dec-2024 and concerns a male patient of unknown age. The patient's medical history and concomitant medication details were not provided. On 03-Dec-2024, the patient took the first dose of Vivotif (batch number (box): 3004085, Expiration date (box): Mar-2024; batch number (blister pack): 3003851; Expiration date: Mar-2024), at a dose of one capsule, orally, for indication typhoid fever prophylaxis. As reported, Vivotif vaccine was with two different batch numbers and expiration dates on the box and on blister packaging (explicitly coded as 'product administration error', 'product lot number issue' and 'expired vaccine used'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif. Additional information received from Bavarian Nordic on 04-Dec-2024 included product complaint reference number (QE-013912) and added one more reporter. 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-20241203-ed62e6 to US-BAVARIAN NORDIC A/S-US-BN-2024-002835, in accordance with ICH guidance on WWID formatting.; Reporter's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication typhoid fever prophylaxis. Reportedly, Vivotif vaccine was with two different batch numbers and expiration dates on the box and on blister packaging which is considered as product administration error, product lot number issue and expired vaccine used. Product administration error, product lot number issue and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error, product lot number issue and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A male patient of unknown age took the first dose of Vivotif, at a dose of one capsule, orally, for indication typhoid fever prophylaxis. Reportedly, Vivotif vaccine was with two different batch numbers and expiration dates on the box and on blister packaging which is considered as product administration error, product lot number issue and expired vaccine used. Product administration error, product lot number issue and expired product administered are all considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif. The patient's medical history and concomitant medication details were not provided. Product administration error, product lot number issue and expired product administered are all assessed as not related to suspect product but to human factor. The case is non-serious.
Comments: None.