Received Mar 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TYP | TYPHOID LIVE ORAL TY21A (VIVOTIF) | BERNA BIOTECH, LTD. | 2 | Unknown | — |
The patient took one capsule of Vivotif on Jan-2024, which was expired on Dec-2023; The patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired; Case reference number US-BN-2024-000056 is a spontaneous case report initially received from a physician via Med Communication (reference number: USBAV24-0081) on 12-Jan-2024 and concerns female patient. The patient's relevant medical history and concomitant medication details were not provided. On unspecified date in Jan-2024, the patient took the first dose of Vivotif vaccine (batch number: 3003824; expiration date: Dec-2023), at a dose reported as one capsule, administered orally, for an unknown indication (explicitly coded as 'expired vaccine used'). The patient was given a replacement that was not expired. On unspecified date, (reported as yesterday), an unknown amount of time after receiving the first dose of Vivotif, the patient took the second dose of Vivotif vaccine (batch number: unknown; expiration date: unknown), at a dose reported as one capsule, via unknown route of administration. As reported, the patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired (explicitly coded as 'extra dose administered'). At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. No further information was provided.; Reporter's Comments: A female patient took the first dose of Vivotif vaccine (expiration date: Dec-2023), at a dose reported as one capsule, administered orally, for an unknown indication on unspecified date in Jan-2024, which is considered as expired vaccine used. Reportedly, the patient took the second dose of Vivotif vaccine, at a dose reported as one capsule. As reported, the patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired, which is considered as extra dose administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Expired product administered and extra dose administered are considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and extra dose administered have 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 female patient took the first dose of Vivotif vaccine (expiration date: Dec-2023), at a dose reported as one capsule, administered orally, for an unknown indication on unspecified date in Jan-2024, which is considered as expired vaccine used. Reportedly, the patient took the second dose of Vivotif vaccine, at a dose reported as one capsule. As reported, the patient took the second dose of Vivotif with the new lot dispensed after taking one capsule of Vivotif that was expired, which is considered as extra dose administered. It was unknown if the patient experienced any adverse event due to Vivotif vaccine. Expired product administered and extra dose administered are considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Expired product administered and extra dose administered have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Comments: None