Received Dec 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| YF | YELLOW FEVER (YF-VAX) | SANOFI PASTEUR | UNK | UK125AA | OT / LA |
administration of an expired product with no reported adverse event; Initial information received on 08-Dec-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 52 years old male patient who had administration of an expired YELLOW FEVER VACCINE - US [YF-VAX] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Dec-2025, the patient received an expired 0.5 ml dose of suspect YELLOW FEVER VACCINE - Solution for injection (lot UK125AA, expiry: 31-Oct-2025, Strength: Standard) via subcutaneous route in the left arm as immunization with no reported adverse event (expired product administered) (Latency: same day). It was reported, "Reporter is asking if they expiration date has been extended, or if they should revaccinate. No Treatment, patient is still at the facility. No other immunizations with suspect." Action taken: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.