Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8440AA | OT |
patient received expired dose with no reported adverse event; Initial information received on 13-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age female patient who received expired dose of influenza trivalent recombinant vaccine [flublok TIV] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Oct-2025, the patient received 0.5 ml of suspect influenza trivalent recombinant vaccine Solution for injection of standard strength, frequency once with lot U8440AA and expiry date 30-APR-2025 via intramuscular route in the arm NOS (Not otherwise specified) with no reported adverse event (Expired product administered) (Latency same day). Action taken was 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.