Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | U8527AA | OT |
administered with an expired fluzone hd vaccine with no reported advesre event; administered with an expired fluzone hd vaccine with no reported advesre event; Initial information received on 05-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 12 years old female patient who was administered with an expired influenza USP trival A-B high dose subvirion vaccine [Fluzone High Dose] with no reported advesre event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Sep-2025, the patient received 0.5 ml of dose 1 of an expired influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with standard strength (expiry date- 30-JUN-2025 and lot U8527AA) once via intramuscular route in unknown administration site for Influenza immunization with no reported adverse event (expired product administered) (product administered to patient of inappropriate age) (latency- same day). Reportedly, List of concomitant vaccines: None. Treatment: No adverse event, no treatment 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.