Received Nov 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8874AA | OT / LL |
patinet received expired vaccine with no reported adverse event; Initial information received on 21-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old male patient who received expired influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included influenza vaccine INACT SAG 3V (Flucelvax) for Immunisation. On 21-Nov-2025, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of standard strength frequency once with lot U8874AA and expiry date 30-Jun-2026 via intramuscular route in the left thigh for Influenza (Influenza immunisation) with no reported adverse event (expired product administered) (Latency same day). It was reported, "The patient received both dose within a span of 2 weeks. patient received 2 flu shots, 1 dose of fluzone hd and another dose of Flucelvax." 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.
FLUCELVAX