Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U88308A | OT / RA |
inappropriate use due to administration of a vaccine intended for 65+ to a 60 year old with no reported adverse event; Initial information received on 03-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 60 years old female patient to whom administration of a Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] intended for 65+ to a 60 year old with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Sep-2025, the 60 years old female patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (strength: unknown, expiry date: 01-jun-2026 and lot U88308A) via unknown route in the right deltoid for immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). 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.