Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8800DA | OT / LA |
fluzone hd was administered to 63 years old patient with no reported adverse event; Initial information received on 14-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 63-year-old female patient received 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), concomitant medication(s), vaccination(s), family history were not provided. On 03-Sep-2025, the patient received 0.5 ml of influenza USP trival A-B HIgh dose SUBVIRION vaccine Suspension for injection in pre-filled syringe, frequency once (strength: unknown) (batch number: U8800DA and expiry date: 30-JUN-2026) via intramuscular in Left Arm for Influenza immunization (product administered to patient of inappropriate age) (Latency same day). It was reported "that fluzone hd was administered not indicated for the patient's age". 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.