Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
45yr old patient received FLUZONE HD with no reported adverse event; Initial information received on 10-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 45 years old and unknown gender patient who 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), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported) via unknown route in unknown administration site for Influenza (Influenza immunisation) with no reported adverse event (product administered to patient of inappropriate age) (same day latency). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.