Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8862AA | OT / RA |
FLUZONE HD was given to a 57 year old patient with no adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 57 years old and unknown gender patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 16-Oct-2025, the patient received a dose 0.5 ml of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (strength high, lot U8862AA and expiry 30-Jun-2026) with no adverse event (product administered to patient of inappropriate age) (latency same day) via intramuscular route in the right deltoid for Influenza. Reportedly:- Nurse was instructed by their clinical service department to contact us because the FLUZONE HD was given to a 57 y/o patient which is not the recommended age. She wanted to make sure that there's no harm on the patient and if there are immediate actions to be taken 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.