Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | UT8820CA | OT |
administering FLUZONE HD to a patient who has already received a high-dose flu shot with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who was administering fluzone hd and has already received a high-dose flu shot with no reported adverse event The patient's past vaccination(s) included FLUZONE HIGH DOSE on 28-JUL-2025. The patient's past medical history, medical treatment(s) and family history were not provided. On 20-Sep-2025, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe by another pharmacist (lot UT8820CA, Expiry date: 30-Jun-2026, dose, strength, route, administration site (extra dose administered; latency: same day). 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.