Received Oct 13, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8874AA | OT / LA |
medication error due to administration of FLUZONE HD to a 64 years old patient with no reported adverse event; Initial information received on 07-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 64 years old female patient who administered to Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Sep-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8874AA, expiry date 30-Jun-2026, strength standard and frequency once) via intramuscular route in the left deltoid for Influenza and was administerted to a 64 years old patient with no reported adverse event (product administered to patient of inappropriate age) (latency same day). Reportedly, pharmacist mentioned that they have given Fluzone Hd, the day before the patient turned 65 and wanted to check if anything needed to be done. 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.