Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8800CA | OT |
ages of 18 64 yearswas administered the Fluzone high dose instead of the Fluzone (standard dose) with no reported adverse event; Initial information received on 25-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves Adult female patient (160 cm and 128 kg) who experienced ages of 18-64 years was administered the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose instead of the fluzone (standard dose) with no reported adverse event. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 08-Sep-2025, the patient ages of 18-64 years received 0.5ml of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine; Suspension for injection in pre-filled syringe with unknown (strength) (lot U8800CA with expiry date JUN-2026) via intramuscular route for prophylactic vaccination (Immunisation) with no reported adverse event (product administered to patient of inappropriate age). Reportedly: The nurse grabbed the vaccine from the standard dose storage cooler and fluzone standard dose box or packaging. Administered the vaccine. Nurse identified the error upon documentation when she was selecting the name of the vaccine and entering the lot number and reading that the lot number wasnt matching up and noticed the label on the syringe read high dose. She retrieved the box she had just used to pull the vaccine from and noticed another Flu high dose syringe mixed in with the rest of the standard dose vaccines in the Fluzone standard dose box/ packaging. 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.