Received Feb 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8527BA | OT / RA |
| FLU4 | INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) | SANOFI PASTEUR | UNK | — | OT |
62-year-old female patient was accidentally administered the Fluzone High-Dose vaccine, rather than the Fluzone vaccine with no reported adverse event; Initial information received on 06-Feb-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 62 years old female patient to whom had accidentally administered the Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd], rather than the Influenza Quadrival A-B Vaccine [Fluzone Qiv] with no reported adverse event The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Oct-2024, the patient received a 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe (lot number U8527BA and expiry date: 01-Jun-2025) via intramuscular route in the right deltoid instead of fluzone vaccine with no reported adverse event (wrong product administered) (latency: same day). Reportedly:" At the time the Fluzone High-Dose vaccine was administered, the patient was observed for 20 minutes after getting the vaccine and experienced no adverse effects during that time. As for the reason for the error, the reporter stated that she does not know without talking to the person who administered the vaccine, but if she had to assess the reason, she would say it probably was due to user error related to inexperience, since the person who administered the Fluzone High-Dose vaccine to the patient had not often administered flu vaccines." 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.