Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
prepared two fluzone hd doses instead of the regular fluzone with no reported adverse event; Initial information received on 09-Oct-2025 regarding an unsolicited non-valid non-serious case received from a other health professional. This case involves 2 patients for whom as reporter prepared two INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] doses instead of the regular fluzone with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, 2 patients received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (strength, dose, batch and expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) and reporter prepared two fluzone HD instead of the regular fluzone with no reported adverse event (product preparation error) (same day latency). It was reported "Caller stated that two patient's had called in wanting to get their flu vaccine and gave him their date of birth, but he did the math wrong in his head.Caller stated that he prepared two FLUZONE HD doses instead of the regular FLUZONE" Action taken- 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.