Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
Technician administered product incorrectly, seeking guidance in how to move forward with no reported adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient with unknown age and gender who was administered to Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] by technician incorrectly, seeking guidance in how to move forward 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, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation) and technician administered product incorrectly, seeking guidance in how to move forward with no reported adverse event (wrong technique in product usage process) (latency same day). Information on the batch number was requested corresponding to the one at time of event occurrence. 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.