Received Oct 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
was ordered the FLUZONE HD but was inadvertently given the standard dose with no reported adverse event; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age and unknown gender patient who ordered FLUZONE HD [Influenza Vaccine Trivalent ] but administered with standard dose of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [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, the patient received an unknown dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for influenza, instead of FLUZONE HD with no reported adverse event (wrong product administered) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence. Reportedly,a patient was ordered the FLUZONE HD but was inadvertently given the standard dose. 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.