Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | — | OT |
Administered with (0.5 ml) and then again inadvertently administered with 1.0 ml of fluzone, with no reported adverse event.; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from other health professional. This case involves an unknown age and gender patient who was administered with (0.5 ml) and then again inadvertently administered with 1.0 ml 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 was administered with 0.5 ml and then inadvertently administered with 1ml (once) dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot number, expiry date: not reported) via unknown route in unknown administration site for Influenza (Influenza immunisation), with no reported adverse event (extra dose administered) (latency: same day). It was reported, "Caller stated that a medical assistant (MA) administered the Fluzone vaccine (0.5mL) to a patient. Then another MA came in and administered an additional FLUZONE dose. The patient got 1.0 mL of FLUZONE." Information on batch number and expiration date corresponding to the one at time of event occurrence was requested. 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.