Received Feb 5, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT |
the patient received a dose in October and then a second dose at the end of December with no reported adverse event; Initial information received on 03-Feb-2026 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown age and gender patient who had received a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] in october and then a second dose at the end of december 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 in October 2025, the patient received a dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (strength, expiry date and lot number not reported for both regimens) via unknown route in unknown administration site as . On an unknown date in December 2025, also received a dose 2 of same vaccine via unknown route in unknown administration site for prophylactic vaccination (immunization) with no reported adverse event (extra dose administered) (same day latency). Information regarding 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.