Received Feb 9, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | UT7683FA | — |
due to two administrations of FLUZONE HD within a single season to one patient, 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 a 71 years old male patient who received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] in a single season with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 30-Sep-2025 he also received a Dose 1of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, Suspension for injection in pre-filled syringe (lot UT7683FA and expiry 30-Jun-2026) (dose, strength, route, lot, expiry and administration site: unknown) and on 16-Dec-2025, patient received dose 2, 0.5 ml (lot UT8794DA, expiry 30-Jun-2026and strength: unknown) via intramuscular route in the left deltoid with no adverse event (extra dose administered) (latency same day) for immunization. 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.