Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
patient received 2 doses of fluzone hd in the same season with no reported adverse event; Initial information received on 07-Nov-2025 regarding an unsolicited valid non-serious case received from a patient. This case involves a 79 years old female patient who received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] in the same season with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 28-Oct-2025 the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (dose, batch and expiry date unknown) via unknown route in unknown administration site for Influenza (Influenza immunization). On 07-Nov-2025, the patient again received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE dose 0.5 ml 1x(once) lot UT8781DA expiry date-30-Jun-2026 via intramuscular route in the left upper arm for Influenza (Influenza immunization) in the same season with no reported adverse event (extra dose administered) (latency same day). 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.