Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | 1 | — | OT / LA |
84 years old patient received 2 doses of fluzone hd with no reported adverse event; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 84 years old male patient who received 2 doses of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2025, the patient received dose 1 of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe dose 0.5 ml frequency once via intramuscular route (batch and expiry date unknown) in the left deltoid for influenza (Influenza immunization). On 31-Oct-2025 he also received dose 2 of same vaccine dose 0.5 ml frequency once with lot U8855CA expiry date-30-Jun-2026 via intramuscular route in the left deltoid for influenza (Influenza immunization) 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.