Report #2899749

Overview

Sex

Unknown

Age

Age unknown

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

administering fluzone high-dose (hd) outside of its intended age indication, including use in patients below age 65 with no reported adverse event; Initial information received on 28-May-2026 regarding an unsolicited valid non-serious case received from a non-healthcare professional (consumer). This case involves a 62-year-old patient of unknown gender who experienced an event administration of quadrivalent influenza vaccine (Fluzone High-Dose) outside of its intended age indication, including use in patients below age 65 with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s), family history, and concomitant medications were not provided. On an unknown date, 62 years patient started taking quadrivalent influenza vaccine suspension for injection (strength, dose, route, batch number and expiry date and administration site: unknown) for prophylactic vaccination (Product administered to patient of inappropriate age) (latency: same day). No adverse event was reported. 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.