Report #2871969

Overview

Sex

Unknown

Age

60 yrs

State

TX

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

fluzone hd was given to a patient whose age is not approved for the vaccine with no adverse event; Initial information received on 04-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 60 years old received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with standard strength (expiry date- 30-JUN-2026 and lot U8855CA) once via intramuscular route in the left deltoid for Influenza (Influenza immunization) with no adverse event (product administered to patient of inappropriate age) (same day latency). 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.