Report #2858010

Overview

Sex

Unknown

Age

37 yrs

State

MI

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

fluzone hd off label used in adult pt of 37 year old pt with no reported adverse event; Initial information received on 08-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 37 years old adult patient with an unknown gender who was received with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] as off label use at younger age group with no reported 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 an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Influenza as off label use at younger age group with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). Information on the batch number was requested corresponding to the one at time of event occurrence Reportedly, Pharmacist wanted to know if the dose must be repeated 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.