Report #2885900

Overview

Sex

Unknown

Age

Age unknown

State

FL

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

this situation is pre-assessed as a medication error an inappropriate use (unknown intention) due to administration of fluzone hd to a patient less than 65 years of age with no adverse event; Initial information received on 16-Feb-2026 regarding an unsolicited valid non-serious case received from a nurse. This case involves less than 65 years of age patient to whom INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] was administered 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 less than 65 years of age received unknown dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe) with no adverse event (product administered to patient of inappropriate age) (latency: same day) (lot number and expiry date not reported) via unknown route in unknown administration site for Influenza. Information regarding batch number corresponding to the one at a time of event occurrence was requested. It was reported "He said the patient's age is less than the age approved in the product labeling. Nurse wanted to know if there are any adverse events they should look out for." 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.