Report #2880689

Overview

Sex

Unknown

Age

0.3 yrs

State

TX

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

medication error (unintentional) due to administration of FLUZONE to a 4-month-old patient with no reported adverse event; Initial information received on 31-Dec-2025 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old and unknown gender patient who had medication error (unintentional) due to administration of influenza usp trival a-b subvirion no preservative vaccine [fluzone] 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 a dose of suspect influenza usp trival a-b subvirion no preservative vaccine Suspension for injection (dose, strength, route, batch number, expiry date, administration site was unknown) as influenza with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). 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.