Report #2871443

Overview

Sex

Unknown

Age

0.4 yrs

State

IN

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

medication error (unintentional) due to a patient younger than indicated population receiving the immunization with no reported adverse event; Initial information received on 31-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 months old and unknown gender patient who was unintentionally administered Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] who was younger than indicated population 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 Subvirion No Preservative Vaccine, Suspension for injection (unknown formulation, strength and expiry date) lot number not reported via unknown route in unknown administration site for influenza immunisation, younger than indicated population with no reported adverse event (product use issue) (latency Same day). There will be no information on batch number and expiration date corresponding to the one at time of event occurrence. 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.