Report #2863535

Overview

Sex

Unknown

Age

5 yrs

State

OK

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

administered FLUBLOK to a five-year-old patient with no adverse event; Initial information received on 02-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old and unknown gender patient who was administered Influenza Trivalent Recombinant Vaccine [Flublok Tiv] 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 of 5 years old received a dose of suspect Influenza Trivalent Recombinant Vaccine Solution for injection (lot number, strength, dose and expiry not reported) via unknown route in unknown administration site as immunization with no adverse event (product administered to patient of inappropriate age) (latency: same day). 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.