Report #2874325

Overview

Sex

Unknown

Age

3 yrs

State

AZ

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

medication error (unintentional)/an inappropriate use (unknown intention) due to the administration of FLUBLOK to individuals under 9 years of age with no reported adverse event; Initial information received on 17-Nov-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to US-SA-2025SA347313, US-SA-2025SA346850. This case involves a 3 years old and unknown gender patient who was administered to Influenza Trivalent Recombinant Vaccine [Flublok], 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 0.5mL of suspect Influenza Trivalent Recombinant Vaccine (lot U8823AA, expiry date 31-May-2026, frequency once and strength standard) via unknown route in unknown administration site for Immunisation, 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.; Sender's Comments: US-SA-2025SA346850: US-SA-2025SA347313: