Report #2861950

Overview

Sex

Female

Age

13 yrs

State

VA

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

administration of fluzone hd to pediatric patient with no reported ae; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 13 years old female patient who had administration of Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] 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 13 year old patient received a dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine Suspension for injection in pre-filled syringe once (lot U8837AA, expiry: 30-Jun-2026) via unknown route in unknown administration site as immunization with no reported ae (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. Sender's comment: Still using product : No