Report #2867770

Overview

Sex

Female

Age

15 yrs

State

—

Recovered

Unknown

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (2)

Symptom narrative

temperature excursion occurred while vaccine was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event; Initial information received on 16-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 15 years old female patient (160 cm and 53.97 kg) who was to receive Influenza USP Trival A-B Subvirion No Preservative Vaccine that had temperature excursion occurred while it was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes 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, a dose of 0.5ml of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection (lot U8827AA and expiry date-30-Jun-2026) (strength-unknown) via intramuscular route in unknown administration site for Prophylactic vaccination (Immunisation) had temperature excursion occurred while it was in storage prior to administartion, temperature reached 25.7 f degrees duration: 4 hours and 17minutes with no reported adverse event (product storage error) (unknown latency). 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.