Report #2868410

Overview

Sex

Male

Age

8 yrs

State

—

Recovered

Unknown

Vaccinated

Oct 7, 2025

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Temperature excursion as temperature reached 25.7°F for a duration of 4 hours and 17 minutes and vaccine was administered post excursion 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 is linked to US-SA-2025SA304532 (master case). This case involves 8 years old male patient and reporter reported temperature excursion as temperature reached 25.7°f for a duration of 4 hours and 17 minutes and INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] was administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 07-Oct-2025, the patient received a dose of 0.5 ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (frequency-once, Strength: standard) (lot U8827AA, expiry date- 30-JUN-2026) via intramuscular route in left arm for Influenza prophylaxis (Influenza immunization), which had temperature excursion as temperature reached 25.7°f for a duration of 4 hours and 17 minutes and vaccine was administered post excursion with no reported adverse event (product storage error). It was reported, ''Temperature excursion occurred while vaccine was in storage prior to administration. The excursion was identified after administration of the vaccine. The temperature reached 25.7°F for a duration of 4 hours and 17 minutes. The routine temperature check at 07:30 showed temperatures were within normal limits; temperatures were not rechecked prior to pulling the vaccine for administration at 13:30. Additionally, the temperature alarm was not alarming at the time staff pulled the vaccine from the storage unit.This incident could have been avoided by: Verifying storage temperatures prior to gathering the vaccine. Having an additional monitor that would alert staff directly if the temperature was out of range (e.g., Temp Stick). No adverse event occurred after administration.''. 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-2025SA304532: