Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT |
patient received Fluzone post temperature excursion; Max temperature reached: 25.7F DEGREES; Duration: 4 hours and 17 minutes 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 was linked with US-SA-2025SA304532 (master case). This case involves a 9 years old male patient (140.97 cm and 38.55 kg) who received influenza USP TRIVAL A-B subvirion no preservative vaccine [Fluzone] post temperature excursion where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes 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 0.5 ml of influenza USP TRIVAL A-B subvirion no preservative vaccine Suspension for injection (strength- unknown, expiry date- 30-JUN-2026 and lot U8827AA) once via intramuscular route in unknown administration site for influenza prophylaxis (Influenza immunization) post temperature excursion where max temperature reached: 25.7f degrees for the duration: 4 hours and 17 minutes with no reported adverse event (product storage error). It was reported that, 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 degrees duration: 4 hours and 17 minutes. The routine temperature check at 07:30 showed temps 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, and by having an additional monitor that would alert staff directly if the temperature was out of range ie. Temp stick. Reason: refrigerator temperature knob was accidentality turned down. There was no Previous Excursion. Human error was involved. The extended stability data did not cover the excursion. 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: