Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT |
temperature excursion: temperature reached: 25.7 f 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 other health professional. This case was linked to other case US-SA-2025SA304532 This case involves a 4 years old male patient (3.5 cm and 19.09 kg) who who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] which had temperature excursion: temperature reached: 25.7 F degrees 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 0.5mL of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot U8827AA, expiry date 30-Jun-2026, frequency once and strength standard) via intradermal route in the right arm for Immunisation and temperature excursion: temperature reached: 25.7 f degrees duration: 4 hours and 17 minutes with no reported adverse event (product storage error). Reportedly, human error occurred as refrigerator temperature knob was accidentality turned down. There was no Previous Excursion and administered post-excursion. The extended stability data did not cover the excursion; The routine check at 07:30 showed temperature within normal limits. 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:Master case