Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8827AA | OT |
fluzone trivalent(unopened) refrigerator temperature knob was accidentality turned down/ max temperature reached: 25.7f degrees for 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 is linked to this case US-SA-2025SA303262. This case involves a 3 years old male patient (107.2 cm and 17.69 kg) who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], post excursion with maximum temperature reached: 25.7 Fahrenheit degrees for 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 dose of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection, lot U8827AA, expiry date:30-Jun-2026, frequency: once, strength :standard via unknown route in the left arm for Immunization, post excursion were exposed with maximum temperature reached: 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event (product storage error). Reportedly, there was no previous excursion. Human error was involved. The product was administered post-excursion. The extended stability data did not cover the excursion. Temperature excursion during vaccine storage. The excursion was identified after the vaccine had already been administered. Routine temperature check at 07:30 showed normal limits. Vaccine was pulled for administration at 13:30, but temperatures were not rechecked. Temperature alarm was not alarming when the vaccine was retrieved. 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-2025SA303262: