Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U8827AA | OT |
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 08-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to US-SA-2025SA303262. This case involves a 4 years old male patient (104.14 cm and 20 kg) who was administered with Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone], post excursion with maximum temperature reached: 25.7 degrees Fahrenheit 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 Influenza prophylaxis (influenza Immunization), post excursion which was exposed to maximum temperature reached 25.7 Fahrenheit degrees for 4 hours and 17 minutes, with no reported adverse event (product storage error). Reportedly, human error was involved: reason for excursion refrigerator temperature knob was accidentality turned down. The extended stability data didn't 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-2025SA303262: