Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8855DA | OT / RA |
Max/low temperature reached: negative 7 °C to 5 °C for 4 hours and 30 minutes with no reported adverse events; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from other health professional. This case was linked with other cases US-SA-2025SA311838 and US-SA-2025SA311712. This case involves a 67 years old male patient who received influenza USP trival A-B high dose subvirion vaccine [fluzone HD] that was exposed to max/low temperature reached: negative 7 °c to 5 °c for 4 hours and 30 minutes with no reported adverse events. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-OCT-2025, the patient received 0.5 ml of suspect influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe of strength: high dose, frequency: once with lot U8855DA and expiry date 30-JUN-2026 via intramuscular route in the right deltoid for Influenza immunization. On an unknown date, the suspect influenza USP trival A-B high dose subvirion vaccine was exposed to max/low temperature reached: negative 7 °c to 5 °c for 4 hours and 30 minutes with no reported adverse events (product storage error). It was reported, "Previous excursion: No. Human error involved. Product was administered. 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-2025SA311838:02693084 US-SA-2025SA311712:02693089 US-SA-2025SA311712:master case