Received Oct 27, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8855DA | OT / LA |
Fluzone HD exposed to temperature excursion; Max/low temperature reached: negative 7 °C to 5 ° C, Duration: 4 hours and 30 minutes with no reported adverse event; Initial information received on 17-Oct-2025 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with US-SA-2025SA312041 (master case). This case involves a 86 years old female patient who received influenza USP TRIVAL A-B high dose subvirion vaccine [Fluzone HD] was exposed to temperature excursion where max/low temperature reached: negative 7 °c to 5 ° c for the duration: 4 hours and 30 minutes with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List of concomitant vaccines: No other vaccines On 15-Oct-2025, the patient received 0.5 ml of influenza USP TRIVAL A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe with strength- high dose (expiry date- 30-JUN-2026 and lot U8855DA) once via intramuscular route in the left deltoid for Influenza (influenza immunization) post excursion where max/low temperature reached: negative 7 °c to 5 ° c, duration: 4 hours and 30 minutes with no reported adverse event (product storage error). It was reported, "Previous Excursion: None. Human error was involved. The extended stability data cover the excursion: No" 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-2025SA312041:master case US-SA-2025SA311838:02693089 US-SA-2025SA312041:02693089