Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8855AA | OT |
fridge went below the storage limit that it got to negative 11F and ended up giving FLUZONE HD to a patient when the vaccines were basically considered frozen with no 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 US-SA-2025SA311022 (master case). This case involves 78 years old female patient and reporter reported fridge went below the storage limit that it got to negative 11f and ended up giving Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] to a patient when the vaccines were basically considered frozen with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. List concomitant or ''no other immunizations'': no other immunizations On 15-Oct-2025, the patient received a dose of 0.5 ml once of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (strength- high dose) (lot U8855AA) (unknown expiry date) via unknown route in unknown administration site for Influenza (Influenza immunization); for which fridge went below the storage limit that it got to negative 11f and ended up giving fluzone HD to a patient when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency- same day). It was reported, ''Office manager called because their fridge went below the storage limit that it got to negative 11F. They ended up giving FLUZONE HD to 8 patients when the vaccines were basically considered frozen. She asked if the patients will experience adverse reactions. No Treatment was received''. 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-2025SA311022:master case