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 11 Fahrenheit/ They ended up giving FLUZONE HD to patient when the vaccines were basically considered frozen with no AE; 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-2025SA311022 [master case]. This case involves a 69 years old female patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] post excursion, when fridge went below the storage limit that it got to negative 11 Fahrenheit and 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. On 15-Oct-2025, the patient received 0.5 ml dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe, lot U8855AA, expiry date not reported , strength: High Dose, Frequency: once, via unknown route in unknown administration site for Influenza [Influenza immunisation] post excursion, fridge went below the storage limit that it got to negative 11 Fahrenheit, when the vaccines were basically considered frozen with no adverse event (poor quality product administered) (latency: same day). Reportedly, 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. 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:patient 1