Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | — | OT |
products were exposed to a temperature of -0.92 degrees Celsius and were out of range for a total of 30 minutes, due to refrigerator malfunction, these vaccines have been administered post excursion with no reported adverse event; Initial information received on 15-Oct-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to this case US-SA-2025SA309664. This case involves an unknown age and unknown gender patient who received Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] which were exposed to a temperature of -0.92 degrees Celsius and were out of range for a total of 30 minutes, due to refrigerator malfunction, these vaccines have been administered post excursion with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown dose of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot number, expiry date ad strength not reported) via unknown route in unknown administration site for Prophylactic vaccination [Immunisation] which were exposed with temperature of -0.92 degrees Celsius and were out of range for a total of 30 minutes, due to refrigerator malfunction, these vaccines have been administered post excursion with no reported adverse event (poor quality product administered) (latency: same day). Reportedly,human error was involved. At the beginning of the call the HCP [ Health care professional] stated these vaccines have been administered post excursion and is asking how to manage those doses. Notified the caller that the extended stability information does not cover an excursion of this length and/or temperature, and the dispensing of the products is no longer supported. 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-2025SA309664: