Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8852MA | OT |
temperature excursion: one of the doses was administered before they found out that the vaccine should not be used with no adverse event; Initial information received on 18-Nov-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 54 years old male patient who was administered to Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] as it went under temperature excursion: one of the doses before they found out that the vaccine should not be used with no adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Nov-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B Subvirion No Preservative Vaccine, Suspension for injection (lot UT8852MA, frequency once and strength standard) (expiry date not reported) via intramuscular route in unknown administration site for Influenza immunization and temperature excursion: one of the doses was administered before they found out that the vaccine should not be used with no adverse event (poor quality product administered) (latency same day). It was reported 'Caller said that one of her coworkers called yesterday about a temperature excursion for Fluzone. She said that they were told that the vaccine is not viable and one of the doses was administered before they found out that the vaccine should not be used.' 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.