Received Nov 6, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8415KA | OT / RA |
patient received an accidental dose of the 2024-2025 FLUZONE vaccine with no adverse event; Initial information received on 28-Oct-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case was linked with other case US-SA-2025SA323293. This case involves a 55 years old female patient who received an accidental dose of the 2024-2025 influenza USP trival A-B subvirion NO preservative vaccine [Fluzone] vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Oct-2025, the patient received 0.5 ml of suspect influenza USP trival A-B Subvirion No Preservative Vaccine Suspension for injection of standard strength frequency once with lot UT8415KA and expiry date 30-jun-2025 via intramuscular route in the right deltoid for Influenza immunization of 2024-2025 with no adverse event (expired product administered) (Latency same day). It was reported, "mentioned that they had 2 employees that received an accidental dose of the 2024-2025 fluzone vaccine" 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-2025SA323293: