Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8764AB | OT / RA |
accidentally administered with FLUZONE HD with no reported adverse event; Initial information received on 24-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 49 years old female patient who was accidentally administered with Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone Hd] with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2025, the patient received 0.5mL of suspect Influenza Usp Trival A-B High Dose Subvirion Vaccine, Suspension for injection in pre-filled syringe (lot U8764AB, expiry date 30-Jun-2026, frequency once and strength standard) via intramuscular route in the right deltoid for Influenza and accidentally administered with fluzone hd with no reported adverse event (vaccination error) (latency same day). Reportedly, the patient was immunocompromised with Lupus and Sjogren's Syndrome taking multiple medications that suppresses the immune system who was accidentally administered with Fluzone HD. 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.