Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | U8837DA | OT / LA |
FLUZONE HD injection that was administered inappropriate use due to potential subcutaneous administration, with no reported adverse event; Initial information received on 23-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 years old female patient as INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HD] injection that was administered inappropriate use due to potential subcutaneous administration, with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 22-Sep-2025, the patient received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE dose 0.5 ml 1x(Once) Suspension for injection in pre-filled syringe (strength unknown) lot U8837DA expiry date-30-Jun-2026 via subcutaneous route in the left arm for immunization inappropriate use due to potential subcutaneous administration, with no reported adverse event (incorrect route of product administration) (same day latency). Action taken- 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.