Received Feb 25, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | U889BA | OT / RA |
medication error (unintentional)/an inappropriate use (unknown intention) due to inadvertent administration of a second FLUZONE NP dose to a patient with no reported adverse event; Initial information received on 21-Feb-2026 regarding an unsolicited valid non-serious case received from a physician. This case involves a 15-year-old male patient who was inadvertently administrated with second INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE] dose to a patient with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 13-Jan-2026 he also received a dose of 0.5ml of vaccine (lot number U889BA and expiry date- 30-JUN-2026) via intramuscular route in the right deltoid and On 13-Feb-2026, the patient inadvertently received an extra dose of 0.5ml of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE Suspension for injection (lot number and expiry date not reported) via intramuscular route in the right deltoid for Influenza (extra dose administered) (latency-one month). 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.