Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8779LA | OT |
child pulled away in the middle of the injection so that he received only a partial dose with no reported adverse event; Initial information received on 19-Sep-2025 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 3-year-old male patient who pulled away in the middle of the injection influenza USP trival A-B subvirion no preservative vaccine [Fluzone] so that he received only a partial dose with no reported adverse. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient received no concomitant vaccines. On 17-Sep-2025, child pulled away in the middle of the Influenza USP Trival A-B Subvirion No Preservative Vaccine Suspension for injection of lot UT8779LA and expiry date: 30-Jun-2026 via intramuscular route in the lateral thigh for Immunization so that he received only a partial dose with no reported adverse event (incorrect dose administered) (latency: on same day). Reportedly, medical assistant asked also for any information related to how soon the repeat dose of FLUZONE PFS can be administered in situations where a dose is not valid. 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.