Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | UT8826LA | OT |
when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event; when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event; when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event; Initial information received on 26-Sep-2025 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (healthcare professional). This case involves a 63 year old male patient who received Influenza USP Trival A-B Subvirion No Preservative Vaccine [Fluzone] and when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect Influenza USP Trival A-B Subvirion No Preservative Vaccine standard strength, frequency -once, (lot UT8826LA and expiry date-30-Jun-2026) via unknown route in unknown administration site for Immunization when the injection was being administered the needle was not screwed on all the way and 1/3 of the vaccine was administered and the rest dripped down his arm with no reported adverse event (accidental exposure to product), (exposure via skin contact) and (incorrect dose administered) (latency-same day). 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.