Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE HIGH-DOSE) | SANOFI PASTEUR | UNK | 66S150 | OT / LA |
stated that she noted that after the after the needle was pulled out of her arm, the liquid was coming out of the syringe with no reported ae; Initial information received on 12-Sep-2025 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 74 years old female patient who received influenza USP trival A-B high dose subvirion vaccine [Fluzone HD] and noted that after the needle was pulled out of her arm, the liquid was coming out of the syringe with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included COVID-19 VACCINE for Immunisation. On 11-Sep-2025, the patient received an unknown dose of influenza USP trival A-B high dose subvirion vaccine Suspension for injection in pre-filled syringe (strength- unknown, expiry date- 30-JUN-2026 and lot 66S150) via unknown route in the left arm for Immunization and noted that after the after the needle was pulled out of her arm, the liquid was coming out of the syringe with no reported adverse event (incorrect dose administered) (latency- same day). Reportedly, caller stated that the customer was not sure if she received the full dose and the caller would like to know if the customer could receive another dose. Clear location of the leakage was unknown. The reporter stated that their cameras do not show the area of the pharmacy where the vaccines are administered, and thus details are limited. The leakage occurred after the needle was removed from the patient's arm. The patient informed the reporter that it was a fair amount dripping from the syringe. 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.
COVID-19 VACCINE