Symptomtext
Another FLUZONE QUAD prefilled syringe from the box had to be used to complete dose with no reported adverse event.; vaccine started to drip out from underneath the luer lock but at the top of syringe FLUZONE QUADRIVALENT prefilled syringe caller reports that it leaked during injection with no reported adverse event.; The liquid got on the patient and on the reporting pharmacist that was injecting with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a pharmacist via Agency (Reference number- 00898016) and transmitted to Sanofi on 14-Dec-2021. This case involves an unknown demographic patient (unknown age and unknown gender) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] another dose from the box had to be used to complete dose (extra dose administered), the liquid got on the patient and on the reporting pharmacist that was injecting (exposure via skin contact) and vaccine started to drip out from underneath the luer lock but at the top of syringe fluzone quadrivalent prefilled syringe caller reports that it leaked during injection (syringe leak). The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ778AB, expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to extra dose administered, syringe issue and exposure via skin contact (latency: same day). At time of reporting, no adverse event reported. 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.