Reporte zur Charge UJ73180

Symptomtext

37 year old was given FLUZONE HIGH DOSE QUADRIVALENT in error by one of her nurses with no reported adverse event; Initial information received on 24-Sep-2021 regarding an unsolicited valid non-serious case received from a other health professional and physician via Agency number: 00784104. This case involves a 37 years old female patient who was administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age). The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On 24-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number: UJ73180 and expiry date: 30-JUN-2022) via intramuscular route in the left deltoid for prophylactic vaccination. It was case of an actual medication error due to inappropriate age at vaccine administration (latency: same day). It was reported "that Nurse manager repeated the above question. She asks if the FLUZONE HIGH DOSE QUADRIVALENT vaccine is valid or should be repeated with a different flu vaccine and what AE's they should look out for". At the time of reporting, no adverse event was 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.