Reporte zur Charge UT7378NA, UT737

Symptomtext

administered expired vaccination - with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves Adult and unknown gender patient who administered expired vaccination - with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor. On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, prefilled syringe (strength: unknown) lot UT7378NA, UT7376JA via intramuscular route in unknown administration site as prophylactic vaccination. On an unknown date the patient was administered expired vaccination - with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. There were no lab data/results available. The company suspect product was inappropriately used as per local Marketing authorization. Intentions were no. Action taken was not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event 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.