Reporte zur Charge UJ9330AA

Symptomtext

57 year old patient received the FLUZONE HIGH-DOSE QIV vaccine, with no reported adverse event; Initial information received on 20-Jan-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional. This case involves a 57-year-old female patient who received the INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT], with no reported adverse event. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Diabetes mellitus and Hypertension, but not immunocompromised. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation. On 20-Jan-2023, the patient received 0.7ml total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation: unknown) (lot number: UJ9330AA and expiry date: 30-Jun-2023) via intramuscular route in the right deltoid for Immunization and a 57-year-old patient received the fluzone high-dose qiv vaccine, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day). It was reported, the caller is requesting recommendations and further guidance and requesting validity and safety information. Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable. At time of reporting, the outcome was Unknown. 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.