Reporte zur Charge UI883AB

Symptomtext

anaphylactic reaction; Initial information received on 16-Aug-2021 regarding an unsolicited valid serious case from a pharmacist via Agency (Reference number- 00726317). This case involves a patient (unknown demographics) who experienced anaphylactic reaction, while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date (2017-2018), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UI883AB and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date (2017-2018), the patient developed a serious anaphylactic reaction (unknown latency), following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. At the time of reporting, the outcome of event was reported as unknown. Information on the batch number was requested.; Sender's Comments: This case involves a patient (unknown demographics) who had anaphylactic reaction, after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of a vaccine cannot be assessed.