Reporte zur Charge UH478AC

Symptomtext

pericarditis; Initial information regarding an unsolicited valid serious case was received from a other healthcare professional via Agency (Reference number- 00438099) and transmitted to Sanofi on 20-Jan-2021. This case involves patient (unknown demographics) who experienced pericarditis, while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE]. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot number: UH478AC and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious pericarditis (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This event was assessed as medically significant. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. The event outcome was unknown for pericarditis.; Sender's Comments: The patient (unknown demographics) who presented with pericarditis after vaccination with FLUZONE. The time to onset is unknown. Medical history, concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon reported information role of vaccine cannot be assessed.