definiens: means an Adverse Event / Reaction that ( i ) results in death ; ( ii ) is life - threatening ; that is, an event where the patient and/or clinical investigation subject was at risk of death at the time ofthe event and not an event that, hypothetically, might have caused death if it had been more severe ; ( iii ) requireshospitalization or prolongation of existing hospitalization ; ( iv ) results in persistent or significant disability or incapacity;(v ) is a congenital anomaly or birth defect in the fetus / child, fetal death, spontaneous abortion and serious adversereactions in the neonate ; ( vi ) involves suspected infection via a Licensed Product of an infectious agent or ( vii ) maynot be immediately life - threatening or result in death or hospitalization and may jeopardize the subject or requiremedical or surgical intervention to prevent one of the outcomes listed in ( i ) - ( vi )