Patient’s initials:

    Check the adequate box below:

    THE ADVERSE REACTION DETERMINED:

    the patient’s deathdisability/ significant or long-lasting incapacityjeopardized the patient’s lifeanomaly/ congenital malformationhospitalization/prolonged hospitalizationother medically important condition


    YESNO


    YESNO


    YESNO


    YESNO


    YESNO


    YESNO


    * all fields are compulsory