Adverse Event Reports (3))

  Cumulative Analysis of Post-authorization Adverse Event Reports (3)

 tamponade;

Cerebrovascular accident;

Change in seizure presentation;

Chest discomfort;

Child- Pugh-Turcotte score abnormal;

Child-Pugh-Turcotte score increased;

Chillblains;

Choking;

Choking sensation;

Cholangitis sclerosing;

Chronic autoimmune glomerulonephritis;

Chronic cutaneous lupus erythematosus;

Chronic fatigue syndrome;

Chronic gastritis;

Chronic inflammatory demyelinating polyradiculoneuropathy:

Chronic lymphocytic inflammation with pontine perivascular enhancement responsive to steroids;

Chronic recurrent multifocal osteomyelitis;

Chronic respiratory failure;:

Chronic spontaneous urticaria;

Circulatory collapse ;

Circumoral oedema;

Circumoral swelling:

Clinically isolated syndrome;

Clonic convulsion;

Coeliac disease:

Cogan's syndrome;

Cold agglutinins positive;

Cold type haemolytie anaemia;

Colitis;

Colitis erosive;

Colitis herpes;

Colitis microscopic;

Colitis ulcerative:

Collagen disorder;

Collagen-vascular disease ;

Complement facto r abnormal;

Complement factor Cl decreased;

Complement factor C2 decreased;

Complement factor C3 decreased;

Complement factor C4 decreased;

Complement factor decreased;

Computerised tomogram liver abnormal;

Concentric sclerosis;

Congenital anomaly;

Congenital bilateral perisylvian syndrome;

Congenital herpes simplex infection;

Congenital myasthenic syndrome;

Congenital varicella infection;

Congestive hepatopathy:

Convulsion in childhood;

Convulsions local;

Convulsive threshold lowered;

Coombs positive haemolytic anaemia;

Coronary artery disease;

Coronary artery embolism;

Coronary artery thrombosis;

Coronary bypass thrombosis;

Coronavirus infection;

Coronavirus test;

Coronavirus test negative ;

Coronavirus test positive;

Corpus callosotomy:

Cough:

Cough variant asthma;

COVID-19;

COVID-19 immunisation;

COVID-19 pneumonia;

COVID-19 prophylaxis;

COVID-19 treatment;

Cranial nerve disorder:

Cranial nerve palsies multiple;

Cranial nerve paralysis;

CREST syndrome;

Crohn's disease;

Cryofibrinogenaemia;

Cryoglobulinaemia;

CSF oligoclona l band present;

CSWS syndrome;

Cutaneous amyloidosis;

Cutaneous lupus erythematosus;

Cutaneous sarcoidosis;

Cutaneous vasculitis;

Cyanosis;

Cyclic neutropenia;

Cystitis interstitial;

Cytokine release syndrome;

Cytokine storm;

De novo purine synthesis inhibitors associated acute inflammatory syndrome;

Death neonatal;

Deep vein thrombosis;

Deep vein thrombosis postoperative;

Deficiency of bile secretion;

Deja vu;

Demyelinating polyneuropathy;

Demyelination;

Dermatitis;

Dermatitis bullous;

Dermatitis herpetiformis;

Dermatomyositis;

Device embolisation:

Device related thrombosis;

Diabetes mellitus;

Diabetic ketoacidosis;

Diabetic mastopathy;

Dialysis amyloidosis;

Dialysis membrane reaction;

Diastolic hypotension;

Diffuse vasculitis:

Digital pitting scar,

Disseminated intravascular coagulation;

Disseminated intravascular coagulation in newborn;

Disseminated neonatal herpes simplex;

Disseminated varicella;

Disseminated varicella zoster vaccine virus infection;

Disseminated varicella zoster virus infection;DNA antibody positive;

Double cortex syndrome;

Double stranded DNA antibody positive;

Dreamy state;

Dressler's syndrome;

Drop attacks;

Drug withdrawal convulsions;

Dyspnoea;

Early infantile epileptic encephalopathy with burst-suppression;

Eclampsia;

Eczema herpeticum;

Embolia cutis medicamentosa;

Embolic cerebellar infarction;

Embolic cerebral infarction ;

Embolic pneumonia;

Embolic stroke;

Embolism;

Embolism arterial;

Embolism venous;

Encephalitis;

Encephalitis allergic;

Encephalitis autoimmune; 

Encephalitis brain stem;

Encephalitis haemorrhagie;

Encephalitis periaxialis diffusa;

Encephalitis post immunisation;

Encephalomyelitis;

Encephalopathy;

Endocrine disorder; 

Endocrine ophthalmopathy;

Endotracheal intubation;

Enteritis;

Enteritis leukopenic;

Enterobacter pneumonia;

Enterocolitis;

Enteropathic spondylitis;

Eosinopenia;

Eosinophilic 

CONFIDENTIAL 

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 FDA-CBER-2021-5683-0000085