Adverse Event Reports (2)

 Cumulative Analysis of Post-authorization Adverse Event Reports (2)

coronary:

Arthralgia; 

Arthritis; 

Arthritis enteropathic:

Ascites; 

Aseptic cavernous sinus thrombosis;

Aspartate aminotransferase abnormal:

Aspartate aminotransferase increased;

 Aspartate-glutamate-transporter deficieney;

AST to platelet ratio index increased:

AST/ALT ratio abnormal; 

Asthma; 

Asymptomatic COVID- 19;

Ataxia;

Atheroembolism; 

Atonic seizures; 

Atrial thrombosis;

Atrophic thyroiditis; 

Atypical benign partial epilepsy:

Atypical pneumonia; 

Aura; 

Autoantibody positive;

Autoimmune anaemia;

Autoimmune aplastic anaemia;

Autoimmune arthritis;

Autoimmune blistering disease;

Autoimmune cholangitis;

Autoimmune colitis;

Autoimmune demyelinating disease; 

Autoimmune dermatitis;

Autoimmune disorder;

Autoimmune encephalopathy;

Autoimmune endocrine disorder; 

Autoimmune enteropathy; 

Autoimmune eye disorder; 

Autoimmune haemolytic anaemia;

Autoimmune heparin-induced thrombocytopenia;

 Autoimmune hepatitis;

Autoimmune hyperlipidaemia;

Autoimmune hypothyroidism;

Autoimmune inner ear disease; 

Autoimmune lung disease; 

Autoimmune lymphoproliferative syndrome; 

Autoimmune myocarditis;

Autoimmune myositis;

Autoimmune nephritis;

Autoimmune neuropathy;

Autoimmune neutropenia;

 Autoimmune pancreatitis:

Autoimmune pancytopenia;

 Autoimmune pericarditis:

Autoimmune retinopathy;

 Autoimmune thyroid disorder;

 Autoimmune thyroiditis;

Autoimmune uveitis;

Autoinflammation with infantile enterocolitis; 

Autoinflammatory disease;

 Automatism epileptic:

Autonomic nervous system imbalance; 

Autonomic seizure;

Axial spondyloarthritis;

Axillary vein thrombosis;

Axonal and demyelinating polyneuropathy: 

Axonal neuropathy;

Bacterascites;

Baltic myoclonic epilepsy;

Band sensation;

Basedow's discase;

Basilar artery thrombosis;

Basophilopenia;

B-cell aplasia;

Behcet's syndrome;

Benign ethnic neutropenia;

Benign familial neonatal convulsions;

Benign familial pemphigus;

Benign rolandic epilepsy;

Beta-2 glycoprotein antibody positive;

Bickerstaff's encephalitis;

Bile output abnormal;

Bile output decreased;

Biliary ascites;

Bilirubin conjugated abnormal;

Bilirubin conjugated increased;

Bilirubin urine present;

Biopsy liver abnormal;

Biotinidase deficiency :

Birdshot chorioretinopathy:

Blood alkaline phosphatase abnormal;

Blood alkaline phosphatase increased;

Blood bilirubin abnormal;

Blood bilirubin increased;

Blood bilirubin unconjugated increased;

Blood cholinesterase abnormal;

Blood cholinesterase decreased;

Blood pressure decreased;

Blood pressure diastolic decreased;

Blood pressure systolic decreased;

Blue toe syndr ome;

 Brachiocephalic vein thrombosis;

Brain stem embolism;

Brain stem thrombosis;

Bromosulphthalein test abnormal;

Bronchial oedema;

Bronchitis;

Bronchitis mycoplasmal;

Bronchitis viral;

Bronchopulmonary aspergillosis allergic;

Bronchospasm;

Budd- Chiari syndrome:

Bulbar palsy;

Butterfly rash;

C1q nephropathy:

Caesarean section; 

Calcium embolism;

Capillaritis;

Caplan's syndrome;

Cardiac amyloidosis;

Cardiac arrest;

Cardiac failure;

Cardiac failure acute;

Cardiac sarcoidosis;

Cardiac ventricular thrombosis;

Cardiogenic shock;

Cardiolipin antibody positive;

Cardiopulmonary failure;

Cardio-respiratory arrest;

Cardio-respiratory distress;

Cardiovascular insufficieney ;

Carotid arterial embolus;

Carotid artery thrombosis;

Cataplexy;

Catheter site thrombosis:

Catheter site vasculitis: 

Cavernous sinus thrombosis; 

CDKL5 deficiency disorder;

CEC syndrome;

Cement embolism; 

Central nervous system lupus; 

Central nervous system vasculitis; 

Cerebellar artery thrombosis;

Cerebellar embolism; 

Cerebral amyloid angiopathy:

Cerebral arteritis;

Cerebral a rtery embolism;

Cerebral artery thrombosis;

Cerebral gas embolism;

Cerebral microembolism;

Cerebral septic infarct;

Cerebral thrombosis;

Cerebral venous sinus thrombosis;

Cerebral venous thrombosis;

Cerebrospinal thrombotic 

CONFIDENTIAL 

Page 2

 FDA-CBER-2021-5683-0000084 BNT16262