APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST

1p36 deletion syndrome;2-Hydroxyglutaric aciduria;5'nucleotidase increased;Acoustic neuritis;Acquired C1 inhibitor deficiency;Acquired epidermolysis bullosa;Acquired epileptic aphasia;Acute cutaneous lupus erythematosus;Acute disseminated encephalomyelitis;Acute encephalitis with refractory, repetitive partial seizures;Acute febrile neutrophilic dermatosis;Acute flaccid myelitis;Acute haemorrhagic leukoencephalitis;Acute haemorrhagic oedema of infancy;Acute kidney injury;Acute macular outer retinopathy;Acute motor axonal neuropathy;Acute motor-sensory axonal neuropathy;Acute myocardial infarction;Acute respiratory distress syndrome;Acute respiratory failure;Addison's disease;Administration site thrombosis;Administration site vasculitis;Adrenal thrombosis;Adverse event following immunisation;Ageusia;Agranulocytosis;Air embolism;Alanine aminotransferase abnormal;Alanine aminotransferase increased;Alcoholic seizure;Allergic bronchopulmonary mycosis;Allergic oedema;Alloimmune hepatitis;Alopecia areata;Alpers disease;Alveolar proteinosis;Ammonia abnormal;Ammonia increased;Amniotic cavity infection;Amygdalohippocampectomy;Amyloid arthropathy;Amyloidosis;Amyloidosis senile;Anaphylactic reaction;Anaphylactic shock;Anaphylactic transfusion reaction;Anaphylactoid reaction;Anaphylactoid shock;Anaphylactoid syndrome of pregnancy;Angioedema;Angiopathic neuropathy;Ankylosing spondylitis;Anosmia;Antiacetylcholine receptor antibody positive;Anti-actin antibody positive;Anti-aquaporin-4 antibody positive;Anti-basal ganglia antibody positive;Anti-cyclic citrullinated peptide antibody positive;Anti-epithelial antibody positive;Anti-erythrocyte antibody positive;Anti-exosome complex antibody positive;AntiGAD antibody negative;Anti-GAD antibody positive;Anti-ganglioside antibody positive;Antigliadin antibody positive;Anti-glomerular basement membrane antibody positive;Anti-glomerular basement membrane disease;Anti-glycyl-tRNA synthetase antibody positive;Anti-HLA antibody test positive;Anti-IA2 antibody positive;Anti-insulin antibody increased;Anti-insulin antibody positive;Anti-insulin receptor antibody increased;Antiinsulin receptor antibody positive;Anti-interferon antibody negative;Anti-interferon antibody positive;Anti-islet cell antibody positive;Antimitochondrial antibody positive;Anti-muscle specific kinase antibody positive;Anti-myelin-associated glycoprotein antibodies positive;Anti-myelin-associated glycoprotein associated polyneuropathy;Antimyocardial antibody positive;Anti-neuronal antibody positive;Antineutrophil cytoplasmic antibody increased;Antineutrophil cytoplasmic antibody positive;Anti-neutrophil cytoplasmic antibody positive vasculitis;Anti-NMDA antibody positive;Antinuclear antibody increased;Antinuclear antibody positive;Antiphospholipid antibodies positive;Antiphospholipid syndrome;Anti-platelet antibody positive;Anti-prothrombin antibody positive;Antiribosomal P antibody positive;Anti-RNA polymerase III antibody positive;Anti-saccharomyces cerevisiae antibody test positive;Anti-sperm antibody positive;Anti-SRP antibody positive;Antisynthetase syndrome;Anti-thyroid antibody positive;Anti-transglutaminase antibody increased;Anti-VGCC antibody positive;AntiVGKC antibody positive;Anti-vimentin antibody positive;Antiviral prophylaxis;Antiviral treatment;Anti-zinc transporter 8 antibody positive;Aortic embolus;Aortic thrombosis;Aortitis;Aplasia pure red cell;Aplastic anaemia;Application site thrombosis;Application site vasculitis;Arrhythmia;Arterial bypass occlusion;Arterial bypass thrombosis;Arterial thrombosis;Arteriovenous fistula thrombosis;Arteriovenous graft site stenosis;Arteriovenous graft thrombosis;Arteritis;Arteritis Page 30 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000083 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 2 coronary;Arthralgia;Arthritis;Arthritis enteropathic;Ascites;Aseptic cavernous sinus thrombosis;Aspartate aminotransferase abnormal;Aspartate aminotransferase increased;Aspartate-glutamate-transporter deficiency;AST to platelet ratio index increased;AST/ALT ratio abnormal;Asthma;Asymptomatic COVID19;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 disease;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 syndrome;Brachiocephalic vein thrombosis;Brain stem embolism;Brain stem thrombosis;Bromosulphthalein test abnormal;Bronchial oedema;Bronchitis;Bronchitis mycoplasmal;Bronchitis viral;Bronchopulmonary aspergillosis allergic;Bronchospasm;BuddChiari 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 insufficiency;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 artery embolism;Cerebral artery thrombosis;Cerebral gas embolism;Cerebral microembolism;Cerebral septic infarct;Cerebral thrombosis;Cerebral venous sinus thrombosis;Cerebral venous thrombosis;Cerebrospinal thrombotic Page 31 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000084 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 3 tamponade;Cerebrovascular accident;Change in seizure presentation;Chest discomfort;ChildPugh-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 haemolytic anaemia;Colitis;Colitis erosive;Colitis herpes;Colitis microscopic;Colitis ulcerative;Collagen disorder;Collagen-vascular disease;Complement factor abnormal;Complement factor C1 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 oligoclonal 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 haemorrhagic;Encephalitis periaxialis diffusa;Encephalitis post immunisation;Encephalomyelitis;Encephalopathy;Endocrine disorder;Endocrine ophthalmopathy;Endotracheal intubation;Enteritis;Enteritis leukopenic;Enterobacter pneumonia;Enterocolitis;Enteropathic spondylitis;Eosinopenia;Eosinophilic Page 32 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000085 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 4 fasciitis;Eosinophilic granulomatosis with polyangiitis;Eosinophilic oesophagitis;Epidermolysis;Epilepsy;Epilepsy surgery;Epilepsy with myoclonic-atonic seizures;Epileptic aura;Epileptic psychosis;Erythema;Erythema induratum;Erythema multiforme;Erythema nodosum;Evans syndrome;Exanthema subitum;Expanded disability status scale score decreased;Expanded disability status scale score increased;Exposure to communicable disease;Exposure to SARS-CoV-2;Eye oedema;Eye pruritus;Eye swelling;Eyelid oedema;Face oedema;Facial paralysis;Facial paresis;Faciobrachial dystonic seizure;Fat embolism;Febrile convulsion;Febrile infection-related epilepsy syndrome;Febrile neutropenia;Felty's syndrome;Femoral artery embolism;Fibrillary glomerulonephritis;Fibromyalgia;Flushing;Foaming at mouth;Focal cortical resection;Focal dyscognitive seizures;Foetal distress syndrome;Foetal placental thrombosis;Foetor hepaticus;Foreign body embolism;Frontal lobe epilepsy;Fulminant type 1 diabetes mellitus;Galactose elimination capacity test abnormal;Galactose elimination capacity test decreased;Gamma-glutamyltransferase abnormal;Gamma-glutamyltransferase increased;Gastritis herpes;Gastrointestinal amyloidosis;Gelastic seizure;Generalised onset non-motor seizure;Generalised tonic-clonic seizure;Genital herpes;Genital herpes simplex;Genital herpes zoster;Giant cell arteritis;Glomerulonephritis;Glomerulonephritis membranoproliferative;Glomerulonephritis membranous;Glomerulonephritis rapidly progressive;Glossopharyngeal nerve paralysis;Glucose transporter type 1 deficiency syndrome;Glutamate dehydrogenase increased;Glycocholic acid increased;GM2 gangliosidosis;Goodpasture's syndrome;Graft thrombosis;Granulocytopenia;Granulocytopenia neonatal;Granulomatosis with polyangiitis;Granulomatous dermatitis;Grey matter heterotopia;Guanase increased;GuillainBarre syndrome;Haemolytic anaemia;Haemophagocytic lymphohistiocytosis;Haemorrhage;Haemorrhagic ascites;Haemorrhagic disorder;Haemorrhagic pneumonia;Haemorrhagic varicella syndrome;Haemorrhagic vasculitis;Hantavirus pulmonary infection;Hashimoto's encephalopathy;Hashitoxicosis;Hemimegalencephaly;Henoch-Schonlein purpura;HenochSchonlein purpura nephritis;Hepaplastin abnormal;Hepaplastin decreased;Heparin-induced thrombocytopenia;Hepatic amyloidosis;Hepatic artery embolism;Hepatic artery flow decreased;Hepatic artery thrombosis;Hepatic enzyme abnormal;Hepatic enzyme decreased;Hepatic enzyme increased;Hepatic fibrosis marker abnormal;Hepatic fibrosis marker increased;Hepatic function abnormal;Hepatic hydrothorax;Hepatic hypertrophy;Hepatic hypoperfusion;Hepatic lymphocytic infiltration;Hepatic mass;Hepatic pain;Hepatic sequestration;Hepatic vascular resistance increased;Hepatic vascular thrombosis;Hepatic vein embolism;Hepatic vein thrombosis;Hepatic venous pressure gradient abnormal;Hepatic venous pressure gradient increased;Hepatitis;Hepatobiliary scan abnormal;Hepatomegaly;Hepatosplenomegaly;Hereditary angioedema with C1 esterase inhibitor deficiency;Herpes dermatitis;Herpes gestationis;Herpes oesophagitis;Herpes ophthalmic;Herpes pharyngitis;Herpes sepsis;Herpes simplex;Herpes simplex cervicitis;Herpes simplex colitis;Herpes simplex encephalitis;Herpes simplex gastritis;Herpes simplex hepatitis;Herpes simplex meningitis;