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;
Herpes simplex meningoencephalitis;Herpes simplex meningomyelitis;Herpes simplex necrotising retinopathy;Herpes simplex oesophagitis;Herpes simplex otitis externa;Herpes simplex pharyngitis;Herpes simplex pneumonia;Herpes simplex reactivation;Herpes simplex sepsis;Herpes simplex viraemia;Herpes simplex virus conjunctivitis neonatal;Herpes simplex visceral;Herpes virus Page 33 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000086 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 5 infection;Herpes zoster;Herpes zoster cutaneous disseminated;Herpes zoster infection neurological;Herpes zoster meningitis;Herpes zoster meningoencephalitis;Herpes zoster meningomyelitis;Herpes zoster meningoradiculitis;Herpes zoster necrotising retinopathy;Herpes zoster oticus;Herpes zoster pharyngitis;Herpes zoster reactivation;Herpetic radiculopathy;Histone antibody positive;Hoigne's syndrome;Human herpesvirus 6 encephalitis;Human herpesvirus 6 infection;Human herpesvirus 6 infection reactivation;Human herpesvirus 7 infection;Human herpesvirus 8 infection;Hyperammonaemia;Hyperbilirubinaemia;Hypercholia;Hypergammaglobulinaemia benign monoclonal;Hyperglycaemic seizure;Hypersensitivity;Hypersensitivity vasculitis;Hyperthyroidism;Hypertransaminasaemia;Hyperventilation;Hypoalbuminaemia;H ypocalcaemic seizure;Hypogammaglobulinaemia;Hypoglossal nerve paralysis;Hypoglossal nerve paresis;Hypoglycaemic seizure;Hyponatraemic seizure;Hypotension;Hypotensive crisis;Hypothenar hammer syndrome;Hypothyroidism;Hypoxia;Idiopathic CD4 lymphocytopenia;Idiopathic generalised epilepsy;Idiopathic interstitial pneumonia;Idiopathic neutropenia;Idiopathic pulmonary fibrosis;IgA nephropathy;IgM nephropathy;IIIrd nerve paralysis;IIIrd nerve paresis;Iliac artery embolism;Immune thrombocytopenia;Immunemediated adverse reaction;Immune-mediated cholangitis;Immune-mediated cholestasis;Immune-mediated cytopenia;Immune-mediated encephalitis;Immune-mediated encephalopathy;Immune-mediated endocrinopathy;Immune-mediated enterocolitis;Immunemediated gastritis;Immune-mediated hepatic disorder;Immune-mediated hepatitis;Immunemediated hyperthyroidism;Immune-mediated hypothyroidism;Immune-mediated myocarditis;Immune-mediated myositis;Immune-mediated nephritis;Immune-mediated neuropathy;Immune-mediated pancreatitis;Immune-mediated pneumonitis;Immune-mediated renal disorder;Immune-mediated thyroiditis;Immune-mediated uveitis;Immunoglobulin G4 related disease;Immunoglobulins abnormal;Implant site thrombosis;Inclusion body myositis;Infantile genetic agranulocytosis;Infantile spasms;Infected vasculitis;Infective thrombosis;Inflammation;Inflammatory bowel disease;Infusion site thrombosis;Infusion site vasculitis;Injection site thrombosis;Injection site urticaria;Injection site vasculitis;Instillation site thrombosis;Insulin autoimmune syndrome;Interstitial granulomatous dermatitis;Interstitial lung disease;Intracardiac mass;Intracardiac thrombus;Intracranial pressure increased;Intrapericardial thrombosis;Intrinsic factor antibody abnormal;Intrinsic factor antibody positive;IPEX syndrome;Irregular breathing;IRVAN syndrome;IVth nerve paralysis;IVth nerve paresis;JC polyomavirus test positive;JC virus CSF test positive;Jeavons syndrome;Jugular vein embolism;Jugular vein thrombosis;Juvenile idiopathic arthritis;Juvenile myoclonic epilepsy;Juvenile polymyositis;Juvenile psoriatic arthritis;Juvenile spondyloarthritis;Kaposi sarcoma inflammatory cytokine syndrome;Kawasaki's disease;Kayser-Fleischer ring;Keratoderma blenorrhagica;Ketosisprone diabetes mellitus;Kounis syndrome;Lafora's myoclonic epilepsy;Lambl's excrescences;Laryngeal dyspnoea;Laryngeal oedema;Laryngeal rheumatoid arthritis;Laryngospasm;Laryngotracheal oedema;Latent autoimmune diabetes in adults;LE cells present;Lemierre syndrome;Lennox-Gastaut syndrome;Leucine aminopeptidase increased;Leukoencephalomyelitis;Leukoencephalopathy;Leukopenia;Leukopenia neonatal;Lewis-Sumner syndrome;Lhermitte's sign;Lichen planopilaris;Lichen planus;Lichen sclerosus;Limbic encephalitis;Linear IgA disease;Lip oedema;Lip swelling;Liver function test abnormal;Liver function test decreased;Liver function test increased;Liver induration;Liver injury;Liver iron concentration abnormal;Liver iron concentration Page 34 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000087 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 6 increased;Liver opacity;Liver palpable;Liver sarcoidosis;Liver scan abnormal;Liver tenderness;Low birth weight baby;Lower respiratory tract herpes infection;Lower respiratory tract infection;Lower respiratory tract infection viral;Lung abscess;Lupoid hepatic cirrhosis;Lupus cystitis;Lupus encephalitis;Lupus endocarditis;Lupus enteritis;Lupus hepatitis;Lupus myocarditis;Lupus myositis;Lupus nephritis;Lupus pancreatitis;Lupus pleurisy;Lupus pneumonitis;Lupus vasculitis;Lupus-like syndrome;Lymphocytic hypophysitis;Lymphocytopenia neonatal;Lymphopenia;MAGIC syndrome;Magnetic resonance imaging liver abnormal;Magnetic resonance proton density fat fraction measurement;Mahler sign;Manufacturing laboratory analytical testing issue;Manufacturing materials issue;Manufacturing production issue;Marburg's variant multiple sclerosis;Marchiafava-Bignami disease;Marine Lenhart syndrome;Mastocytic enterocolitis;Maternal exposure during pregnancy;Medical device site thrombosis;Medical device site vasculitis;MELAS syndrome;Meningitis;Meningitis aseptic;Meningitis herpes;Meningoencephalitis herpes simplex neonatal;Meningoencephalitis herpetic;Meningomyelitis herpes;MERS-CoV test;MERS-CoV test negative;MERS-CoV test positive;Mesangioproliferative glomerulonephritis;Mesenteric artery embolism;Mesenteric artery thrombosis;Mesenteric vein thrombosis;Metapneumovirus infection;Metastatic cutaneous Crohn's disease;Metastatic pulmonary embolism;Microangiopathy;Microembolism;Microscopic polyangiitis;Middle East respiratory syndrome;Migraine-triggered seizure;Miliary pneumonia;Miller Fisher syndrome;Mitochondrial aspartate aminotransferase increased;Mixed connective tissue disease;Model for end stage liver disease score abnormal;Model for end stage liver disease score increased;Molar ratio of total branched-chain amino acid to tyrosine;Molybdenum cofactor deficiency;Monocytopenia;Mononeuritis;Mononeuropathy multiplex;Morphoea;Morvan syndrome;Mouth swelling;Moyamoya disease;Multifocal motor neuropathy;Multiple organ dysfunction syndrome;Multiple sclerosis;Multiple sclerosis relapse;Multiple sclerosis relapse prophylaxis;Multiple subpial transection;Multisystem inflammatory syndrome in children;Muscular sarcoidosis;Myasthenia gravis;Myasthenia gravis crisis;Myasthenia gravis neonatal;Myasthenic syndrome;Myelitis;Myelitis transverse;Myocardial infarction;Myocarditis;Myocarditis post infection;Myoclonic epilepsy;Myoclonic epilepsy and ragged-red fibres;Myokymia;Myositis;Narcolepsy;Nasal herpes;Nasal obstruction;Necrotising herpetic retinopathy;Neonatal Crohn's disease;Neonatal epileptic seizure;Neonatal lupus erythematosus;Neonatal mucocutaneous herpes simplex;Neonatal pneumonia;Neonatal seizure;Nephritis;Nephrogenic systemic fibrosis;Neuralgic amyotrophy;Neuritis;Neuritis cranial;Neuromyelitis optica pseudo relapse;Neuromyelitis optica spectrum disorder;Neuromyotonia;Neuronal neuropathy;Neuropathy peripheral;Neuropathy, ataxia, retinitis pigmentosa syndrome;Neuropsychiatric lupus;Neurosarcoidosis;Neutropenia;Neutropenia neonatal;Neutropenic colitis;Neutropenic infection;Neutropenic sepsis;Nodular rash;Nodular vasculitis;Noninfectious myelitis;Noninfective encephalitis;Noninfective encephalomyelitis;Noninfective oophoritis;Obstetrical pulmonary embolism;Occupational exposure to communicable disease;Occupational exposure to SARS-CoV-2;Ocular hyperaemia;Ocular myasthenia;Ocular pemphigoid;Ocular sarcoidosis;Ocular vasculitis;Oculofacial paralysis;Oedema;Oedema blister;Oedema due to hepatic disease;Oedema mouth;Oesophageal achalasia;Ophthalmic artery thrombosis;Ophthalmic herpes simplex;Ophthalmic herpes zoster;Ophthalmic vein thrombosis;Optic neuritis;Optic Page 35 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000088 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 7 neuropathy;Optic perineuritis;Oral herpes;Oral lichen planus;Oropharyngeal oedema;Oropharyngeal spasm;Oropharyngeal swelling;Osmotic demyelination syndrome;Ovarian vein thrombosis;Overlap syndrome;Paediatric autoimmune neuropsychiatric disorders associated with streptococcal infection;Paget-Schroetter syndrome;Palindromic rheumatism;Palisaded neutrophilic granulomatous dermatitis;Palmoplantar keratoderma;Palpable purpura;Pancreatitis;Panencephalitis;Papillophlebitis;Paracancerous pneumonia;Paradoxical embolism;Parainfluenzae viral laryngotracheobronchitis;Paraneoplastic dermatomyositis;Paraneoplastic pemphigus;Paraneoplastic thrombosis;Paresis cranial nerve;Parietal cell antibody positive;Paroxysmal nocturnal haemoglobinuria;Partial seizures;Partial seizures with secondary generalisation;Patient isolation;Pelvic venous thrombosis;Pemphigoid;Pemphigus;Penile vein thrombosis;Pericarditis;Pericarditis lupus;Perihepatic discomfort;Periorbital oedema;Periorbital swelling;Peripheral artery thrombosis;Peripheral embolism;Peripheral ischaemia;Peripheral vein thrombus extension;Periportal oedema;Peritoneal fluid protein abnormal;Peritoneal fluid protein decreased;Peritoneal fluid protein increased;Peritonitis lupus;Pernicious anaemia;Petit mal epilepsy;Pharyngeal oedema;Pharyngeal swelling;Pityriasis lichenoides et varioliformis acuta;Placenta praevia;Pleuroparenchymal fibroelastosis;Pneumobilia;Pneumonia;Pneumonia adenoviral;Pneumonia cytomegaloviral;Pneumonia herpes viral;Pneumonia influenzal;Pneumonia measles;Pneumonia mycoplasmal;Pneumonia necrotising;Pneumonia parainfluenzae viral;Pneumonia respiratory syncytial viral;Pneumonia viral;POEMS syndrome;Polyarteritis nodosa;Polyarthritis;Polychondritis;Polyglandular autoimmune syndrome type I;Polyglandular autoimmune syndrome type II;Polyglandular autoimmune syndrome type III;Polyglandular disorder;Polymicrogyria;Polymyalgia rheumatica;Polymyositis;Polyneuropathy;Polyneuropathy idiopathic progressive;Portal pyaemia;Portal vein embolism;Portal vein flow decreased;Portal vein pressure increased;Portal vein thrombosis;Portosplenomesenteric venous thrombosis;Post procedural hypotension;Post procedural pneumonia;Post procedural pulmonary embolism;Post stroke epilepsy;Post stroke seizure;Post thrombotic retinopathy;Post thrombotic syndrome;Post viral fatigue syndrome;Postictal headache;Postictal paralysis;Postictal psychosis;Postictal state;Postoperative respiratory distress;Postoperative respiratory failure;Postoperative thrombosis;Postpartum thrombosis;Postpartum venous thrombosis;Postpericardiotomy syndrome;Post-traumatic epilepsy;Postural orthostatic tachycardia syndrome;Precerebral artery thrombosis;Pre-eclampsia;Preictal state;Premature labour;Premature menopause;Primary amyloidosis;Primary biliary cholangitis;Primary progressive multiple sclerosis;Procedural shock;Proctitis herpes;Proctitis ulcerative;Product availability issue;Product distribution issue;Product supply issue;Progressive facial hemiatrophy;Progressive multifocal leukoencephalopathy;Progressive multiple sclerosis;Progressive relapsing multiple sclerosis;Prosthetic cardiac valve thrombosis;Pruritus;Pruritus allergic;Pseudovasculitis;Psoriasis;Psoriatic arthropathy;Pulmonary amyloidosis;Pulmonary artery thrombosis;Pulmonary embolism;Pulmonary fibrosis;Pulmonary haemorrhage;Pulmonary microemboli;Pulmonary oil microembolism;Pulmonary renal syndrome;Pulmonary sarcoidosis;Pulmonary sepsis;Pulmonary thrombosis;Pulmonary tumour thrombotic microangiopathy;Pulmonary vasculitis;
Pulmonary veno-occlusive disease;Pulmonary venous thrombosis;Pyoderma gangrenosum;Pyostomatitis vegetans;Pyrexia;Quarantine;Radiation leukopenia;Radiculitis Page 36 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000089 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 8 brachial;Radiologically isolated syndrome;Rash;Rash erythematous;Rash pruritic;Rasmussen encephalitis;Raynaud's phenomenon;Reactive capillary endothelial proliferation;Relapsing multiple sclerosis;Relapsing-remitting multiple sclerosis;Renal amyloidosis;Renal arteritis;Renal artery thrombosis;Renal embolism;Renal failure;Renal vascular thrombosis;Renal vasculitis;Renal vein embolism;Renal vein thrombosis;Respiratory arrest;Respiratory disorder;Respiratory distress;Respiratory failure;Respiratory paralysis;Respiratory syncytial virus bronchiolitis;Respiratory syncytial virus bronchitis;Retinal artery embolism;Retinal artery occlusion;Retinal artery thrombosis;Retinal vascular thrombosis;Retinal vasculitis;Retinal vein occlusion;Retinal vein thrombosis;Retinol binding protein decreased;Retinopathy;Retrograde portal vein flow;Retroperitoneal fibrosis;Reversible airways obstruction;Reynold's syndrome;Rheumatic brain disease;Rheumatic disorder;Rheumatoid arthritis;Rheumatoid factor increased;Rheumatoid factor positive;Rheumatoid factor quantitative increased;Rheumatoid lung;Rheumatoid neutrophilic dermatosis;Rheumatoid nodule;Rheumatoid nodule removal;Rheumatoid scleritis;Rheumatoid vasculitis;Saccadic eye movement;SAPHO syndrome;Sarcoidosis;SARS-CoV-1 test;SARS-CoV-1 test negative;SARS-CoV-1 test positive;SARS-CoV-2 antibody test;SARS-CoV-2 antibody test negative;SARS-CoV-2 antibody test positive;SARS-CoV-2 carrier;SARS-CoV-2 sepsis;SARS-CoV-2 test;SARSCoV-2 test false negative;SARS-CoV-2 test false positive;SARS-CoV-2 test negative;SARSCoV-2 test positive;SARS-CoV-2 viraemia;Satoyoshi syndrome;Schizencephaly;Scleritis;Sclerodactylia;Scleroderma;Scleroderma associated digital ulcer;Scleroderma renal crisis;Scleroderma-like reaction;Secondary amyloidosis;Secondary cerebellar degeneration;Secondary progressive multiple sclerosis;Segmented hyalinising vasculitis;Seizure;Seizure anoxic;Seizure cluster;Seizure like phenomena;Seizure prophylaxis;Sensation of foreign body;Septic embolus;Septic pulmonary embolism;Severe acute respiratory syndrome;Severe myoclonic epilepsy of infancy;Shock;Shock symptom;Shrinking lung syndrome;Shunt thrombosis;Silent thyroiditis;Simple partial seizures;Sjogren's syndrome;Skin swelling;SLE arthritis;Smooth muscle antibody positive;Sneezing;Spinal artery embolism;Spinal artery thrombosis;Splenic artery thrombosis;Splenic embolism;Splenic thrombosis;Splenic vein thrombosis;Spondylitis;Spondyloarthropathy;Spontaneous heparin-induced thrombocytopenia syndrome;Status epilepticus;Stevens-Johnson syndrome;Stiff leg syndrome;Stiff person syndrome;Stillbirth;Still's disease;Stoma site thrombosis;Stoma site vasculitis;Stress cardiomyopathy;Stridor;Subacute cutaneous lupus erythematosus;Subacute endocarditis;Subacute inflammatory demyelinating polyneuropathy;Subclavian artery embolism;Subclavian artery thrombosis;Subclavian vein thrombosis;Sudden unexplained death in epilepsy;Superior sagittal sinus thrombosis;Susac's syndrome;Suspected COVID19;Swelling;Swelling face;Swelling of eyelid;Swollen tongue;Sympathetic ophthalmia;Systemic lupus erythematosus;Systemic lupus erythematosus disease activity index abnormal;Systemic lupus erythematosus disease activity index decreased;Systemic lupus erythematosus disease activity index increased;Systemic lupus erythematosus rash;Systemic scleroderma;Systemic sclerosis pulmonary;Tachycardia;Tachypnoea;Takayasu's arteritis;Temporal lobe epilepsy;Terminal ileitis;Testicular autoimmunity;Throat tightness;Thromboangiitis obliterans;Thrombocytopenia;Thrombocytopenic purpura;Thrombophlebitis;Thrombophlebitis migrans;Thrombophlebitis Page 37 090177e196ea1800\Approved\Approved On: 30-A pr-2021 09:26 (GMT) FDA-CBER-2021-5683-0000090 BNT162b2 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports CONFIDENTIAL Page 9 neonatal;Thrombophlebitis septic;Thrombophlebitis superficial;Thromboplastin antibody positive;Thrombosis;Thrombosis corpora cavernosa;Thrombosis in device;Thrombosis mesenteric vessel;Thrombotic cerebral infarction;Thrombotic microangiopathy;Thrombotic stroke;Thrombotic thrombocytopenic purpura;Thyroid disorder;Thyroid stimulating immunoglobulin increased;Thyroiditis;Tongue amyloidosis;Tongue biting;Tongue oedema;Tonic clonic movements;Tonic convulsion;Tonic posturing;Topectomy;Total bile acids increased;Toxic epidermal necrolysis;Toxic leukoencephalopathy;Toxic oil syndrome;Tracheal obstruction;Tracheal oedema;Tracheobronchitis;Tracheobronchitis mycoplasmal;Tracheobronchitis viral;Transaminases abnormal;Transaminases increased;Transfusion-related alloimmune neutropenia;Transient epileptic amnesia;Transverse sinus thrombosis;Trigeminal nerve paresis;Trigeminal neuralgia;Trigeminal palsy;Truncus coeliacus thrombosis;Tuberous sclerosis complex;Tubulointerstitial nephritis and uveitis syndrome;Tumefactive multiple sclerosis;Tumour embolism;Tumour thrombosis;Type 1 diabetes mellitus;Type I hypersensitivity;Type III immune complex mediated reaction;Uhthoff's phenomenon;Ulcerative keratitis;Ultrasound liver abnormal;Umbilical cord thrombosis;Uncinate fits;Undifferentiated connective tissue disease;Upper airway obstruction;Urine bilirubin increased;Urobilinogen urine decreased;Urobilinogen urine increased;Urticaria;Urticaria papular;Urticarial vasculitis;Uterine rupture;Uveitis;Vaccination site thrombosis;Vaccination site vasculitis;Vagus nerve paralysis;Varicella;Varicella keratitis;Varicella post vaccine;Varicella zoster gastritis;Varicella zoster oesophagitis;Varicella zoster pneumonia;Varicella zoster sepsis;Varicella zoster virus infection;Vasa praevia;Vascular graft thrombosis;Vascular pseudoaneurysm thrombosis;Vascular purpura;Vascular stent thrombosis;Vasculitic rash;Vasculitic ulcer;Vasculitis;Vasculitis gastrointestinal;Vasculitis necrotising;Vena cava embolism;Vena cava thrombosis;Venous intravasation;Venous recanalisation;Venous thrombosis;Venous thrombosis in pregnancy;Venous thrombosis limb;Venous thrombosis neonatal;Vertebral artery thrombosis;Vessel puncture site thrombosis;Visceral venous thrombosis;VIth nerve paralysis;VIth nerve paresis;Vitiligo;Vocal cord paralysis;Vocal cord paresis;Vogt-Koyanagi-Harada disease;Warm type haemolytic anaemia;Wheezing;White nipple sign;XIth nerve paralysis;X-ray hepatobiliary abnormal;Young's syndrome;Zika virus associated Guillain Barre syndrome.