Pfizer BNT162b2 Covid-19 Vaccine, LIST OF ADVERSE EVENTS OF SPECIAL INTEREST (1200+)

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

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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

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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

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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

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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; Hypocalcaemic 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

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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

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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

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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

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

About janpenguin

Email: k2.mountain [at] gmail [dot] com Every content on the blog is made by Free and Open Source Software in GNU/Linux.
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