Plant Trees SF Events 2022 Archive: 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022

Event

 
Report Prepared by:  Pfizer
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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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
090177e196ea1800ApprovedApproved 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.
For updates and info, contact scott at planttrees dot org.