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Pfizer released adverse events

JackDinn
Mar 25th, 2022
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  1. BNT162b2
  2. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  3. APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST
  4. 1p36 deletion syndrome;2-Hydroxyglutaric aciduria;5'nucleotidase increased;Acoustic
  5. neuritis;Acquired C1 inhibitor deficiency;Acquired epidermolysis bullosa;Acquired epileptic
  6. aphasia;Acute cutaneous lupus erythematosus;Acute disseminated encephalomyelitis;Acute
  7. encephalitis with refractory, repetitive partial seizures;Acute febrile neutrophilic
  8. dermatosis;Acute flaccid myelitis;Acute haemorrhagic leukoencephalitis;Acute
  9. haemorrhagic oedema of infancy;Acute kidney injury;Acute macular outer retinopathy;Acute
  10. motor axonal neuropathy;Acute motor-sensory axonal neuropathy;Acute myocardial
  11. infarction;Acute respiratory distress syndrome;Acute respiratory failure;Addison's
  12. disease;Administration site thrombosis;Administration site vasculitis;Adrenal
  13. thrombosis;Adverse event following immunisation;Ageusia;Agranulocytosis;Air
  14. embolism;Alanine aminotransferase abnormal;Alanine aminotransferase increased;Alcoholic
  15. seizure;Allergic bronchopulmonary mycosis;Allergic oedema;Alloimmune
  16. hepatitis;Alopecia areata;Alpers disease;Alveolar proteinosis;Ammonia abnormal;Ammonia
  17. increased;Amniotic cavity infection;Amygdalohippocampectomy;Amyloid
  18. arthropathy;Amyloidosis;Amyloidosis senile;Anaphylactic reaction;Anaphylactic
  19. shock;Anaphylactic transfusion reaction;Anaphylactoid reaction;Anaphylactoid
  20. shock;Anaphylactoid syndrome of pregnancy;Angioedema;Angiopathic
  21. neuropathy;Ankylosing spondylitis;Anosmia;Antiacetylcholine receptor antibody
  22. positive;Anti-actin antibody positive;Anti-aquaporin-4 antibody positive;Anti-basal ganglia
  23. antibody positive;Anti-cyclic citrullinated peptide antibody positive;Anti-epithelial antibody
  24. positive;Anti-erythrocyte antibody positive;Anti-exosome complex antibody positive;Anti-
  25. GAD antibody negative;Anti-GAD antibody positive;Anti-ganglioside antibody
  26. positive;Antigliadin antibody positive;Anti-glomerular basement membrane antibody
  27. positive;Anti-glomerular basement membrane disease;Anti-glycyl-tRNA synthetase antibody
  28. positive;Anti-HLA antibody test positive;Anti-IA2 antibody positive;Anti-insulin antibody
  29. increased;Anti-insulin antibody positive;Anti-insulin receptor antibody increased;Anti-
  30. insulin receptor antibody positive;Anti-interferon antibody negative;Anti-interferon antibody
  31. positive;Anti-islet cell antibody positive;Antimitochondrial antibody positive;Anti-muscle
  32. specific kinase antibody positive;Anti-myelin-associated glycoprotein antibodies
  33. positive;Anti-myelin-associated glycoprotein associated polyneuropathy;Antimyocardial
  34. antibody positive;Anti-neuronal antibody positive;Antineutrophil cytoplasmic antibody
  35. increased;Antineutrophil cytoplasmic antibody positive;Anti-neutrophil cytoplasmic
  36. antibody positive vasculitis;Anti-NMDA antibody positive;Antinuclear antibody
  37. increased;Antinuclear antibody positive;Antiphospholipid antibodies
  38. positive;Antiphospholipid syndrome;Anti-platelet antibody positive;Anti-prothrombin
  39. antibody positive;Antiribosomal P antibody positive;Anti-RNA polymerase III antibody
  40. positive;Anti-saccharomyces cerevisiae antibody test positive;Anti-sperm antibody
  41. positive;Anti-SRP antibody positive;Antisynthetase syndrome;Anti-thyroid antibody
  42. positive;Anti-transglutaminase antibody increased;Anti-VGCC antibody positive;Anti-
  43. VGKC antibody positive;Anti-vimentin antibody positive;Antiviral prophylaxis;Antiviral
  44. treatment;Anti-zinc transporter 8 antibody positive;Aortic embolus;Aortic
  45. thrombosis;Aortitis;Aplasia pure red cell;Aplastic anaemia;Application site
  46. thrombosis;Application site vasculitis;Arrhythmia;Arterial bypass occlusion;Arterial bypass
  47. thrombosis;Arterial thrombosis;Arteriovenous fistula thrombosis;Arteriovenous graft site
  48. stenosis;Arteriovenous graft thrombosis;Arteritis;Arteritis
  49. CONFIDENTIAL
  50. Page 1
  51. FDA-CBER-2021-5683-0000083
  52. Page 30
  53. )
  54. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  55. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  56. coronary;Arthralgia;Arthritis;Arthritis enteropathic;Ascites;Aseptic cavernous sinus
  57. thrombosis;Aspartate aminotransferase abnormal;Aspartate aminotransferase
  58. increased;Aspartate-glutamate-transporter deficiency;AST to platelet ratio index
  59. increased;AST/ALT ratio abnormal;Asthma;Asymptomatic COVID-
  60. 19;Ataxia;Atheroembolism;Atonic seizures;Atrial thrombosis;Atrophic thyroiditis;Atypical
  61. benign partial epilepsy;Atypical pneumonia;Aura;Autoantibody positive;Autoimmune
  62. anaemia;Autoimmune aplastic anaemia;Autoimmune arthritis;Autoimmune blistering
  63. disease;Autoimmune cholangitis;Autoimmune colitis;Autoimmune demyelinating
  64. disease;Autoimmune dermatitis;Autoimmune disorder;Autoimmune
  65. encephalopathy;Autoimmune endocrine disorder;Autoimmune enteropathy;Autoimmune eye
  66. disorder;Autoimmune haemolytic anaemia;Autoimmune heparin-induced
  67. thrombocytopenia;Autoimmune hepatitis;Autoimmune hyperlipidaemia;Autoimmune
  68. hypothyroidism;Autoimmune inner ear disease;Autoimmune lung disease;Autoimmune
  69. lymphoproliferative syndrome;Autoimmune myocarditis;Autoimmune myositis;Autoimmune
  70. nephritis;Autoimmune neuropathy;Autoimmune neutropenia;Autoimmune
  71. pancreatitis;Autoimmune pancytopenia;Autoimmune pericarditis;Autoimmune
  72. retinopathy;Autoimmune thyroid disorder;Autoimmune thyroiditis;Autoimmune
  73. uveitis;Autoinflammation with infantile enterocolitis;Autoinflammatory disease;Automatism
  74. epileptic;Autonomic nervous system imbalance;Autonomic seizure;Axial
  75. spondyloarthritis;Axillary vein thrombosis;Axonal and demyelinating
  76. polyneuropathy;Axonal neuropathy;Bacterascites;Baltic myoclonic epilepsy;Band
  77. sensation;Basedow's disease;Basilar artery thrombosis;Basophilopenia;B-cell
  78. aplasia;Behcet's syndrome;Benign ethnic neutropenia;Benign familial neonatal
  79. convulsions;Benign familial pemphigus;Benign rolandic epilepsy;Beta-2 glycoprotein
  80. antibody positive;Bickerstaff's encephalitis;Bile output abnormal;Bile output
  81. decreased;Biliary ascites;Bilirubin conjugated abnormal;Bilirubin conjugated
  82. increased;Bilirubin urine present;Biopsy liver abnormal;Biotinidase deficiency;Birdshot
  83. chorioretinopathy;Blood alkaline phosphatase abnormal;Blood alkaline phosphatase
  84. increased;Blood bilirubin abnormal;Blood bilirubin increased;Blood bilirubin unconjugated
  85. increased;Blood cholinesterase abnormal;Blood cholinesterase decreased;Blood pressure
  86. decreased;Blood pressure diastolic decreased;Blood pressure systolic decreased;Blue toe
  87. syndrome;Brachiocephalic vein thrombosis;Brain stem embolism;Brain stem
  88. thrombosis;Bromosulphthalein test abnormal;Bronchial oedema;Bronchitis;Bronchitis
  89. mycoplasmal;Bronchitis viral;Bronchopulmonary aspergillosis allergic;Bronchospasm;Budd-
  90. Chiari syndrome;Bulbar palsy;Butterfly rash;C1q nephropathy;Caesarean section;Calcium
  91. embolism;Capillaritis;Caplan's syndrome;Cardiac amyloidosis;Cardiac arrest;Cardiac
  92. failure;Cardiac failure acute;Cardiac sarcoidosis;Cardiac ventricular thrombosis;Cardiogenic
  93. shock;Cardiolipin antibody positive;Cardiopulmonary failure;Cardio-respiratory
  94. arrest;Cardio-respiratory distress;Cardiovascular insufficiency;Carotid arterial
  95. embolus;Carotid artery thrombosis;Cataplexy;Catheter site thrombosis;Catheter site
  96. vasculitis;Cavernous sinus thrombosis;CDKL5 deficiency disorder;CEC syndrome;Cement
  97. embolism;Central nervous system lupus;Central nervous system vasculitis;Cerebellar artery
  98. thrombosis;Cerebellar embolism;Cerebral amyloid angiopathy;Cerebral arteritis;Cerebral
  99. artery embolism;Cerebral artery thrombosis;Cerebral gas embolism;Cerebral
  100. microembolism;Cerebral septic infarct;Cerebral thrombosis;Cerebral venous sinus
  101. thrombosis;Cerebral venous thrombosis;Cerebrospinal thrombotic
  102. CONFIDENTIAL
  103. Page 2
  104. FDA-CBER-2021-5683-0000084
  105. Page 31
  106. )
  107. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  108. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  109. tamponade;Cerebrovascular accident;Change in seizure presentation;Chest discomfort;Child-
  110. Pugh-Turcotte score abnormal;Child-Pugh-Turcotte score
  111. increased;Chillblains;Choking;Choking sensation;Cholangitis sclerosing;Chronic
  112. autoimmune glomerulonephritis;Chronic cutaneous lupus erythematosus;Chronic fatigue
  113. syndrome;Chronic gastritis;Chronic inflammatory demyelinating
  114. polyradiculoneuropathy;Chronic lymphocytic inflammation with pontine perivascular
  115. enhancement responsive to steroids;Chronic recurrent multifocal osteomyelitis;Chronic
  116. respiratory failure;Chronic spontaneous urticaria;Circulatory collapse;Circumoral
  117. oedema;Circumoral swelling;Clinically isolated syndrome;Clonic convulsion;Coeliac
  118. disease;Cogan's syndrome;Cold agglutinins positive;Cold type haemolytic
  119. anaemia;Colitis;Colitis erosive;Colitis herpes;Colitis microscopic;Colitis ulcerative;Collagen
  120. disorder;Collagen-vascular disease;Complement factor abnormal;Complement factor C1
  121. decreased;Complement factor C2 decreased;Complement factor C3 decreased;Complement
  122. factor C4 decreased;Complement factor decreased;Computerised tomogram liver
  123. abnormal;Concentric sclerosis;Congenital anomaly;Congenital bilateral perisylvian
  124. syndrome;Congenital herpes simplex infection;Congenital myasthenic syndrome;Congenital
  125. varicella infection;Congestive hepatopathy;Convulsion in childhood;Convulsions
  126. local;Convulsive threshold lowered;Coombs positive haemolytic anaemia;Coronary artery
  127. disease;Coronary artery embolism;Coronary artery thrombosis;Coronary bypass
  128. thrombosis;Coronavirus infection;Coronavirus test;Coronavirus test negative;Coronavirus
  129. test positive;Corpus callosotomy;Cough;Cough variant asthma;COVID-19;COVID-19
  130. immunisation;COVID-19 pneumonia;COVID-19 prophylaxis;COVID-19 treatment;Cranial
  131. nerve disorder;Cranial nerve palsies multiple;Cranial nerve paralysis;CREST
  132. syndrome;Crohn's disease;Cryofibrinogenaemia;Cryoglobulinaemia;CSF oligoclonal band
  133. present;CSWS syndrome;Cutaneous amyloidosis;Cutaneous lupus erythematosus;Cutaneous
  134. sarcoidosis;Cutaneous vasculitis;Cyanosis;Cyclic neutropenia;Cystitis interstitial;Cytokine
  135. release syndrome;Cytokine storm;De novo purine synthesis inhibitors associated acute
  136. inflammatory syndrome;Death neonatal;Deep vein thrombosis;Deep vein thrombosis
  137. postoperative;Deficiency of bile secretion;Deja vu;Demyelinating
  138. polyneuropathy;Demyelination;Dermatitis;Dermatitis bullous;Dermatitis
  139. herpetiformis;Dermatomyositis;Device embolisation;Device related thrombosis;Diabetes
  140. mellitus;Diabetic ketoacidosis;Diabetic mastopathy;Dialysis amyloidosis;Dialysis membrane
  141. reaction;Diastolic hypotension;Diffuse vasculitis;Digital pitting scar;Disseminated
  142. intravascular coagulation;Disseminated intravascular coagulation in newborn;Disseminated
  143. neonatal herpes simplex;Disseminated varicella;Disseminated varicella zoster vaccine virus
  144. infection;Disseminated varicella zoster virus infection;DNA antibody positive;Double cortex
  145. syndrome;Double stranded DNA antibody positive;Dreamy state;Dressler's syndrome;Drop
  146. attacks;Drug withdrawal convulsions;Dyspnoea;Early infantile epileptic encephalopathy with
  147. burst-suppression;Eclampsia;Eczema herpeticum;Embolia cutis medicamentosa;Embolic
  148. cerebellar infarction;Embolic cerebral infarction;Embolic pneumonia;Embolic
  149. stroke;Embolism;Embolism arterial;Embolism venous;Encephalitis;Encephalitis
  150. allergic;Encephalitis autoimmune;Encephalitis brain stem;Encephalitis
  151. haemorrhagic;Encephalitis periaxialis diffusa;Encephalitis post
  152. immunisation;Encephalomyelitis;Encephalopathy;Endocrine disorder;Endocrine
  153. ophthalmopathy;Endotracheal intubation;Enteritis;Enteritis leukopenic;Enterobacter
  154. pneumonia;Enterocolitis;Enteropathic spondylitis;Eosinopenia;Eosinophilic
  155. CONFIDENTIAL
  156. Page 3
  157. FDA-CBER-2021-5683-0000085
  158. Page 32
  159. )
  160. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  161. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  162. fasciitis;Eosinophilic granulomatosis with polyangiitis;Eosinophilic
  163. oesophagitis;Epidermolysis;Epilepsy;Epilepsy surgery;Epilepsy with myoclonic-atonic
  164. seizures;Epileptic aura;Epileptic psychosis;Erythema;Erythema induratum;Erythema
  165. multiforme;Erythema nodosum;Evans syndrome;Exanthema subitum;Expanded disability
  166. status scale score decreased;Expanded disability status scale score increased;Exposure to
  167. communicable disease;Exposure to SARS-CoV-2;Eye oedema;Eye pruritus;Eye
  168. swelling;Eyelid oedema;Face oedema;Facial paralysis;Facial paresis;Faciobrachial dystonic
  169. seizure;Fat embolism;Febrile convulsion;Febrile infection-related epilepsy syndrome;Febrile
  170. neutropenia;Felty's syndrome;Femoral artery embolism;Fibrillary
  171. glomerulonephritis;Fibromyalgia;Flushing;Foaming at mouth;Focal cortical resection;Focal
  172. dyscognitive seizures;Foetal distress syndrome;Foetal placental thrombosis;Foetor
  173. hepaticus;Foreign body embolism;Frontal lobe epilepsy;Fulminant type 1 diabetes
  174. mellitus;Galactose elimination capacity test abnormal;Galactose elimination capacity test
  175. decreased;Gamma-glutamyltransferase abnormal;Gamma-glutamyltransferase
  176. increased;Gastritis herpes;Gastrointestinal amyloidosis;Gelastic seizure;Generalised onset
  177. non-motor seizure;Generalised tonic-clonic seizure;Genital herpes;Genital herpes
  178. simplex;Genital herpes zoster;Giant cell arteritis;Glomerulonephritis;Glomerulonephritis
  179. membranoproliferative;Glomerulonephritis membranous;Glomerulonephritis rapidly
  180. progressive;Glossopharyngeal nerve paralysis;Glucose transporter type 1 deficiency
  181. syndrome;Glutamate dehydrogenase increased;Glycocholic acid increased;GM2
  182. gangliosidosis;Goodpasture's syndrome;Graft
  183. thrombosis;Granulocytopenia;Granulocytopenia neonatal;Granulomatosis with
  184. polyangiitis;Granulomatous dermatitis;Grey matter heterotopia;Guanase increased;Guillain-
  185. Barre syndrome;Haemolytic anaemia;Haemophagocytic
  186. lymphohistiocytosis;Haemorrhage;Haemorrhagic ascites;Haemorrhagic
  187. disorder;Haemorrhagic pneumonia;Haemorrhagic varicella syndrome;Haemorrhagic
  188. vasculitis;Hantavirus pulmonary infection;Hashimoto's
  189. encephalopathy;Hashitoxicosis;Hemimegalencephaly;Henoch-Schonlein purpura;Henoch-
  190. Schonlein purpura nephritis;Hepaplastin abnormal;Hepaplastin decreased;Heparin-induced
  191. thrombocytopenia;Hepatic amyloidosis;Hepatic artery embolism;Hepatic artery flow
  192. decreased;Hepatic artery thrombosis;Hepatic enzyme abnormal;Hepatic enzyme
  193. decreased;Hepatic enzyme increased;Hepatic fibrosis marker abnormal;Hepatic fibrosis
  194. marker increased;Hepatic function abnormal;Hepatic hydrothorax;Hepatic
  195. hypertrophy;Hepatic hypoperfusion;Hepatic lymphocytic infiltration;Hepatic mass;Hepatic
  196. pain;Hepatic sequestration;Hepatic vascular resistance increased;Hepatic vascular
  197. thrombosis;Hepatic vein embolism;Hepatic vein thrombosis;Hepatic venous pressure
  198. gradient abnormal;Hepatic venous pressure gradient increased;Hepatitis;Hepatobiliary scan
  199. abnormal;Hepatomegaly;Hepatosplenomegaly;Hereditary angioedema with C1 esterase
  200. inhibitor deficiency;Herpes dermatitis;Herpes gestationis;Herpes oesophagitis;Herpes
  201. ophthalmic;Herpes pharyngitis;Herpes sepsis;Herpes simplex;Herpes simplex
  202. cervicitis;Herpes simplex colitis;Herpes simplex encephalitis;Herpes simplex gastritis;Herpes
  203. simplex hepatitis;Herpes simplex meningitis;Herpes simplex meningoencephalitis;Herpes
  204. simplex meningomyelitis;Herpes simplex necrotising retinopathy;Herpes simplex
  205. oesophagitis;Herpes simplex otitis externa;Herpes simplex pharyngitis;Herpes simplex
  206. pneumonia;Herpes simplex reactivation;Herpes simplex sepsis;Herpes simplex
  207. viraemia;Herpes simplex virus conjunctivitis neonatal;Herpes simplex visceral;Herpes virus
  208. CONFIDENTIAL
  209. Page 4
  210. FDA-CBER-2021-5683-0000086
  211. Page 33
  212. )
  213. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  214. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  215. infection;Herpes zoster;Herpes zoster cutaneous disseminated;Herpes zoster infection
  216. neurological;Herpes zoster meningitis;Herpes zoster meningoencephalitis;Herpes zoster
  217. meningomyelitis;Herpes zoster meningoradiculitis;Herpes zoster necrotising
  218. retinopathy;Herpes zoster oticus;Herpes zoster pharyngitis;Herpes zoster
  219. reactivation;Herpetic radiculopathy;Histone antibody positive;Hoigne's syndrome;Human
  220. herpesvirus 6 encephalitis;Human herpesvirus 6 infection;Human herpesvirus 6 infection
  221. reactivation;Human herpesvirus 7 infection;Human herpesvirus 8
  222. infection;Hyperammonaemia;Hyperbilirubinaemia;Hypercholia;Hypergammaglobulinaemia
  223. benign monoclonal;Hyperglycaemic seizure;Hypersensitivity;Hypersensitivity
  224. vasculitis;Hyperthyroidism;Hypertransaminasaemia;Hyperventilation;Hypoalbuminaemia;H
  225. ypocalcaemic seizure;Hypogammaglobulinaemia;Hypoglossal nerve paralysis;Hypoglossal
  226. nerve paresis;Hypoglycaemic seizure;Hyponatraemic seizure;Hypotension;Hypotensive
  227. crisis;Hypothenar hammer syndrome;Hypothyroidism;Hypoxia;Idiopathic CD4
  228. lymphocytopenia;Idiopathic generalised epilepsy;Idiopathic interstitial pneumonia;Idiopathic
  229. neutropenia;Idiopathic pulmonary fibrosis;IgA nephropathy;IgM nephropathy;IIIrd nerve
  230. paralysis;IIIrd nerve paresis;Iliac artery embolism;Immune thrombocytopenia;Immune-
  231. mediated adverse reaction;Immune-mediated cholangitis;Immune-mediated
  232. cholestasis;Immune-mediated cytopenia;Immune-mediated encephalitis;Immune-mediated
  233. encephalopathy;Immune-mediated endocrinopathy;Immune-mediated enterocolitis;Immune-
  234. mediated gastritis;Immune-mediated hepatic disorder;Immune-mediated hepatitis;Immune-
  235. mediated hyperthyroidism;Immune-mediated hypothyroidism;Immune-mediated
  236. myocarditis;Immune-mediated myositis;Immune-mediated nephritis;Immune-mediated
  237. neuropathy;Immune-mediated pancreatitis;Immune-mediated pneumonitis;Immune-mediated
  238. renal disorder;Immune-mediated thyroiditis;Immune-mediated uveitis;Immunoglobulin G4
  239. related disease;Immunoglobulins abnormal;Implant site thrombosis;Inclusion body
  240. myositis;Infantile genetic agranulocytosis;Infantile spasms;Infected vasculitis;Infective
  241. thrombosis;Inflammation;Inflammatory bowel disease;Infusion site thrombosis;Infusion site
  242. vasculitis;Injection site thrombosis;Injection site urticaria;Injection site vasculitis;Instillation
  243. site thrombosis;Insulin autoimmune syndrome;Interstitial granulomatous
  244. dermatitis;Interstitial lung disease;Intracardiac mass;Intracardiac thrombus;Intracranial
  245. pressure increased;Intrapericardial thrombosis;Intrinsic factor antibody abnormal;Intrinsic
  246. factor antibody positive;IPEX syndrome;Irregular breathing;IRVAN syndrome;IVth nerve
  247. paralysis;IVth nerve paresis;JC polyomavirus test positive;JC virus CSF test positive;Jeavons
  248. syndrome;Jugular vein embolism;Jugular vein thrombosis;Juvenile idiopathic
  249. arthritis;Juvenile myoclonic epilepsy;Juvenile polymyositis;Juvenile psoriatic
  250. arthritis;Juvenile spondyloarthritis;Kaposi sarcoma inflammatory cytokine
  251. syndrome;Kawasaki's disease;Kayser-Fleischer ring;Keratoderma blenorrhagica;Ketosis-
  252. prone diabetes mellitus;Kounis syndrome;Lafora's myoclonic epilepsy;Lambl's
  253. excrescences;Laryngeal dyspnoea;Laryngeal oedema;Laryngeal rheumatoid
  254. arthritis;Laryngospasm;Laryngotracheal oedema;Latent autoimmune diabetes in adults;LE
  255. cells present;Lemierre syndrome;Lennox-Gastaut syndrome;Leucine aminopeptidase
  256. increased;Leukoencephalomyelitis;Leukoencephalopathy;Leukopenia;Leukopenia
  257. neonatal;Lewis-Sumner syndrome;Lhermitte's sign;Lichen planopilaris;Lichen planus;Lichen
  258. sclerosus;Limbic encephalitis;Linear IgA disease;Lip oedema;Lip swelling;Liver function
  259. test abnormal;Liver function test decreased;Liver function test increased;Liver
  260. induration;Liver injury;Liver iron concentration abnormal;Liver iron concentration
  261. CONFIDENTIAL
  262. Page 5
  263. FDA-CBER-2021-5683-0000087
  264. Page 34
  265. )
  266. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  267. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  268. increased;Liver opacity;Liver palpable;Liver sarcoidosis;Liver scan abnormal;Liver
  269. tenderness;Low birth weight baby;Lower respiratory tract herpes infection;Lower respiratory
  270. tract infection;Lower respiratory tract infection viral;Lung abscess;Lupoid hepatic
  271. cirrhosis;Lupus cystitis;Lupus encephalitis;Lupus endocarditis;Lupus enteritis;Lupus
  272. hepatitis;Lupus myocarditis;Lupus myositis;Lupus nephritis;Lupus pancreatitis;Lupus
  273. pleurisy;Lupus pneumonitis;Lupus vasculitis;Lupus-like syndrome;Lymphocytic
  274. hypophysitis;Lymphocytopenia neonatal;Lymphopenia;MAGIC syndrome;Magnetic
  275. resonance imaging liver abnormal;Magnetic resonance proton density fat fraction
  276. measurement;Mahler sign;Manufacturing laboratory analytical testing issue;Manufacturing
  277. materials issue;Manufacturing production issue;Marburg's variant multiple
  278. sclerosis;Marchiafava-Bignami disease;Marine Lenhart syndrome;Mastocytic
  279. enterocolitis;Maternal exposure during pregnancy;Medical device site thrombosis;Medical
  280. device site vasculitis;MELAS syndrome;Meningitis;Meningitis aseptic;Meningitis
  281. herpes;Meningoencephalitis herpes simplex neonatal;Meningoencephalitis
  282. herpetic;Meningomyelitis herpes;MERS-CoV test;MERS-CoV test negative;MERS-CoV test
  283. positive;Mesangioproliferative glomerulonephritis;Mesenteric artery embolism;Mesenteric
  284. artery thrombosis;Mesenteric vein thrombosis;Metapneumovirus infection;Metastatic
  285. cutaneous Crohn's disease;Metastatic pulmonary
  286. embolism;Microangiopathy;Microembolism;Microscopic polyangiitis;Middle East
  287. respiratory syndrome;Migraine-triggered seizure;Miliary pneumonia;Miller Fisher
  288. syndrome;Mitochondrial aspartate aminotransferase increased;Mixed connective tissue
  289. disease;Model for end stage liver disease score abnormal;Model for end stage liver disease
  290. score increased;Molar ratio of total branched-chain amino acid to tyrosine;Molybdenum
  291. cofactor deficiency;Monocytopenia;Mononeuritis;Mononeuropathy
  292. multiplex;Morphoea;Morvan syndrome;Mouth swelling;Moyamoya disease;Multifocal
  293. motor neuropathy;Multiple organ dysfunction syndrome;Multiple sclerosis;Multiple sclerosis
  294. relapse;Multiple sclerosis relapse prophylaxis;Multiple subpial transection;Multisystem
  295. inflammatory syndrome in children;Muscular sarcoidosis;Myasthenia gravis;Myasthenia
  296. gravis crisis;Myasthenia gravis neonatal;Myasthenic syndrome;Myelitis;Myelitis
  297. transverse;Myocardial infarction;Myocarditis;Myocarditis post infection;Myoclonic
  298. epilepsy;Myoclonic epilepsy and ragged-red fibres;Myokymia;Myositis;Narcolepsy;Nasal
  299. herpes;Nasal obstruction;Necrotising herpetic retinopathy;Neonatal Crohn's disease;Neonatal
  300. epileptic seizure;Neonatal lupus erythematosus;Neonatal mucocutaneous herpes
  301. simplex;Neonatal pneumonia;Neonatal seizure;Nephritis;Nephrogenic systemic
  302. fibrosis;Neuralgic amyotrophy;Neuritis;Neuritis cranial;Neuromyelitis optica pseudo
  303. relapse;Neuromyelitis optica spectrum disorder;Neuromyotonia;Neuronal
  304. neuropathy;Neuropathy peripheral;Neuropathy, ataxia, retinitis pigmentosa
  305. syndrome;Neuropsychiatric lupus;Neurosarcoidosis;Neutropenia;Neutropenia
  306. neonatal;Neutropenic colitis;Neutropenic infection;Neutropenic sepsis;Nodular rash;Nodular
  307. vasculitis;Noninfectious myelitis;Noninfective encephalitis;Noninfective
  308. encephalomyelitis;Noninfective oophoritis;Obstetrical pulmonary embolism;Occupational
  309. exposure to communicable disease;Occupational exposure to SARS-CoV-2;Ocular
  310. hyperaemia;Ocular myasthenia;Ocular pemphigoid;Ocular sarcoidosis;Ocular
  311. vasculitis;Oculofacial paralysis;Oedema;Oedema blister;Oedema due to hepatic
  312. disease;Oedema mouth;Oesophageal achalasia;Ophthalmic artery thrombosis;Ophthalmic
  313. herpes simplex;Ophthalmic herpes zoster;Ophthalmic vein thrombosis;Optic neuritis;Optic
  314. CONFIDENTIAL
  315. Page 6
  316. FDA-CBER-2021-5683-0000088
  317. Page 35
  318. )
  319. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  320. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  321. neuropathy;Optic perineuritis;Oral herpes;Oral lichen planus;Oropharyngeal
  322. oedema;Oropharyngeal spasm;Oropharyngeal swelling;Osmotic demyelination
  323. syndrome;Ovarian vein thrombosis;Overlap syndrome;Paediatric autoimmune
  324. neuropsychiatric disorders associated with streptococcal infection;Paget-Schroetter
  325. syndrome;Palindromic rheumatism;Palisaded neutrophilic granulomatous
  326. dermatitis;Palmoplantar keratoderma;Palpable
  327. purpura;Pancreatitis;Panencephalitis;Papillophlebitis;Paracancerous pneumonia;Paradoxical
  328. embolism;Parainfluenzae viral laryngotracheobronchitis;Paraneoplastic
  329. dermatomyositis;Paraneoplastic pemphigus;Paraneoplastic thrombosis;Paresis cranial
  330. nerve;Parietal cell antibody positive;Paroxysmal nocturnal haemoglobinuria;Partial
  331. seizures;Partial seizures with secondary generalisation;Patient isolation;Pelvic venous
  332. thrombosis;Pemphigoid;Pemphigus;Penile vein thrombosis;Pericarditis;Pericarditis
  333. lupus;Perihepatic discomfort;Periorbital oedema;Periorbital swelling;Peripheral artery
  334. thrombosis;Peripheral embolism;Peripheral ischaemia;Peripheral vein thrombus
  335. extension;Periportal oedema;Peritoneal fluid protein abnormal;Peritoneal fluid protein
  336. decreased;Peritoneal fluid protein increased;Peritonitis lupus;Pernicious anaemia;Petit mal
  337. epilepsy;Pharyngeal oedema;Pharyngeal swelling;Pityriasis lichenoides et varioliformis
  338. acuta;Placenta praevia;Pleuroparenchymal fibroelastosis;Pneumobilia;Pneumonia;Pneumonia
  339. adenoviral;Pneumonia cytomegaloviral;Pneumonia herpes viral;Pneumonia
  340. influenzal;Pneumonia measles;Pneumonia mycoplasmal;Pneumonia necrotising;Pneumonia
  341. parainfluenzae viral;Pneumonia respiratory syncytial viral;Pneumonia viral;POEMS
  342. syndrome;Polyarteritis nodosa;Polyarthritis;Polychondritis;Polyglandular autoimmune
  343. syndrome type I;Polyglandular autoimmune syndrome type II;Polyglandular autoimmune
  344. syndrome type III;Polyglandular disorder;Polymicrogyria;Polymyalgia
  345. rheumatica;Polymyositis;Polyneuropathy;Polyneuropathy idiopathic progressive;Portal
  346. pyaemia;Portal vein embolism;Portal vein flow decreased;Portal vein pressure
  347. increased;Portal vein thrombosis;Portosplenomesenteric venous thrombosis;Post procedural
  348. hypotension;Post procedural pneumonia;Post procedural pulmonary embolism;Post stroke
  349. epilepsy;Post stroke seizure;Post thrombotic retinopathy;Post thrombotic syndrome;Post viral
  350. fatigue syndrome;Postictal headache;Postictal paralysis;Postictal psychosis;Postictal
  351. state;Postoperative respiratory distress;Postoperative respiratory failure;Postoperative
  352. thrombosis;Postpartum thrombosis;Postpartum venous thrombosis;Postpericardiotomy
  353. syndrome;Post-traumatic epilepsy;Postural orthostatic tachycardia syndrome;Precerebral
  354. artery thrombosis;Pre-eclampsia;Preictal state;Premature labour;Premature
  355. menopause;Primary amyloidosis;Primary biliary cholangitis;Primary progressive multiple
  356. sclerosis;Procedural shock;Proctitis herpes;Proctitis ulcerative;Product availability
  357. issue;Product distribution issue;Product supply issue;Progressive facial
  358. hemiatrophy;Progressive multifocal leukoencephalopathy;Progressive multiple
  359. sclerosis;Progressive relapsing multiple sclerosis;Prosthetic cardiac valve
  360. thrombosis;Pruritus;Pruritus allergic;Pseudovasculitis;Psoriasis;Psoriatic
  361. arthropathy;Pulmonary amyloidosis;Pulmonary artery thrombosis;Pulmonary
  362. embolism;Pulmonary fibrosis;Pulmonary haemorrhage;Pulmonary microemboli;Pulmonary
  363. oil microembolism;Pulmonary renal syndrome;Pulmonary sarcoidosis;Pulmonary
  364. sepsis;Pulmonary thrombosis;Pulmonary tumour thrombotic microangiopathy;Pulmonary
  365. vasculitis;Pulmonary veno-occlusive disease;Pulmonary venous thrombosis;Pyoderma
  366. gangrenosum;Pyostomatitis vegetans;Pyrexia;Quarantine;Radiation leukopenia;Radiculitis
  367. CONFIDENTIAL
  368. Page 7
  369. FDA-CBER-2021-5683-0000089
  370. Page 36
  371. )
  372. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  373. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  374. brachial;Radiologically isolated syndrome;Rash;Rash erythematous;Rash pruritic;Rasmussen
  375. encephalitis;Raynaud's phenomenon;Reactive capillary endothelial proliferation;Relapsing
  376. multiple sclerosis;Relapsing-remitting multiple sclerosis;Renal amyloidosis;Renal
  377. arteritis;Renal artery thrombosis;Renal embolism;Renal failure;Renal vascular
  378. thrombosis;Renal vasculitis;Renal vein embolism;Renal vein thrombosis;Respiratory
  379. arrest;Respiratory disorder;Respiratory distress;Respiratory failure;Respiratory
  380. paralysis;Respiratory syncytial virus bronchiolitis;Respiratory syncytial virus
  381. bronchitis;Retinal artery embolism;Retinal artery occlusion;Retinal artery thrombosis;Retinal
  382. vascular thrombosis;Retinal vasculitis;Retinal vein occlusion;Retinal vein thrombosis;Retinol
  383. binding protein decreased;Retinopathy;Retrograde portal vein flow;Retroperitoneal
  384. fibrosis;Reversible airways obstruction;Reynold's syndrome;Rheumatic brain
  385. disease;Rheumatic disorder;Rheumatoid arthritis;Rheumatoid factor increased;Rheumatoid
  386. factor positive;Rheumatoid factor quantitative increased;Rheumatoid lung;Rheumatoid
  387. neutrophilic dermatosis;Rheumatoid nodule;Rheumatoid nodule removal;Rheumatoid
  388. scleritis;Rheumatoid vasculitis;Saccadic eye movement;SAPHO
  389. syndrome;Sarcoidosis;SARS-CoV-1 test;SARS-CoV-1 test negative;SARS-CoV-1 test
  390. positive;SARS-CoV-2 antibody test;SARS-CoV-2 antibody test negative;SARS-CoV-2
  391. antibody test positive;SARS-CoV-2 carrier;SARS-CoV-2 sepsis;SARS-CoV-2 test;SARS-
  392. CoV-2 test false negative;SARS-CoV-2 test false positive;SARS-CoV-2 test negative;SARS-
  393. CoV-2 test positive;SARS-CoV-2 viraemia;Satoyoshi
  394. syndrome;Schizencephaly;Scleritis;Sclerodactylia;Scleroderma;Scleroderma associated
  395. digital ulcer;Scleroderma renal crisis;Scleroderma-like reaction;Secondary
  396. amyloidosis;Secondary cerebellar degeneration;Secondary progressive multiple
  397. sclerosis;Segmented hyalinising vasculitis;Seizure;Seizure anoxic;Seizure cluster;Seizure
  398. like phenomena;Seizure prophylaxis;Sensation of foreign body;Septic embolus;Septic
  399. pulmonary embolism;Severe acute respiratory syndrome;Severe myoclonic epilepsy of
  400. infancy;Shock;Shock symptom;Shrinking lung syndrome;Shunt thrombosis;Silent
  401. thyroiditis;Simple partial seizures;Sjogren's syndrome;Skin swelling;SLE arthritis;Smooth
  402. muscle antibody positive;Sneezing;Spinal artery embolism;Spinal artery thrombosis;Splenic
  403. artery thrombosis;Splenic embolism;Splenic thrombosis;Splenic vein
  404. thrombosis;Spondylitis;Spondyloarthropathy;Spontaneous heparin-induced
  405. thrombocytopenia syndrome;Status epilepticus;Stevens-Johnson syndrome;Stiff leg
  406. syndrome;Stiff person syndrome;Stillbirth;Still's disease;Stoma site thrombosis;Stoma site
  407. vasculitis;Stress cardiomyopathy;Stridor;Subacute cutaneous lupus erythematosus;Subacute
  408. endocarditis;Subacute inflammatory demyelinating polyneuropathy;Subclavian artery
  409. embolism;Subclavian artery thrombosis;Subclavian vein thrombosis;Sudden unexplained
  410. death in epilepsy;Superior sagittal sinus thrombosis;Susac's syndrome;Suspected COVID-
  411. 19;Swelling;Swelling face;Swelling of eyelid;Swollen tongue;Sympathetic
  412. ophthalmia;Systemic lupus erythematosus;Systemic lupus erythematosus disease activity
  413. index abnormal;Systemic lupus erythematosus disease activity index decreased;Systemic
  414. lupus erythematosus disease activity index increased;Systemic lupus erythematosus
  415. rash;Systemic scleroderma;Systemic sclerosis
  416. pulmonary;Tachycardia;Tachypnoea;Takayasu's arteritis;Temporal lobe epilepsy;Terminal
  417. ileitis;Testicular autoimmunity;Throat tightness;Thromboangiitis
  418. obliterans;Thrombocytopenia;Thrombocytopenic
  419. purpura;Thrombophlebitis;Thrombophlebitis migrans;Thrombophlebitis
  420. CONFIDENTIAL
  421. Page 8
  422. FDA-CBER-2021-5683-0000090
  423. Page 37
  424. )
  425. TMG(62:901202-rpA-03:nOdevorppA\devorppA\0081ae691e771090BNT162b2
  426. 5.3.6 Cumulative Analysis of Post-authorization Adverse Event Reports
  427. neonatal;Thrombophlebitis septic;Thrombophlebitis superficial;Thromboplastin antibody
  428. positive;Thrombosis;Thrombosis corpora cavernosa;Thrombosis in device;Thrombosis
  429. mesenteric vessel;Thrombotic cerebral infarction;Thrombotic microangiopathy;Thrombotic
  430. stroke;Thrombotic thrombocytopenic purpura;Thyroid disorder;Thyroid stimulating
  431. immunoglobulin increased;Thyroiditis;Tongue amyloidosis;Tongue biting;Tongue
  432. oedema;Tonic clonic movements;Tonic convulsion;Tonic posturing;Topectomy;Total bile
  433. acids increased;Toxic epidermal necrolysis;Toxic leukoencephalopathy;Toxic oil
  434. syndrome;Tracheal obstruction;Tracheal oedema;Tracheobronchitis;Tracheobronchitis
  435. mycoplasmal;Tracheobronchitis viral;Transaminases abnormal;Transaminases
  436. increased;Transfusion-related alloimmune neutropenia;Transient epileptic
  437. amnesia;Transverse sinus thrombosis;Trigeminal nerve paresis;Trigeminal
  438. neuralgia;Trigeminal palsy;Truncus coeliacus thrombosis;Tuberous sclerosis
  439. complex;Tubulointerstitial nephritis and uveitis syndrome;Tumefactive multiple
  440. sclerosis;Tumour embolism;Tumour thrombosis;Type 1 diabetes mellitus;Type I
  441. hypersensitivity;Type III immune complex mediated reaction;Uhthoff's
  442. phenomenon;Ulcerative keratitis;Ultrasound liver abnormal;Umbilical cord
  443. thrombosis;Uncinate fits;Undifferentiated connective tissue disease;Upper airway
  444. obstruction;Urine bilirubin increased;Urobilinogen urine decreased;Urobilinogen urine
  445. increased;Urticaria;Urticaria papular;Urticarial vasculitis;Uterine
  446. rupture;Uveitis;Vaccination site thrombosis;Vaccination site vasculitis;Vagus nerve
  447. paralysis;Varicella;Varicella keratitis;Varicella post vaccine;Varicella zoster
  448. gastritis;Varicella zoster oesophagitis;Varicella zoster pneumonia;Varicella zoster
  449. sepsis;Varicella zoster virus infection;Vasa praevia;Vascular graft thrombosis;Vascular
  450. pseudoaneurysm thrombosis;Vascular purpura;Vascular stent thrombosis;Vasculitic
  451. rash;Vasculitic ulcer;Vasculitis;Vasculitis gastrointestinal;Vasculitis necrotising;Vena cava
  452. embolism;Vena cava thrombosis;Venous intravasation;Venous recanalisation;Venous
  453. thrombosis;Venous thrombosis in pregnancy;Venous thrombosis limb;Venous thrombosis
  454. neonatal;Vertebral artery thrombosis;Vessel puncture site thrombosis;Visceral venous
  455. thrombosis;VIth nerve paralysis;VIth nerve paresis;Vitiligo;Vocal cord paralysis;Vocal cord
  456. paresis;Vogt-Koyanagi-Harada disease;Warm type haemolytic anaemia;Wheezing;White
  457. nipple sign;XIth nerve paralysis;X-ray hepatobiliary abnormal;Young's syndrome;Zika virus
  458. associated Guillain Barre syndrome.
  459. CONFIDENTIAL
  460. Page 9
  461. FDA-CBER-2021-5683-0000091
  462. Page 38
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