Pfizer Documents (PHMPT/FDA)

The court-ordered FDA release of Pfizer's COVID-19 vaccine BLA submission (~450K pages across 4 sub-collections), mirrored from PHMPT.org. Searchable with AI explain.

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2373 documents

125742 45 S211 M5 c4591001 A 6mth report cci leukemia 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 3 pages

CCI_Leukemia MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_LeukemiaCode: 90002928Extension: CCIReport Date/Time: 27-Oct-2020:10:46:53 AM EDT Term Code Level Category Weight Scope Leukaemic infiltration ovary 10075853 PT Leukaemic infiltration hepatic 10058671 PT Leukaemic infiltration gingiva 10067431 PT Leukaemic infiltration extramedullary 10067117 PT Leukaemic infiltration 10069360 PT Leukaemic cardiac infiltration 10077563 PT Leukaemia recurrent 10062489 PT Leukaemia…

125742 45 S211 M5 c4591001 A 6mth report cci hemiplegia 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1 page

CCI_Hemiplegia MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_HemiplegiaCode: 90002927Extension: CCIReport Date/Time: 27-Oct-2020:10:46:23 AM EDT Term Code Level Category Weight Scope Tropical spastic paresis 10044696 PT Tick paralysis 10077336 PTThoracic spinal cord paralysis 10057277 PTSupranuclear palsy 10048327 PTSpinal cord paralysis 10057268 PTQuadriplegia 10037714 PTQuadriparesis 10049680 PTPseudobulbar palsy 10037114 PTPeripheral paralysis 10054808 PTParesis 10033985…

125742 45 S211 M5 c4591001 A 6mth report cci dementia 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1 page

CCI_Dementia MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_DementiaCode: 90002953Extension: CCIReport Date/Time: 27-Oct-2020:10:44:39 AM EDT Term Code Level Category Weight Scope Vascular dementia 10057678 PT Senile psychosis 10039987 PT Senile dementia 10039966 PT Progressive supranuclear palsy 10036813 PT Prodromal Alzheimer's disease 10074616 PT Presenile dementia 10036631 PT Posterior cortical atrophy 10078207 PT Neurodegenerative disorder 10053643 PT Mixed dementia 10075174…

125742 45 S211 M5 c4591001 A 6mth report cci chf 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

CCI_CHF MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_CHFCode: 90002959Extension: CCIReport Date/Time: 27-Oct-2020:10:43:25 AM EDT Term Code Level Category Weight Scope Cardiac failure acute 10007556 PT Cardiac failure 10007554 PT Cardiac asthma 10007522 PT Cardiac amyloidosis 10007509 PTAcute right ventricular failure 10063082 PTAcute pulmonary oedema 10001029 PTAcute left ventricular failure 10063081 PTViral cardiomyopathy 10068767 PTVentricular failure 10060953 PTThyrotoxic…

125742 45 S211 M5 c4591001 A 6mth report cci cerebrovascular 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 3 pages

CCI_Cerebrovascular MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_CerebrovascularCode: 90002958Extension: CCIReport Date/Time: 27-Oct-2020:10:44:05 AM EDT Term Code Level Category Weight Scope Vertebrobasilar insufficiency 10047334 PT Vertebral artery thrombosis 10057777 PT Vertebral artery stenosis 10047330 PT Vertebral artery perforation 10075735 PT Vertebral artery occlusion 10048965 PT Vertebral artery dissection 10071716 PT Vascular encephalopathy 10063661 PT Transient…

125742 45 S211 M5 c4591001 A 6mth report cci any malignancy 06aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 21 pages

CCI_Any malignancy MedDRA Dictionary Version: 240 Status: ACTIVE Term Name: CCI_Any malignancy Code: 90002950 Extension: CCI Report Date/Time: 06-Aug-2021:02:13:04 PM EDT Term Code Level Category Weight Scope Small cell carcinoma of the cervix 10041057 PT Small cell carcinoma 10041056 PT Signet-ring cell carcinoma 10057266 PT Serous cystadenocarcinoma ovary 10054913 PT Cystadenocarcinoma pancreas 10065908 PT Seminoma 10039956 PT Secretory adenoma of pituitary 10039893 PT Second primary…

125742 45 S211 M5 c4591001 A 6mth report cci aids hiv 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

CCI_AIDS HI V MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_AIDS HIVCode: 90002940Extension: CCIReport Date/Time: 27-Oct-2020:10:39:40 AM EDT Term Code Level Category Weight Scope Blood HIV RNA increased 10049827 PT Blood HIV RNA fluctuation 10076287 PT Asymptomatic HIV infection 10003581 PT AIDS retinopathy 10053227 PT AIDS related complex 10001513 PT AIDS cholangiopathy 10067092 PT Acute HIV infection 10000807 PT Acquired immunodeficiency syndrome 10000565 PT Perinatal HIV…

125742 45 S211 M5 c4591001 A 6mth newlist c4591001 6k participants enrolled v3 17sep2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 141 pages

Unique Subject Identifier C4591001 1001 10011081C4591001 1001 10011082C4591001 1001 10011083C4591001 1001 10011084C4591001 1001 10011085C4591001 1001 10011086C4591001 1001 10011087C4591001 1001 10011088C4591001 1001 10011089C4591001 1001 10011090C4591001 1001 10011091C4591001 1001 10011092C4591001 1001 10011093C4591001 1001 10011094C4591001 1001 10011095C4591001 1001 10011096C4591001 1001 10011097C4591001 1001 10011098C4591001 1001 10011099C4591001 1001 10011100C4591001 1001 10011101C4591001…

125742 45 S211 M5 c4591001 A 6mth first c4591001 360 participants enrolled v1 13aug20 update

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 9 pages

Site Subject ID 1001 10011081 1001 10011084 1001 10011085 1001 10011086 1001 10011087 1001 10011088 1001 10011089 1001 10011090 1001 10011091 1001 10011092 1001 10011093 1001 10011094 1001 10011095 1001 10011096 1001 10011097 1001 10011098 1001 10011099 1001 10011100 1001 10011101 1001 10011102 1001 10011103 1001 10011104 1003 10031088 1003 10031089 1003 10031090 1003 10031091 1003 10031092 1003 10031093 1003 10031094 1003 10031095 1003 10031096 1003 10031097 1003 10031098 1003 10031099 1003…

125742 45 S211 M5 c4591001 A 6mth c4591001 subject list for 12 25 immuno analysis 27jan2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 15 pages

USUBJID SUBJID C4591001 1005 10051328 10051328 C4591001 1005 10051400 10051400 C4591001 1005 10051412 10051412 C4591001 1005 10051416 10051416C4591001 1005 10051419 10051419C4591001 1006 10061136 10061136C4591001 1006 10061137 10061137C4591001 1006 10061159 10061159C4591001 1006 10061162 10061162C4591001 1006 10061170 10061170C4591001 1006 10061184 10061184C4591001 1006 10061192 10061192C4591001 1006 10061194 10061194C4591001 1006 10061202 10061202C4591001 1006 10061209 10061209C4591001 1006…

125742 45 S211 M5 c4591001 A 6mth bmi 12 15 scale

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 3 pages

GenderAge (in months)95th Percentile BMI Value Male 143.5 24.1475 Male 144.5 24.22985 Male 145.5 24.31172 Male 146.5 24.3931 Male 147.5 24.47397 Male 148.5 24.55434 Male 149.5 24.6342 Male 150.5 24.71352 Male 151.5 24.79232 Male 152.5 24.87058 Male 153.5 24.94829 Male 154.5 25.02545 Male 155.5 25.10206 Male 156.5 25.17811 Male 157.5 25.2536 Male 158.5 25.32853 Male 159.5 25.40289 Male 160.5 25.47668 Male 161.5 25.5499 Male 162.5 25.62256 Male 163.5 25.69464 Male 164.5 25.76616 Male 165.5…

125742 45 S211 M5 c4591001 A 6mth 201114 hiv preferred terms

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

Level Term Code SOC PT Acute HIV infection 10000807 INFECTIONS AND INFESTATION S PT Asymptomatic HIV infection 10003581 INFECTIONS AND INFESTATION S PT Blood HIV RNA 10049826 INVESTIGATIONS PT Blood HIV RNA below assay limit 10049829 INVESTIGATIONS PT Blood HIV RNA decreased 10049828 INVESTIGATIONS PT Blood HIV RNA fluctuation 10076287 INVESTIGATIONS PT Blood HIV RNA increased 10049827 INVESTIGATIONS PT Congenital HIV infection 10010504 CONGENITAL, FAMILIAL AND GENETIC DISORDER S PT CSF HIV…

125742 45 S211 M5 c4591001 A 1mth c4591001 subject list for 12 25 immuno analysis 27jan2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 15 pages

USUBJID SUBJID C4591001 1005 10051328 10051328 C4591001 1005 10051400 10051400 C4591001 1005 10051412 10051412 C4591001 1005 10051416 10051416 C4591001 1005 10051419 10051419 C4591001 1006 10061136 10061136 C4591001 1006 10061137 10061137 C4591001 1006 10061159 10061159 C4591001 1006 10061162 10061162 C4591001 1006 10061170 10061170 C4591001 1006 10061184 10061184 C4591001 1006 10061192 10061192 C4591001 1006 10061194 10061194 C4591001 1006 10061202 10061202 C4591001 1006 10061209 10061209…

125742 45 S211 M5 c4591001 A 6mth report cci rheumatic 06aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

CCI_Rheumatic MedDRA Dictionary Version: 240 Status: ACTIVE Term Name: CCI_Rheumatic Code: 90002944 Extension: CCI Report Date/Time: 06-Aug-2021:02:18:49 PM EDT Term Code Level Category Weight Scope Scleroderma-like reaction 10039714 PT Scleroderma renal crisis 10062553 PT Scleroderma 10039710 PT Rheumatoid vasculitis 10048628 PT Rheumatoid scleritis 10067427 PT Rheumatoid nodule removal 10053291 PT Rheumatoid nodule 10048694 PT Rheumatoid neutrophilic dermatosis 10072362 PT Rheumatoid lung…

125742 45 S211 M5 c4591001 A 6mth report cci renal 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 2 pages

CCI_Renal MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_RenalCode: 90002943Extension: CCIReport Date/Time: 27-Oct-2020:10:54:51 AM EDT Term Code Level Category Weight Scope Renal cortical necrosis 10038422 PT Renal cell dysplasia 10078656 PT Renal atrophy 10038381 PT Renal artery thrombosis 10038380 PT Renal artery stenosis 10038378 PT Renal artery perforation 10075737 PT Renal artery occlusion 10048988 PT Renal artery hyperplasia 10038377 PT Renal artery fibromuscular dysplasia…

125742 45 S211 M5 c4591001 A 6mth report cci diabetes without comp 30oct2020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1 page

CCI_Diabetes without comp MedDRA Dictionary Version: 230 Status: ACTIVETerm Name: CCI_Diabetes without compCode: 90002932Extension: CCIReport Date/Time: 27-Oct-2020:10:45:46 AM EDT Term Code Level Category Weight Scope Type 3 diabetes mellitus 10072659 PT Type 2 diabetes mellitus 10067585 PTType 1 diabetes mellitus 10067584 PTSomogyi phenomenon 10052093 PTShock hypoglycaemic 10040576 PTPancreatogenous diabetes 10033660 PTMonogenic diabetes 10075980 PTMauriac syndrome 10060761 PTLatent…

125742 45 S211 M5 c4591001 A 6mth report cci diabetes with comp 06aug2021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1 page

CCI_Diabetes with comp MedDRA Dictionary Version: 240 Status: ACTIVE Term Name: CCI_Diabetes with comp Code: 90002931 Extension: CCI Report Date/Time: 06-Aug-2021:02:16:14 PM EDT Term Code Level Category Weight Scope Diabetic eye disease 10012661 PT Diabetic endorgan damage 10071091 PT Diabetic end stage renal disease 10012660 PT Diabetic complication 10061104 PT Diabetic autonomic neuropathy 10012645 PT Cataract diabetic 10007749 PT Diabetic vascular disorder 10061815 PT Diabetic ulcer…

125742 45 S211 M5 c4591001 A 6mth comorbidity categories

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 1 page

Category Sheet AIDS/HIV Report_CCI_AIDS HIV_30Oct2020 Any Malignancy Report_CCI_Any malignancy_06Aug2021 Cerebrovascular Disease Report_CCI_Cerebrovascular_30Oct2020 Chronic Pulmonary Disease Report_CCI_Pulmonary_30Oct2020 Congestive Heart Failure Report_CCI_CHF_30Oct2020 Dementia Report_CCI_Dementia_30Oct2020 Diabetes With Chronic Complication Report_CCI_Diabetes with comp_06Aug2021 Diabetes Without Chronic Complication Report_CCI_Diabetes without comp_30Oct2020 Hemiplegia or Paraplegia…

125742 45 S364 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 10 pages

07/01/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Gosia Mineo, Director, Global Regulatory Affairs - Vaccines 125742 45 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…

125742 45 S328 M1 356h

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 12 15 Documents · 10 pages

05/13/2022 BioNTech Manufacturing GmbH +49 (0) 6131 9084-7593 +49 (0) 6131 9084-390 An der Goldgrube 12 Mainz N/A Germany 55131 [email protected] 117645848 2229 Kathleen Collins, Senior Director, Global Regulatory Affairs 125742 45 [COVID-19 mRNA Vaccine (nucleoside modified)] COMIRNATY [COVID-19 Vaccine (BNT162, PF-07302048)] Liquid 30 mcg Intramuscular Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age COVID-19; SARS-CoV-2; Disease caused by…