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 S1 M5 CRF c4591001 1042 10421259

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 144 pages

Page 1 of 144 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1042 Site Name: (1042) HealthFirst Medical Group Subject No: 10421259 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 04:44 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…

125742 S1 M5 CRF c4591001 1090 10901486

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 149 pages

Page 1 of 149 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901486 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901415

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 304 pages

Page 1 of 304 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901415 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901394

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 179 pages

Page 1 of 179 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901394 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901384

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 146 pages

Page 1 of 146 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901384 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901354

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 154 pages

Page 1 of 154 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901354 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901300

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 243 pages

Page 1 of 243 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901300 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901187

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 252 pages

Page 1 of 252 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901187 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901175

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 280 pages

Page 1 of 280 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901175 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901140

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 224 pages

Page 1 of 224 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901140 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901099

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 255 pages

Page 1 of 255 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901099 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1071 10711172

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 195 pages

Page 1 of 195 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1071 Site Name: (1071) Quality Clinical Research Subject No: 10711172 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…

125742 S1 M5 CRF c4591001 1071 10711171

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 169 pages

Page 1 of 169 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1071 Site Name: (1071) Quality Clinical Research Subject No: 10711171 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…

125742 S1 M5 CRF c4591001 1071 10711169

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 171 pages

Page 1 of 171 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1071 Site Name: (1071) Quality Clinical Research Subject No: 10711169 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…

125742 S1 M5 CRF c4591001 1071 10711023

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 141 pages

Page 1 of 141 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1071 Site Name: (1071) Quality Clinical Research Subject No: 10711023 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:05 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option…

125742 S1 M5 CRF c4591001 1092 10921010

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 222 pages

Page 1 of 222 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1092 Site Name: (1092) Sterling Research Group, Ltd. Subject No: 10921010 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901536

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 161 pages

Page 1 of 161 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901536 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3 option is…

125742 S1 M5 CRF c4591001 1090 10901507

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 164 pages

Page 1 of 164 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901507 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1090 10901492

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 220 pages

Page 1 of 220 ***Confidential*** Header Text: c4591001 Visit: COHORT_SELECTION Form: COHORT SELECTION Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1090 Site Name: (1090) Wake Research Associates, LLC Subject No: 10901492 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 10:31 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3…

125742 S1 M5 CRF c4591001 1110 11101236

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 464 pages

FDA-CBER-2021-5683-0925403 FDA-CBER-2021-5683-0925404 FDA-CBER-2021-5683-0925405 FDA-CBER-2021-5683-0925406 FDA-CBER-2021-5683-0925407 FDA-CBER-2021-5683-0925408 FDA-CBER-2021-5683-0925409 FDA-CBER-2021-5683-0925410 FDA-CBER-2021-5683-0925411 FDA-CBER-2021-5683-0925412 FDA-CBER-2021-5683-0925413 FDA-CBER-2021-5683-0925414 FDA-CBER-2021-5683-0925415 FDA-CBER-2021-5683-0925416 FDA-CBER-2021-5683-0925417 FDA-CBER-2021-5683-0925418 FDA-CBER-2021-5683-0925419 FDA-CBER-2021-5683-0925420…