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 1231 12314255

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 177 pages

Page 1 of 177 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314255 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314233

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 181 pages

Page 1 of 181 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314233 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314216

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 159 pages

Page 1 of 159 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314216 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314197

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 318 pages

Page 1 of 318 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314197 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1231 12314134

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 284 pages

Page 1 of 284 ***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: 1231 Site Name: (1231) Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Subject No: 12314134 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 20:34 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per…

125742 S1 M5 CRF c4591001 1131 11311021

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 170 pages

Page 1 of 170 ***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: 1131 Site Name: (1131) PriMED Clinical Research Subject No: 11311021 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:34 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 1130 11301081

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 228 pages

Page 1 of 228 ***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research Subject No: 11301081 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:25 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,…

125742 S1 M5 CRF c4591001 1130 11301031

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 230 pages

Page 1 of 230 ***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: 1130 Site Name: (1130) Kaiser Permanente Center For Health Research Subject No: 11301031 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:25 eCRF Audit Trail History Cohort Selection DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment…

125742 S1 M5 CRF c4591001 1126 11261244

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 150 pages

Page 1 of 150 ***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara Subject No: 11261244 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1126 11261017

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 429 pages

Page 1 of 429 ***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: 1126 Site Name: (1126) Kaiser Permanente Santa Clara Subject No: 11261017 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1125 11251243

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 202 pages

Page 1 of 202 ***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: 1125 Site Name: (1125) Meridian Clinical Research Subject No: 11251243 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1125 11251154

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 395 pages

Page 1 of 395 ***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: 1125 Site Name: (1125) Meridian Clinical Research Subject No: 11251154 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1125 11251020

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 250 pages

Page 1 of 250 ***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: 1125 Site Name: (1125) Meridian Clinical Research Subject No: 11251020 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1125 11251014

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 382 pages

Page 1 of 382 ***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: 1125 Site Name: (1125) Meridian Clinical Research Subject No: 11251014 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1124 11241223

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 127 pages

Page 1 of 127 ***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: 1124 Site Name: (1124) Omega Medical Research Subject No: 11241223 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1124 11241207

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: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified Site No: 1124 Site Name: (1124) Omega Medical Research Subject No: 11241207 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1124 11241128

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 352 pages

Page 1 of 352 ***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: 1124 Site Name: (1124) Omega Medical Research Subject No: 11241128 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1124 11241106

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 135 pages

Page 1 of 135 ***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: 1124 Site Name: (1124) Omega Medical Research Subject No: 11241106 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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 1123 11231381

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 131 pages

FDA-CBER-2021-5683-0930965 FDA-CBER-2021-5683-0930966 FDA-CBER-2021-5683-0930967 FDA-CBER-2021-5683-0930968 FDA-CBER-2021-5683-0930969 FDA-CBER-2021-5683-0930970 FDA-CBER-2021-5683-0930971 FDA-CBER-2021-5683-0930972 FDA-CBER-2021-5683-0930973 FDA-CBER-2021-5683-0930974 FDA-CBER-2021-5683-0930975 FDA-CBER-2021-5683-0930976 FDA-CBER-2021-5683-0930977 FDA-CBER-2021-5683-0930978 FDA-CBER-2021-5683-0930979 FDA-CBER-2021-5683-0930980 FDA-CBER-2021-5683-0930981 FDA-CBER-2021-5683-0930982…

125742 S1 M5 CRF c4591001 1123 11231204

Pfizer Documents (PHMPT/FDA) · Pfizer Bla Submission / Pfizer 16 Plus Documents · 155 pages

Page 1 of 155 ***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: 1123 Site Name: (1123) Meridian Clinical Research Subject No: 11231204 Subject Initials: --- Generated By: Generated Time (GMT): 29-Mar-2021 11:09 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…