125742 S1 M5 CRF c4591001 1079 10791228

Document text

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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 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 is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955290
Page 2 of 170
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955291
Page 3 of 170
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10791228]
2.Birth Date: /1954
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955292
Page 4 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955293
Page 5 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955294
Page 6 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955295
Page 7 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergy to Codeine]
Start Date: UNK/UNK/1960
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Low Testosterone]
Start Date: UNK/UNK/1983
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955296
Page 8 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Type 2 Diabetes]
Start Date: UNK/UNK/2005
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Deep Vein Thrombosis]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Depression]
Start Date: UNK/UNK/2010
Ongoing: YES
1 hLine/MH Number: [8] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pressure in Eyes] Comments
Start Date: UNK/UNK/2018 Comments
Ongoing: YES Comments
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Erectile Dysfunction]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955297
Page 9 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tonsillectomy]
Start Date: UNK/UNK/1960
Ongoing: NO
End Date:
UNK/UNK/1960
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendectomy]
Start Date: UNK/UNK/1964
Ongoing: NO
End Date:
UNK/UNK/1964
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia Repair]
Start Date: UNK/UNK/1970
Ongoing: NO
End Date:
UNK/UNK/1970
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hernia Repair]
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
UNK/UNK/1978
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955298
Page 10 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Testicular Cancer]
Start Date: UNK/UNK/1982
Ongoing: NO
End Date:
UNK/UNK/1982
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955299
Page 11 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [100.9]
3.Unit: kg
4.Height: [187.0]
5.Unit: cm
6.Body Mass Index: [28.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955300
Page 12 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249348]
3.Randomization Group: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955301
Page 13 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPCSGV]
5.bSample ID [BPCSJR]
5.cSample ID [BPY3RR]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955302
Page 14 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPXVT8]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955303
Page 15 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 11:33
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955304
Page 16 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955305
Page 17 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/29/2020
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955306
Page 18 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/29/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.2]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955307
Page 19 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPB0N8]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955308
Page 20 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/29/2020 13:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955309
Page 21 of 170
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955310
Page 22 of 170
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSH8RF]
5.bSample ID [BSH8RW]
5.cSample ID [BPB0Y5]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955311
Page 23 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955312
Page 24 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955313
Page 25 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955314
Page 26 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955315
Page 27 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955316
Page 28 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955317
Page 29 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955318
Page 30 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955319
Page 31 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955320
Page 32 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955321
Page 33 of 170
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955322
Page 34 of 170
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955323
Page 35 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955324
Page 36 of 170
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955325
Page 37 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Central Retinal Artery O
cclusion Sep/29/2020 1
5:30 YES  Repeating
Pages
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955326
Page 38 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Central Retinal Artery Occlusion]
4.Start Date Time: Sep/29/2020 15:30
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955327
Page 39 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Pre-existing medical conditions,hypercoagulable state due to hypertension,
TIID]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020383603]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955328
Page 40 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955329
Page 41 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955330
Page 42 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955331
Page 43 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955332
Page 44 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955333
Page 45 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955334
Page 46 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955335
Page 47 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955336
Page 48 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955337
Page 49 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955338
Page 50 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955339
Page 51 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955340
Page 52 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955341
Page 53 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955342
Page 54 of 170
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955343
Page 55 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/18/2020
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955344
Page 56 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received
only placebo at Vaccination 1/2
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955345
Page 57 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/21/2020
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955346
Page 58 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Dec/21/2020
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955347
Page 59 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955348
Page 60 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Dec/21/2020
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955349
Page 61 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BS79YN]
5.bSample ID [BPZ0VS]
5.cSample ID [BS7B3F]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955350
Page 62 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Dec/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZ0V7]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955351
Page 63 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Dec/21/2020 12:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955352
Page 64 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/18/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955353
Page 65 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955354
Page 66 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955355
Page 67 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955356
Page 68 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/11/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPZ12D]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955357
Page 69 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/11/2021 11:46
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955358
Page 70 of 170
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/12/2021
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955359
Page 71 of 170
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/12/2021
3.Comments: [Subject reported, "no changes in health since last visit."]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955360
Page 72 of 170
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955361
Page 73 of 170
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955362
Page 74 of 170
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955363
Page 75 of 170
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955364
Page 76 of 170
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Feb/12/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955365
Page 77 of 170
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/29/2020
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955366
Page 78 of 170
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955367
Page 79 of 170
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad  Approved Mar-10-2021 19:01:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955368
Page 80 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-07-2020 19:32:06 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955369
Page 81 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1 hSep-07-2020 19:38:09 (UTC-05:00) Eastern
Time (US & Canada)I am checking with site for clarification on the
"eye pressure" I will update once I receive new
information.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955370
Page 82 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1 hSep-07-2020 19:38:09 (UTC-05:00) Eastern
Time (US & Canada)I am checking with site for clarification on the
"eye pressure" I will update once I receive new
information.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955371
Page 83 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1 hSep-07-2020 19:38:09 (UTC-05:00) Eastern
Time (US & Canada)I am checking with site for clarification on the
"eye pressure" I will update once I receive new
information.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955372
Page 84 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1 hSep-07-2020 19:38:09 (UTC-05:00) Eastern
Time (US & Canada)I am checking with site for clarification on the
"eye pressure" I will update once I receive new
information.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955373
Page 85 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-08-2021 14:52:24 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955374
Page 86 of 170
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-11-2021 13:19:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955375
Page 87 of 170
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Jan-11-2021 13:19:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955376
Page 88 of 170
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormJan-11-2021 13:20:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955377
Page 89 of 170
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Jan-11-2021 13:20:11 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955378
Page 90 of 170
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad  Approved Mar-10-2021 19:01:13 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-15-2021 17:21:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad  Approved Jan-22-2021 11:26:22 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-08-2021 14:47:29 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955379
Page 91 of 170
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
George Raad  Approved Nov-06-2020 10:09:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-29-2020 20:16:50 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad  Approved Oct-27-2020 15:59:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955380
Page 92 of 170
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-07-2020 19:31:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-07-2020 19:31:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955381
Page 93 of 170
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-07-2020 19:31:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Sep/2/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955382
Page 94 of 170
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-07-2020 19:31:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10791228Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-07-2020 19:31:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1954Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-07-2020 19:31:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-07-2020 19:31:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-07-2020 19:31:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955383
Page 95 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-07-2020 19:32:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955384
Page 96 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-07-2020 19:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-07-2020 19:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-07-2020 19:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955385
Page 97 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-07-2020 19:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Allergy to Co
deine
Start Date: UNK/UNK/19
60
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Allergy to CodeineInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-07-2020 19:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-07-2020 19:33:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955386
Page 98 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.b
Date Location User Value Reason
Sep-07-2020 19:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Low Testoster
one
Start Date: UNK/UNK/1
983
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low TestosteroneInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-07-2020 19:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1983Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-07-2020 19:33:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955387
Page 99 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-07-2020 19:34:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Hypercholester
olemia
Start Date: UNK/UNK/200
0
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:34:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:34:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-07-2020 19:34:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-07-2020 19:34:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955388
Page 100 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-07-2020 19:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:4
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-07-2020 19:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-07-2020 19:34:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-07-2020 19:35:01
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 5Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955389
Page 101 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) :
Medical History T
erm:Type 2 Diabe
tes
Start Date: UNK/UNK/2
005
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type 2 DiabetesInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-07-2020 19:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-07-2020 19:35:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-07-2020 19:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955390
Page 102 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical History
Term:Deep Vein Thro
mbosis
Start Date: UNK/UNK/201
0
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Deep Vein ThrombosisInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-07-2020 19:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-07-2020 19:35:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-07-2020 19:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:DepressionInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955391
Page 103 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date: UNK/UNK/2
010
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DepressionInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-07-2020 19:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-07-2020 19:36:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-09-2020 23:49:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Pressure in E
yes
Start Date: UNK/UNK/
2018Transcription Error
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955392
Page 104 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: YES
Sep-07-2020 19:37:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:"Eye Pressur
e"
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955393
Page 105 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.h Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:37:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020
08:56:08
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1: C
losedDiscrepancy has
been closed.
Sep-09-2020
23:49:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
AnsweredTranscription
Error
Sep-09-2020
23:49:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
Pressure in
EyesTranscription
Error
Sep-07-2020
21:40:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query 1:
OpenedClarify "EYE
PRESSURE" as
follows...Term is
unclear. Are you
reporting
SENSATION OF
PRESSURE IN
EYE?
INTRAOCULAR
PRESSURE
TEST? Other?
Please update the
verbatim term to
clarify. Thank
you.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955394
Page 106 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-07-2020
19:37:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
"Eye Press
ure"Initial Entry
1.h Start Date:
Date Location User Value Reason
Sep-07-2020 19:37:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-07-2020 19:37:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-07-2020 19:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Erectile Dysfu
nction
Start Date: UNK/UNK/20
19
Ongoing: YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955395
Page 107 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.i Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Erectile DysfunctionInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-07-2020 19:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-07-2020 19:38:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955396
Page 108 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.j
Date Location User Value Reason
Sep-07-2020 19:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:10
Medical History
Term:Tonsillectomy
Start Date: UNK/UNK/19
60
Ongoing: NO
End Date:
UNK/UNK/
1960Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955397
Page 109 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.j Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TonsillectomyInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-07-2020 19:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1960Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-07-2020 19:40:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1960Initial Entry
1.k
Date Location User Value Reason
Sep-07-2020 19:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Appendectomy
Start Date: UNK/UNK/19
64Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955398
Page 110 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
UNK/UNK/
1964
1.k Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AppendectomyInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-07-2020 19:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1964Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-07-2020 19:41:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1964Initial Entry
1.l
Date Location User Value Reason
Sep-07-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955399
Page 111 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical History
Term:Hernia Repair
Start Date: UNK/UNK/19
70
Ongoing: NO
End Date:
UNK/UNK/
1970
1.l Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hernia RepairInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-07-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-07-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1970Initial Entry
1.m
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955400
Page 112 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-07-2020 19:42:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:13
Medical History
Term:Hernia Repair
Start Date: UNK/UNK/19
78
Ongoing: NO
End Date:
UNK/UNK/
1978Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955401
Page 113 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.m Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:42:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:42:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hernia RepairInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-07-2020 19:42:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1978Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-07-2020 19:42:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1978Initial Entry
1.n
Date Location User Value Reason
Sep-07-2020 19:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:14
Medical History
Term:Testicular Canc
er
Start Date: UNK/UNK/19
82Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955402
Page 114 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Ongoing: NO
End Date:
UNK/UNK/
1982
1.n Line/MH Number:
Date Location User Value Reason
Sep-07-2020 19:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 19:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Testicular CancerInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-07-2020 19:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1982Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-07-2020 19:43:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1982Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955403
Page 115 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
100.9Initial Entry
3. Unit:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
187.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.9Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955404
Page 116 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 97.8
Temperature Unit
:F
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-07-2020 19:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955405
Page 117 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-07-2020 19:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-07-2020 19:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
249348Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955406
Page 118 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 19:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 19:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 19:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 19:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 19:45:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 19:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCSGVTranscription Error
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955407
Page 119 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-07-2020 19:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BCSGVTranscription Error
Sep-07-2020 19:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXVT8Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-07-2020 19:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-07-2020 19:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPCSGVTranscription Error
Sep-07-2020 19:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in
length. Please
review and correct
as appropriate.
Sep-07-2020 19:46:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BCSGVTranscription Error
Sep-07-2020 19:45:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXVT8Initial Entry
5.b
Date Location User Value Reason
Sep-07-2020 19:47:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCSJRInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955408
Page 120 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.b Sample ID
Date Location User Value Reason
Sep-07-2020 19:47:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPCSJRInitial Entry
5.c
Date Location User Value Reason
Sep-07-2020 19:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3RRInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-07-2020 19:47:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3RRInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955409
Page 121 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-07-2020 19:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-07-2020 19:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-07-2020 19:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-07-2020 19:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-07-2020 19:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Sep-19-2020 06:19:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955410
Page 122 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020 11:14:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Corrected
Sep-18-2020 11:14:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robyn Glancy Data Entry: Corrected
Sep-18-2020 06:25:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM : If sample
was collected
according to
protocol, please do
not record any
response in this
specified field,
Thank you.
Sep-17-2020 16:31:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Robyn Glancy Data Entry:
BPXVT8Initial Entry
5.a
Date Location User Value Reason
Sep-07-2020 19:46:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXVT8Initial Entry
5.a Sample ID
Date Location User ValueReason
Sep-10-2020
17:20:50
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Sep-09-2020
05:51:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4632095;The
barcode BPXVT8 is
recorded for two
subjects 10791128
and 10791228. Please
review and update as
appropriate.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955411
Page 123 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-07-2020
19:46:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BPX
VT8Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955412
Page 124 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 11:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955413
Page 125 of 170
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-07-2020 19:48:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955414
Page 126 of 170
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-07-2020 19:48:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955415
Page 127 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-05-2020 05:36:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed As per site
confirmation -
updated PD tracker
Oct-03-2020 21:31:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered COrrect - out of
window due to
schedule conflicts
Oct-01-2020 03:41:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened PDQ: DOV at this
visit is out of
window (4 day)
from DOV (02/Sep
/2020) at
V1D1VX1L.
Please either update
DOV or confirm
whether visit is out
of window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Sep-30-2020 12:44:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 10:24:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-30-2020 10:24:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
Sep-26-2020 03:52:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Vaccination,
Vital Signs' forms
at this visit. Thank
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955416
Page 128 of 170
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
you.
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955417
Page 129 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-30-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020Initial Entry
2.a
Date Location User Value Reason
Sep-30-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.2
Temperature Unit
:F
Temperature Loca
tion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-30-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-30-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-30-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955418
Page 130 of 170
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
2.a Temperature Location:
Date Location User Value Reason
Sep-30-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955419
Page 131 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-30-2020 10:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-30-2020 10:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-30-2020 10:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-30-2020 10:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-30-2020 10:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/29/2020Initial Entry
5.a
Date Location User Value Reason
Sep-30-2020 10:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPB0N8Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955420
Page 132 of 170
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Sep-30-2020 10:25:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPB0N8Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955421
Page 133 of 170
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020 13:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955422
Page 134 of 170
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-30-2020 10:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955423
Page 135 of 170
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-29-2020 20:16:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955424
Page 136 of 170
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-29-2020 20:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-29-2020 20:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-29-2020 20:17:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 20:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-29-2020 20:17:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-29-2020 20:17:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSH8RFInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955425
Page 137 of 170
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Oct-29-2020 20:17:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSH8RFInitial Entry
5.b
Date Location User Value Reason
Oct-29-2020 20:17:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSH8RWInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-29-2020 20:17:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSH8RWInitial Entry
5.c
Date Location User Value Reason
Oct-29-2020 20:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPB0Y5Initial Entry
5.c Sample ID
Date Location User Value Reason
Oct-29-2020 20:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPB0Y5Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955426
Page 138 of 170
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-29-2020 20:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-29-2020 20:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-29-2020 20:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955427
Page 139 of 170
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955428
Page 140 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-09-2020 17:01:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Query closed but
will follow for
safety update on
testicular CA
Oct-08-2020 09:28:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Will be resubmitted
Oct-05-2020 09:08:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL please
submit a SAE
safety update to
include the past
medical history of
Testicular Cancer
(1982), along with
the low testosterone
history already
reported.
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Central Retinal Artery Occlusio
nInitial Entry
4. Start Date Time:
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955429
Page 141 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/29/2020 15:30Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 23:49:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-06-2020 20:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered CORRECT
Oct-05-2020 09:09:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Please
confirm severity
grade = 1 for this
SAE report of
monocular vision
loss
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-10-2020 15:12:18 ACV0PFEINFP6000  Query 2: Closed Response satisfies
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955430
Page 142 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00) Eastern
Time (US & Canada)query
Nov-10-2020 10:05:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered SAE form
resubmitted
10/Nov/2020
1008am
Nov-04-2020 09:55:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical – Thank
you. If NO hospital
COVID test was
performed is known,
please submit this
information on a
follow-up SAE
form, as pertinent
information for this
trial.
Nov-03-2020 15:02:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered One was not
performed. No
mention in medical
records of it
Oct-23-2020 16:45:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020383603] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the
results.
Oct-05-2020 06:54:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-03-2020 21:31:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This was reported to
safety by email and
fax notification.
Oct-03-2020 08:14:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
Central Retinal
Artery
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955431
Page 143 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Occlusion(Onset
date:29Sep2020) is
not reported to
Safety database but
marked serious on
AE CRF. Confirm
seriousness and
report to Pfizer
immediately. If this
event is not serious,
downgrade the event
on AE CRF
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Central
Retinal Artery
Occlusion:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YES
Did this serious event result
in persistent or significant d
isability/incapacity?
NOInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955432
Page 144 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-08-2020 12:18:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-08-2020 09:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-08-2020 09:31:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Pre-existing medical cond
itions,hypercoagulable sta
te due to hypertension, TI
IDNew Information
Oct-05-2020 14:57:43
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Opened CLINICAL Please
specify the
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955433
Page 145 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Pre-existing
medical condition
or conditions
related to this event
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
Pre-existing medical cond
itionsInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-07-2020
04:37:12
(UTC-05:00)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955434
Page 146 of 170
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Eastern Time (US &
Canada)
Oct-06-2020
20:45:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-06-2020
20:45:33
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/
NOT RESOLVEDTranscription Error
Oct-05-2020
06:57:44
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020383603,outcome
was reported as NOT
RECOVERED/NOT RESOLVED to
Safety DB however, recorded as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Oct-02-2020
12:56:05
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-02-2020 12:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-05-2020 06:49:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020383603Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955435
Page 147 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021 14:47:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955436
Page 148 of 170
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-11-2021 13:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-11-2021 00:00:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-08-2021 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Jan-08-2021 14:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return f
or Vaccination 3
Participant is:
eligible per local/national re
commendations and confirm
ed to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955437
Page 149 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-08-2021 14:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955438
Page 150 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION - eCRF
Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Jan-08-2021 14:48:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Dec/21/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955439
Page 151 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
- eCRF Audit Trail History
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Jan-08-2021 14:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Jan-08-2021 14:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
REPEAT SCREENING 1Initial Entry
3. Status:
Date Location User Value Reason
Jan-08-2021 14:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955440
Page 152 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 14:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 14:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021 13:31:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-11-2021 06:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-08-2021 14:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-08-2021 14:53:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955441
Page 153 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a
Date Location User Value Reason
Jan-11-2021 13:31:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS79YNInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 13:31:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS79YNInitial Entry
5.b
Date Location User Value Reason
Jan-11-2021 13:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ0VSInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-11-2021 13:32:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPZ0VSInitial Entry
5.c
Date Location User Value Reason
Jan-11-2021 13:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7B3FInitial Entry
5.c Sample ID
Date Location User Value Reason
Jan-11-2021 13:32:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS7B3FInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955442
Page 154 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-08-2021 14:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-08-2021 14:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-08-2021 14:53:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-08-2021 14:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-08-2021 14:53:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Dec/21/2020Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 13:35:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ0V7Transcription Error
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0955443
Page 155 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Jan-08-2021 14:53:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP20V7Initial Entry
5.a Sample ID
Date Location User ValueReason
Jan-11-2021
22:05:32
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_06
Jan-11-2021
13:35:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dTranscription Error
Jan-11-2021
13:35:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BPZ0
V7Transcription Error
Jan-10-2021
23:45:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW6764635;The
barcode BP20V7 is
recorded for three
subjects 10791228,
and 12321203, please
review and update as
appropriate.
Jan-08-2021
14:53:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP20
V7Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0955444
Page 156 of 170
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2020 12:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955445
Page 157 of 170
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-08-2021 14:54:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955446
Page 158 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-11-2021 13:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-11-2021 13:19:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONTranscription Error
Jan-11-2021 13:19:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SUBJECT SAFETY CONCERNInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0955447
Page 159 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-11-2021 13:19:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955448
Page 160 of 170
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-11-2021 13:20:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955449
Page 161 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-11-2021 13:35:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955450
Page 162 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Jan-11-2021 13:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Jan-11-2021 13:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-11-2021 13:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-11-2021 13:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Jan-11-2021 13:35:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Jan-11-2021 13:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPZ12DInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955451
Page 163 of 170
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.a Sample ID
Date Location User Value Reason
Jan-11-2021 13:36:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPZ12DInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955452
Page 164 of 170
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BNT162b2Initial Entry
3. Formulation:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021 11:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955453
Page 165 of 170
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada)
7. Route:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
8. Actual Dose:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30.0Initial Entry
9. Unit:
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ugInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30 MINUTESInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Jan-11-2021 13:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955454
Page 166 of 170
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-16-2021 23:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-16-2021 17:35:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Feb-16-2021 05:12:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Patient
completed
Vaccination 3 visit
through the
1-month post
vaccination visit
after the
Vaccination 4.
Please complete
treatment
disposition CRF
and update date of
EOT2 to match
date of visit at visit
103.
Feb-15-2021 17:21:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/12/2021Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955455
Page 167 of 170
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Contact Type:
Date Location User Value Reason
Feb-15-2021 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Feb-15-2021 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:
Feb/12/2021Initial Entry
3. Comments:
Date Location User Value Reason
Feb-15-2021 17:22:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subject reported, "no changes i
n health since last visit."Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955456
Page 168 of 170
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User ValueReason
Feb-17-2021
02:57:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedIncorrect query
Feb-16-2021
22:43:00
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW7276572;Status
on the Disposition -
Treatment form is
COMPLETED, but
Date is different than
Visit 3 Date. Please
review and update as
appropriate.
Feb-16-2021
17:35:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Feb/1
2/202
1Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Feb-16-2021 17:35:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
OPEN LABEL TREATMENTInitial Entry
3. Status:
Date Location User Value Reason
Feb-16-2021 17:35:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955457
Page 169 of 170
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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1. Subject Status
Date Location User Value Reason
Oct-29-2020 20:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-07-2020 19:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-07-2020 19:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-29-2020 20:17:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
Sep-07-2020 19:45:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
Sep-07-2020 19:32:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Initial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955458
Page 170 of 170
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791228 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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1. Casebook Signature
Date Location User Value Reason
Oct-27-2020 14:36:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f20\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955459