125742 S1 M5 CRF c4591001 1134 11341250

Pfizer Documents (PHMPT/FDA)

Pfizer Bla Submission

Pfizer 16 Plus Documents

166

Download PDF ↗ Live URL (may be dead)

Document text

Page 1 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option 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
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806133
Page 2 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/3/2020
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806134
Page 3 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Demography
1.Subject ID [11341250]
2.Birth Date: /1944
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806135
Page 4 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/3/2020
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806136
Page 5 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806137
Page 6 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806138
Page 7 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[gout]
Start Date: Mar/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[anxiety]
Start Date: UNK/UNK/2009
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[rheumatoid arthritis]
Start Date: UNK/UNK/1970
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[left inner ear infection]
Start Date: Sep/12/2018
Ongoing: NO
End Date:
Sep/18/2018
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806139
Page 8 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[bilateral cataracts]
Start Date: UNK/UNK/2015
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[post menopausal]
Start Date: UNK/UNK/1994
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[appendicitis]
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/1949
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[tonsillitis]
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1953
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[right hammer toe]
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1979
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806140
Page 9 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[left hand carpal tunnel syndrome]
Start Date: UNK/UNK/1983
Ongoing: NO
End Date:
UNK/UNK/1983
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[left fractured femur]
Start Date: Dec/1/2017
Ongoing: NO
End Date:
Dec/1/2017
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[kidney stones]
Start Date: Aug/UNK/2020
Ongoing: NO
End Date:
Aug/UNK/2020
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[appendectomy]
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/1949
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[tonsillectomy]
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1953
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806141
Page 10 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[bunions to left foot]
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1979
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[hammer toe repair to right foot]
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1979
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[left fractured femur repair]
Start Date: Dec/1/1971
Ongoing: NO
End Date:
Dec/1/1971
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug Allergies:[ER visit for kidney stones]
Start Date: Aug/UNK/2020
Ongoing: NO
End Date:
Aug/UNK/2020
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806142
Page 11 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/3/2020
2.Weight: [119.0]
3.Unit: LB
4.Height: [60.0]
5.Unit: in
6.Body Mass Index: [23.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [99.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806143
Page 12 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806144
Page 13 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/3/2020
2.Randomization Number: [250406]
3.Randomization Group: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806145
Page 14 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BP9LD3]
5.bSample ID [BP9LD4]
5.cSample ID [BP9LD5]
5.dSample ID [BPHC2M]
5.eSample ID [BPHC2N]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806146
Page 15 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/3/2020
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 [BP9LHZ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806147
Page 16 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/3/2020 10:06
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
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806148
Page 17 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806149
Page 18 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806150
Page 19 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806151
Page 20 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806152
Page 21 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BM9194]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806153
Page 22 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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/24/2020 09:37
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
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
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806154
Page 23 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806155
Page 24 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE Comments
2.Sample Type SERUM Comments
3.Sample Collected? YES
Date of Collection:
Nov/10/2020Comments
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ] Comments
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSMRZL]
5.bSample ID [BSMRY3]
5.cSample ID [BRCWM8]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806156
Page 25 of 166
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806157
Page 26 of 166
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806158
Page 27 of 166
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806159
Page 28 of 166
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806160
Page 29 of 166
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806161
Page 30 of 166
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806162
Page 31 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806163
Page 32 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806164
Page 33 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806165
Page 34 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806166
Page 35 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806167
Page 36 of 166
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806168
Page 37 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806169
Page 38 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806170
Page 39 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806171
Page 40 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Unplanned Assessments
1.Assessments
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806172
Page 41 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806173
Page 42 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806174
Page 43 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806175
Page 44 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806176
Page 45 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  ADRENAL ADENOCARCI
NOMA Oct/20/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806177
Page 46 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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)[ADRENAL ADENOCARCINOMA]
4.Start Date Time: Oct/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 4
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?
YES
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
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:
[IDIOPATHIC]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? YES
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806178
Page 47 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[2020416797]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806179
Page 48 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806180
Page 49 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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[ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806181
Page 50 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.[ ]      [ ]    Repeating
Pages
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806182
Page 51 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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: //
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806183
Page 52 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806184
Page 53 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806185
Page 54 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806186
Page 55 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806187
Page 56 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806188
Page 57 of 166
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806189
Page 58 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806190
Page 59 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806191
Page 60 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806192
Page 61 of 166
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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?
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806193
Page 62 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806194
Page 63 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806195
Page 64 of 166
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806196
Page 65 of 166
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806197
Page 66 of 166
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806198
Page 67 of 166
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806199
Page 68 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806200
Page 69 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
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 and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806201
Page 70 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/4/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806202
Page 71 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806203
Page 72 of 166
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806204
Page 73 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/10/2020
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806205
Page 74 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806206
Page 75 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jonathan Wilson  Approved Jan-14-2021 17:05:46 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JonathanWilson, 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.
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806207
Page 76 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-03-2020 15:12:53 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806208
Page 77 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806209
Page 78 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Sep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806210
Page 79 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Sep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806211
Page 80 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Sep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806212
Page 81 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Sep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806213
Page 82 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Sep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806214
Page 83 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806215
Page 84 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806216
Page 85 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-03-2020 15:14:21 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806217
Page 86 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormSep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806218
Page 87 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Sep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806219
Page 88 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Sep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806220
Page 89 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Sep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806221
Page 90 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Sep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806222
Page 91 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
5Sep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806223
Page 92 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806224
Page 93 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806225
Page 94 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
6.aSep-24-2020 17:28:38 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806226
Page 95 of 166
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
FormNov-10-2020 18:00:08 (UTC-05:00) Eastern Time
(US & Canada)
FormSep-29-2020 18:51:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806227
Page 96 of 166
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
1Nov-10-2020 18:00:08 (UTC-05:00) Eastern Time
(US & Canada)
1Sep-29-2020 18:51:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806228
Page 97 of 166
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
2Nov-10-2020 18:00:08 (UTC-05:00) Eastern Time
(US & Canada)
2Sep-29-2020 18:51:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806229
Page 98 of 166
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
3Nov-10-2020 18:00:08 (UTC-05:00) Eastern Time
(US & Canada)
3Sep-29-2020 18:51:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806230
Page 99 of 166
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
ItemDate User Comment
4Nov-10-2020 18:00:08 (UTC-05:00) Eastern Time
(US & Canada)
4Sep-29-2020 18:51:30 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806231
Page 100 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jonathan Wilson  Approved Jan-14-2021 17:05:46 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JonathanWilson, 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-06-2021 10:10:23 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan Wilson  Approved Nov-11-2020 10:19:13 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JonathanWilson, 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 Nov-10-2020 17:59:43 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jonathan Wilson  Approved Nov-06-2020 13:55:23 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806232
Page 101 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Affidavit:
By my dated signature below, I, JonathanWilson, 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.
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806233
Page 102 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020 15:11:05
(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-03-2020 15:11:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806234
Page 103 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020 15:13:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 15:12:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Sep-03-2020 15:11:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/3/2020Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806235
Page 104 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-28-2020 23:57:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Event entered in Inform
Oct-28-2020 10:41:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered updated
Oct-28-2020 05:49:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020416797
Adrenal
adenocarcinoma(onset
date:20Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-03-2020 15:10:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11341250Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 15:10:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020 15:11:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020 15:11:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(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-2021-5683-0806236
Page 105 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020 15:11:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806237
Page 106 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 15:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-03-2020 15:13:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Transcription Error
Sep-03-2020 15:12:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Visit is before
the Date Written
Consent Obtained.
Please review and
update as appropriate.
Sep-03-2020 15:12:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806238
Page 107 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020 15:13:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 15:13:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020 15:13:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806239
Page 108 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 15:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:gout
Start Date: Mar/UNK/201
8
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:27:39
(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-03-2020 15:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
goutInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 15:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020 15:27:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-03-2020 15:28:13
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806240
Page 109 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada) Line/MH Number: 2
Medical History Ter
m:anxiety
Start Date: UNK/UNK/20
09
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:28:13
(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-03-2020 15:28:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
anxietyInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 15:28:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 15:28:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-03-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Gastroesophageal ref
lux disease
Start Date: UNK/UNK/1990
Ongoing: YESInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806241
Page 110 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 15:29:33
(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-03-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 15:29:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-03-2020 19:11:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:rheumatoid arthr
itis
Start Date: UNK/UNK/197
0
Ongoing: YESInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806242
Page 111 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:11:30
(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-08-2020 18:28:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Carlos Linn Query 1: Closed Response satisfies
query
Sep-08-2020 17:28:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject is not taking
any systemic
glucocorticoid,
immunosuppressant, or
biological
immunotherapy. PI has
no concern about her
autoimmune status.
Sep-08-2020 05:24:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Carlos Linn Query 1: Opened For on-going
rheumatoid arthritis,
any systemic
glucocorticoid,
immunosuppressant, or
biological
immunotherapy
applied? any concern
of her autoimmune
status?
Sep-03-2020 19:11:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
rheumatoid arthritisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 19:11:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 19:11:30 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806243
Page 112 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern Time
(US & Canada)YES
1.e
Date Location User Value Reason
Sep-03-2020 19:12:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:left inner ear infec
tion
Start Date: Sep/12/2018
Ongoing: NO
End Date:
Sep/18/2018Initial Entry
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:12:11
(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-03-2020 19:12:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left inner ear infectionInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-03-2020 19:12:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/12/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020 19:12:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Sep/18/2018Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806244
Page 113 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.f
Date Location User Value Reason
Sep-03-2020 19:12:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:bilateral catarac
ts
Start Date: UNK/UNK/201
5
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:12:41
(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-03-2020 19:12:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
bilateral cataractsInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-03-2020 19:12:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-03-2020 19:12:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-03-2020 19:13:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:post menopaus
alInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806245
Page 114 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Start Date: UNK/UNK/19
94
Ongoing: YES
1.g Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:13:08
(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-03-2020 19:13:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
post menopausalInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-03-2020 19:13:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-03-2020 19:13:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-03-2020 19:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:appendicitis
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/1
949Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806246
Page 115 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.h Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:13:41
(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-03-2020 19:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
appendicitisInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-03-2020 19:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1949Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-03-2020 19:13:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1949Initial Entry
1.i
Date Location User Value Reason
Sep-03-2020 19:14:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 9
Medical History Te
rm:tonsillitis
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1
953Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806247
Page 116 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.i Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:14:18
(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-03-2020 19:14:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
tonsillitisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-03-2020 19:14:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1953Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-03-2020 19:14:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1953Initial Entry
1.j
Date Location User Value Reason
Sep-03-2020 19:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:right hammer toe
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1
979Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806248
Page 117 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:15:17
(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-03-2020 19:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
right hammer toeInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-03-2020 19:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-03-2020 19:15:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1979Initial Entry
1.k
Date Location User Value Reason
Sep-03-2020 19:16:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:left hand carpal tunnel
syndrome
Start Date: UNK/UNK/1983
Ongoing: NO
End Date:
UNK/UNK/1983Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806249
Page 118 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.k Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:16:03
(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-03-2020 19:16:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left hand carpal tunnel syndromeInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-03-2020 19:16:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1983Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-03-2020 19:16:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1983Initial Entry
1.l
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Te
rm:left fractured fe
mur
Start Date: Dec/1/2017
Ongoing: NO
End Date:
Dec/1/2017Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806250
Page 119 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.l Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:16:43
(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-03-2020 19:16:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left fractured femurInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/1/2017Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-03-2020 19:16:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/1/2017Initial Entry
1.m
Date Location User Value Reason
Sep-03-2020 19:17:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Te
rm:kidney stones
Start Date: Aug/UNK/2020
Ongoing: NO
End Date:
Aug/UNK/20
20Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806251
Page 120 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.m Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:17:16
(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-03-2020 19:17:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kidney stonesInitial Entry
1.m Start Date:
Date Location User Value Reason
Sep-03-2020 19:17:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2020Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-03-2020 19:17:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/UNK/2020Initial Entry
1.n
Date Location User Value Reason
Sep-03-2020 19:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 14
Medical History Te
rm:appendectomy
Start Date: UNK/UNK/1949
Ongoing: NO
End Date:
UNK/UNK/1
949Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806252
Page 121 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.n Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:18:01
(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-03-2020 19:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
appendectomyInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-03-2020 19:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1949Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-03-2020 19:18:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1949Initial Entry
1.o
Date Location User Value Reason
Sep-03-2020 19:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Te
rm:tonsillectomy
Start Date: UNK/UNK/1953
Ongoing: NO
End Date:
UNK/UNK/1
953Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806253
Page 122 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.o Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 19:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
tonsillectomyInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-03-2020 19:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1953Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-03-2020 19:18:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1953Initial Entry
1.p
Date Location User Value Reason
Sep-03-2020 19:24:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History Te
rm:bunions to left fo
ot
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1
979Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806254
Page 123 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.p Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:24:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 19:24:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
bunions to left footInitial Entry
1.p Start Date:
Date Location User Value Reason
Sep-03-2020 19:24:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.p Ongoing:
Date Location User Value Reason
Sep-03-2020 19:24:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1979Initial Entry
1.q
Date Location User Value Reason
Sep-03-2020 19:25:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:17
Medical Histor
y Term:hammer toe repair to
right foot
Start Date: UNK/UNK/1979
Ongoing: NO
End Date:
UNK/UNK/1979Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806255
Page 124 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.q Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:25:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 19:25:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hammer toe repair to right footInitial Entry
1.q Start Date:
Date Location User Value Reason
Sep-03-2020 19:25:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1979Initial Entry
1.q Ongoing:
Date Location User Value Reason
Sep-03-2020 19:25:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1979Initial Entry
1.r
Date Location User Value Reason
Sep-03-2020 19:26:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:18
Medical History
Term:left fractured femur
repair
Start Date: Dec/1/1971
Ongoing: NO
End Date:
Dec/1/1971Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806256
Page 125 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.r Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:26:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 19:26:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left fractured femur repairInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-03-2020 19:26:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/1/1971Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-03-2020 19:26:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/1/1971Initial Entry
1.s
Date Location User Value Reason
Sep-03-2020 19:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:19
Medical History
Term:ER visit for kidney
stones
Start Date: Aug/UNK/2020
Ongoing: NO
End Date:
Aug/UNK/2020Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806257
Page 126 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
1.s Line/MH Number:
Date Location User Value Reason
Sep-03-2020 19:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020 19:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ER visit for kidney stonesInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-03-2020 19:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2020Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-03-2020 19:27:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/UNK/2020Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806258
Page 127 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
119.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
60.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.2Initial Entry
7.a
Date Location User Value Reason
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806259
Page 128 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 99.1
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
99.1Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020 15:14:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806260
Page 129 of 166
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
ableInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806261
Page 130 of 166
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-03-2020 15:14:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806262
Page 131 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-03-2020 15:14:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-03-2020 15:14:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
250406Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806263
Page 132 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 20:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 20:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-03-2020 20:23:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 20:23:24
(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-03-2020 20:23:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 20:23:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9LD3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 20:23:48
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP9LD3Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0806264
Page 133 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
5.b
Date Location User Value Reason
Sep-03-2020 20:23:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9LD4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-03-2020 20:23:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP9LD4Initial Entry
5.c
Date Location User Value Reason
Sep-03-2020 20:24:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9LD5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-03-2020 20:24:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP9LD5Initial Entry
5.d
Date Location User Value Reason
Sep-03-2020 20:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHC2MInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-03-2020 20:24:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHC2MInitial Entry
5.e
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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)
(b) (4)
FDA-CBER-2021-5683-0806265
Page 134 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Sep-03-2020 20:24:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHC2NInitial Entry
5.e Sample ID
Date Location User Value Reason
Sep-03-2020 20:24:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPHC2NInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0806266
Page 135 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-03-2020 20:23:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-03-2020 20:23:07
(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-03-2020 20:23:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-03-2020 20:23:07
(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-03-2020 20:23:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/3/2020Initial Entry
5.a
Date Location User Value Reason
Sep-03-2020 20:23:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9LHZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-03-2020 20:23:14
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BP9LHZInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0806267
Page 136 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806268
Page 137 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020 15:24:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 15:24:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 15:24:04
(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-03-2020 15:24:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/3/2020 10:06Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 15:24:04
(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-03-2020 15:24:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806269
Page 138 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-03-2020 15:24:04
(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-03-2020 15:24:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-03-2020 15:24:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806270
Page 139 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-03-2020 15:24:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIA
RY NOT COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806271
Page 140 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-28-2020
10:24:31
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clos
edAlternate query present on V3
to mark the visit erroneous.
Sep-25-2020
15:55:38
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
wereddate of visit was entered
incorrectly and should be
deleted
Sep-25-2020
03:07:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW4814209;The Date of
Visit at Visit V2_VAX2_L is
the same as the other Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L.
Please review for duplication
and update as appropriate.
Sep-24-2020
17:27:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry:
Sep/24
/2020Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806272
Page 141 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date:
Date Location User Value Reason
Sep-24-2020 17:28:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2.a
Date Location User Value Reason
Sep-24-2020 17:28:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-24-2020 17:28:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-24-2020 17:28:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-24-2020 17:28:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-24-2020 17:28:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806273
Page 142 of 166
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide
ntifier:Not Applic
able
Test:: Not Applic
ableInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806274
Page 143 of 166
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-24-2020 17:28:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806275
Page 144 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-24-2020 16:05:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-24-2020 16:05:05
(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-24-2020 16:05:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-24-2020 16:05:05
(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-24-2020 16:05:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
Sep-24-2020 16:05:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9194Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 16:05:20
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
BM9194Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b)(4),
(b)(6)
(b)(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0806276
Page 145 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US & Canada)
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806277
Page 146 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 17:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 17:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 17:29:20
(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-24-2020 17:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 09:37Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 17:29:20
(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-24-2020 17:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806278
Page 147 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-24-2020 17:29:20
(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-24-2020 17:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-24-2020 17:29:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0806279
Page 148 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User ValueReason
Nov-11-2020
16:26:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Clo
sedResponse satisfies query
Nov-11-2020
09:29:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Ans
weredOriginal value is correct
Nov-11-2020
04:27:27
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
5: Op
enedPDQ: Date of visit at
V3_MONTH1_POSTVAX2_L
is out of window for 12 days
from V2_VAX2_L DOV or
V2 Vaccination date. Please
verify and update. Else,
confirm in query response
appropriately. 
Nov-10-2020
17:59:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Del
etedClose Auto Query
Nov-10-2020
17:59:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Can
didateErroneous Visit is marked, but
date of visit is entered. Please
check whether other
assessments are performed at
this visit.
Nov-10-2020
17:59:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Nov/1
0/202
0New Information
Sep-29-2020 ACV0PFEINFP6000  QueryNo other assessments are
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806280
Page 149 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
07:11:59
(UTC-05:00)
Eastern Time
(US &
Canada)3: Del
etedperformed at this visit.
Sep-29-2020
01:05:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies query
Sep-28-2020
13:40:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
weredChanged data per query
Sep-28-2020
13:38:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Can
didateErroneous Visit is marked, but
date of visit is entered. Please
check whether other
assessments are performed at
this visit.
Sep-28-2020
10:23:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedAlternate query present to
mark the visit erroneous.
Sep-28-2020
06:21:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dPDQ RQ1: As per the query
response, if visit was entered
incorrectly, please mark
response to 'Erroneous Visit',
else keep the query open until
data available and update.
Thank you.
Sep-25-2020
15:54:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Ans
wereddate of visit was entered
incorrectly and should be
deleted
Sep-25-2020
15:54:34
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  Query
1: Ans
wereddate of visit was entered
incorrectly and should be
deleted
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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)
(b) (4)
FDA-CBER-2021-5683-0806281
Page 150 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(US &
Canada)
Sep-25-2020
05:19:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedPDQ: DOV at this visit is out
of window (-28 day) from
DOV (24/Sep/2020) at V2.
Please reconcile and update
accordingly, else confirm date
is correct as is.
Sep-25-2020
03:07:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4814210;The Date of
Visit at Visit
V3_MONTH1_POSTVAX2_L
is the same as the other Date
of Visit at Visit V2_VAX2_L.
Please review for duplication
and update as appropriate.
Sep-24-2020
16:48:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Sep/2
4/202
0Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-10-2020 17:59:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: New Information
Sep-28-2020 13:38:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806282
Page 151 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 18:00:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
Nov-10-2020 18:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Sep-29-2020 18:51:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 18:00:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
Nov-10-2020 18:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Sep-29-2020 18:51:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 18:00:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 18:00:32
(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.
Nov-10-2020 18:00:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806283
Page 152 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Nov/10/2020
Nov-10-2020 18:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Sep-29-2020 18:51:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-10-2020 18:00:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Sep-29-2020 18:51:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5.a
Date Location User Value Reason
Nov-10-2020 18:00:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMRZLInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 18:00:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSMRZLInitial Entry
5.b
Date Location User Value Reason
Nov-10-2020 18:01:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSMRY3Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806284
Page 153 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
5.b Sample ID
Date Location User Value Reason
Nov-10-2020 18:01:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSMRY3Initial Entry
5.c
Date Location User Value Reason
Nov-10-2020 18:01:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRCWM8Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-10-2020 18:01:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BRCWM8Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806285
Page 154 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-11-2020 01:19:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-10-2020 18:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Nov-10-2020 18:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/10/2020New Information
Nov-10-2020 16:31:14
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Steven Finegan
ProdQuery 2: Opened Per CRF guidelines,
the treatment period
is defined as Vax 1
through Visit 3.If the
V3 was not yet
completed, please
remove all EOT data
so that the form is
blank. If the V3 has
occurred, please enter
the visit and update
the EOT date to
match V3 date.
Sep-29-2020 09:07:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Sep-28-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
Sep-27-2020 08:35:00
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM Query: Kindly
review and complete
‘Disposition -
Treatment form' at
this visit. Thank you.
2. Phase of Disposition:
Date Location User Value Reason
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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)
FDA-CBER-2021-5683-0806286
Page 155 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Sep-28-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-28-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806287
Page 156 of 166
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
Date Location User Value Reason
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806288
Page 157 of 166
***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, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Category:
Date Location User Value Reason
Oct-28-2020 10:36:21
(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-28-2020 10:36:21
(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
Nov-02-2020 16:30:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the
response. Thank you!
Nov-02-2020 15:54:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirmed no covid
test was done. Follow
up to safety will be
sent today
02NOV2020.
Nov-01-2020 21:05:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Kindly confirm if any
SARS-CoV-2 (NAAT
or other) tests were
performed on the SAE
submitted to safety. If
test performed = YES,
please provide FU
report with results. If
test was NOT done or
NOT available, please
FU as well. Thanks
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ADRENAL ADENOCARCINOMAInitial Entry
4. Start Date Time:
Date Location User Value Reason
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0806289
Page 158 of 166
***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, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Feb-23-2021 17:00:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Feb-23-2021 15:26:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Per the source this is
still ongoing
Feb-22-2021 12:26:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINQUERY -
ADRENAL
ADENOCARCINOMA
( 20 Oct 20) is still
reported as ONGOING.
Please confirm still
present or enter END
DATE (Remission) if
known.
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial 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
Oct-28-2020 23:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-28-2020 10:36:21 ACV0PFEINFP6000  auto query Query 1: Candidate For AE ADRENAL
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806290
Page 159 of 166
***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, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
(UTC-05:00) Eastern Time
(US & Canada)(autoquery) ADENOCARCINOMA:
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event Number"
is blank.
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated with
congenital anomaly or birth defect?
NO
Did this serious event result in deat
h?
NO
Did this serious event require or pro
long hospitalization?
YES
Did this serious event result in persi
stent or significant disability/incapa
city?
NO
Is this serious event life threatening
?
YES
Other medically important serious e
vent
NOInitial Entry
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-28-2020 10:36:21
(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
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806291
Page 160 of 166
***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, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s), t
his event is due to:
OTHER
If Other, specify:
IDIOPATHICInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-28-2020 10:36:21
(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-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-28-2020 10:36:21
(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-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RESOLVE
DInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-28-2020 10:36:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (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-2021-5683-0806292
Page 161 of 166
***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, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Date Location User Value Reason
Oct-28-2020 23:56:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020416797Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806293
Page 162 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021 10:10:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806294
Page 163 of 166
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-06-2021 10:11:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for V
accination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806295
Page 164 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-06-2021 10:10:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-06-2021 10:10:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADD
ITIONAL VACCINATIONInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0806296
Page 165 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-28-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-03-2020 15:14:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-03-2020 15:13:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-10-2020 18:01:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/10/2020New Information
Sep-28-2020 14:13:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/24/2020Initial Entry
Sep-03-2020 15:14:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
Sep-03-2020 15:13:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/3/2020Initial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) (4)
FDA-CBER-2021-5683-0806297
Page 166 of 166
***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: 1134 Site Name: (1134) PMG Research of Winston-Salem
Subject No: 11341250 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:34
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 12:37:16
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae300b\Final\Final On: 01-Apr-2021 03:58 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0806298