125742 S1 M5 CRF c4591001 1080 10801152

Document text

Page 1 of 179
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956626
Page 2 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956627
Page 3 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Demography
1.Subject ID [10801152]
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:
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956628
Page 4 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956629
Page 5 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956630
Page 6 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956631
Page 7 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroid]
Start Date: UNK/UNK/1984
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acid Reflux]
Start Date: UNK/UNK/1997
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2000
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hiatal Hernia]
Start Date: UNK/UNK/1997
Ongoing: YES
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956632
Page 8 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibroids]
Start Date: UNK/UNK/1974
Ongoing: NO
End Date:
UNK/UNK/1974
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Histerectomy]
Start Date: UNK/UNK/1974
Ongoing: NO
End Date:
UNK/UNK/1974
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Growth on Thyroid]
Start Date: UNK/UNK/1974
Ongoing: NO
End Date:
UNK/UNK/1975
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Partial Thyroidectomy]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1975
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956633
Page 9 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Obesity]
Start Date: UNK/UNK/1990
Ongoing: YES
1.kLine/MH Number: Not Applicable
[ ]Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]Comments
Start Date: Not Applicable
//Comments
Ongoing: Not Applicable Comments
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Knee Replacement Surgery]
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998
1 mLine/MH Number: Not Applicable
[ ]Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:Not Applicable
[ ]Comments
Start Date: Not Applicable
//Comments
Ongoing: Not Applicable Comments
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956634
Page 10 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Knee Replacement Surgery]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Arrhythmia- A-Fib]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956635
Page 11 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [135.4]
3.Unit: kg
4.Height: [167.0]
5.Unit: cm
6.Body Mass Index: [48.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956636
Page 12 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956637
Page 13 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [251698]
3.Randomization Group: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956638
Page 14 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BPTS2J]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956639
Page 15 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
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 [BP59N4]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956640
Page 16 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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/4/2020 09:46
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
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956641
Page 17 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956642
Page 18 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956643
Page 19 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956644
Page 20 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956645
Page 21 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BPTS8V]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956646
Page 22 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: Oct/1/2020 08:28
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
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956647
Page 23 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/2/2020
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956648
Page 24 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/2/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPRC6B]
5.bSample ID [BPRC6C]
5.cSample ID [BPTSJD]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956649
Page 25 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956650
Page 26 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956651
Page 27 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956652
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956653
Page 29 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956654
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956655
Page 31 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956656
Page 32 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956657
Page 33 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956658
Page 34 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956659
Page 35 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956660
Page 36 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956661
Page 37 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956662
Page 38 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956663
Page 39 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956664
Page 40 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Unplanned Assessments
1.Assessments
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956665
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956666
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956667
Page 43 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956668
Page 44 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956669
Page 45 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#CategoryAE Iden
tifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Worsening of WATER RETENTION
in lower extremities Sep/16/2020 U
NK:UNK NO
End Date Time:
Sep/18/2020 UNK:U
NK
 Repeating
Pages
 2.ADVERSE E
VENT 2  Worsening of HYPERTENSION  Sep/16/2020 U
NK:UNK NO
End Date Time:
Sep/18/2020 UNK:U
NK
 Repeating
Pages
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956670
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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)[Worsening of WATER RETENTION in lower extremities]
4.Start Date Time: Sep/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
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:
[UNKNOWN]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956671
Page 47 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/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[2020363610]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956672
Page 48 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of HYPERTENSION]
4.Start Date Time: Sep/16/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/18/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956673
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
[UNKNOWN]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/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[2020363610]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956674
Page 50 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956675
Page 51 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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[ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956676
Page 52 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956677
Page 53 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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: //
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956678
Page 54 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956679
Page 55 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956680
Page 56 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
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Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0956682
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Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
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FDA-CBER-2021-5683-0956683
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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1.Transfusion Type:
2.Date of Transfusion: //
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
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(b) (4)
FDA-CBER-2021-5683-0956685
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Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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(b) (4)
FDA-CBER-2021-5683-0956686
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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:
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(b) (4)
FDA-CBER-2021-5683-0956687
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Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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?
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(b) (4)
FDA-CBER-2021-5683-0956688
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
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(b) (4)
FDA-CBER-2021-5683-0956689
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***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956690
Page 66 of 179
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956691
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956692
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956693
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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 [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956694
Page 70 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956695
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Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
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
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956696
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Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956697
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Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
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(b) (4)
FDA-CBER-2021-5683-0956698
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Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956699
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Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
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Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Form Comments
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/2/2020
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(b) (4)
FDA-CBER-2021-5683-0956700
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956701
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sylvia Shoffner  Approved Jan-21-2021 16:33:30 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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.
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(b) (4)
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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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-04-2020 18:42:37 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956703
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.kSep-09-2020 18:35:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956704
Page 80 of 179
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.kSep-09-2020 18:35:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956705
Page 81 of 179
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.kSep-09-2020 18:35:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956706
Page 82 of 179
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Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.kSep-09-2020 18:35:36 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956707
Page 83 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.mSep-09-2020 18:36:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956708
Page 84 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.mSep-09-2020 18:36:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956709
Page 85 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.mSep-09-2020 18:36:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956710
Page 86 of 179
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1.mSep-09-2020 18:36:40 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956711
Page 87 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956712
Page 88 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
1Sep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956713
Page 89 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
2Sep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956714
Page 90 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
3Sep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956715
Page 91 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
4Sep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956716
Page 92 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
5Sep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956717
Page 93 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956718
Page 94 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956719
Page 95 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
6.aSep-04-2020 18:47:39 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956720
Page 96 of 179
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
ItemDate User Comment
FormSep-24-2020 13:47:06 (UTC-05:00) Eastern Time
(US & Canada)Please unlock medical hx for patient
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956721
Page 97 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Sylvia Shoffner  Approved Jan-21-2021 16:33:30 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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 11:10:15 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Sylvia Shoffner  Approved Nov-06-2020 13:51:04 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, SylviaShoffner, 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.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956722
Page 98 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-04-2020 18:41:30
(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-04-2020 18:41:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956723
Page 99 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-04-2020 18:41:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/4/2020Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956724
Page 100 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-04-2020 18:41:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10801152Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-04-2020 18:41:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-04-2020 18:42:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-04-2020 18:42:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-04-2020 18:42:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956725
Page 101 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-04-2020 18:42:28
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956726
Page 102 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-04-2020 18:43:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-04-2020 18:43:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-04-2020 18:43:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956727
Page 103 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.a
Date Location User Value Reason
Sep-04-2020 18:46:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
Sep-04-2020 18:44:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/20
08
Ongoing:Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-04-2020 18:44:13
(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
Oct-02-2020 03:14:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 13:56:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-30-2020 10:20:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Changed data per
query
Sep-30-2020 10:20:06
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Answered Changed data per
query
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956728
Page 104 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Time (US & Canada)
Sep-29-2020 13:53:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL On
review of the SAE
report for
Arrhythmia and
Fluid Retention, past
medical history of
heart arrhythmia was
reported, yet is not in
the CRF. Please
review for clinical
relevance and update
Med Hx as
appropriate.
Sep-25-2020 05:42:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Medical
History Form has
been Unfrozen as per
request in comment
present on Subject
Status form.
Sep-04-2020 18:44:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-04-2020 18:44:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-04-2020 18:46:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-04-2020 18:45:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956729
Page 105 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Medical History Ter
m:Hypothyroid
Start Date: UNK/UNK/19
84
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Sep-04-2020 18:45:02
(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-04-2020 18:45:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-04-2020 18:45:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1984Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-04-2020 18:45:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-04-2020 18:46:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 3
Medical History Ter
m:Acid Reflux
Start Date: UNK/UNK/19
97Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956730
Page 106 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: YES
Sep-04-2020 18:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Acid Reflux
Start Date: UNK/UNK/19
97
Ongoing:Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-04-2020 18:45:45
(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-04-2020 18:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Acid RefluxInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-04-2020 18:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1997Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-04-2020 18:46:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-08-2020 11:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956731
Page 107 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Medical History Te
rm:Seasonal Allerg
ies
Start Date: UNK/UNK/20
00
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:27:50
(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 11:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal AllergiesInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-08-2020 11:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-08-2020 11:27:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-08-2020 11:29:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History Ter
m:Hiatal Hernia
Start Date: UNK/UNK/19
97Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956732
Page 108 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:29:15
(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-08-2020 11:29:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Hiatal HerniaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-08-2020 11:29:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1997Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-08-2020 11:29:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-08-2020 11:30:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Fibroids
Start Date: UNK/UNK/197
4Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956733
Page 109 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/1
974
1.f Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:30:24
(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-08-2020 11:30:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FibroidsInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-08-2020 11:30:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1974Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-08-2020 11:30:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1974Initial Entry
1.g
Date Location User Value Reason
Sep-08-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number
:7
Medical History T
erm:HisterectomyTranscription Error
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956734
Page 110 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/UNK/197
4
Ongoing: NO
End Date:
UNK/UNK/1
974
Sep-08-2020 11:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Fibroids Surgery
Start Date: UNK/UNK/197
4
Ongoing: NO
End Date:
UNK/UNK/1
974Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956735
Page 111 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.g Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:31:13
(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-08-2020 11:37:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HisterectomyTranscription Error
Sep-08-2020 11:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Fibroids SurgeryInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-08-2020 11:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1974Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-08-2020 11:31:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1974Initial Entry
1.h
Date Location User Value Reason
Sep-08-2020 11:33:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Growth on Thyr
oid
Start Date: UNK/UNK/197
4Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956736
Page 112 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/1
975
1.h Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:33:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 11:33:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Growth on ThyroidInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-08-2020 11:33:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1974Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-08-2020 11:33:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1975Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956737
Page 113 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.i
Date Location User Value Reason
Sep-08-2020 11:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Partial Thyroidec
tomy
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/19
75Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956738
Page 114 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.i Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:34:26
(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-08-2020 11:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Partial ThyroidectomyInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-08-2020 11:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1975Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-08-2020 11:34:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1975Initial Entry
1.j
Date Location User Value Reason
Sep-08-2020 11:35:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:Obesity
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956739
Page 115 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.j Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:35:05
(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-08-2020 11:35:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ObesityInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-08-2020 11:35:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-08-2020 11:35:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-10-2020 12:27:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: Not Applica
ble
Medical History Te
rm:Not Applica
ble
Start Date: Not Applica
ble
Ongoing: Not Applica
bleTranscription Error
(DELETED)
Sep-09-2020 18:35:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: Not Applica
bleInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956740
Page 116 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Medical History Te
rm:Not Applica
ble
Start Date: Not Applica
ble
Ongoing: Not Applica
ble
Sep-09-2020 18:35:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
Sep-09-2020 18:35:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:
Medical History
Term:
Start Date: UNK/UNK/199
8
Ongoing: NO
End Date:
UNK/UNK/
1998Transcription Error
Sep-09-2020 18:33:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:11
Medical Histo
ry Term:Left Knee REPLA
CEMENT
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/199
8Transcription Error
Sep-08-2020 11:40:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11
Medical Histor
y Term:Left Knee Bone o
n Bone
Start Date: UNK/UNK/1998Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956741
Page 117 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Ongoing: NO
End Date:
UNK/UNK/19
98
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956742
Page 118 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.k Line/MH Number:
Date Location User Value Reason
Sep-10-2020 12:27:12
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableTranscription Error
(DELETED)
Sep-09-2020 18:35:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-09-2020 18:35:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-08-2020 11:40:03
(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 ValueReason
Sep-13-2020
08:15:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Saumitra Dubey TMS
QueryQuery
2: Clo
sedLog is deleted.
Sep-10-2020
12:27:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleTranscription Error
(DELETED)
Sep-10-2020
12:27:12
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: Ans
weredTranscription Error
Sep-10-2020
05:08:59
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Op
enedNull Term: Verbatim
term must not be
null/blank.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956743
Page 119 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Canada)
Sep-10-2020
03:56:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Clo
sedDiscrepancy has been
closed.
Sep-09-2020
18:35:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Not A
pplica
bleInitial Entry
Sep-09-2020
18:35:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:Transcription Error
Sep-09-2020
18:33:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
1: Ans
weredTranscription Error
Sep-09-2020
18:33:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Left K
nee R
EPLA
CEM
ENTTranscription Error
Sep-08-2020
13:13:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Op
enedClarify LEFT KNEE
BONE ON BONE as
follows...Are you
reporting a disease
process such as LEFT
KNEE BONE ON
BONE (ARTHRITIS)?
LEFT KNEE BONE
ON BONE
(OSTEOARTHRITIS)?
If so, please edit as
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956744
Page 120 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
such. Otherwise,
specify BONE ON
BONE further. Thank
you.
Sep-08-2020
11:40:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Left K
nee B
one o
n Bon
eInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-10-2020 12:27:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableTranscription Error
(DELETED)
Sep-09-2020 18:35:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-09-2020 18:35:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-08-2020 11:40:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-10-2020 12:27:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableTranscription Error
(DELETED)
Sep-09-2020 18:35:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-09-2020 18:35:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0956745
Page 121 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-08-2020 11:40:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.l
Date Location User Value Reason
Sep-08-2020 11:41:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:Left Knee Replacem
ent Surgery
Start Date: UNK/UNK/1998
Ongoing: NO
End Date:
UNK/UNK/1998Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956746
Page 122 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.l Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:41:42
(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-08-2020 11:41:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Left Knee Replacement SurgeryInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-08-2020 11:41:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.l Ongoing:
Date Location User Value Reason
Sep-08-2020 11:41:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1998Initial Entry
1.m
Date Location User Value Reason
Sep-10-2020 12:28:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: Not Applica
ble
Medical History Te
rm:Not Applica
ble
Start Date: Not Applica
ble
Ongoing: Not Applica
bleTranscription Error
(DELETED)
Sep-09-2020 18:36:40 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956747
Page 123 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)(autocalc) Line/MH Number: Not Applica
ble
Medical History Te
rm:Not Applica
ble
Start Date: Not Applica
ble
Ongoing: Not Applica
ble
Sep-09-2020 18:36:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number:
Medical History Term:
Start Date:
Ongoing:Transcription Error
Sep-09-2020 18:36:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:
Medical History
Term:
Start Date:
Ongoing: NO
End Date:
UNK/UNK/
2016Transcription Error
Sep-09-2020 18:35:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:
Medical History
Term:
Start Date: UNK/UNK/201
6
Ongoing: NO
End Date:
UNK/UNK/
2016Transcription Error
Sep-08-2020 11:43:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:Right Knee bone
on BoneInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956748
Page 124 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/20
16
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956749
Page 125 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1.m Line/MH Number:
Date Location User Value Reason
Sep-10-2020 12:28:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableTranscription Error
(DELETED)
Sep-09-2020 18:36:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-09-2020 18:35:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-08-2020 11:43:49
(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-13-2020
08:15:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Saumitra Dubey TMS
QueryQuery
2: Clos
edLog is deleted.
Sep-10-2020
12:28:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleTranscription Error
(DELETED)
Sep-10-2020
12:28:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: Ans
weredTranscription Error
Sep-10-2020
05:09:08
(UTC-05:00)
Eastern TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
2: Ope
nedNull Term: Verbatim
term must not be
null/blank.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956750
Page 126 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(US &
Canada)
Sep-10-2020
03:56:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Clos
edDiscrepancy has been
closed.
Sep-09-2020
18:36:40
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry:
Not A
pplica
bleInitial Entry
Sep-09-2020
18:35:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
1: Ans
weredTranscription Error
Sep-09-2020
18:35:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry:Transcription Error
Sep-08-2020
13:13:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Ope
nedClarify RIGHT KNEE
BONE ON BONE as
follows...Are you
reporting a disease
process such as RIGHT
KNEE BONE ON
BONE (ARTHRITIS)?
LEFT KNEE BONE
ON BONE
(OSTEOARTHRITIS)?
If so, please edit as
such. Otherwise,
specify BONE ON
BONE further. Thank
you.
Sep-08-2020
11:43:49
(UTC-05:00)ACV0PFEINFP6000  Data
Entry:
RightInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956751
Page 127 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Eastern Time
(US &
Canada)Knee b
one on
Bone
1.m Start Date:
Date Location User Value Reason
Sep-10-2020 12:28:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableTranscription Error
(DELETED)
Sep-09-2020 18:36:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-09-2020 18:36:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-08-2020 11:43:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.m Ongoing:
Date Location User Value Reason
Sep-10-2020 12:28:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableTranscription Error
(DELETED)
Sep-09-2020 18:36:40
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-09-2020 18:36:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-08-2020 11:43:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.n
Date Location User Value Reason
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956752
Page 128 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-08-2020 11:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:14
Medical Histo
ry Term:Right Knee Replace
ment Surgery
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016Initial Entry
1.n Line/MH Number:
Date Location User Value Reason
Sep-08-2020 11:45:45
(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-08-2020 11:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Right Knee Replacement SurgeryInitial Entry
1.n Start Date:
Date Location User Value Reason
Sep-08-2020 11:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.n Ongoing:
Date Location User Value Reason
Sep-08-2020 11:45:45
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.o
Date Location User Value Reason
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956753
Page 129 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-01-2020 10:35:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number
:15
Medical History T
erm:Arrhythmia- A
-Fib
Start Date: UNK/UNK/19
96
Ongoing: YESNew Information
Sep-30-2020 10:19:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 15
Medical History Te
rm:Arrhythmia
Start Date: UNK/UNK/1
996
Ongoing: YESInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956754
Page 130 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
1.o Line/MH Number:
Date Location User Value Reason
Sep-30-2020 10:19:55
(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
Oct-01-2020 16:04:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Oct-01-2020 10:35:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-01-2020 10:35:32
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Arrhythmia- A-FibNew Information
Oct-01-2020 09:45:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY: Please
review if more
description can be
added to clarify the
type of arrhythmia in
event term
Sep-30-2020 10:19:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ArrhythmiaInitial Entry
1.o Start Date:
Date Location User Value Reason
Sep-30-2020 10:19:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.o Ongoing:
Date Location User Value Reason
Sep-30-2020 10:19:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956755
Page 131 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
135.4Initial Entry
3. Unit:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
167.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48.5Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956756
Page 132 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
7.a
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Location
::FOREHEA
DInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.3Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 18:47:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956757
Page 133 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 18:47:39
(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-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Iden Not ApplicaInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956758
Page 134 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
tifier: ble
Test:: Not Applica
ble
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-04-2020 18:47:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956759
Page 135 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-04-2020 18:48:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020
01:30:16
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clo
sedResponse
satisfies query
Sep-08-2020
14:54:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Sep-08-2020
14:54:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
251698Transcription
Error
Sep-05-2020
10:11:36
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Ope
nedAs per Impala,
Randomization
Number is
251698 . Please
review and
update as
appropriate.
Sep-04-2020
18:48:15
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP59N4Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956760
Page 136 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 18:48:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 18:48:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-09-2020 18:31:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-07-2020 00:29:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-04-2020 18:48:26
(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-04-2020 18:48:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956761
Page 137 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-24-2020 08:28:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTS2JChanged Information
Sep-09-2020 18:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTS2LInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-24-2020 08:28:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPTS2JChanged Information
Sep-09-2020 18:31:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPTS2LInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956762
Page 138 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 18:48:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 18:48:42
(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-04-2020 18:48:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 18:48:42
(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-04-2020 18:48:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 18:48:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP59N4Initial Entry
5.a Sample ID
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956763
Page 139 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-04-2020 18:48:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP59N4Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956764
Page 140 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-04-2020 18:49:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 18:49:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 18:49:24
(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-04-2020 18:49:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 09:46Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 18:49:24
(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-04-2020 18:49:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956765
Page 141 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
7. Route:
Date Location User Value Reason
Sep-04-2020 18:49:24
(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-04-2020 18:49:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-04-2020 18:49:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956766
Page 142 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020 18:49:33
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIARY
NOT COLLECTED FOR THIS SUB
JECTInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956767
Page 143 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 08:44:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed V2 updated
Oct-12-2020 02:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed As per site
confirmation -
updated PD tracker
Oct-09-2020 09:26:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Date entered is
correct. Visit
proformed out of
window but not due
to delay in
vaccination.
Oct-06-2020 09:43:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened PDQ: DOV at this
visit is out of
window (4 day) from
DOV (04/Sep/2020)
at V1D1VX1L.
Please either update
DOV or confirm
whether visit is out
of window due to
temporary delay of
vaccination/ else
provide details as
appropriate.
Oct-02-2020 03:19:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Need to wait till visit
occurs.
Oct-01-2020 08:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-01-2020 08:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
Sep-30-2020 12:53:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Please respond to this
query once action has
been taken.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956768
Page 144 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-30-2020 12:47:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered V2 has not occurred
yet
Sep-30-2020 05:30:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM 1: Visit 1 was
completed on "4/Sep
/2020", however visit
2 is not entered,
please review and
update all forms
under the visit, else
clarify, thank you.
Sep-29-2020 16:24:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Visit has not be
preformed
Sep-29-2020 08:26:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal Swab,
Pregnancy Test,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0956769
Page 145 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date:
Date Location User Value Reason
Oct-09-2020 09:22:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-09-2020 09:22:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Locatio
n::FOREHEA
DInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-09-2020 09:22:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-09-2020 09:22:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-09-2020 09:22:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956770
Page 146 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-09-2020 09:22:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956771
Page 147 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define 113Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956772
Page 148 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
d Identifier:
Test:: Choriogonadotropi
n Beta_PX113
Result::
Not Done:: NOT DONE
6.a Sponsor ID:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-09-2020 09:23:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956773
Page 149 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-09-2020 09:23:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-09-2020 09:23:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-09-2020 09:24:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-09-2020 09:23:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-09-2020 09:23:49
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
5.a
Date Location User Value Reason
Oct-09-2020 09:24:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTS8VInitial Entry
5.a Sample ID
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956774
Page 150 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Oct-09-2020 09:24:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPTS8VInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956775
Page 151 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 08:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956776
Page 152 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
7. Route:
Date Location User Value Reason
Oct-09-2020 09:26:04
(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
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-09-2020 09:26:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956777
Page 153 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-02-2020 17:57:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956778
Page 154 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-02-2020 17:58:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-02-2020 17:58:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-03-2020 08:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-03-2020 03:47:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-02-2020 17:58:02
(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-02-2020 17:58:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/2/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956779
Page 155 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Nov-03-2020 08:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRC6BInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-03-2020 08:37:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPRC6BInitial Entry
5.b
Date Location User Value Reason
Nov-03-2020 08:38:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRC6CInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-03-2020 08:38:08
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPRC6CInitial Entry
5.c
Date Location User Value Reason
Nov-03-2020 08:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPTSJDInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-03-2020 08:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPTSJDInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956780
Page 156 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-02-2020 17:58:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-02-2020 17:58:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-02-2020 17:58:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956781
Page 157 of 179
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956782
Page 158 of 179
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956783
Page 159 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-01-2020
13:01:07
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Close
dResponse satisfies
query
Sep-30-2020
12:41:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredNew Information
Sep-30-2020
12:41:51
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Worsening of
WATER RETE
NTION in low
er extremitiesNew Information
Sep-25-2020
13:34:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reiss
ued:OpenedGPD CLINQUERY:
Please clarify
anatomic location of
water retention.
Sep-24-2020
16:41:29
(UTC-05:00)
Eastern TimeACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Close
dDiscrepancy has
been closed.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956784
Page 160 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(US & Canada)
Sep-24-2020
13:41:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answ
eredNew Information
Sep-24-2020
13:41:59
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Worsening of
WATER RETE
NTIONNew Information
Sep-23-2020
17:52:27
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2: Open
edMultiple concepts in
the term WATER
RETENTION DUE
TO
UNCONTROLLED
HYPERTENSION.
Split the term into
WATER
RETENTION and
UNCONTROLLED
HYPERTENSION
and report
separately. Thank
you.
Sep-23-2020
13:00:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answ
eredNew Information
Sep-23-2020
13:00:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WATER RETE
NTION DUE
TO UNCONT
ROLLED HYP
ERTENSIONNew Information
Sep-21-2020
09:14:18
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Open
edGPD CLINQUERY:
Regarding 'water
retention', please
clarify anatomic
location and nature
of water retention.
For example, does
this refer to
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956785
Page 161 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
peripheral edema, or
pulmonary edema,
or urinary bladder
retention or other?
Sep-18-2020
18:37:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WATER RETE
NTIONInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-30-2020 12:46:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/18/2020 UNK:UNKNew Information
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956786
Page 162 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Oct-29-2020 14:08:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Query closed; will
follow for SAE update
with the requested
COVID test info
Oct-29-2020 11:30:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Will update
Oct-29-2020 00:13:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical – Thank you.
If NO hospital Covid
test was performed is
known, please submit
this information on a
follow-up SAE form,
as pertinent
information for this
trial.
Oct-28-2020 11:48:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Patient was not tested
for COVID per
medical records
Oct-23-2020 16:52:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical - COVID
testing has not been
reported in the SAE
submitted to safety.
Please submit a
follow-up SAE form
[#2020363610] to
provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Sep-21-2020 05:55:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event recorded in SDB
Sep-20-2020 10:34:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
WATER
RETENTION(Onset
date:16Sep2020) is not
reported on SAE
Report Form but
marked serious on AE
CRF. Confirm
seriousness and report
to Pfizer immediately.
If this event is not
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956787
Page 163 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
serious, downgrade the
event on AE CRF
Sep-18-2020 18:37:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE WATER
RETENTION:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Sep-18-2020 18:37:25
(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 d
eath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in p
ersistent or significant disability/
incapacity?
NO
Is this serious event life threaten
ing?
NO
Other medically important serio
us event
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.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0956788
Page 164 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Date Location User Value Reason
Sep-18-2020 18:37:25
(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
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
UNKNOWNInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020 18:37:25
(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
Sep-30-2020 12:46:24 ACV0PFEINFP6000  auto query Query 2: Closed Close Auto Query
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956789
Page 165 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)(autoquery)
Sep-30-2020 12:41:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Worsening of WATER
RETENTION in lower extremities :
Response to "What was the outcome
of this adverse event?" is 3 but End
Date/Time is missing.
Sep-29-2020 07:34:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Outcome updated in Inform
Sep-28-2020 16:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Worsening of WATER
RETENTION : Response to "What
was the outcome of this adverse
event?" is 3 but End Date/Time is
missing.
Sep-28-2020 16:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-28-2020 16:46:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLV
EDTranscription Error
Sep-28-2020 05:32:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opene
dSAE RECON 1: Per latest SAE
listing, ,outcome was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form.
Sep-25-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-25-2020 10:24:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOL
VINGTranscription Error
Sep-25-2020 06:41:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020363610,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
NOT RECOVERED/NOT
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956790
Page 166 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Sep-18-2020 18:37:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NO
T RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020 18:37:25
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-21-2020 05:55:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020363610Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956791
Page 167 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Category:
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020 00:12:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-28-2020 11:48:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Will send report
Oct-18-2020 21:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened CLINICAL Please FAX
a SAE safety update
with the med Hx
condition of
arrhythmia, and the
start year (1996)
Oct-14-2020 12:32:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Year was inadvertently
missed from SAE
report. Satrt date of
arrhythmia is 1996.
Please advise.
Oct-02-2020 14:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened CLINICAL SAE
update on 30 Sep 2020
does not provide the
missing start date (1996
per Med Hx) for
medical history
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956792
Page 168 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
condition of arrhythmia
Oct-01-2020 10:36:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered SAE report has been
sent in again on 30 SEP
2020
Oct-01-2020 07:30:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-30-2020 19:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL Please
submit a SAE safety
update to provide the
missing start date
(1996) for medical
history condition
arrhythmia; provide
info on type of rhythm
disturbance in past if
known
Sep-30-2020 14:42:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered New SAE FU Report
has been submitted.
Sep-28-2020 05:35:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened SAE RECON 1: Per
latest SAE listing, event
HEART ARRYTHMIA
is still recorded in
Safety DB.Please
confirm if event indeed
occurred and should be
recorded as a separate
SAE3 in AE CRF.
Sep-25-2020 10:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered WORSENING OF
HYPERTENSION IS
CORRECT TERM.
SAE FUP REPORT
HAS BEEN
SUBMITTED
Sep-25-2020 06:36:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
AER#2020363610,term
was updated to
'WORSENING OF
HYPERTENSION'
while retained as
HEART ARRYTHMIA
in SDB.. Please
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956793
Page 169 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
confirm correct term.If
safety update is
required, please submit
a follow-up form.
Sep-24-2020 14:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-24-2020 13:42:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Worsening of HYPERTENSIONNew Information
Sep-23-2020 13:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Sep-23-2020 13:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEART ARRHYTHMIA - ATRI
AL FIBNew Information
Sep-21-2020 09:23:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPD CLINQUERY:
Please clarify specific
heart arrhythmia
diagnosis, or provide
further detail regarding
the nature of the
arrhythmia e.g.
supraventricular vs
ventricular, tachycardia
vs bradycardia.
Sep-18-2020 18:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEART ARRHYTHMIAInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-30-2020 14:42:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:New Information
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (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-2021-5683-0956794
Page 170 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep/18/2020 UNK:UNK
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial 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
Sep-21-2020 05:56:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed recorded in SDB
Sep-20-2020 10:35:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON: HEART
ARRHYTHM(Onset
date:16Sep2020) is not
reported on SAE
Report Form but
marked serious on AE
CRF. Confirm
seriousness and report
to Pfizer immediately.
If this event is not
serious, downgrade the
event on AE CRF
Sep-18-2020 18:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE HEART
ARRHYTHMIA :
Response to "Is the
adverse event serious?"
is 'Yes' but "Serious
Adverse Event
Number" is blank.
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956795
Page 171 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Sep-18-2020 18:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth de
fect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
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
Sep-18-2020 18:38:43
(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
Sep-18-2020 18:38:43
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956796
Page 172 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(US & Canada) If Not Related to study treatment(s)
, this event is due to:
OTHER
If Other, specify:
UNKNOWN
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-18-2020 18:38:43
(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
Sep-30-2020 23:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Sep-30-2020 14:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-30-2020 14:42:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Sep-30-2020 14:42:32 ACV0PFEINFP6000  Data Entry: New Information
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0956797
Page 173 of 179
***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, Locked, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
(UTC-05:00) Eastern
Time (US & Canada)RECOVERED/RESOLV
ED
Sep-30-2020 14:42:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE Worsening of
HYPERTENSION: Response to
"What was the outcome of this
adverse event?" is 'Not
Recovered/Not Resolved' but AE
End Date/Time is present.
Sep-28-2020 05:40:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020363610,outcome
was reported as
RECOVERED/RESOLVED to
Safety DB however, recorded as
NOT RECOVERED/NOT
RESOLVED on AE CRF. Please
confirm correct outcome. If safety
update is required, please submit a
follow-up form.
Sep-18-2020 18:38:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NO
T RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-18-2020 18:38:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Sep-23-2020 05:19:35
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020363610Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0956798
Page 174 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021 11:10:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956799
Page 175 of 179
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-06-2021 11:11:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-06-2021 11:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Jan-06-2021 11:10:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for Va
ccination 3
Participant is:
eligible and NOT confirmed to h
ave received only placebo at Vac
cination 1/2Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956800
Page 176 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-06-2021 11:11:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-06-2021 11:11:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR ADDI
TIONAL VACCINATIONInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0956801
Page 177 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-09-2021 10:18:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed thanks for clarifying.
Mar-09-2021 09:30:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mollie
MaplesQuery 1: Answered I just spoke with the
patient to clarify
further. The Nystatin
was prescribed
because the patient is
overweight and the
folds in the skin
create painful rashes
for the patient.
Mar-08-2021 17:28:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Reissued:Opened Was the nystatin
prescribed for
obesity?
Mar-04-2021 13:23:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Mollie
MaplesQuery 1: Answered Patient is still
currently taking this
medication as needed
to our knowledge.
Mar-03-2021 17:54:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Medical Monitor, Per
report (AER#
2020363610), subject
is using "nystatin
from 2019 and
ongoing for obesity".
Pls advise if the
information is
accurate. Thanks
Nov-02-2020 17:58:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-04-2020 18:48:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-04-2020 18:43:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956802
Page 178 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
2. Subject Status Date
Date Location User Value Reason
Nov-02-2020 17:58:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/2/2020Initial Entry
Sep-04-2020 18:48:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-04-2020 18:43:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
FDA-CBER-2021-5683-0956803
Page 179 of 179
***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: 1080 Site Name: (1080) PMG Research of Raleigh, LLC dba PMG Research of
Cary
Subject No: 10801152 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:11
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-06-2020 13:50:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Sylvia
ShoffnerData Entry:
Click Here to EnableInitial Entry
090177e196ae40cc\Final\Final On: 01-Apr-2021 05:44 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0956804