Document text
Page 1 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option 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
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898433
Page 2 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/24/2020
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898434
Page 3 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10211084]
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:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898435
Page 4 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/24/2020
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898436
Page 5 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898437
Page 6 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898438
Page 7 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Biaxin Allergy]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tetracycline Allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Tylenol Allergy]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898439
Page 8 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sulfa Allergy]
Start Date: UNK/UNK/1995
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vaginal Dryness]
Start Date: UNK/UNK/2010
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[L Shoulder Injury]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
Jun/25/2020
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2010
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Knee Osteoarthritis]
Start Date: Jan/UNK/2020
Ongoing: YES
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898440
Page 9 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis of Back]
Start Date: UNK/UNK/1980
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2018
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Thinning Skin]
Start Date: Jan/UNK/2020
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteopenia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vaginal Bleeding]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1975
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898441
Page 10 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gallstones]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/1968
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendicitis]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/1968
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herniated Disc Lumbar Spine]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ruptured Disc Lumbar Spine]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898442
Page 11 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Achalasia]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2016
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[L Shoulder Surgery]
Start Date: Jun/25/2020
Ongoing: NO
End Date:
Jun/25/2020
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Total Hysterectomy]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/1975
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cholecystectomy]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/1968
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898443
Page 12 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Appendectomy]
Start Date: UNK/UNK/1968
Ongoing: NO
End Date:
UNK/UNK/1968
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herniated Disc Repair Lumbar Spine]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Ruptured Disc Repair Lumbar Spine]
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Esophagomyotomy]
Start Date: UNK/UNK/2016
Ongoing: NO
End Date:
UNK/UNK/2016
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898444
Page 13 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Sinusitis]
Start Date: UNK/UNK/1990
Ongoing: YES
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sinus Surgery]
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
Jan/UNK/2020
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898445
Page 14 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/24/2020
2.Weight: [87.0]
3.Unit: kg
4.Height: [162.0]
5.Unit: cm
6.Body Mass Index: [33.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898446
Page 15 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898447
Page 16 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/24/2020
2.Randomization Number: [237783]
3.Randomization Group: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898448
Page 17 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9D0L]
5.bSample ID [BP9D0M]
5.cSample ID [BP9D0N]
5.dSample ID [BPRXKD]
5.eSample ID [BPRXKF]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898449
Page 18 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/24/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9CW9]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898450
Page 19 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: Aug/24/2020 13:35
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898451
Page 20 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898452
Page 21 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/15/2020
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898453
Page 22 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/15/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.5]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898454
Page 23 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898455
Page 24 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/15/2020
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 [BP9DD1]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898456
Page 25 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/15/2020 16:04
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898457
Page 26 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898458
Page 27 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BLX6ZX]
5.bSample ID [BSHLBN]
5.cSample ID [BSHLBP]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898459
Page 28 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898460
Page 29 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898461
Page 30 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898462
Page 31 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898463
Page 32 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898464
Page 33 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898465
Page 34 of 186
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898466
Page 35 of 186
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898467
Page 36 of 186
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898468
Page 37 of 186
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898469
Page 38 of 186
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898470
Page 39 of 186
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898471
Page 40 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898472
Page 41 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898473
Page 42 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898474
Page 43 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898475
Page 44 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death :Oct/13/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898476
Page 45 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898477
Page 46 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898478
Page 47 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898479
Page 48 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still On
goingForm Instance
1.ADVERSE EVE
NT 1 R Knee Sprai
n Sep/3/2020 UNK:U
NK NO
End Date Time:
Sep/6/2020 UNK:UNK
Repeating
Pages
2.ADVERSE EVE
NT 2 Vomiting blo
od Mar/6/2021 UNK:U
NK YES Repeating
Pages
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898480
Page 49 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[R Knee Sprain]
4.Start Date Time: Sep/3/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/6/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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:
[AE is not related to any drug/non-drug treatment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898481
Page 50 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898482
Page 51 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Vomiting blood]
4.Start Date Time: Mar/6/2021 UNK:UNK
5.Is the adverse event still ongoing? YES
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
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898483
Page 52 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021253662]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898484
Page 53 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
1. Repeating
Pages
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898485
Page 54 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898486
Page 55 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898487
Page 56 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898488
Page 57 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898489
Page 58 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898490
Page 59 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
1. Repeating Pages
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898491
Page 60 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898492
Page 61 of 186
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898493
Page 62 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898494
Page 63 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898495
Page 64 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898496
Page 65 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898497
Page 66 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898498
Page 67 of 186
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898499
Page 68 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898500
Page 69 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898501
Page 70 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898502
Page 71 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898503
Page 72 of 186
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898504
Page 73 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898505
Page 74 of 186
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898506
Page 75 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898507
Page 76 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Not Applicable
//Comments
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898508
Page 77 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898509
Page 78 of 186
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/13/2020
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898510
Page 79 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898511
Page 80 of 186
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
John Rubino Approved Mar-11-2021 07:55:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898512
Page 81 of 186
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-24-2020 15:15:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898513
Page 82 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898514
Page 83 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Aug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898515
Page 84 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Aug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898516
Page 85 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Aug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898517
Page 86 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Aug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898518
Page 87 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Aug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898519
Page 88 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898520
Page 89 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898521
Page 90 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-24-2020 15:27:08 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898522
Page 91 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898523
Page 92 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898524
Page 93 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898525
Page 94 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898526
Page 95 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898527
Page 96 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898528
Page 97 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898529
Page 98 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898530
Page 99 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-15-2020 15:56:15 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898531
Page 100 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-14-2021 11:33:59 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898532
Page 101 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition Form: WITHDRAWAL OF CONSENT - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-14-2021 11:33:59 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898533
Page 102 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-14-2021 11:34:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898534
Page 103 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Jan-14-2021 11:34:09 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0898535
Page 104 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
John Rubino Approved Mar-11-2021 07:55:27 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
N/A Feb-23-2021 10:56:20 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
John Rubino Approved Jan-21-2021 15:34:53 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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-05-2021 10:34:20 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898536
Page 105 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
John Rubino Approved Oct-20-2020 19:52:02 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JohnRubino, 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.
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898537
Page 106 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-24-2020 15:14:30
(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
Aug-24-2020 15:14:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898538
Page 107 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-24-2020 15:14:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/24/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898539
Page 108 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-24-2020 15:14:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10211084Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-24-2020 15:14:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1944Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-24-2020 15:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-24-2020 15:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-24-2020 15:14:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
WHITEInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898540
Page 109 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-24-2020 15:15:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898541
Page 110 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-24-2020 15:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-24-2020 15:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-24-2020 15:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898542
Page 111 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-24-2020 15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Penicillin Alle
rgy
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Penicillin AllergyInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-24-2020 15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-24-2020 15:15:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898543
Page 112 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b
Date Location User Value Reason
Aug-24-2020 15:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Biaxin Allerg
y
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:15:53
(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
Aug-24-2020 15:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Biaxin AllergyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-24-2020 15:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-24-2020 15:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898544
Page 113 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020 15:16:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Tetracycline
Allergy
Start Date: UNK/UNK/1
995
Ongoing: YESTranscription Error
Aug-24-2020 15:16:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Tetracycline
Start Date: UNK/UNK/
1995
Ongoing: YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898545
Page 114 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:16:07
(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
Aug-24-2020 15:16:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tetracycline AllergyTranscription Error
Aug-24-2020 15:16:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TetracyclineInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-24-2020 15:16:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-24-2020 15:16:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-24-2020 15:17:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Line/MH Numb
er:4
Medical History
Term:Tylenol Alle
rgy
Start Date: UNK/UNK/
2018
Ongoing: YESTranscription Error
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898546
Page 115 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020 15:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Tylenol
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:17:37
(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
Aug-24-2020 15:17:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Tylenol AllergyTranscription Error
Aug-24-2020 15:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
TylenolInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-24-2020 15:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-24-2020 15:17:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898547
Page 116 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020 15:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Sulfa Allergy
Start Date: UNK/UNK/1
995
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:18:02
(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
Aug-24-2020 15:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sulfa AllergyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-24-2020 15:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1995Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-24-2020 15:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-24-2020 15:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 6Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898548
Page 117 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History T
erm:Vaginal Dryn
ess
Start Date: UNK/UNK/2
010
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:18:20
(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
Aug-24-2020 15:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vaginal DrynessInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-24-2020 15:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-24-2020 15:18:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-24-2020 15:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:L Shoulder Inj
uryInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898549
Page 118 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/20
19
Ongoing: NO
End Date:
Jun/25/202
0
1.g Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:18:58
(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
Aug-24-2020 15:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
L Shoulder InjuryInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-24-2020 15:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2019Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-24-2020 15:18:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/25/2020Initial Entry
1.h
Date Location User Value Reason
Aug-24-2020 15:19:12
(UTC-05:00) EasternACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 8Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898550
Page 119 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
010
Ongoing: YES
1.h Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:19:12
(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
Aug-24-2020 15:19:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
HypertensionInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-24-2020 15:19:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2010Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-24-2020 15:19:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-24-2020 15:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:Bilateral Knee Ost
eoarthritisInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898551
Page 120 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: Jan/UNK/2020
Ongoing: YES
1.i Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:19:39
(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
Aug-24-2020 15:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Bilateral Knee OsteoarthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-24-2020 15:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-24-2020 15:19:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-24-2020 15:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:Osteoarthritis of
Back
Start Date: UNK/UNK/198
0
Ongoing: YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898552
Page 121 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.j Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:19:58
(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
Aug-24-2020 15:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Osteoarthritis of BackInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-24-2020 15:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1980Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-24-2020 15:19:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-24-2020 15:20:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:11
Medical Hist
ory Term:Gastroesophageal
Reflux Disease
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898553
Page 122 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.k Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:20:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:20:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Gastroesophageal Reflux Diseas
eInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-24-2020 15:20:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-24-2020 15:20:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-24-2020 15:20:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 12
Medical History Te
rm:Thinning Ski
n
Start Date: Jan/UNK/20
20
Ongoing: YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898554
Page 123 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:20:36
(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
Aug-24-2020 15:20:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Thinning SkinInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-24-2020 15:20:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-24-2020 15:20:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-24-2020 15:21:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History T
erm:Osteopenia
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898555
Page 124 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:21:33
(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
Aug-24-2020 15:21:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
OsteopeniaInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-24-2020 15:21:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-24-2020 15:21:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-24-2020 15:22:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:14
Medical History
Term:Vaginal Bleedin
g
Start Date: UNK/UNK/197
5
Ongoing: NO
End Date:
UNK/UNK/
1975Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898556
Page 125 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.n Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:22:14
(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
Aug-24-2020 15:22:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vaginal BleedingInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-24-2020 15:22:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-24-2020 15:22:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1975Initial Entry
1.o
Date Location User Value Reason
Aug-24-2020 15:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:15
Medical History
Term:Gallstones
Start Date: UNK/UNK/196
8Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898557
Page 126 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
1968
1.o Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:22:30
(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
Aug-24-2020 15:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
GallstonesInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-24-2020 15:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1968Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-24-2020 15:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1968Initial Entry
1.p
Date Location User Value Reason
Aug-24-2020 15:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898558
Page 127 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Appendicitis
Start Date: UNK/UNK/196
8
Ongoing: NO
End Date:
UNK/UNK/
1968
1.p Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AppendicitisInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-24-2020 15:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1968Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-24-2020 15:22:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1968Initial Entry
1.q
Date Location User Value Reason
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898559
Page 128 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020 15:23:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:17
Medical Histo
ry Term:Herniated Disc Lu
mbar Spine
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/198
8Initial Entry
1.q Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:23:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:23:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Herniated Disc Lumbar SpineInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-24-2020 15:23:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-24-2020 15:23:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.r
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898560
Page 129 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-24-2020 15:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:18
Medical Histo
ry Term:Ruptured Disc Lu
mbar Spine
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/200
0Initial Entry
1.r Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ruptured Disc Lumbar SpineInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-24-2020 15:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-24-2020 15:23:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898561
Page 130 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.s
Date Location User Value Reason
Aug-24-2020 15:23:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:19
Medical History
Term:Achalasia
Start Date: UNK/UNK/200
0
Ongoing: NO
End Date:
UNK/UNK/
2016Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898562
Page 131 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.s Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:23:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:23:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AchalasiaInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-24-2020 15:23:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-24-2020 15:23:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.t
Date Location User Value Reason
Aug-24-2020 15:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:20
Medical History
Term:L Shoulder Sur
gery
Start Date: Jun/25/2020
Ongoing: NO
End Date:
Jun/25/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898563
Page 132 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.t Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
L Shoulder SurgeryInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-24-2020 15:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jun/25/2020Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-24-2020 15:24:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jun/25/2020Initial Entry
1.u
Date Location User Value Reason
Aug-24-2020 15:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:21
Medical History
Term:Total Hysterect
omy
Start Date: UNK/UNK/197
5Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898564
Page 133 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
1975
1.u Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Total HysterectomyInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-24-2020 15:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1975Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-24-2020 15:24:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1975Initial Entry
1.v
Date Location User Value Reason
Aug-24-2020 15:24:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:22Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898565
Page 134 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Cholecystectom
y
Start Date: UNK/UNK/196
8
Ongoing: NO
End Date:
UNK/UNK/
1968
1.v Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:24:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:24:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
CholecystectomyInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-24-2020 15:24:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1968Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-24-2020 15:24:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1968Initial Entry
1.w
Date Location User Value Reason
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898566
Page 135 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020 15:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:23
Medical History
Term:Appendectomy
Start Date: UNK/UNK/196
8
Ongoing: NO
End Date:
UNK/UNK/
1968Initial Entry
1.w Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
AppendectomyInitial Entry
1.w Start Date:
Date Location User Value Reason
Aug-24-2020 15:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1968Initial Entry
1.w Ongoing:
Date Location User Value Reason
Aug-24-2020 15:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1968Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898567
Page 136 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.x
Date Location User Value Reason
Aug-24-2020 15:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH N
umber:24
Medical His
tory Term:Herniated Disc Repa
ir Lumbar Spine
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988Initial Entry
1.x Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Herniated Disc Repair Lumbar S
pineInitial Entry
1.x Start Date:
Date Location User Value Reason
Aug-24-2020 15:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1988Initial Entry
1.x Ongoing:
Date Location User Value Reason
Aug-24-2020 15:25:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898568
Page 137 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.y
Date Location User Value Reason
Aug-24-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:25
Medical Hist
ory Term:Ruptured Disc Repai
r Lumbar Spine
Start Date: UNK/UNK/2000
Ongoing: NO
End Date:
UNK/UNK/2000Initial Entry
1.y Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Ruptured Disc Repair Lumbar S
pineInitial Entry
1.y Start Date:
Date Location User Value Reason
Aug-24-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2000Initial Entry
1.y Ongoing:
Date Location User Value Reason
Aug-24-2020 15:25:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2000Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898569
Page 138 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.z
Date Location User Value Reason
Aug-24-2020 15:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:26
Medical History
Term:Esophagomyoto
my
Start Date: UNK/UNK/201
6
Ongoing: NO
End Date:
UNK/UNK/
2016Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898570
Page 139 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.z Line/MH Number:
Date Location User Value Reason
Aug-24-2020 15:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-24-2020 15:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
EsophagomyotomyInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-24-2020 15:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/2016Initial Entry
1.z Ongoing:
Date Location User Value Reason
Aug-24-2020 15:26:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.aa
Date Location User Value Reason
Oct-13-2020 15:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 27
Medical History T
erm:Chronic Sinus
itis
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898571
Page 140 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aa Line/MH Number:
Date Location User Value Reason
Oct-13-2020 15:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 15:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Chronic SinusitisInitial Entry
1.aa Start Date:
Date Location User Value Reason
Oct-13-2020 15:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
UNK/UNK/1990Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Oct-13-2020 15:18:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
1.ab
Date Location User Value Reason
Oct-13-2020 15:19:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number
:28
Medical History T
erm:Sinus Surgery
Start Date: Jan/UNK/2020
Ongoing: NO
End Date:
Jan/UNK/2
020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898572
Page 141 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ab Line/MH Number:
Date Location User Value Reason
Oct-13-2020 15:19:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-13-2020 15:19:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sinus SurgeryInitial Entry
1.ab Start Date:
Date Location User Value Reason
Oct-13-2020 15:19:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/UNK/2020Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Oct-13-2020 15:19:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date:
Jan/UNK/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898573
Page 142 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
87.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
162.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
33.2Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898574
Page 143 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7.a
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 98.0
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-24-2020 15:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898575
Page 144 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898576
Page 145 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cable
6.a Sponsor ID:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-24-2020 15:27:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898577
Page 146 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-24-2020 15:27:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-24-2020 15:27:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
237783Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898578
Page 147 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 15:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 15:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 15:48:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 15:28:30
(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.
Aug-24-2020 15:28:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 15:48:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9D0LInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898579
Page 148 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 15:48:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9D0LInitial Entry
5.b
Date Location User Value Reason
Aug-24-2020 15:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9D0MInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-24-2020 15:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9D0MInitial Entry
5.c
Date Location User Value Reason
Aug-24-2020 15:48:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9D0NInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-24-2020 15:48:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9D0NInitial Entry
5.d
Date Location User Value Reason
Aug-24-2020 15:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRXKDInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898580
Page 149 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-24-2020 15:49:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRXKDInitial Entry
5.e
Date Location User Value Reason
Aug-24-2020 15:49:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BPRXKFInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-24-2020 15:49:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BPRXKFInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898581
Page 150 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-24-2020 15:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-24-2020 15:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-24-2020 15:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-24-2020 15:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-24-2020 15:28:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Aug/24/2020Initial Entry
5.a
Date Location User Value Reason
Aug-24-2020 15:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9CW9Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898582
Page 151 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-24-2020 15:49:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9CW9Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898583
Page 152 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Aug/24/2020 13:35Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898584
Page 153 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Aug-24-2020 15:29:16
(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
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-24-2020 15:29:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898585
Page 154 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-24-2020 15:29:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898586
Page 155 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-15-2020 15:55:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898587
Page 156 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-15-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020Initial Entry
2.a
Date Location User Value Reason
Sep-15-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Record Identifier:: 1
Temperature: 97.5
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-15-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-15-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
97.5Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-15-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898588
Page 157 of 186
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-15-2020 15:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
FOREHEADInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898589
Page 158 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-15-2020 15:56:15
(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-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) EasternACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898590
Page 159 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sponsor-Defined I
dentifier:Not Appli
cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cable
6.a Sponsor ID:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-15-2020 15:56:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898591
Page 160 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-15-2020 15:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-15-2020 15:56:29
(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-15-2020 15:56:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 15:56:29
(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-15-2020 15:56:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Sep/15/2020Initial Entry
5.a
Date Location User Value Reason
Sep-15-2020 15:56:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BP9DD1Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898592
Page 161 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Sep-15-2020 15:56:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BP9DD1Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898593
Page 162 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-23-2020 12:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-23-2020 12:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-23-2020 12:06:22
(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-23-2020 12:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/15/2020 16:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-23-2020 12:06:22
(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-23-2020 12:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RIGHTInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898594
Page 163 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
7. Route:
Date Location User Value Reason
Sep-23-2020 12:06:22
(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-23-2020 12:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-23-2020 12:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898595
Page 164 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 12:08:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898596
Page 165 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 12:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 12:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 13:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 12:12:30
(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-13-2020 12:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
Oct-13-2020 13:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BLX6ZXInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898597
Page 166 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 13:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BLX6ZXInitial Entry
5.b
Date Location User Value Reason
Oct-13-2020 13:39:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHLBNInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-13-2020 13:39:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSHLBNInitial Entry
5.c
Date Location User Value Reason
Oct-13-2020 13:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sample ID: BSHLBPInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-13-2020 13:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
BSHLBPInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898598
Page 167 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-13-2020 12:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Oct/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-13-2020 12:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-13-2020 12:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
COMPLETEDInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898599
Page 168 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898600
Page 169 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898601
Page 170 of 186
***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
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 15:58:54
(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-15-2020 15:58:54
(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
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
R Knee SprainInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Sep/3/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NO
End Date Time:
Sep/6/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898602
Page 171 of 186
***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
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
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-15-2020 15:58:54
(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-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
AE is not related to any dr
ug/non-drug treatmentInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-15-2020 15:58:54 ACV0PFEINFP6000 Data Entry: Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898603
Page 172 of 186
***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
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-05:00) Eastern
Time (US & Canada)NOT APPLICABLE
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020 15:58:54
(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-15-2020 15:58:54
(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-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-15-2020 15:58:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898604
Page 173 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 07:39:55
(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
Mar-12-2021 15:39:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies
query
Mar-12-2021 09:39:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered no further
information is
known at this time-
once site can reach
subject and an
update is obtained,
follow up report
will be submitted
Mar-11-2021 19:43:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened Clinical - please
clarify followup
plan for this subject
with hematemesis
and no known
etiology; if
appropriate please
submit a SAE safety
update
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Vomiting bloodInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898605
Page 174 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Mar/6/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 07:39:55
(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
Mar-09-2021 20:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate For AE Vomiting
blood: Response to
"Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
YES
Is this serious event associatedInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898606
Page 175 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
with congenital anomaly or birt
h 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
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-09-2021 07:39:55
(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
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT RELATED
If Not Related to study treatment
(s), this event is due to:Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898607
Page 176 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 07:39:55
(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
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-09-2021 07:39:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (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-2021-5683-0898608
Page 177 of 186
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-09-2021 20:15:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
2021253662Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898609
Page 178 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-05-2021 10:34:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898610
Page 179 of 186
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021 10:56:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed to
have received only placebo at
Vaccination 1/2Transcription Error
Jan-05-2021 10:36:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Participant is NOT willing to retu
rn for Vaccination 3 OR otherwise
not eligibleInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898611
Page 180 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-14-2021 11:33:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Jan/5/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-23-2021
16:22:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-23-2021
10:57:28
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: An
swere
dChanged data per query
Feb-22-2021
23:34:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Query
1: Rei
ssued:
Opene
dDM : REVAX CONF
CRF is unfrozen.
Primary Reason for
Unblinding is
"ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the REVAX
CONF CRF. Please
update or clarify.
Feb-22-2021
15:18:27
(UTC-05:00)
Eastern Time
(US &ACV0PFEINFP6000 Query
1: An
swere
dPlease unfreeze Revax
Cont page
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898612
Page 181 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Canada)
Feb-22-2021
02:33:37
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY Query
1: Op
enedDMW7348694;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-14-2021
11:33:51
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000 Data
Entry
:
ASSE
SS EL
IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ONInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0898613
Page 182 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Withdrawal of Consent Date :
Date Location User Value Reason
Jan-14-2021 11:33:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898614
Page 183 of 186
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Collection / Notification of Death:
Date Location User Value Reason
Jan-14-2021 11:34:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Not ApplicableInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4),
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0898615
Page 184 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-13-2020 12:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-24-2020 15:27:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-24-2020 15:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Mar-09-2021 20:16:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Closed Response satisfies query
Mar-09-2021 10:37:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Answered AE has been added
Mar-09-2021 06:21:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Query 1: Opened SAE
RECON:AER#2021253662
Vomiting blood(onset
date:06Mar2021)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-13-2020 12:12:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Oct/13/2020Initial Entry
Aug-24-2020 15:27:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898616
Page 185 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-24-2020 15:15:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Aug/24/2020Initial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
FDA-CBER-2021-5683-0898617
Page 186 of 186
***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: 1021 Site Name: (1021) PMG Research of Raleigh, LLC
Subject No: 10211084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-20-2020 11:29:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Data Entry:
Click Here to EnableInitial Entry
090177e196ae3d1c\Final\Final On: 01-Apr-2021 04:26 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0898618