125742 S1 M5 CRF c4591001 1079 10791246

Document text

Page 1 of 154
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955460
Page 2 of 154
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/4/2020
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955461
Page 3 of 154
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10791246]
2.Birth Date: /1947
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:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955462
Page 4 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955463
Page 5 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955464
Page 6 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/4/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955465
Page 7 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis, right knee]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Post Menopausal]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955466
Page 8 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
2.Weight: [189.0]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [29.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955467
Page 9 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955468
Page 10 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/4/2020
2.Randomization Number: [252558]
3.Randomization Group: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955469
Page 11 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3S9]
5.bSample ID [BPCSH7]
5.cSample ID [BPCSHR]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955470
Page 12 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPY3WG]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955471
Page 13 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/4/2020 15:36
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955472
Page 14 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955473
Page 15 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955474
Page 16 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Sep/25/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.1]
Unit: F
Temperature Location: FOREHEAD
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955475
Page 17 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955476
Page 18 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BPY43C]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955477
Page 19 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/25/2020 14:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955478
Page 20 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955479
Page 21 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/29/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BSH8RH]
5.bSample ID [BSH8RY]
5.cSample ID [BPB0Y7]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955480
Page 22 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955481
Page 23 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955482
Page 24 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955483
Page 25 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955484
Page 26 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955485
Page 27 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955486
Page 28 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955487
Page 29 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955488
Page 30 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955489
Page 31 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955490
Page 32 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955491
Page 33 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955492
Page 34 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955493
Page 35 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955494
Page 36 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955495
Page 37 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955496
Page 38 of 154
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Oct/29/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955497
Page 39 of 154
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955498
Page 40 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: DATE OF VISIT - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955499
Page 41 of 154
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_REPEAT_SWAB - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - REPEAT SWAB
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955500
Page 42 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  CVA  Oct/22/2020 UNK:
UNK NO
End Date Time:
Oct/26/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Expressive Aph
asia Oct/22/2020 UNK:
UNK NO
End Date Time:
Oct/26/2020 UNK:UNK
 Repeating
Pages
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955501
Page 43 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CVA]
4.Start Date Time: Oct/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[PENDING MEDICAL RECORDS]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955502
Page 44 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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?: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[2020414935]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955503
Page 45 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Expressive Aphasia]
4.Start Date Time: Oct/22/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/26/2020 UNK:UNK
6.Toxicity Grade: 2
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
[Pending medical records]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955504
Page 46 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
11.Was a Concomitant Medication
given?NO
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[ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955505
Page 47 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yMedication Er
rorStart Da
teIs the medication error Still On
goingStudy Medication Errors A
ctionForm Instance
 1.          Repeating
Pages
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955506
Page 48 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955507
Page 49 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955508
Page 50 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955509
Page 51 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955510
Page 52 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955511
Page 53 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955512
Page 54 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955513
Page 55 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955514
Page 56 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955515
Page 57 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955516
Page 58 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955517
Page 59 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
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:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955518
Page 60 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955519
Page 61 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955520
Page 62 of 154
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955521
Page 63 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955522
Page 64 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955523
Page 65 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955524
Page 66 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955525
Page 67 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955526
Page 68 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955527
Page 69 of 154
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/19/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955528
Page 70 of 154
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955529
Page 71 of 154
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955530
Page 72 of 154
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/29/2020
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955531
Page 73 of 154
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955532
Page 74 of 154
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad  Approved Mar-10-2021 18:48:55 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955533
Page 75 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-08-2020 23:02:41 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955534
Page 76 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormSep-08-2020 23:05:51 (UTC-05:00) Eastern
Time (US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955535
Page 77 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Sep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955536
Page 78 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Sep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955537
Page 79 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Sep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955538
Page 80 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Sep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955539
Page 81 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Sep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955540
Page 82 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955541
Page 83 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955542
Page 84 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aSep-08-2020 23:05:51 (UTC-05:00) Eastern Time
(US & Canada)Subject post menopausal since 2000
Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955543
Page 85 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormOct-03-2020 21:56:54 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955544
Page 86 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
1Oct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955545
Page 87 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
2Oct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955546
Page 88 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
3Oct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955547
Page 89 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
4Oct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955548
Page 90 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
5Oct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955549
Page 91 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aOct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955550
Page 92 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aOct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955551
Page 93 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
6.aOct-03-2020 21:56:54 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955552
Page 94 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
George Raad  Approved Mar-10-2021 18:48:55 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-17-2021 10:07:06 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad  Approved Nov-13-2020 14:30:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-13-2020 07:58:42 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
George Raad  Approved Nov-06-2020 10:31:03 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955553
Page 95 of 154
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, GeorgeRaad, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955554
Page 96 of 154
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-08-2020 23:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-08-2020 23:01:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955555
Page 97 of 154
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: MAIN INFORMED CONSENT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-08-2020 23:01:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/4/2020Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955556
Page 98 of 154
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-08-2020 23:01:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10791246Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-08-2020 23:01:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-08-2020 23:01:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-08-2020 23:01:52
(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
Sep-08-2020 23:01:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955557
Page 99 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-08-2020 23:02:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955558
Page 100 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-08-2020 23:02:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-08-2020 23:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-08-2020 23:02:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955559
Page 101 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Sep-08-2020 23:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Osteoarthritis, rig
ht knee
Start Date: UNK/UNK/2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-08-2020 23:03:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 23:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Osteoarthritis, right kneeInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-08-2020 23:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-08-2020 23:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955560
Page 102 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-08-2020 23:04:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-08-2020 23:04:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 23:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal AllergiesInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-08-2020 23:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-08-2020 23:04:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-08-2020 23:04:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955561
Page 103 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical History Te
rm:Post Menopau
sal
Start Date: UNK/UNK/20
00
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-08-2020 23:04:56
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-08-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Post MenopausalInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-08-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-08-2020 23:04:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955562
Page 104 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
189.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29.6Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955563
Page 105 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7.a
Date Location User Value Reason
Sep-08-2020 23:05:31
(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
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-08-2020 23:05:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955564
Page 106 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-08-2020 23:05:51
(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-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined I Not AppliInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955565
Page 107 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
dentifier: cable
Test:: Not Appli
cable
Result:: Not Appli
cable
Not Done:: Not Appli
cable
6.a Sponsor ID:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-08-2020 23:05:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955566
Page 108 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: RANDOMIZATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-08-2020 23:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-08-2020 23:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
252558Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955567
Page 109 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 23:06:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 23:06:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020 16:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 02:34:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 23:06:52
(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-08-2020 23:06:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955568
Page 110 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-17-2020 16:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3S9Transcription Error
Sep-17-2020 16:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BY3S9Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-17-2020 16:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-17-2020 16:09:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3S9Transcription Error
Sep-17-2020 16:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Sep-17-2020 16:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BY3S9Initial Entry
5.b
Date Location User Value Reason
Sep-17-2020 16:08:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCSH7Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-17-2020 16:08:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPCSH7Initial Entry
5.c
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955569
Page 111 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-17-2020 16:08:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPCSHRInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-17-2020 16:08:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPCSHRInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955570
Page 112 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 23:07:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 23:07:03
(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-08-2020 23:07:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-08-2020 23:07:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-08-2020 23:07:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-08-2020 23:07:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY3WGInitial Entry
5.a Sample ID
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955571
Page 113 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Sep-08-2020 23:07:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPY3WGInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955572
Page 114 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-08-2020 23:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-08-2020 23:07:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-08-2020 23:07:43
(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-08-2020 23:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 15:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-08-2020 23:07:43
(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-08-2020 23:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955573
Page 115 of 154
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Sep-08-2020 23:07:43
(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-08-2020 23:07:43
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-08-2020 23:07:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955574
Page 116 of 154
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: REACTOGENICITY DIARY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-08-2020 23:07:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955575
Page 117 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-10-2020 03:56:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed As per the update
Oct-08-2020 23:09:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-08-2020 09:23:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Thanks for the
response, however
Pregnancy Test,
Vaccination, Vital
Signs forms are not
updated yet, please
review and update,
else clarify.
Oct-06-2020 21:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered to be updated
Oct-04-2020 07:03:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM: Kindly review
and complete
‘Pregnancy Test,
Vaccination, Vital
Signs' forms at this
visit. Thank you.
Oct-03-2020 21:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Initial Entry
Oct-03-2020 21:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
Sep-29-2020 08:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly review
and complete ‘Date
of Visit, Nasal
Swab, Pregnancy
Test, Vaccination,
Vital Signs' forms at
this visit. Thank
you.
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955576
Page 118 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Oct-08-2020 23:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2.a
Date Location User Value Reason
Oct-08-2020 23:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.1
Temperature Unit: F
Temperature Locat
ion::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-08-2020 23:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-08-2020 23:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.1Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-08-2020 23:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955577
Page 119 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-08-2020 23:08:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955578
Page 120 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Ide Not ApplicInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955579
Page 121 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
ntifier: able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
able
6.a Sponsor ID:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Oct-03-2020 21:56:54
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955580
Page 122 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-03-2020 21:57:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-03-2020 21:57:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 21:13:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-04-2020 02:54:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-03-2020 21:57:22
(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-03-2020 21:57:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955581
Page 123 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-06-2020 21:13:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPY43CInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-06-2020 21:13:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPY43CInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955582
Page 124 of 154
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020 14:38Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955583
Page 125 of 154
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
7. Route:
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-08-2020 23:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955584
Page 126 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-31-2020 17:39:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955585
Page 127 of 154
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-31-2020 17:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-31-2020 17:39:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-31-2020 17:40:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-31-2020 17:39:57
(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-31-2020 17:39:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/29/2020Initial Entry
5.a
Date Location User Value Reason
Oct-31-2020 17:40:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSH8RHInitial Entry
5.a Sample ID
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955586
Page 128 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-31-2020 17:40:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSH8RHInitial Entry
5.b
Date Location User Value Reason
Oct-31-2020 17:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSH8RYInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-31-2020 17:40:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSH8RYInitial Entry
5.c
Date Location User Value Reason
Oct-31-2020 17:40:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPB0Y7Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955587
Page 129 of 154
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.c Sample ID
Date Location User Value Reason
Nov-03-2020
21:33:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
ClosedAuto closed by
Validation Check:
VC_BEETRK001_06
Nov-03-2020
15:06:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
Answere
dcorrect for this
subject 1271 updated
Nov-02-2020
03:05:44
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1:
OpenedDMW5234426;The
barcode BPB0Y7 is
recorded for two
subjects 10791246
and 10791271, Please
review and update as
appropriate.
Oct-31-2020
17:40:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data En
try:
BPB0Y7Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955588
Page 130 of 154
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-31-2020 17:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/29/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-31-2020 17:40:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-31-2020 17:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955589
Page 131 of 154
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955590
Page 132 of 154
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955591
Page 133 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-26-2020 11:03:29
(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 ValueReason
Nov-11-2020
02:02:33
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Salim Bouguermouh Query
1: Clo
sedResponse satisfies
query
Nov-10-2020
10:34:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dThis was submitted
10/Nov/2020 10:30
Nov-05-2020
08:37:16
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Opene
dClinical – Thank you.
If NO hospital
COVID test was
performed is known,
please submit this
information on a
follow-up SAE form,
as pertinent
information for this
trial.
Nov-04-2020
13:20:27ACV0PFEINFP6000  Query
3: Cloterm updated and
coded
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955592
Page 134 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-05:00)
Eastern Time
(US &
Canada)sed
Nov-04-2020
12:25:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dno test was completed
Nov-04-2020
05:45:36
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedResponse satisfies
query
Nov-04-2020
00:12:49
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Salim Bouguermouh Query
1: Rei
ssued:
Opene
dClin: Please confirm
if any SARS-CoV-2
(NAAT or other) tests
were performed.
Please provide any
test results and update
accordingly the initial
SAE report via an
SAE follow-up report.
Nov-03-2020
15:04:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
3: An
swere
dTranscription Error
Nov-03-2020
15:04:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: An
swere
dTranscription Error
Nov-03-2020
15:04:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
1: An
swere
dTranscription Error
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955593
Page 135 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-03-2020
15:04:54
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
CVATranscription Error
Nov-02-2020
16:21:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Opene
dThank you for
recording the term
Expressive Aphasia;
however, please
update this term to
only include CVA.
Please also spell out
CVA.
Nov-01-2020
15:18:10
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Salim Bouguermouh Query
1: Rei
ssued:
Opene
dClin: Please confirm
if any SARS-CoV-2
(NAAT or other) tests
were performed.
Please provide any
test results and update
accordingly the initial
SAE report via an
SAE follow-up report.
Oct-30-2020
06:47:34
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dSAE RECON 2:
Thank you for adding
expressive aphasia as
separate entry. For
AE#1,please consider
to update the term to
CVA to facilitate
coding.
Oct-29-2020
13:40:58
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
3: An
swere
dChanged data per
query
Oct-29-2020
13:40:47
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dChanged data per
query
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955594
Page 136 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-27-2020
22:45:43
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Opene
dSAE RECON 1:
Thank you for the
update.however,please
consider to split the
term and record CVA
and Expressive
Aphasia as separate
entries.
Oct-27-2020
17:29:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
3: Op
enedMultiple concepts in
the term CVA WITH
EXPRESSIVE
APHASIA. Split the
term into CVA and
EXPRESSIVE
APHASIA and submit
separately. Thank you.
Oct-27-2020
14:12:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
2: An
swere
dNew Information
Oct-27-2020
14:12:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
1: An
swere
dNew Information
Oct-27-2020
14:12:45
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
CVA
with
Expre
ssive
Aphas
iaNew Information
Oct-27-2020
10:26:57
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedSAE RECON:
AER#2020414935,the
term in Safety
database was reported
as CVA with
expressive aphasia.
The stroke event was
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955595
Page 137 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
recorded in AE CRF
however, APHASIA
was missing in
Inform. Please
confirm if this should
be reported as
separate event in AE
CRF.
Oct-27-2020
09:50:39
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Salim Bouguermouh Query
1: Op
enedClin: Please confirm
if any SARS-CoV-2
(NAAT or other) tests
were performed.
Please provide any
test results and update
accordingly the initial
SAE report via an
SAE follow-up report.
Oct-26-2020
11:03:29
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
STRO
KEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-27-2020 22:42:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Oct-27-2020 14:11:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-27-2020 14:11:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020 UNK:UNKTranscription Error
Oct-27-2020 05:34:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020414935 ,onset
date was reported as
22Oct2020 in Safety
DB however, recorded
as 23Oct2020 on AE
CRF. Please confirm
correct Onset Date. If
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955596
Page 138 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
safety update is
required, please submit
a follow-up SAE form.
Oct-26-2020 11:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/23/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/26/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-04-2020 11:46:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-03-2020 15:05:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-03-2020 15:05:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Transcription Error
Oct-28-2020 09:20:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical As the
subject had a full
CNS evaluation and
3 day hospitalization
for this event, please
review clinical Grade
I severity as
reported.
Oct-26-2020 11:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955597
Page 139 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-27-2020 05:26:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-26-2020 11:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE STROKE:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-26-2020 11:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wit
h congenital anomaly or birth defe
ct?
NO
Did this serious event result in dea
th?
NO
Did this serious event require or p
rolong hospitalization?
YES
Did this serious event result in per
sistent or significant disability/inc
apacity?
NO
Is this serious event life threatenin
g?
NO
Other medically important seriousInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955598
Page 140 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(s
), this event is due to:
OTHER
If Other, specify:
PENDING MEDICAL RECO
RDSInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955599
Page 141 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-26-2020 11:03:29
(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
Oct-26-2020 11:03:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-27-2020 05:26:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020414935Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955600
Page 142 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Oct-29-2020 13:37:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-29-2020 13:37:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Expressive AphasiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/26/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955601
Page 143 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-04-2020 05:51:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Closed Response satisfies
query
Nov-03-2020 15:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-03-2020 15:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Transcription Error
Oct-30-2020 09:01:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Ahmed Hassan Query 1: Opened Clin: Expressive
Aphasia: please can
you review the
toxicity grading for
this AE as it
currently pertains to
'does not interfere
with subjects' usual
function. Thanks
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-14-2020 11:16:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed AE not in SAE listing
Nov-11-2020 14:34:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered I updated the SAE form
Nov-11-2020 10:18:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened DM RQ: Thank you for
your response, however
both are in the SAE listing
and therefore please update
to YES. Thank you.
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955602
Page 144 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-10-2020 09:00:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed for downgrading of event
iN SDB
Nov-07-2020 11:28:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Reissued:Opened SAE RECON 1: Per
Clinical review, please
update event with the final
diagnosis as the CT/MRI
were negative. '
Nov-05-2020 15:27:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Deleted Query is invalid or does not
apply
Nov-05-2020 01:22:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Reissued:Candid
ateSAE RECON: For Clinical
review
Nov-04-2020 12:24:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered The original SAE was the
Diagnosis give by hospital
- CVA with expresive
aphasia. EDC wantd me to
split the terms for coding
purposes. This is not an
SAE.
Nov-04-2020 11:36:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered The original diagnosis from
the hospital was CVA with
Aphasia. Thats what i
reported for the SAE. The
EDC wants it split for
coding, however both are
not the SAE.
Nov-04-2020 07:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Opened SAE
RECON:AER#2020414935
expressive aphasia(onset
date:22Oct2020)was
reported as serious in
Safety database but
updated to non serious in
AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Nov-03-2020 17:37:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Both CVA and Aphasia
were reported as Serious
Adverse Events to the
Safety Unit, Question #7
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955603
Page 145 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
should therefore be YES
(SAE Case ID is already
reported) and all other
information should be
provided for this event.
Thank you!
Nov-03-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Candidate For AE Expressive
Aphasia: Response to "Is
the adverse event serious?"
is 'No' but "Serious
Adverse Event Number" is
present.
Nov-03-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Answer Auto Query
Nov-03-2020 15:04:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOTranscription Error
Oct-30-2020 09:10:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened DM: At least one
seriousness criterion is
expected to be YES for
serious events. Please
review and update as
appropriate.
Oct-30-2020 06:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-29-2020 13:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Changed data per query
Oct-29-2020 13:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened 'Is the adverse event
serious?' is marked as YES,
but responses to all of the
seriousness criteria are NO.
At least one seriousness
criterion is expected to be
YES for serious events.
Please review and update
as appropriate.
Oct-29-2020 13:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955604
Page 146 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-29-2020 13:38:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event assoc
iated with congenital ano
maly or birth defect?
NO
Did this serious event res
ult in death?
NO
Did this serious event req
uire or prolong hospitaliz
ation?
NO
Did this serious event res
ult in persistent or signifi
cant disability/incapacity
?
NO
Is this serious event life t
hreatening?
NO
Other medically importan
t serious event
NOTranscription Error
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported 'Yes',
but at least one seriousness
criteria is missing. Please
review and update as
appropriate.
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Expressive
Aphasia: Response to "Is
the adverse event serious?"
is 'Yes' but "Serious
Adverse Event Number" is
blank.
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955605
Page 147 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Oct-29-2020 13:37:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-29-2020 13:38:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-29-2020 13:39:39
(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:
Pending medical recordsTranscription Error
Oct-29-2020 13:39:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-29-2020 13:39:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-29-2020 13:40:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955606
Page 148 of 154
***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: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Oct-29-2020 13:40:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-29-2020 13:40:13
(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
Oct-29-2020 13:40:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-13-2020 07:58:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry: downgraded to non
serious
Oct-30-2020 06:43:05
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020414935Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0955607
Page 149 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-17-2021 10:07:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955608
Page 150 of 154
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit Trail
History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-17-2021 10:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-17-2021 10:07:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date is
missing in the DISP
visit. Please complete
this date.
Feb-17-2021 10:07:26
(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 1/2Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955609
Page 151 of 154
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Feb-17-2021 10:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Feb-17-2021 10:07:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0955610
Page 152 of 154
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Mar-04-2021 16:56:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Mar-04-2021 16:28:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Confirming that the
CT and MRI were
conducted in the ER
prior to the patient
being admitted in the
hospital.
Mar-03-2021 21:36:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_ Per report
(AER 2020414935),
"on 22 Oct 2020
(Day 49) a CT of the
brain and neck and
MRI" subject were
performed. However,
was hospitalized on
23 Oct 2020. Pls
advice if test were
performed prior
hospital stay.
Oct-31-2020 17:40:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Sep-08-2020 23:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Sep-08-2020 23:02:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-31-2020 17:40:52
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/29/2020Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0955611
Page 153 of 154
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-08-2020 23:06:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
Sep-08-2020 23:02:58
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/4/2020Initial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0955612
Page 154 of 154
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1079 Site Name: (1079) PMG Research of Charlotte LLC
Subject No: 10791246 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Nov-04-2020 11:43:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae2f1f\Final\Final On: 01-Apr-2021 03:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0955613