125742 S1 M5 CRF c4591001 1071 10711023

Document text

Page 1 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919093
Page 2 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Aug/12/2020
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919094
Page 3 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Demography
1.Subject ID [10711023]
2.Birth Date: 1964
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919095
Page 4 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919096
Page 5 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919097
Page 6 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919098
Page 7 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:[HYPERCHOLESTEROLEMIA]
Start Date: Jan/UNK/2019
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CONGESTIVVE HEART FAILURE]
Start Date: UNK/UNK/2017
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2015
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL ANKLE EDEMA]
Start Date: Jun/UNK/2019
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE II DIABETES]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919099
Page 8 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/2013
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGIC RHINITIS]
Start Date: UNK/UNK/2017
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[PARTIAL HYSTERECTOMY]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[STROKE]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[VISION LOSS]
Start Date: Feb/UNK/2020
Ongoing: YES
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919100
Page 9 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[BILATERAL LEG EDEMA]
Start Date: Jan/UNK/2019
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919101
Page 10 of 141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [100.7]
3.Unit: kg
4.Height: [172.7]
5.Unit: cm
6.Body Mass Index: [33.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.2]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919102
Page 11 of 141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/12/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919103
Page 12 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [226390]
3.Randomization Group: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919104
Page 13 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
Aug/12/2020
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 [BP54D9]
5.bSample ID [BP54DB]
5.cSample ID [BP54DC]
5.dSample ID [BPRK9N]
5.eSample ID [BPRK9P]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919105
Page 14 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
Aug/12/2020
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 [BP542F]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919106
Page 15 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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: Aug/12/2020 12:15
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
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919107
Page 16 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919108
Page 17 of 141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919109
Page 18 of 141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919110
Page 19 of 141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919111
Page 20 of 141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919112
Page 21 of 141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919113
Page 22 of 141
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919114
Page 23 of 141
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919115
Page 24 of 141
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM RESOLVED
DATES
Form Version: 30-Jul-2020 21:30 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?
2.Symptom:
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the Subject
Diary was completed?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919116
Page 25 of 141
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919117
Page 26 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919118
Page 27 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919119
Page 28 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919120
Page 29 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919121
Page 30 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919122
Page 31 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919123
Page 32 of 141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919124
Page 33 of 141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919125
Page 34 of 141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919126
Page 35 of 141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919127
Page 36 of 141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919128
Page 37 of 141
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919129
Page 38 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919130
Page 39 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919131
Page 40 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919132
Page 41 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Unplanned Assessments
1.Assessments
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919133
Page 42 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Aug/23/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919134
Page 43 of 141
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Aug/28/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919135
Page 44 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919136
Page 45 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919137
Page 46 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  WORSENING coronary art
ery disease Aug/23/2020 UN
K:UNK NO
End Date Time:
Aug/31/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919138
Page 47 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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)[WORSENING coronary artery disease]
4.Start Date Time: Aug/23/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 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
YES
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:
[Hypertensive cardiovascular disease or arteriosclerotic heart disease]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919139
Page 48 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? YES
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?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[2020323142]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919140
Page 49 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919141
Page 50 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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[ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919142
Page 51 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919143
Page 52 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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: //
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919144
Page 53 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919145
Page 54 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919146
Page 55 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919147
Page 56 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919148
Page 57 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919149
Page 58 of 141
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919150
Page 59 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919151
Page 60 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919152
Page 61 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919153
Page 62 of 141
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919154
Page 63 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919155
Page 64 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919156
Page 65 of 141
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919157
Page 66 of 141
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919158
Page 67 of 141
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919159
Page 68 of 141
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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 [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919160
Page 69 of 141
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919161
Page 70 of 141
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919162
Page 71 of 141
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919163
Page 72 of 141
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919164
Page 73 of 141
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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: [ ]
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919165
Page 74 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Aug/28/2020
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919166
Page 75 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919167
Page 76 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Michael Dunn  Approved Mar-09-2021 16:08:34 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, 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.
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919168
Page 77 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
ItemDate User Comment
FormAug-13-2020 09:59:45 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919169
Page 78 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Michael Dunn  Approved Mar-09-2021 16:08:34 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, 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-24-2021 17:13:55 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dunn  Approved Nov-17-2020 13:19:18 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-24-2020 11:02:12 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dunn  Approved Oct-12-2020 12:39:43 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919170
Page 79 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Affidavit:
By my dated signature below, I, MichaelDunn, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-09-2020 10:57:52 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Michael Dunn  Approved Sep-24-2020 11:27:42 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MichaelDunn, 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.
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919171
Page 80 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Aug-13-2020 09:59:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-13-2020 09:59:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919172
Page 81 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 09:59:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919173
Page 82 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-13-2020 09:58:58
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10711023Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 09:58:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 09:59:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-13-2020 09:59:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-13-2020 09:59:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMERICA
NInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919174
Page 83 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020 09:59:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919175
Page 84 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Aug-13-2020 10:00:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 10:00:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 10:00:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919176
Page 85 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 10:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histo
ry Term:HYPERCHOLEST
EROLEMIA
Start Date: Jan/UNK/2019
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTEROLEMIAInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 10:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 10:00:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919177
Page 86 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-13-2020 10:00:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:CONGESTIVVE HE
ART FAILURE
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:00:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:00:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CONGESTIVVE HEART FAILUREInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 10:00:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 10:00:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020 10:00:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Te
rm:HYPERTENSI
ONInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919178
Page 87 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Start Date: UNK/UNK/201
5
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:00:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:00:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 10:00:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 10:00:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-15-2020 13:28:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:4
Medical Histo
ry Term:BILATERAL AN
KLE EDEMA
Start Date: Jun/UNK/2019
Ongoing: YESNew Information
Aug-13-2020 10:01:12
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919179
Page 88 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(US & Canada) Medical History Te
rm:EDEMA
Start Date: Jun/UNK/20
19
Ongoing: YES
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919180
Page 89 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:01:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-17-2020 04:19:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Aug-15-2020 13:28:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Aug-15-2020 13:28:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL ANKLE EDEMANew Information
Aug-14-2020 10:41:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened GPD Clin: Please
con you add the
location of this
condition to the event
term
Aug-13-2020 10:01:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EDEMAInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 10:01:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 10:01:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919181
Page 90 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-13-2020 10:01:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:TYPE II DIABE
TES
Start Date: UNK/UNK/201
6
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:01:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:01:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
TYPE II DIABETESInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 10:01:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 10:01:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-13-2020 10:01:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919182
Page 91 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical His
tory Term:GASTROESOPHAGE
AL REFLUX DISEAS
E
Start Date: UNK/UNK/2013
Ongoing: YES
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:01:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:01:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
GASTROESOPHAGEAL REFLUX
DISEASEInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 10:01:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 10:01:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-13-2020 10:02:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:ALLERGIC RHI
NITIS
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919183
Page 92 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:02:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:02:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGIC RHINITISInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020 10:02:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020 10:02:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-13-2020 10:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histo
ry Term:PARTIAL HYSTER
ECTOMY
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2012Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919184
Page 93 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PARTIAL HYSTERECTOMYInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 10:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 10:02:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2012Initial Entry
1.i
Date Location User Value Reason
Sep-18-2020 15:55:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:9
Medical History
Term:STROKE
Start Date: UNK/UNK/201
9
Ongoing: NO
End Date:
UNK/UNK/2
019Transcription Error
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919185
Page 94 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020 15:55:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:9
Medical History
Term:STROKE
Start Date: UNK/UNK/201
9
Ongoing: NO
End Date:
UNK/UNK/2
020Transcription Error
Aug-13-2020 10:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:STROKE
Start Date: Feb/UNK/2020
Ongoing: NO
End Date:
UNK/UNK/2
020Initial Entry
1.i Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 10:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STROKEInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919186
Page 95 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1.i Start Date:
Date Location User Value Reason
Sep-18-2020 15:55:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Transcription Error
Aug-13-2020 10:02:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.i Ongoing:
Date Location User Value Reason
Nov-21-2020 16:18:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Query closed; will
follow for SAE
update with the
requested med Hx
start info
Nov-19-2020 16:26:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered DATA CORRECT
AS ENTERED.
CORRECTED SAE
MED HX FORM
SUBMITTED.
Nov-19-2020 13:27:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Med Hx of
Stroke has date of
occurrence 2019;
however, SAE Med
Hx has date of
occurrence as Feb
2020. Please review,
harmonize reporting,
and update in the
appropriate location.
Sep-18-2020 15:55:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Transcription Error
Aug-13-2020 10:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2020Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919187
Page 96 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.j
Date Location User Value Reason
Aug-20-2020 11:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 10
Medical History Ter
m:VISION LOS
S
Start Date: Feb/UNK/20
20
Ongoing: YESChanged Information
Aug-13-2020 10:02:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History Te
rm:LOSS OF SIG
HT
Start Date: Feb/UNK/202
0
Ongoing: YESInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919188
Page 97 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.j Line/MH Number:
Date Location User Value Reason
Aug-13-2020 10:02:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 11:34:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VISION LOSSChanged Information
Aug-13-2020 10:02:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LOSS OF SIGHTInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-13-2020 10:02:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/UNK/2020Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-13-2020 10:02:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Sep-05-2020 12:01:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:11
Medical Histo
ry Term:BILATERAL LE
G EDEMA
Start Date: Jan/UNK/2019
Ongoing: YESTranscription Error
Sep-03-2020 08:41:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 11Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919189
Page 98 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Medical History Te
rm:EDEMA
Start Date: Jan/UNK/20
19
Ongoing: YES
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919190
Page 99 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.k Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:41:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-07-2020 09:00:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Sep-05-2020 12:01:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-05-2020 12:01:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BILATERAL LEG EDEMATranscription Error
Sep-04-2020 13:16:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Katherine
PuigQuery 1: Opened CLINQUERY: Please
clarify location of
edema in MH term
Sep-04-2020 09:21:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Candidate CLINQUERY: Please
clarify location of
edema in MH term
Sep-03-2020 08:41:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EDEMAInitial Entry
1.k Start Date:
Date Location User Value Reason
Sep-03-2020 08:41:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/UNK/2019Initial Entry
1.k Ongoing:
Date Location User Value Reason
Sep-03-2020 08:41:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919191
Page 100 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.l
Date Location User Value Reason
Sep-18-2020 10:01:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:CORONARY ART
ERY DISEASE
Start Date: UNK/UNK/2019
Ongoing: YESChanged Information
Sep-18-2020 10:00:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:12
Medical Histo
ry Term:CORONARY ART
ERY DISEASE
Start Date: UNK/UNK/2017
Ongoing: YESChanged Information
Sep-11-2020 09:56:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:12
Medical History
Term:ARTERIOSCLE
ROSIS
Start Date: UNK/UNK/2017
Ongoing: YESChanged Information
Sep-03-2020 08:41:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:12
Medical His
tory Term:ARTERIOSCLEROSI
S HEART DISEASE
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919192
Page 101 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.l Line/MH Number:
Date Location User Value Reason
Sep-03-2020 08:41:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-18-2020 10:00:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORONARY ARTERY DISEASEChanged Information
Sep-11-2020 09:56:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ARTERIOSCLEROSISChanged Information
Sep-09-2020 11:53:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-08-2020 09:00:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered FOLLOWUP
SUBMITTED
Sep-04-2020 12:37:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL Start date
for this medical
history condition not
provided in original
SAE report; please
submit as SAE
followup
Sep-03-2020 08:41:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ARTERIOSCLEROSIS HEART D
ISEASEInitial Entry
1.l Start Date:
Date Location User Value Reason
Sep-18-2020 10:01:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Changed Information
Sep-03-2020 08:41:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919193
Page 102 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
1.l Ongoing:
Date Location User Value Reason
Sep-03-2020 08:41:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919194
Page 103 of 141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
100.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
172.7Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33.8Initial Entry
7.a
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919195
Page 104 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 36.2
Temperature Unit: C
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
36.2Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020 10:03:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919196
Page 105 of 141
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919197
Page 106 of 141
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020 10:03:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919198
Page 107 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020 10:03:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 10:03:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
226390Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919199
Page 108 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 10:04:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 10:04:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 10:04:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 10:04:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-13-2020 10:04:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 10:04:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP54D9Initial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919200
Page 109 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-13-2020 10:04:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP54D9Initial Entry
5.b
Date Location User Value Reason
Aug-13-2020 10:04:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP54DBInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 10:04:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP54DBInitial Entry
5.c
Date Location User Value Reason
Aug-13-2020 10:04:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP54DCInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 10:04:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP54DCInitial Entry
5.d
Date Location User Value Reason
Aug-13-2020 10:04:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRK9NInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919201
Page 110 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 10:04:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPRK9NInitial Entry
5.e
Date Location User Value Reason
Aug-13-2020 10:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRK9PInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 10:05:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPRK9PInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919202
Page 111 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 10:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 10:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 10:11:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 10:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Aug-13-2020 10:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 10:11:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP542FInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919203
Page 112 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-13-2020 10:11:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BP542FInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919204
Page 113 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 12:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919205
Page 114 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020 10:11:30
(UTC-06:00) Central 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
Aug-13-2020 10:11:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919206
Page 115 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Aug-13-2020 10:11:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIAR
Y COLLECTED FOR THIS SUBJE
CTInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919207
Page 116 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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-18-2020 19:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-18-2020 19:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-21-2020 08:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Sep-21-2020 08:38:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Sep-21-2020 08:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened Status is reported as
Adverse Event, but
there is no Adverse
Event with 'Did the
adverse event cause
the subject to be
discontinued from the
study' reported as
YES. Please check
and correct the data.
Sep-21-2020 08:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE EVENT
but "Specify Status" is
Provided.
Sep-21-2020 08:38:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTTranscription Error
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919208
Page 117 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020 19:32:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-18-2020 19:32:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is NO LONGER
MEETS
ELIGIBILITY
CRITERIA but
"Specify Status" is
missing.
Sep-18-2020 19:32:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-18-2020 19:32:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO LONGER MEETS ELIGIBILI
TY CRITERIATranscription Error
Sep-18-2020 19:30:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Sep-18-2020 19:30:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Status is selected as
''WITHDRAWAL BY
SUBJECT'' and
WITHDRAWAL OF
CONSENT form is
not initiated. Please
review and update as
appropriate.
Sep-18-2020 19:30:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-21-2020 08:38:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-18-2020 19:32:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
subject no longer meets inclusion 3Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919209
Page 118 of 141
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 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
Nov-10-2020 10:46:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Nov-10-2020 08:00:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered UPDATES MADE
Nov-10-2020 01:23:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 2: Reissued:Opened AE page unfrozen
Nov-09-2020 15:19:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered UNABLE TO
UPDATE SAE END
DATE. PAGE
FROZEN
Nov-09-2020 12:39:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Since subject was
discontinued on
28AUG2020, please
update SAE End Date
to Ongoing to reflect
status on that
particular date.
Oct-28-2020 08:37:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered SINCE LAST
CONTACT WITH
SUBJECT WAS
28AUG20020 AND
END DATE FOR AE
CAME FROM
HOSPITAL
RECORDS
SHOULD AE BE
CHANGED TO
ONGOING?
Oct-28-2020 03:43:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 2: Opened SAE 'Coronary artery
disease' resolved on
31Aug2020, but
disposition follow up
date is recorded as
28Aug2020. The last
contact with the
subject to be
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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-2021-5683-0919210
Page 119 of 141
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
documented as end of
study date. Please
review and update
this date. Else clarify.
Oct-26-2020 14:56:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-24-2020 11:02:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered PER NOTES FROM
SUBJECT SOURCE:
end of participation
was 28 Aug 2020.
subject withdrawn
due to SAE no longer
meets the eligibility
requirement of
inclusion 3
Oct-24-2020 11:02:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020PER NOTES FROM
SUBJECT SOURCE:
end of participation
was 28 Aug 2020.
subject withdrawn
due to SAE no longer
meets the eligibility
requirement of
inclusion 3
Oct-24-2020 07:07:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened SAE 'Coronary artery
disease' resolved on
31Aug2020, but
disposition follow up
date is recorded as
22Aug2020. Please
confirm whether the
subject was contacted
on 31Aug2020. If
yes, please consider
updating the
disposition date in
this CRF. Else clarify
Sep-22-2020 10:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/23/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919211
Page 120 of 141
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-22-2020 10:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Sep-22-2020 10:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919212
Page 121 of 141
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
Date Location User Value Reason
Aug-19-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919213
Page 122 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Category:
Date Location User Value Reason
Aug-19-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-19-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Sep-17-2020 14:30:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-16-2020 07:55:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed acceptable discrepancy
per Clinical comment
Sep-15-2020 08:52:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered FOLLOW UP FORM
SUBMITTED
Sep-15-2020 05:38:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SAE RECON:
AER#2020323142,the
term in AE CRF was
updated to
'WORSENING
coronary artery disease'
however, retained as
'Worsening of
arteriosclerosis' in
Safety. If safety update
is required, please
submit a follow-up
form.
Sep-14-2020 18:44:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919214
Page 123 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-14-2020 18:44:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WORSENING coronary artery di
seaseNew Information
Sep-14-2020 14:04:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-14-2020 14:04:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Sep-14-2020 14:03:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLINICAL Thank you
for the clarification.
Please submit SAE
followup that discharge
date for CABG
hospitalization is
unknown, to make it
clear that the 'discharge
the next day' statement
refers to the preceding
overnight testing
hospital stay.
Sep-12-2020 08:27:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered CONFIRMING
ELIGIBLE PER
INCLUSION 3
Sep-11-2020 18:33:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered the subject was not
discharged the nest
date. We have not been
able to obtain records
of discharge date
Sep-11-2020 18:32:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered We currently have no
update on the stress
test. We have not been
able to obtain medical
records
Sep-11-2020 06:51:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL Subject
reports being more
“winded" after
exercising since Jun
2020. Please review for
Inclusion Criterion 3.
Sep-10-2020 16:39:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL Please
clarify with the subject
if exercise test on 18
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919215
Page 124 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug 2020 was a
routine planned visit
(like an annual test),or
was scheduled for
18Aug2020 due to
worsening clinical
symptoms.
Sep-10-2020 16:02:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL As per the
SAE, subject had
bypass surgery and was
reported discharged the
next day. Clinically do
not expect such a quick
d/c after major cardiac
surgery. Please submit
a SAE followup report
to clarify.
Sep-10-2020 11:33:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WORSENING ARTERISCLERO
SISNew Information
Aug-31-2020 08:22:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WORSENING ARTERISCLERO
SIS HEART DISEASEChanged Information
Aug-20-2020 08:03:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WORSENING CONGESTIVE H
EART FAILUREChanged Information
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
worsening congestive heart failur
eInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-14-2020 18:44:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/23/2020 UNK:UNKNew Information
Sep-09-2020 07:11:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed onset date updated in
SDB. Issue resolved
Sep-08-2020 08:50:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered CORRECTION
SUBMITTED. DATE
CORRECT AS
ENTERED IN EDC
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919216
Page 125 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-07-2020 05:30:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
AER#2020323142 
Sep-04-2020 09:44:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Changed Information
Sep-04-2020 09:44:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020 UNK:UNKChanged Information
Sep-03-2020 07:01:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate SAE RECON: To
monitor update in the
SAE listing
Sep-02-2020 09:22:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered FOLLOW UP SAE
FORM SUBMITTED
TO CORRECT DATE
IN SDB
Sep-01-2020 05:46:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:
AER#2020323142 
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User ValueReason
Mar-04-2021
16:32:39
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Clo
sedResponse satisfies query
Feb-24-2021
17:13:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Ans
weredNew Information
Feb-24-2021
17:13:55
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
NO
EndNew Information
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919217
Page 126 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Canada) Date
Tim
e:
Au
g/3
1/2
02
0
U
N
K:
U
N
K
Feb-22-2021
20:17:09
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Op
enedCLINICAL Event end date
is none (ongoing); however,
SAE report end date is
31Aug20. Please review
end date, harmonize
reporting, and update where
appropriate
Nov-10-2020
11:56:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedAe ongoing at disposition
Nov-10-2020
07:59:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Ans
weredAE EVENT MADE
ONGOING PER QUERY
INSTRUCTIONS
Nov-10-2020
07:58:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
3: Op
ened'Disposition Follow-up
form is completed and this
Adverse Event is still
ongoing. Please review and
update as appropriate.
Nov-10-2020
07:58:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Del
etedChanged Information
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919218
Page 127 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Nov-10-2020
07:58:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
YESChanged Information
Nov-10-2020
01:23:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Balaji Prabu R Query
2: Can
didatesite will need to make the
ongoing item as ongoing.
Please do not freeze this
page until update is made.
Sep-23-2020
07:35:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Erica Weaver Query
1: Clo
sedAs per SAE follow up.
Sep-22-2020
14:10:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4777398;‘End Date'
is after ‘Date of
Completion/Discontinuation
/Death’ on the Disposition -
Follow-up eCRF. Please
clarify or correct.
Sep-14-2020
18:44:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
NO
End
Date
Tim
e:
Au
g/3
1/2
02
0
U
N
K:
U
N
KNew Information
Aug-19-2020
15:50:06ACV0PFEINFP6000  Data
EntryInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919219
Page 128 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time
(US &
Canada):
YES
6. Toxicity Grade:
Date Location User Value Reason
Aug-19-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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-25-2020 21:56:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for SAE update
with the requested
COVID test info
Nov-25-2020 16:07:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered will update SAE with
no COVID results
obtain while in
hospital
Nov-23-2020 16:20:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL
Followup/COVID
testing in Hosp has
not been reported in
the SAE. Please
submit a follow-up
SAE [#202323142]
form to provide
whether COVID
testing was performed
(yes/no) and if yes, the
date & results.
Oct-26-2020 13:50:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed query closed; will
follow for SAE update
submitted with
requested COVID test
info
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919220
Page 129 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-26-2020 10:46:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered FOLLOW UP
FORM TO BE
SUBMITTED
Oct-25-2020 20:29:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened COVID testing has
not been reported in
the SAE submitted to
safety. Please submit
a follow-up SAE
form [#202323142]
to provide whether
COVID testing was
performed (yes/no)
and if yes, the results.
Aug-24-2020 02:53:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Answer Auto Query
Aug-21-2020 12:28:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Candidate Response does not
satisfy query
Aug-20-2020 08:04:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Serious Adverse
Event Number: For
Pfizer Use Only
Aug-20-2020 04:30:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened For AE worsening
congestive heart
failure: Response to
"Is the adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE worsening
congestive heart
failure: Response to
"Is the adverse event
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919221
Page 130 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated w
ith congenital anomaly or birth d
efect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/i
ncapacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
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
Aug-19-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919222
Page 131 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date Location User Value Reason
Aug-28-2020 08:49:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Aug-28-2020 08:09:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Aug-28-2020 08:09:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:
OTHER
If Other, specify:
Hypertensive cardiovascular
disease or arteriosclerotic he
art diseaseNew Information
Aug-28-2020 04:57:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY: Please
complete the question
'If Not Related to
study treatment, this
event is due to'
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Sep-21-2020
14:09:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: C
losedAuto closed by
Validation Check:
VC_AE001_32
Sep-21-2020
13:18:22
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: C
losedResponse satisfies
query
Sep-21-2020
08:39:35ACV0PFEINFP6000  Query 2: A
nsweredUPDATE MADE
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919223
Page 132 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
(UTC-06:00)
Central Time
(US & Canada)
Sep-21-2020
01:21:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 2: O
penedDMW4751714;The
Latest Action to
Study Treatment is
DRUG
WITHDRAWN, but
the Disposition-
Treatment Form
Status is not
DEATH OR
ADVERSE
EVENT. Please
review and update
as appropriate.
Sep-18-2020
19:33:09
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: A
nsweredcompleted
Sep-16-2020
05:49:04
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: O
penedCLINQUERY: AE
reported as leading
to DRUG
WITHDRAWN. If
this is correct, and
subject will not
receive Vax2, then
please complete the
EOT tab of the CRF
Sep-14-2020
18:45:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
DRUG WI
THDRAW
NNew Information
Aug-19-2020
15:50:06
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
NOT APP
LICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919224
Page 133 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-19-2020 15:50:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-11-2020 20:29:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-09-2020 10:57:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Oct-09-2020 10:57:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Oct-08-2020 18:01:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL SAE
reports subject
underwent non-drug
treatment with
CABG x4 on 24 Aug
2020; please review
and update if
appropriate
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Feb-24-2021 17:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Closed Close Auto Query
Feb-24-2021 17:14:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Feb-24-2021 17:13:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Opened For AE WORSENING
coronary artery disease:
Response to "What was the
outcome of this adverse
event?" is 'Not Recovered/Not
Resolved' but AE End
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0919225
Page 134 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Date/Time is present.
Nov-17-2020 08:54:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Acceptable discrepancy
Nov-16-2020 10:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate Pending SDB update
Nov-16-2020 08:12:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered FOLLOW UP SAE FORM
SUBMITTED TO SAFETY
DATABASE
Nov-15-2020 04:49:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON 2: Per query
response 'SUBJECT STUDY
PARTICIPATION ENDED
28AUG2020 WITH AE
STILL ONGOING AT THAT
TIME.. IF AE correct
outcome is not recovered/not
resolved, please submit a
follow up SAE form to update
safety database.
Nov-14-2020 09:28:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate For Clinical review
Nov-13-2020 08:12:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered DATA CHANGED PER
PREVIOUS QUERY
INSTRUCTIONS. SUBJECT
STUDY PARTICIPATION
ENDED 28AUG2020 WITH
AE STILL ONGOING AT
THAT TIME.
Nov-13-2020 04:23:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened SAE RECON 1: outcome was
updated to
RECOVERED/RESOLVED
in Safety database. Please
confirm correct outcome and
update accordingly.
Nov-12-2020 10:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered DATA CHANGED PER
QUERY INSTRUCTIONS.
FOLLOW-UP FORM TO BE
SUBMITTED.
Nov-12-2020 04:06:44
(UTC-06:00) CentralACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020323142
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (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), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919226
Page 135 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Time (US & Canada) Outcome was updated to NOT
RECOVERED/NOT
RESOLVED in AE CRF
however, recorded as
RECOVERED/RESOLVED
on AE CRF. Please confirm
correct outcome. If safety
update is required, please
submit a follow-up form.
Nov-10-2020 07:59:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT R
ESOLVEDChanged Information
Sep-14-2020 18:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-14-2020 18:45:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDNew Information
Sep-14-2020 18:44:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened For AE WORSENING
coronary artery disease:
Response to "What was the
outcome of this adverse
event?" is 'Not Recovered/Not
Resolved' but AE End
Date/Time is present.
Sep-14-2020 08:11:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Sep-14-2020 08:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-14-2020 08:09:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT R
ESOLVEDTranscription Error
Sep-14-2020 04:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020323142
Outcome was reported as
NOT RECOVERED/NOT
RESOLVED in Safety
Database however, recorded
as
RECOVERING/RESOLVING
on AE CRF. Please confirm
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919227
Page 136 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
correct outcome. If safety
update is required, please
submit a follow-up form.
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVIN
GInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 11:40:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 2: Closed Response satisfies
query
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0919228
Page 137 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-22-2020 10:25:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered FUP TAB UPDATED
Sep-22-2020 09:37:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Reissued:Opened CLINQUERY: Please
complete the FUP tab
of the CRF to match
study discontinuation
Sep-22-2020 08:17:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered DATA CORRECT
AS ENTERED.
Sep-21-2020 14:33:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 2: Opened CLINQUERY: Data
indicates subject has
not only discontinued
from treatment but
also from the study
i.e. no follow up to be
performed. Please
review data entry and
confirm if this is
correct
Sep-21-2020 14:27:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Deleted EOT is updated with
AE as reason.
Sep-21-2020 08:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Did the adverse
event cause the
subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Sep-21-2020 08:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0919229
Page 138 of 141
***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, Frozen, Verified
Site No: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Aug-19-2020 15:50:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Aug-24-2020 02:53:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020323142Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919230
Page 139 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Subject Status
Date Location User Value Reason
Sep-22-2020 10:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Sep-21-2020 08:38:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Sep-18-2020 19:32:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDTranscription Error
Sep-18-2020 19:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-13-2020 10:03:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-13-2020 10:00:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-24-2020 11:02:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/28/2020PER NOTES FROM
SUBJECT SOURCE:
end of participation
was 28 Aug 2020.
subject withdrawn
due to SAE no longer
meets the eligibility
requirement of
inclusion 3
Sep-22-2020 10:24:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/23/2020Initial Entry
Sep-21-2020 08:38:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/23/2020Transcription Error
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919231
Page 140 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Sep-18-2020 19:32:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/23/2020Transcription Error
Sep-18-2020 19:30:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/23/2020Initial Entry
Aug-13-2020 10:03:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
Aug-13-2020 10:00:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0919232
Page 141 of 141
***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: 1071 Site Name: (1071) Quality Clinical Research
Subject No: 10711023 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:05
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-24-2020 11:19:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f0f\Final\Final On: 01-Apr-2021 05:08 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0919233