125742 S1 M5 CRF c4591001 1019 10191071

Document text

Page 1 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896297
Page 2 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/20/2020
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896298
Page 3 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10191071]
2.Birth Date: /1950
3.Sex: MALE
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:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896299
Page 4 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/20/2020
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896300
Page 5 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896301
Page 6 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/20/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896302
Page 7 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Presbyopia]
Start Date: UNK/UNK/1998
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Obstructive Pulmonary Disease]
Start Date: UNK/UNK/2013
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1988
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cardiomegaly]
Start Date: Oct/4/2016
Ongoing: YES
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896303
Page 8 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Inguinal Hernia]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign Prostate Hypertrophy]
Start Date: UNK/UNK/2012
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Kidney Disease Stage II]
Start Date: UNK/UNK/2016
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis Bilateral Hips]
Start Date: UNK/UNK/2008
Ongoing: YES
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896304
Page 9 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fractured Right Hip]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Bilateral Hips Joint Pain]
Start Date: UNK/UNK/2008
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Recurrent Back Pain]
Start Date: UNK/UNK/2008
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fractured Left Hip]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896305
Page 10 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gout]
Start Date: Apr/UNK/2018
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Total Replacement Left Hip Surgery]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herniorraphy Inguinal]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Hip Fracture Repair and Internal Fixation]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896306
Page 11 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Hip Fracture Repair and Internal Fixation]
Start Date: UNK/UNK/1985
Ongoing: NO
End Date:
UNK/UNK/1985
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1952
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pneumonia]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896307
Page 12 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: UNK/UNK/2007
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal Reflux Disease]
Start Date: UNK/UNK/2007
Ongoing: YES
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896308
Page 13 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/20/2020
2.Weight: [130.7]
3.Unit: LB
4.Height: [66.5]
5.Unit: in
6.Body Mass Index: [20.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: EAR
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896309
Page 14 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/20/2020
2.Randomization Number: [234465]
3.Randomization Group: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896310
Page 15 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BM86K1]
5.bSample ID [BM86K2]
5.cSample ID [BM86K3]
5.dSample ID [BPRM77]
5.eSample ID [BPRM78]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896311
Page 16 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/20/2020
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 [BM861M]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896312
Page 17 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/20/2020 08:32
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
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896313
Page 18 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896314
Page 19 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/11/2020
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896315
Page 20 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/11/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.3]
Unit: F
Temperature Location: EAR
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896316
Page 21 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/11/2020
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 [BM8687]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896317
Page 22 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/11/2020 09:53
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
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896318
Page 23 of 165
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/15/2020
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896319
Page 24 of 165
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/15/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR85NJ]
5.bSample ID [BRTLTG]
5.cSample ID [BRTLTH]
5.dSample ID [BRTLTJ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896320
Page 25 of 165
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/5/2021
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896321
Page 26 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896322
Page 27 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896323
Page 28 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896324
Page 29 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896325
Page 30 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896326
Page 31 of 165
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896327
Page 32 of 165
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896328
Page 33 of 165
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896329
Page 34 of 165
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896330
Page 35 of 165
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896331
Page 36 of 165
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896332
Page 37 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896333
Page 38 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896334
Page 39 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896335
Page 40 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896336
Page 41 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/15/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896337
Page 42 of 165
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896338
Page 43 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896339
Page 44 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896340
Page 45 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# CategoryAE Ident
ifierAdverse E
ventStart DateIs the Adverse Event Sti
ll OngoingForm Instanc
e
 1. ADVERSE E
VENT 1  Anemia  Dec/17/2020 UN
K:UNK NO
End Date Time:
Dec/19/2020 UNK:U
NK
 Repeating
Pages
 2. DELETED           Repeating
Pages
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896341
Page 46 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Anemia]
4.Start Date Time: Dec/17/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/19/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896342
Page 47 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Iron Deficiency]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
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?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020520664]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896343
Page 48 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: //
5.Is the adverse event still ongoing?
6.Toxicity Grade:
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).
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.
9.Is this event related to study
treatment:
10.Latest Action Taken with Study
Treatment:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896344
Page 49 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
11.Was a Concomitant Medication
given?
12.Was a Non-Drug Treatment given?
13.What was the outcome of this
adverse event?:
14.Did the adverse event cause the
subject to be discontinued from
the study?
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896345
Page 50 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896346
Page 51 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from
the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896347
Page 52 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896348
Page 53 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896349
Page 54 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896350
Page 55 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name
is unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896351
Page 56 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896352
Page 57 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896353
Page 58 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.WHOLE BLOOD  Dec/18/2020  Repeating Pages
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896354
Page 59 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
1.Transfusion Type: WHOLE BLOOD
2.Date of Transfusion: Dec/18/2020
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896355
Page 60 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896356
Page 61 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896357
Page 62 of 165
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896358
Page 63 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896359
Page 64 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896360
Page 65 of 165
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896361
Page 66 of 165
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896362
Page 67 of 165
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896363
Page 68 of 165
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896364
Page 69 of 165
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896365
Page 70 of 165
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Answered Queries, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896366
Page 71 of 165
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/30/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896367
Page 72 of 165
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896368
Page 73 of 165
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896369
Page 74 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/15/2020
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896370
Page 75 of 165
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896371
Page 76 of 165
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896372
Page 77 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-20-2020 10:13:14 (UTC-06:00) Central
Time (US & Canada)N/A
Not Applicable
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896373
Page 78 of 165
***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, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Feb-11-2021 10:36:01 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-21-2021 18:21:28 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I , verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-12-2021 15:27:08 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-21-2020 13:48:09 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896374
Page 79 of 165
***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, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , 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.
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896375
Page 80 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-20-2020 10:12:27
(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-20-2020 10:12:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896376
Page 81 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-20-2020 10:12:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtaine
d
Aug/20/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896377
Page 82 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-20-2020 10:12:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10191071Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-20-2020 10:12:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1950Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-20-2020 10:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-20-2020 10:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-20-2020 10:12:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMER
ICANInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896378
Page 83 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-20-2020 10:13:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896379
Page 84 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-20-2020 10:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-20-2020 10:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-20-2020 10:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896380
Page 85 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-20-2020 10:14:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Presbyopia
Start Date: UNK/UNK/1
998
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:14:25
(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-20-2020 10:14:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PresbyopiaInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-20-2020 10:14:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-20-2020 10:14:25
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896381
Page 86 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
1.b
Date Location User Value Reason
Aug-20-2020 10:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:2
Medical Hi
story Term:Chronic Obstructiv
e Pulmonary Diseas
e
Start Date: UNK/UNK/2013
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:14:54
(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-20-2020 10:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic Obstructive Pulmonary
DiseaseInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-20-2020 10:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-20-2020 10:14:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896382
Page 87 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c
Date Location User Value Reason
Aug-20-2020 10:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Hypertension
Start Date: UNK/UNK/1
988
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:15:18
(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-20-2020 10:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-20-2020 10:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-20-2020 10:15:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896383
Page 88 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020 10:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Cardiomeg
aly
Start Date: Oct/4/2016
Ongoing: YESInitial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:15:46
(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-20-2020 10:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CardiomegalyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-20-2020 10:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/4/2016Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-20-2020 10:15:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-20-2020 10:16:21 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896384
Page 89 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Numb
er:5
Medical History
Term:Inguinal Herni
a
Start Date: UNK/UNK/20
13
Ongoing: NO
End Date:
UNK/UNK/
2013
1.e Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:16:21
(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-20-2020 10:16:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inguinal HerniaInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-20-2020 10:16:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-20-2020 10:16:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896385
Page 90 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f
Date Location User Value Reason
Aug-20-2020 10:16:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:Benign Prostate
Hypertrophy
Start Date: UNK/UNK/2012
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:16:45
(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-20-2020 10:16:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Benign Prostate HypertrophyInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-20-2020 10:16:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-20-2020 10:16:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896386
Page 91 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-20-2020 10:17:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Chronic Kidney D
isease Stage II
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
1.g Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:17:15
(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-20-2020 10:17:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic Kidney Disease Stage I
IInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-20-2020 10:17:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-20-2020 10:17:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896387
Page 92 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020 10:17:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:8
Medical Histo
ry Term:Osteoarthritis Bil
ateral Hips
Start Date: UNK/UNK/2008
Ongoing: YESInitial Entry
1.h Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:17:34
(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-20-2020 10:17:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Osteoarthritis Bilateral HipsInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-20-2020 10:17:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-20-2020 10:17:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-20-2020 10:17:56
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb 9Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896388
Page 93 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) er:
Medical History
Term:Fractured Righ
t Hip
Start Date: UNK/UNK/19
85
Ongoing: NO
End Date:
UNK/UNK/
1985
1.i Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:17:56
(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-20-2020 10:17:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Fractured Right HipInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-20-2020 10:17:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1985Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-20-2020 10:17:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1985Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896389
Page 94 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j
Date Location User Value Reason
Aug-20-2020 10:18:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:Bilateral Hips J
oint Pain
Start Date: UNK/UNK/200
8
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:18:18
(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 10:18:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bilateral Hips Joint PainInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-20-2020 10:18:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-20-2020 10:18:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896390
Page 95 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Aug-20-2020 10:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:11
Medical History
Term:Recurrent Bac
k Pain
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:18:42
(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
Aug-20-2020 10:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Recurrent Back PainInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-20-2020 10:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-20-2020 10:18:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896391
Page 96 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l
Date Location User Value Reason
Aug-20-2020 10:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:12
Medical History
Term:Fractured Left
Hip
Start Date: UNK/UNK/19
90
Ongoing: NO
End Date:
UNK/UNK/
1990Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896392
Page 97 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:19:10
(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
Aug-20-2020 10:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Fractured Left HipInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-20-2020 10:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-20-2020 10:19:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.m
Date Location User Value Reason
Aug-20-2020 10:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:13
Medical History T
erm:Gout
Start Date: Apr/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896393
Page 98 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 10:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GoutInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-20-2020 10:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/UNK/2018Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-20-2020 10:19:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-20-2020 10:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:14
Medical His
tory Term:Total Replacement
Left Hip Surgery
Start Date: UNK/UNK/2013Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896394
Page 99 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/201
3
1.n Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 10:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Total Replacement Left Hip Sur
geryInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-20-2020 10:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-20-2020 10:19:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.o
Date Location User Value Reason
Aug-20-2020 10:20:21
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num 15Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896395
Page 100 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) ber:
Medical Histor
y Term:Herniorraphy In
guinal
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2013
1.o Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 10:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Herniorraphy InguinalInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-20-2020 10:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-20-2020 10:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896396
Page 101 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.p
Date Location User Value Reason
Aug-20-2020 10:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:16
Medical H
istory Ter
m:Left Hip Fracture Re
pair and Internal Fix
ation
Start Date
:UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896397
Page 102 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.p Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 10:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Left Hip Fracture Repair and In
ternal FixationInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-20-2020 10:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-20-2020 10:20:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.q
Date Location User Value Reason
Aug-20-2020 10:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:17
Medical
History T
erm:Right Hip Fracture R
epair and Internal Fix
ation
Start Date
:UNK/UNK/1985Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896398
Page 103 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/1985
1.q Line/MH Number:
Date Location User Value Reason
Aug-20-2020 10:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-20-2020 10:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right Hip Fracture Repair and I
nternal FixationInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-20-2020 10:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1985Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-20-2020 10:21:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1985Initial Entry
1.r
Date Location User Value Reason
Sep-17-2020 14:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:18Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896399
Page 104 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Asthma
Start Date: UNK/UNK/1
952
Ongoing: YES
1.r Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AsthmaInitial Entry
1.r Start Date:
Date Location User Value Reason
Sep-17-2020 14:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1952Initial Entry
1.r Ongoing:
Date Location User Value Reason
Sep-17-2020 14:46:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Sep-17-2020 14:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:19Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896400
Page 105 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Pneumonia
Start Date: UNK/UNK/19
93
Ongoing: NO
End Date:
UNK/UNK/
1993
1.s Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PneumoniaInitial Entry
1.s Start Date:
Date Location User Value Reason
Sep-17-2020 14:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.s Ongoing:
Date Location User Value Reason
Sep-17-2020 14:46:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
1.t
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896401
Page 106 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-17-2020 14:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:20
Medical Histor
y Term:Hypercholester
olemia
Start Date: UNK/UNK/20
07
Ongoing: YESInitial Entry
1.t Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.t Start Date:
Date Location User Value Reason
Sep-17-2020 14:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.t Ongoing:
Date Location User Value Reason
Sep-17-2020 14:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896402
Page 107 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.u
Date Location User Value Reason
Sep-17-2020 14:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:21
Medical Histor
y Term:Coronary Arter
y Disease
Start Date: UNK/UNK/200
7
Ongoing: YESInitial Entry
1.u Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery DiseaseInitial Entry
1.u Start Date:
Date Location User Value Reason
Sep-17-2020 14:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.u Ongoing:
Date Location User Value Reason
Sep-17-2020 14:47:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896403
Page 108 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.v
Date Location User Value Reason
Sep-17-2020 14:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:22
Medical Hist
ory Term:Gastroesophageal
Reflux Disease
Start Date: UNK/UNK/2007
Ongoing: YESInitial Entry
1.v Line/MH Number:
Date Location User Value Reason
Sep-17-2020 14:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-17-2020 14:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal Reflux Disea
seInitial Entry
1.v Start Date:
Date Location User Value Reason
Sep-17-2020 14:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.v Ongoing:
Date Location User Value Reason
Sep-17-2020 14:47:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896404
Page 109 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
130.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
66.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896405
Page 110 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20.8Initial Entry
7.a
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-20-2020 10:22:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896406
Page 111 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-20-2020 10:22:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-20-2020 10:22:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
234465Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896407
Page 112 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 15:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 15:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-20-2020 15:38:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 15:37:55
(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-20-2020 15:37:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 15:38:03
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896408
Page 113 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BM86K1
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 15:38:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM86K1Initial Entry
5.b
Date Location User Value Reason
Aug-20-2020 15:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM86K2Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-20-2020 15:38:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM86K2Initial Entry
5.c
Date Location User Value Reason
Aug-20-2020 15:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM86K3Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-20-2020 15:38:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM86K3Initial Entry
5.d
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896409
Page 114 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020 15:38:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRM77Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-20-2020 15:38:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRM77Initial Entry
5.e
Date Location User Value Reason
Aug-20-2020 15:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPRM78Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-20-2020 15:38:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPRM78Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896410
Page 115 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-20-2020 15:39:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-20-2020 15:39:19
(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-20-2020 15:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-20-2020 15:39:19
(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-20-2020 15:39:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/20/2020Initial Entry
5.a
Date Location User Value Reason
Aug-20-2020 15:39:26
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896411
Page 116 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BM861M
5.a Sample ID
Date Location User Value Reason
Aug-20-2020 15:39:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM861MInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896412
Page 117 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-20-2020 10:23:37
(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-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020 08:32Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896413
Page 118 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-20-2020 10:23:37
(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-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-20-2020 10:23:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896414
Page 119 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-20-2020 10:23:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-D
IARY NOT COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896415
Page 120 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-11-2020 10:00:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896416
Page 121 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-11-2020 11:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Initial Entry
2.a
Date Location User Value Reason
Sep-11-2020 11:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.3
Temperature Unit: F
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-11-2020 11:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-11-2020 11:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-11-2020 11:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896417
Page 122 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-11-2020 11:33:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896418
Page 123 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-11-2020 10:00:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-11-2020 10:00:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-11-2020 10:01:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-11-2020 10:00:56
(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.
Sep-11-2020 10:00:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/11/2020Initial Entry
5.a
Date Location User Value Reason
Sep-11-2020 10:01:05
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896419
Page 124 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BM8687
5.a Sample ID
Date Location User Value Reason
Sep-11-2020 10:01:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM8687Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896420
Page 125 of 165
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020 09:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896421
Page 126 of 165
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-11-2020 11:33:47
(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
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-11-2020 11:33:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896422
Page 127 of 165
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-15-2020 10:19:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896423
Page 128 of 165
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-15-2020 11:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-15-2020 11:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-15-2020 11:11:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-15-2020 11:11:20
(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.
Oct-15-2020 11:11:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/15/2020Initial Entry
5.a
Date Location User Value Reason
Oct-15-2020 11:11:51
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896424
Page 129 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) Sample ID: BR85NJ
5.a Sample ID
Date Location User Value Reason
Oct-15-2020 11:11:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR85NJInitial Entry
5.b
Date Location User Value Reason
Oct-15-2020 11:12:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTLTGInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-15-2020 11:12:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTLTGInitial Entry
5.c
Date Location User Value Reason
Oct-15-2020 11:12:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTLTHInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-15-2020 11:12:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTLTHInitial Entry
5.d
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896425
Page 130 of 165
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-15-2020 11:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRTLTJInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-15-2020 11:12:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRTLTJInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896426
Page 131 of 165
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-05-2021 13:08:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/5/2021Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896427
Page 132 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-15-2020 10:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/15/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-15-2020 10:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-15-2020 10:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896428
Page 133 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896429
Page 134 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Mar-12-2021 13:52:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Mar-12-2021 13:48:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Undeleted Transcription
Error
Feb-16-2021 13:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896430
Page 135 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-12-2021 15:27:08
(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
Mar-05-2021 21:38:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Response satisfies
query
Mar-05-2021 21:37:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Mar-04-2021 11:39:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered SAE update has
been submitted.
Mar-04-2021 11:38:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered SAE update has
been submitted.
Mar-04-2021 10:55:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened Clinical - thank
you; however the
03Mar21 SAE
update medical
history section does
NOT yet report
HTN and stage II
CKD. Please submit
an update.
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896431
Page 136 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-04-2021 10:54:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical - thank
you; however
03Mar21 SAE
update does NOT
include BUN/Cr
laboratory test
results. Are these
available; please
submit
Mar-03-2021 09:54:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered SAE F/U has been
submitted.
Mar-03-2021 09:53:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered SAE F/U has been
submitted.
Feb-16-2021 19:06:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-16-2021 19:05:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Reissued:Opened Clinical Thank you;
however only gout
was reported as an
indirect measure of
renal disease; please
report Med Hx of
HTN and stage II
CKD to SAE Med
Hx, as potential
causes of anemia
Feb-16-2021 19:04:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened Clinical - Thank
you. Please also
submit renal
function
laboratories as subj
has stage II CKD
which can
contribute to
anemia
Feb-16-2021 18:51:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896432
Page 137 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Feb-11-2021 13:50:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Form has been
updated.
Feb-11-2021 13:48:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Form has been
updated.
Feb-11-2021 13:48:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Form has been
updated.
Feb-11-2021 10:36:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-13-2021 08:50:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened Clinical Please
submit a SAE
safety update with
subject's relevant
prior Med Hx for
anemia/blood loss
(GI, CKD/gout, CV,
ortho conditions if
NSAIDs).
Jan-13-2021 08:44:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL Please
submit a SAE
safety update with
all Con Meds being
taken at time of
hospital admission,
including
ASA/NSAIDs used
Jan-13-2021 08:42:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical Please
submit a SAE
safety update with
hematology
laboratory
parameters pre/post
transfusion, iron
studies, renal
function (hx CKD)
and any other
anemia evaluation
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896433
Page 138 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-13-2021 08:36:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL SAE
(#2020520664)
reported blood
transfusion during
17-19 Dec 2020
hospitalization;
please complete the
Log CRF for
transfusion
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AnemiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/17/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-20-2021 10:22:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-18-2021 08:04:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Updated SAE form
Submitted
Jan-13-2021 08:32:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL End
date is 19Dec20;
however, SAE
report has no end
date. Please submit
end date to SAE
event section at
Stop DATE/TIME
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896434
Page 139 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec/19/2020 UNK:UNK
6. Toxicity Grade:
Date Location User Value Reason
Jan-19-2021 08:51:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed serious criteria
updated to include
only hospitalization.
Jan-18-2021 08:05:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered updated cause
Jan-13-2021 06:33:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN: Toxicity
grade listed as G3
however, serious
criteria of life
threatening event is
checked YES.
Please review grade
& seriousness
criteria and update
if applicable. Else,
please clarify.
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-16-2021 18:56:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-11-2021 13:51:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Form has been
updated.
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896435
Page 140 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Jan-20-2021 10:23:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020520664] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Jan-20-2021 10:18:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Jan-18-2021 08:04:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered Transcription Error
Jan-18-2021 08:04:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Jan-18-2021 08:04:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event resultTranscription Error
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896436
Page 141 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious event
NO
Jan-13-2021 08:32:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020520664] to
document if COVID
testing was
performed
(YES/NO or info
not available) and if
yes, the date and
results.
Jan-13-2021 08:31:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL Serious
criteria for the event
'anemia' are
Hospitalization &
Life-threatening;
however, SAE
report criterion is
Hospitalization.
Please review,
harmonize
reporting, and
update in the
appropriate location
Jan-13-2021 03:13:17
(UTC-06:00) CentralACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896437
Page 142 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Anemia:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
YES
Other medically important s
erious event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896438
Page 143 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Feb-16-2021 18:57:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Feb-11-2021 13:37:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Feb-11-2021 13:37:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Iron DeficiencyNew Information
Jan-20-2021 10:24:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Opened CLINICAL 'Other'
cause for anemia is
Concom non-drug
treatment;
however, SAE
reports subject was
diagnosed with
iron deficiency.
Please review
Other cause, and
update as
appropriate
Jan-18-2021 08:05:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:Transcription Error
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896439
Page 144 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
CONCOMITANT NON-D
RUG TREATMENT
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4)
FDA-CBER-2021-5683-0896440
Page 145 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-18-2021 08:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Jan-18-2021 08:05:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
CONCOMITANT DRUG
TREATMENTTranscription Error
Jan-13-2021 08:37:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL 'Other'
cause for anemia is
Unknown;
however, SAE
reports subject was
diagnosed with
iron deficiency.
Please review
Other cause, and
update as
appropriate
Jan-13-2021 08:37:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed will update
wording
Jan-13-2021 08:25:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL 'Other'
cause for anemia is
Unknown;
however, subject
has Med Hx of
chronic kidney
disease. Please
review Other
cause, and update
as appropriate
Jan-12-2021 15:27:08
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896441
Page 146 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
unknown
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-20-2021 10:26:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-18-2021 08:05:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-18-2021 08:05:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESTranscription Error
Jan-13-2021 08:22:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL SAE
reports subject
received
transfusion. Please
review non-Drug
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896442
Page 147 of 165
***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, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Treatment given,
and update as
applicable
Jan-12-2021 15:27:08
(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
Jan-12-2021 15:27:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-12-2021 15:27:08
(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
Jan-13-2021 03:13:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020520664Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896443
Page 148 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Mar-12-2021 13:49:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-12-2021 13:49:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-12-2021
13:49:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:Transcription
Error
Mar-01-2021
08:39:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Cl
osedsite reported
transfusion on
correct CRF; this
AE was deleted
Feb-16-2021
13:42:12ACV0PFEINFP6000  Query 2: A
nsweredMoved to
Transfusion Log
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896444
Page 149 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-06:00)
Central Time
(US & Canada)CRF
Feb-15-2021
18:27:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: O
penedClinical please
move document
of blood
transfused to the
Transfusion Log
CRF
Feb-11-2021
16:34:20
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Feb-11-2021
12:40:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredChanged
Information
Feb-11-2021
12:40:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Blood Tran
sfusionChanged
Information
Feb-11-2021
12:10:48
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedMultiple concepts
in the term
BLOOD
TRANSFUSION
DUE TO
ANEMIA. Split
the term into
BLOOD
TRANSFUSION
and ANEMIA
and submit
separately. Thank
you.
Feb-11-2021
10:37:47ACV0PFEINFP6000  Data Entry
:New Information
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896445
Page 150 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-06:00)
Central Time
(US & Canada)Blood Tran
sfusion due
to Anemia
Feb-11-2021
10:36:01
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Blood Tran
sfusionInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-12-2021 13:49:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 13:49:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/18/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-12-2021 13:49:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
2Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896446
Page 151 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-12-2021 13:49:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-12-2021 13:49:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Deleted Close Auto Query
Mar-12-2021 13:48:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate For AE Blood
Transfusion:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-16-2021 23:54:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed inactivated
Feb-16-2021 13:42:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Transcription Error
Feb-15-2021 05:06:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE
RECON:BLOOD
TRANSFUSION
was recorded as
SAE in AE CRF
however, missing in
SDB. Also, Per CRF
completion
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896447
Page 152 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
guidelines, please
avoid use of a
procedure for the
AE event name;
please review and
update accordingly.
Feb-15-2021 05:05:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Deleted Query can be
addressed internally
Feb-11-2021 12:40:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Blood
Transfusion:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-11-2021 10:37:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Blood
Transfusion due to
Anemia: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Blood
Transfusion:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly or
birth defect?
NOInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896448
Page 153 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant dis
ability/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-12-2021 13:50:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896449
Page 154 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Mar-12-2021
22:03:04
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: ClosedResponse
satisfies query
Mar-12-2021
13:50:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:Transcription
Error
Mar-12-2021
13:48:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Answe
redChanged data
per query
Feb-17-2021
03:34:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1
: Reissu
ed:Open
edIf AE is meant
to be striked out
please erase all
out data for this
AE by using the
eraser icon. Or
clarify.
Feb-16-2021
13:42:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1
: Answe
redTranscription
Error
Feb-15-2021
23:40:32
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1
: Opene
dPlease review
"If not related
to study
treatment other"
field, the
following text
was indicated in
the comment
field
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896450
Page 155 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
[Diverticulosis].
Any symptoms,
AEs or other
key data should
be collected on
the appropriate
page. Please
review and
update as
necessary.
Feb-11-2021
10:36:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data E
ntry:
NOT R
ELATE
D
If Not
Relate
d to st
udy tr
eatme
nt(s), t
his ev
ent is
due to:
OTH
ER
If
Oth
er,
spe
cify
:
D
iv
er
ti
c
ulInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0896451
Page 156 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
os
is
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-12-2021 13:50:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-12-2021 13:50:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-12-2021 13:50:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(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
Mar-12-2021 13:50:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (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-2021-5683-0896452
Page 157 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
*** THIS REPEATING FORM HAS BEEN DELETED ***
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-12-2021 13:51:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Feb-11-2021 10:36:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896453
Page 158 of 165
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - Audit Trail
Form Version: 22-Apr-2020 21:03 Form Status:
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Feb-16-2021 13:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896454
Page 159 of 165
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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1. Transfusion Type:
Date Location User Value Reason
Feb-16-2021 13:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHOLE BLOODInitial Entry
2. Date of Transfusion:
Date Location User Value Reason
Feb-16-2021 13:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/18/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896455
Page 160 of 165
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 13:50:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896456
Page 161 of 165
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Answered Queries, Not Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-08-2021 09:16:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Source has been
updated.
Mar-07-2021 13:55:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Source document
was not available in
Florence. Please
upload.
Mar-02-2021 13:51:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 13:50:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate The response
indicates participant
was unblinded,
however the
TREATMENT
UNBLINDED date
is missing in the
DISP visit. Please
complete this date.
Mar-02-2021 13:50:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return
for Vaccination 3
Participant is:
eligible and NOT confirme
d to have received only pla
cebo at Vaccination 1/2Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0896457
Page 162 of 165
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Mar-02-2021 13:51:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/30/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Mar-02-2021 13:51:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR A
DDITIONAL VACCINATIONInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896458
Page 163 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-15-2020 10:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-20-2020 10:22:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-20-2020 10:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-13-2021
08:34:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed moving query onto the AE
Jan-13-2021
08:33:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed SAE report for anemia
submitted
Jan-06-2021
09:13:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL SAE
(32020520664) reported
blood transfusion on 27
Dec 2020; please complete
the Log CRF for
transfusion
Jan-06-2021
09:12:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL SAE
(#2020520664) reports a
procedure (Blood
Transfusion); however, a
medical event is required.
Please consider if this
would be anemia and
update SAE / report AE if
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896459
Page 164 of 165
***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: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
appropriate.
Jan-04-2021
06:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event no longer listed as
SAE in SDB
Jan-02-2021
05:02:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020520664
Blood transfusion(onset
date:17Dec2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Oct-15-2020
10:19:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/15/2020Initial Entry
Aug-20-2020
10:22:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
Aug-20-2020
10:13:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/20/2020Initial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896460
Page 165 of 165
***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, Verified
Site No: 1019 Site Name: (1019) Diagnostics Research Group
Subject No: 10191071 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-21-2020 13:32:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3e28\Final\Final On: 01-Apr-2021 04:47 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0896461