125742 S1 M5 CRF c4591001 1174 11741042

Document text

Page 1 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815496
Page 2 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815497
Page 3 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Demography
1.Subject ID [11741042]
2.Birth Date: /1949
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815498
Page 4 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815499
Page 5 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815500
Page 6 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815501
Page 7 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypertension]
Start Date: UNK/UNK/2005
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypothyroidism]
Start Date: UNK/UNK/2005
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[hypercholesterolaemia]
Start Date: UNK/UNK/2005
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left inguinal Hernia repair]
Start Date: Aug/UNK/2019
Ongoing: NO
End Date:
Aug/UNK/2019
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815502
Page 8 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoidectomy]
Start Date: Jul/UNK/2020
Ongoing: NO
End Date:
Jul/UNK/2020
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Microdiscectomy Lumbar spine]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Microdiscectomy Lumbar spine]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoid]
Start Date: UNK/UNK/2015
Ongoing: NO
End Date:
Jul/UNK/2020
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815503
Page 9 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Herniated disc L4-L5]
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2005
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar radiculopathy]
Start Date: UNK/UNK/2019
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[nephrolithiasis]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815504
Page 10 of 200
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Sep/16/2020
2.Weight: Not Done
[ ]Comments
3.Unit: Not Done Comments
4.Height: Not Done
[ ]Comments
5.Unit: Not Done Comments
6.Body Mass Index: [ ]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.4]
Unit: F
Temperature Location: EAR
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815505
Page 11 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/16/2020
2.Randomization Number: [256899]
3.Randomization Group: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815506
Page 12 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPYGR3]
5.bSample ID [BL9WLD]
5.cSample ID [BL9WLF]
5.dSample ID [BL9WLG]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815507
Page 13 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/16/2020
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 [BPYGR4]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815508
Page 14 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay of Vaccination
RECENT NON-STUDY VACCINATION
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/16/2020 08:53
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
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815509
Page 15 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815510
Page 16 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/6/2020
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815511
Page 17 of 200
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vital Signs
1.Date: Oct/6/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.9]
Unit: F
Temperature Location: EAR
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815512
Page 18 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/6/2020
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 [BPYGTP]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815513
Page 19 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/6/2020 09:57
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: RIGHT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815514
Page 20 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/5/2020
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815515
Page 21 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/5/2020
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 [BPYGX7]
5.bSample ID [BSGGD3]
5.cSample ID [BSGGD4]
5.dSample ID [BSGGD5]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815516
Page 22 of 200
***Confidential***
 
Header Text: C4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815517
Page 23 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815518
Page 24 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815519
Page 25 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815520
Page 26 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815521
Page 27 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815522
Page 28 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815523
Page 29 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815524
Page 30 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815525
Page 31 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815526
Page 32 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815527
Page 33 of 200
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815528
Page 34 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815529
Page 35 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815530
Page 36 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020 Comments
2.Erroneous Visit ERRONEOUS VISIT
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815531
Page 37 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Unplanned Assessments
1.Assessments Not Applicable Comments
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815532
Page 38 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Contact Outcome
1.Contact Type: Not Applicable Comments
2.Was contact made? Not Applicable Comments
3.Comments: Not Applicable
[ ]Comments
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815533
Page 39 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Vital Signs
1.Date: Not Applicable
//Comments
Vital Signs Details
2.aRecord Identifier: Not Applicable
1
Temperature: Not Applicable
[ ]Comments
Unit: Not Applicable Comments
Temperature Location: Not Applicable Comments
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815534
Page 40 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Form Comments
eCRF Audit Trail History
Unplanned Assessment Of Local Reaction
1.Date of Assessment: Not Applicable
//Comments
2.Injection Site Location Not Applicable Comments
3.Injection Site Body Side: Not Applicable Comments
Reaction
4.aReaction: REDNESS
Reaction Present: Not Applicable Comments
4.bReaction: SWELLING
Reaction Present: Not Applicable Comments
Symptom
5.aSymptom: PAIN AT INJECTION SITE
Symptom Present: Not Applicable Comments
5.bSymptom: FATIGUE/TIREDNESS
Symptom Present: Not Applicable Comments
5.cSymptom: HEADACHE
Symptom Present: Not Applicable Comments
5.dSymptom: VOMITING
Symptom Present: Not Applicable Comments
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815535
Page 41 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.eSymptom: DIARRHEA
Symptom Present: Not Applicable Comments
5 fSymptom: NEW OR WORSENED MUSCLE PAIN
Symptom Present: Not Applicable Comments
5.gSymptom: NEW OR WORSENED JOINT PAIN
Symptom Present: Not Applicable Comments
5.hSymptom: CHILLS
Symptom Present: Not Applicable Comments
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815536
Page 42 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815537
Page 43 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815538
Page 44 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815539
Page 45 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815540
Page 46 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#CategoryAE Identifi
erAdverse Eve
ntStart DateIs the Adverse Event Still Ong
oingForm Instance
 1.ADVERSE EVE
NT 1  nephrolithiasis
 Oct/2/2020 UNK:U
NK NO
End Date Time:
Oct/6/2020 UNK:UNK
 Repeating
Pages
 2.ADVERSE EVE
NT 2  Hydronephros
is Oct/2/2020 UNK:U
NK NO
End Date Time:
Oct/6/2020 UNK:UNK
 Repeating
Pages
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815541
Page 47 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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)[nephrolithiasis]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/6/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Intercurrent illness]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815542
Page 48 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
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[2020389747]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815543
Page 49 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hydronephrosis]
4.Start Date Time: Oct/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/6/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Nephrolithiasis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815544
Page 50 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
11.Was a Concomitant Medication
given?YES
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[ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815545
Page 51 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815546
Page 52 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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[ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815547
Page 53 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart Da
teForm Instanc
e
 1.1  VACCINATIONS  NO  influenza vaccin
e Sep/2/20
20 Repeating
Pages
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815548
Page 54 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[influenza vaccine]
5.Date: Sep/2/2020
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815549
Page 55 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815550
Page 56 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815551
Page 57 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815552
Page 58 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815553
Page 59 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815554
Page 60 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815555
Page 61 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815556
Page 62 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815557
Page 63 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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?
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815558
Page 64 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815559
Page 65 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815560
Page 66 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815561
Page 67 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815562
Page 68 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815563
Page 69 of 200
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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 [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815564
Page 70 of 200
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/6/2021
2.Erroneous Visit
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815565
Page 71 of 200
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
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
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815566
Page 72 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/6/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815567
Page 73 of 200
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815568
Page 74 of 200
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815569
Page 75 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/5/2020
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815570
Page 76 of 200
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815571
Page 77 of 200
***Confidential***
 
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Donald Poretz  Approved Jan-27-2021 19:11:36 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldPoretz, 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.
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815572
Page 78 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormSep-09-2020 16:06:58 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815573
Page 79 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Sep-29-2020 14:16:57 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815574
Page 80 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Sep-29-2020 14:17:45 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815575
Page 81 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4Sep-29-2020 14:19:20 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815576
Page 82 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - Comments
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5Sep-29-2020 14:19:40 (UTC-05:00) Eastern Time
(US & Canada)Not Done
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815577
Page 83 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Sep-30-2020 16:53:13 (UTC-05:00) Eastern Time
(US & Canada)Date cannot be deleted
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0815578
Page 84 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-14-2020 09:15:49 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815579
Page 85 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED VISIT - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-14-2020 09:15:49 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815580
Page 86 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-14-2020 09:16:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815581
Page 87 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-14-2020 09:16:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815582
Page 88 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-14-2020 09:16:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815583
Page 89 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: CONTACT OUTCOME - UNPLANNED - Comments
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-14-2020 09:16:20 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815584
Page 90 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-14-2020 09:16:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815585
Page 91 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-14-2020 09:16:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815586
Page 92 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:16:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815587
Page 93 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:16:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815588
Page 94 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: VITAL SIGNS - TEMP - Comments
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2.aDec-14-2020 09:16:43 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815589
Page 95 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
FormDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815590
Page 96 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
1Dec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815591
Page 97 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
2Dec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815592
Page 98 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
3Dec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815593
Page 99 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4.aDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815594
Page 100 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
4.bDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815595
Page 101 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.aDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815596
Page 102 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.bDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815597
Page 103 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.cDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815598
Page 104 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.dDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815599
Page 105 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.eDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815600
Page 106 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.fDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815601
Page 107 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.gDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815602
Page 108 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - Comments
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
ItemDate User Comment
5.hDec-14-2020 09:17:01 (UTC-05:00) Eastern Time
(US & Canada)Not Applicable
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0815603
Page 109 of 200
***Confidential***
Header Text: C4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Donald Poretz  Approved Jan-27-2021 19:11:36 (UTC-05:00) Eastern Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldPoretz, 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 Dec-14-2020 09:15:49 (UTC-05:00) Eastern Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Donald Poretz  Approved Nov-13-2020 17:55:35 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DonaldPoretz, 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.
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815604
Page 110 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-09-2020 16:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-09-2020 16:03:31
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815605
Page 111 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-30-2020 02:33:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-29-2020 14:25:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered consent date is
correct, but there
were a temporary
delay due to proper
vaccine
Sep-29-2020 14:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Sep-09-2020 16:03:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/9/2020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815606
Page 112 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-09-2020 16:03:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11741042Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-09-2020 16:03:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-12-2020
01:02:47
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edData updated.
Sep-11-2020
15:17:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Sep-11-2020
15:17:54
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALETranscription
Error
Sep-11-2020
12:11:05
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Ope
nedAs per Impala,
Sex is recorded
as Male. Please
review and
update as
appropriate.
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815607
Page 113 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-09-2020
16:03:53
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-09-2020 16:03:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A)
OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-09-2020 16:03:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815608
Page 114 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-29-2020 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Transcription Error
Sep-29-2020 14:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Transcription Error
Sep-17-2020 02:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-16-2020 09:02:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-15-2020 10:13:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
complete the VACIN
TRT form to avoid
yellow traffic light.
Thank you.
Sep-09-2020 16:04:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815609
Page 115 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-09-2020 16:07:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-09-2020 16:07:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-09-2020 16:07:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815610
Page 116 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 09:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:hypertension
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 09:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 09:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 09:15:06
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815611
Page 117 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-16-2020 09:15:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Ter
m:hypothyroidis
m
Start Date: UNK/UNK/20
05
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:15:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 09:15:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
hypothyroidismInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020 09:15:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020 09:15:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-16-2020 11:02:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:3
Medical History
Term:hypercholestero
laemiaTranscription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815612
Page 118 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Start Date: UNK/UNK/200
5
Ongoing: YES
Sep-16-2020 09:17:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:hypercholestrol
aemia
Start Date: UNK/UNK/200
5
Ongoing: YESInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815613
Page 119 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-16-2020
12:26:13
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy has been closed.
Sep-16-2020
11:02:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: Ans
weredTranscription Error
Sep-16-2020
11:02:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
hyper
choles
terola
emiaTranscription Error
Sep-16-2020
10:56:56
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify
HYPERCHOLESTROLAEMIA
as follows...Should the spelling be
HYPERCHOLESTEROLAEMIA?
If so, edit. Otherwise clarify.
Thank you.
Sep-16-2020
09:17:17
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
hyper
choles
trolae
miaInitial Entry
1.c Start Date:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815614
Page 120 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-16-2020 09:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020 09:17:17
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-16-2020 09:18:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:left inguinal Herni
a repair
Start Date: Aug/UNK/2019
Ongoing: NO
End Date:
Aug/UNK/2019Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815615
Page 121 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:18:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 09:18:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left inguinal Hernia repairInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020 09:18:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020 09:18:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/UNK/2019Initial Entry
1.e
Date Location User Value Reason
Sep-16-2020 09:20:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Hemorrhoidecto
my
Start Date: Jul/UNK/2020
Ongoing: NO
End Date:
Jul/UNK/202
0Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815616
Page 122 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.e Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:20:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 10:00:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 09:40:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The medical history
CRF was updated to
include The condition
or diagnosis that led
to this recent
surgery/procedure.
Sep-21-2020 14:43:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Per CRF
completion
requirements (8.7),
please document the
condition or diagnosis
that led to this recent
surgery/procedure as a
separate MH entry.
Sep-21-2020 10:40:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate ClinQuery: Per CRF
completion
requirements (8.7),
please document the
condition or diagnosis
that led to this recent
surgery/procedure as a
separate MH entry.
Sep-16-2020 09:20:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HemorrhoidectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-16-2020 09:20:09
(UTC-05:00) Eastern TimeACV0PFEINFP6000  Data Entry:
Jul/UNK/2020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815617
Page 123 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(US & Canada)
1.e Ongoing:
Date Location User Value Reason
Sep-16-2020 09:20:09
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jul/UNK/2020Initial Entry
1.f
Date Location User Value Reason
Oct-07-2020 15:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Microdiscectomy L
umbar spine
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/198
0Transcription Error
Sep-16-2020 09:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Hist
ory Term:Microdiscectomy L
umber spine
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/198
0Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815618
Page 124 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.f Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:21:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 15:40:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Microdiscectomy Lumbar spineTranscription Error
Sep-16-2020 09:21:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Microdiscectomy Lumber spineInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-16-2020 09:21:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-16-2020 09:21:24
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
1.g
Date Location User Value Reason
Oct-07-2020 15:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Microdiscectomy L
umbar spine
Start Date: UNK/UNK/2005Transcription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815619
Page 125 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Ongoing: NO
End Date:
UNK/UNK/200
5
Sep-16-2020 09:22:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Hist
ory Term:Microdiscectomy L
umber spine
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/200
5Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815620
Page 126 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.g Line/MH Number:
Date Location User Value Reason
Sep-16-2020 09:22:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 15:40:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Microdiscectomy Lumbar spineTranscription Error
Oct-06-2020 13:04:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-06-2020 10:52:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The condition or
diagnosis that led to
the surgery/procedure
was documented.
herniated disc L4-L5.
Oct-02-2020 15:33:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Per CRF
completion
requirements (8.7),
please document the
condition or diagnosis
that led to the
surgery/procedure as
a separate MH entry.
Oct-02-2020 12:59:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate ClinQuery: Per CRF
completion
requirements (8.7),
please document the
condition or diagnosis
that led to the
surgery/procedure as
a separate MH entry.
Sep-16-2020 09:22:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Microdiscectomy Lumber spineInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815621
Page 127 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1.g Start Date:
Date Location User Value Reason
Sep-16-2020 09:22:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-16-2020 09:22:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.h
Date Location User Value Reason
Sep-30-2020 09:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number
:8
Medical History T
erm:Hemorrhoid
Start Date: UNK/UNK/20
15
Ongoing: NO
End Date:
Jul/UNK/2
020Transcription Error
Sep-30-2020 09:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number
:8
Medical History T
erm:Hemorrhoid
Start Date: Jul/UNK/2020
Ongoing: NO
End Date:
Jul/UNK/2
020Transcription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815622
Page 128 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-30-2020 09:18:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:8
Medical History T
erm:Hemorrhoid
Start Date: UNK/UNK/20
20
Ongoing: NO
End Date:
Jul/UNK/2
020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815623
Page 129 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.h Line/MH Number:
Date Location User Value Reason
Sep-30-2020 09:18:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-30-2020 09:18:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HemorrhoidInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-30-2020 09:36:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Transcription Error
Sep-30-2020 09:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-30-2020 09:19:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/UNK/2020Transcription Error
Sep-30-2020 09:18:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Start Date is after or
equal to the first
vaccination date
16/Sep/2020. Please
review and update as
appropriate.
Sep-30-2020 09:18:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2020Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-30-2020 09:18:48
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815624
Page 130 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Jul/UNK/2020
1.i
Date Location User Value Reason
Oct-06-2020 10:50:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History T
erm:Herniated disc L
4-L5
Start Date: UNK/UNK/2005
Ongoing: NO
End Date:
UNK/UNK/2
005Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4)
FDA-CBER-2021-5683-0815625
Page 131 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
1.i Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:50:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-06-2020 10:50:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Herniated disc L4-L5Initial Entry
1.i Start Date:
Date Location User Value Reason
Oct-06-2020 10:50:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.i Ongoing:
Date Location User Value Reason
Oct-06-2020 10:50:26
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2005Initial Entry
1.j
Date Location User Value Reason
Oct-07-2020 15:38:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:10
Medical History
Term:Lumbar radicul
opathy
Start Date: UNK/UNK/201
9
Ongoing: YESTranscription Error
Oct-06-2020 10:53:23
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N 10Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815626
Page 132 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) umber:
Medical Hi
story Term
:Lower back pain with
left sided radiculopat
hy
Start Date: UNK/UNK/2019
Ongoing: YES
1.j Line/MH Number:
Date Location User Value Reason
Oct-06-2020 10:53:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-07-2020 15:38:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Lumbar radiculopathyTranscription Error
Oct-06-2020 10:53:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Lower back pain with left sided rad
iculopathyInitial Entry
1.j Start Date:
Date Location User Value Reason
Oct-06-2020 10:53:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.j Ongoing:
Date Location User Value Reason
Oct-06-2020 10:53:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Oct-12-2020 11:32:39
(UTC-05:00) Eastern TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 11Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815627
Page 133 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(US & Canada) :
Medical History T
erm:nephrolithiasis
Start Date: UNK/UNK/200
8
Ongoing: NO
End Date:
UNK/UNK/2
008
1.k Line/MH Number:
Date Location User Value Reason
Oct-12-2020 11:32:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-12-2020 11:32:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
nephrolithiasisInitial Entry
1.k Start Date:
Date Location User Value Reason
Oct-12-2020 11:32:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.k Ongoing:
Date Location User Value Reason
Oct-12-2020 11:32:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815628
Page 134 of 200
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Sep-29-2020 14:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-29-2020 14:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Transcription Error
Sep-29-2020 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Vital signs Date
11/Sep/2020 is not
same as Date of Visit
16/Sep/2020. Please
review and update as
appropriate or clarify.
Sep-29-2020 14:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-29-2020 14:01:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs Date
11/Sep/2020 is not
same as Date of Visit
09/Sep/2020. Please
review and update as
appropriate or clarify.
Sep-29-2020 14:01:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/11/2020Transcription Error
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-05-2020 09:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-05-2020 09:14:58
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Answered The subject height
was 68.3 in, and the
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815629
Page 135 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) weight was 154.8 lb
collected on
9/9/2020. the height
and weight were not
collected when the
subject was dosed on
9/16/2020
Oct-02-2020 18:45:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Not Done
is entered for several
vital signs. Even
though a temp delay
was done, the Vitals
should reflect the data
from when the
subject was dosed on
16Sep2020. Please
review and update the
Vitals as appropriate.
Sep-29-2020 14:16:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Sep-29-2020 14:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: WEIGHT WAS
COOLECTED ON
9/9/2020. THE
WEIGHT WAS 154.8
LB
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
154.8Initial Entry
3. Unit:
Date Location User Value Reason
Sep-29-2020 14:17:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Sep-29-2020 14:10:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815630
Page 136 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4. Height:
Date Location User Value Reason
Sep-29-2020 14:19:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Sep-29-2020 14:12:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: HIGHT WAS
COLLECTED ON
9/9/2020. THE
HIGHT WAS 68.25
IN. Hight was
collected on
9/9/2020. the height
was 68.25 IN. The
was not collected on
9/16/2020.
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
68.25Initial Entry
5. Unit:
Date Location User Value Reason
Sep-29-2020 14:19:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Sep-29-2020 14:12:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-29-2020 14:12:30
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-29-2020 14:12:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: HIGHT WAS
COLLECTED ON
9/9/2020. THE
HIGHT WAS 68.25
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815631
Page 137 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
IN. Hight was
collected on 9/9/2020.
the height was 68.25
IN. The was not
collected on
9/16/2020.
Sep-29-2020 14:10:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-29-2020 14:09:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: WEIGHT WAS
COOLECTED ON
9/9/2020. THE
WEIGHT WAS 154.8
LB
Sep-09-2020 16:09:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.4Initial Entry
7.a
Date Location User Value Reason
Sep-29-2020 14:04:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Location:: EARTranscription Error
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.2
Temperature Unit: F
Temperature Location:: EARInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-09-2020 16:09:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815632
Page 138 of 200
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-29-2020 14:04:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Transcription Error
Sep-09-2020 16:09:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-09-2020 16:09:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-09-2020 16:09:46
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815633
Page 139 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-29-2020 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-29-2020 14:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Randomization Date
16/Sep/2020 is before
or more than 1 day
after corresponding
Date of Visit 11/Sep
/2020. Please review
and update as
appropriate.
Sep-24-2020 01:02:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-23-2020 14:51:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The data was entered
in the unplanned
visit.
Sep-18-2020 02:37:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM 2: Thank you for
the response.
However, Please
review and update the
new data on Vitals
sign form. Else,
clarify.
Sep-17-2020 08:07:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Vital sign was
repeated on Sep/16
/2020: Weight: 154.8
Ib Height: 68.3 in
Temp: 97.4 f
Sep-17-2020 02:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: VACIN TRT is
done on 16/Sep/2020.
However, VITAL
TEMP is done on
9/Sep/20. Please
review and explain
why Vitals signs is
not repeated on the
vaccination day. If
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815634
Page 140 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
repeated, please
review and update the
repeated Vital signs
data with date.Else,
clarify
Sep-16-2020 09:06:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered there was a
temperately delay
because of prior
vaccination with
influenza vaccine
Sep-16-2020 09:01:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Randomization Date
16/Sep/2020 is before
or more than 1 day
after corresponding
Date of Visit 09/Sep
/2020. Please review
and update as
appropriate.
Sep-16-2020 09:01:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-16-2020 09:01:13
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
256899Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815635
Page 141 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 10:17:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 10:17:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-17-2020
02:56:00
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: C
losedResponse satisfies
query
Sep-16-2020
15:28:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: A
nsweredThere was a
temporary delay due
to prior influenza
vaccine
Sep-16-2020
14:55:37
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query 1: O
penedDMW4722423;Date
of Collection is
earlier or more than
1 day after Date of
Visit. Please clarify
or correct.
Sep-16-2020
10:17:29
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entr
y:
YES
Date of C
ollection:
Sep/16/
2020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815636
Page 142 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.a
Date Location User Value Reason
Sep-16-2020 10:17:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYGR3Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 10:17:19
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYGR3Initial Entry
5.b
Date Location User Value Reason
Sep-16-2020 10:17:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9WLDInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-16-2020 10:17:55
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BL9WLDInitial Entry
5.c
Date Location User Value Reason
Sep-16-2020 10:18:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9WLFInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-16-2020 10:18:11
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BL9WLFInitial Entry
5.d
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815637
Page 143 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-16-2020 10:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BL9WLGInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-16-2020 10:18:23
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BL9WLGInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815638
Page 144 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-16-2020 10:15:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-16-2020 10:15:02
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-29-2020 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Sep-29-2020 14:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Date of Collection
16/Sep/2020 is more
than 1 day after Date
of Visit 11/Sep/2020.
Please review and
update as
appropriate, else
clarify.
Sep-17-2020 02:55:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-16-2020 10:16:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered there was a
temperately delay
because of prior
influenza vaccine
Sep-16-2020 10:15:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Sep-16-2020 10:15:02 ACV0PFEINFP6000  auto query Query 2: Candidate 'Sample Collected?'
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815639
Page 145 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
(UTC-05:00) Eastern
Time (US & Canada)(autoquery) is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-16-2020 10:15:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of Collection
16/Sep/2020 is more
than 1 day after Date
of Visit 09/Sep/2020.
Please review and
update as
appropriate, else
clarify.
Sep-16-2020 10:15:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/16/2020Initial Entry
5.a
Date Location User Value Reason
Sep-16-2020 10:15:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYGR4Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-16-2020 10:15:18
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYGR4Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815640
Page 146 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-09-2020 16:11:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-09-2020 16:11:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of First Delay:
Sep/9/2020
Reason(s) for Temporary Delay o
f Vaccination
RECENT NON-STUDY VACC
INATIONTranscription Error
Sep-09-2020 16:10:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened 'Was there a
temporary delay of
vaccination?' is
marked as Yes and
'Date of First Delay'
is not entered. Please
review and update as
appropriate.
Sep-09-2020 16:10:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Reason(s) for Temporary Delay o
f Vaccination
RECENT NON-STUDY VACC
INATIONInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815641
Page 147 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-29-2020 14:02:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-29-2020 14:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Dose Date is before
or more than 1 day
after Date of Visit
11/Sep/2020 of the
corresponding Visit.
Please review and
update as
appropriate.
Sep-17-2020 02:55:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-16-2020 09:05:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered there was a
temperately delay
because of prior
vaccination with
influenza vaccine
Sep-16-2020 09:00:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Dose Date is before
or more than 1 day
after Date of Visit
09/Sep/2020 of the
corresponding Visit.
Please review and
update as
appropriate.
Sep-16-2020 09:00:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020 08:53Initial Entry
5. Anatomical Location:
Date Location User Value Reason
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815642
Page 148 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Sep-16-2020 09:00:41
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815643
Page 149 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-16-2020 09:00:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815644
Page 150 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-06-2020 11:59:21
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815645
Page 151 of 200
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Oct-06-2020 12:08:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020Initial Entry
2.a
Date Location User Value Reason
Oct-06-2020 12:08:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.9
Temperature Unit: F
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-06-2020 12:08:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-06-2020 12:08:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.9Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-06-2020 12:08:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815646
Page 152 of 200
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-06-2020 12:08:59
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815647
Page 153 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-06-2020 12:15:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-06-2020 12:15:29
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-06-2020 12:15:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-06-2020 12:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Oct-06-2020 12:15:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/6/2020Initial Entry
5.a
Date Location User Value Reason
Oct-06-2020 12:15:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYGTPInitial Entry
5.a Sample ID
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815648
Page 154 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-06-2020 12:15:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYGTPInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815649
Page 155 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/6/2020 09:57Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815650
Page 156 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
7. Route:
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Oct-06-2020 12:09:50
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815651
Page 157 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-05-2020 11:43:47
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815652
Page 158 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-05-2020 11:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-05-2020 11:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 11:44:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-05-2020 11:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Nov-05-2020 11:44:07
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/5/2020Initial Entry
5.a
Date Location User Value Reason
Nov-05-2020 11:44:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPYGX7Initial Entry
5.a Sample ID
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815653
Page 159 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Nov-05-2020 11:44:38
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPYGX7Initial Entry
5.b
Date Location User Value Reason
Nov-05-2020 11:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGGD3Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-05-2020 11:44:53
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSGGD3Initial Entry
5.c
Date Location User Value Reason
Nov-05-2020 11:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGGD4Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-05-2020 11:45:03
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSGGD4Initial Entry
5.d
Date Location User Value Reason
Nov-05-2020 11:45:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSGGD5Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815654
Page 160 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Sample ID
Date Location User Value Reason
Nov-05-2020 11:45:15
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BSGGD5Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815655
Page 161 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-14-2020 23:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Per database update.
Dec-14-2020 09:18:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered all data cleared and
the form marked not
applicable
Dec-11-2020 11:59:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: As this is
erroneous visit, any
forms within the visit
which were started in
error should be
cleared of all data
entered and marked
Not Applicable at the
form level, not the
item level. Please
update all forms in
this visit.
Oct-01-2020 09:35:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Deleted ok as is
Sep-30-2020 19:58:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-30-2020 16:52:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Sep-30-2020 16:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Sep-30-2020 02:38:40
(UTC-05:00) EasternACV0PFEINFP6000  Query 2: Opened Erroneous Visit is
marked, but date of
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815656
Page 162 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Time (US & Canada) visit is entered.
Please check whether
other assessments are
performed at this
visit.
Sep-29-2020 14:00:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered the subject didn't
have UNPL visit
Sep-29-2020 13:52:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Erroneous Visit is
marked, but date of
visit is entered.
Please check whether
other assessments are
performed at this
visit.
Sep-26-2020 20:41:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Subject is
listed to have a
UNPL visit. Subject
is not part of the
reactogenicity subset.
Please update the AE
log to indicate why
the subject had an
UNPL visit. Thanks
Sep-23-2020 10:28:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Erroneous Visit
Date Location User Value Reason
Sep-30-2020 16:52:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
Sep-30-2020 16:51:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-29-2020 13:52:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ERRONEOUS VISITInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815657
Page 163 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Assessments
Date Location User Value Reason
Dec-14-2020 09:15:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:55:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 10:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Contact Outcome is
ticked however
'CONTACT
OUTCOME' form is
not entered. Please
review and update as
appropriate.
Sep-23-2020 10:41:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CONTACT OUTCOMEInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815658
Page 164 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Contact Type:
Date Location User Value Reason
Dec-14-2020 09:16:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:55:44
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-23-2020 10:45:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
TELEPHONE VISITInitial Entry
2. Was contact made?
Date Location User Value Reason
Dec-14-2020 09:16:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-23-2020 10:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Contact Outcome' is
selected as 'VISIT
ARRANGED' but no
'VITAL SIGNS'
and/or
'UNPLANNED
ASSESSMENT OF
LOCAL REACTION'
form(s) is/are entered.
Please review and
update as appropriate.
Sep-23-2020 10:45:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Contact:Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815659
Page 165 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: CONTACT OUTCOME - UNPLANNED - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep/16/2020
Contact Outcome:
VISIT ARRANGED
3. Comments:
Date Location User Value Reason
Dec-14-2020 09:16:20
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815660
Page 166 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date:
Date Location User Value Reason
Dec-14-2020 09:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 14:13:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2.a
Date Location User Value Reason
Dec-14-2020 09:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: Not Applica
ble
Temperature Unit: Not Applica
ble
Temperature Locati
on::Not Applica
bleInitial Entry
Sep-29-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Location::Transcription Error
Sep-29-2020 14:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature:
Temperature Unit:
Temperature Location:: EARTranscription Error
Sep-29-2020 13:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature:Transcription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815661
Page 167 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Temperature Unit: F
Temperature Location:: EAR
Sep-23-2020 10:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.4
Temperature Unit: F
Temperature Location:: EARInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-23-2020 10:46:22
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Dec-14-2020 09:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.4Initial Entry
2.a Unit:
Date Location User Value Reason
Dec-14-2020 09:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 14:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815662
Page 168 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
2.a Temperature Location:
Date Location User Value Reason
Dec-14-2020 09:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 14:13:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:46:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EARInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815663
Page 169 of 200
***Confidential***
 
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:56:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/16/2020Initial Entry
2. Injection Site Location
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:56:57
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
3. Injection Site Body Side:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:57:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815664
Page 170 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
4.a
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: REDNESS
Reaction Present:
:Not Applicabl
eInitial Entry
Sep-29-2020 13:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: REDNESS
Reaction Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: REDNESS
Reaction Present:: NOInitial Entry
4.a Reaction:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
4.a Reaction Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: SWELLINGInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815665
Page 171 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Reaction Present:
:Not Applicabl
e
Sep-29-2020 13:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: SWELLING
Reaction Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Reaction:: SWELLING
Reaction Present:: NOInitial Entry
4.b Reaction:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
4.b Reaction Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: PAIN AT INJECTI
ON SITE
Symptom Pr
esent::Not ApplicableInitial Entry
Sep-29-2020 13:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: PAIN AT INJECTITranscription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815666
Page 172 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
ON SITE
Symptom Pr
esent::
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: PAIN AT INJECTI
ON SITE
Symptom Pr
esent::NOInitial Entry
5.a Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.a Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:57:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUE/TIRED
NESS
Symptom Pres
ent::Not ApplicableInitial Entry
Sep-29-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUE/TIRED
NESSTranscription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815667
Page 173 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Symptom Pres
ent::
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUE/TIRED
NESS
Symptom Pres
ent::NOInitial Entry
5.b Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUE/TIREDNESSInitial Entry
5.b Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:57:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADACHE
Symptom Present
::Not Applicabl
eInitial Entry
Sep-29-2020 13:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADACH
E
Symptom Present:
:Transcription Error
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815668
Page 174 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADACH
E
Symptom Present:
:NOInitial Entry
5.c Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
5.c Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:58:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.d
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VOMITING
Symptom Present
::Not Applicabl
eInitial Entry
Sep-29-2020 13:58:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VOMITING
Symptom Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VOMITING
Symptom Present:: NOInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815669
Page 175 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.d Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
5.d Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:58:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.e
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIARRHEA
Symptom Present
::Not Applicabl
eInitial Entry
Sep-29-2020 13:58:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIARRHEA
Symptom Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIARRHEA
Symptom Present:: NOInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815670
Page 176 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.e Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
5.e Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:58:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.f
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:
:NEW OR WORSENE
D MUSCLE PAIN
Symptom
Present::Not ApplicableInitial Entry
Sep-29-2020 13:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:
:NEW OR WORSENE
D MUSCLE PAIN
Symptom
Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:
:NEW OR WORSENE
D MUSCLE PAIN
Symptom
Present::NOInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815671
Page 177 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.f Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE
PAINInitial Entry
5.f Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:58:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.g
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR WORSEN
ED JOINT PAIN
Symptom
Present::Not ApplicableInitial Entry
Sep-29-2020 13:59:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR WORSEN
ED JOINT PAIN
Symptom
Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR WORSEN
ED JOINT PAIN
Symptom
Present::NOInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815672
Page 178 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
5.g Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
5.g Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:59:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.h
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CHILLS
Symptom Present:
:Not Applicabl
eInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815673
Page 179 of 200
***Confidential***
Header Text: C4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/16/2020Form: UNPLANNED ASSESSMENT OF LOCAL REACTION -
SYSTEMIC EVENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:51 Form Status: Data Complete, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
5.h
Date Location User Value Reason
Sep-29-2020 13:59:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CHILLS
Symptom Present::Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CHILLS
Symptom Present:: NOInitial Entry
5.h Symptom:
Date Location User Value Reason
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
5.h Symptom Present:
Date Location User Value Reason
Dec-14-2020 09:17:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
Sep-29-2020 13:59:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Sep-23-2020 10:47:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815674
Page 180 of 200
***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: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Nov-05-2020 11:45:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-05-2020 11:45:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-05-2020 11:45:39
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815675
Page 181 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815676
Page 182 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
Date Location User Value Reason
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815677
Page 183 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Nov-11-2020
15:26:58
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: Cl
osedResponse
satisfies query
Nov-11-2020
14:55:10
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Cl
osedThank you.
Nov-11-2020
11:06:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 3: An
sweredNephrolithiasis
on medical
history was
resolved in 2008;
it's not a baseline
condition.
Nephrolithiasis in
10/02/2020 is a
new condition.
Nov-10-2020
15:23:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 3: Op
enedThe AE
nephrolithiasis
was reported but
is also listed in
Medical History.
Please clarify if
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815678
Page 184 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
this is a
worsening of the
baseline
condition, and if
so, please
consider adding
"worsening" to
the AE term. AE
as baseline
conditions should
only be reported
as AEs if they
worsen. 
Nov-10-2020
10:02:25
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredThe test was not
performed and
this information
will be reflected
in the updated
SAE case
narrative.
Oct-22-2020
13:34:32
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Rei
ssued:Opene
dIf test was NOT
performed or
NOT available,
please add this
information as
well so it is
reflected in the
SAE case
narrative. Thank
you.
Oct-21-2020
11:56:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 2: An
sweredCOVID testing
was NOT
performed during
hospitalization.
Oct-21-2020
11:34:22
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 2: Op
enedCOVID testing
has not been
reported in the
SAE submitted to
safety. Please
submit a
follow-up SAE
form to provide
whether COVID
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815679
Page 185 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
testing was
performed during
hospitalization
(yes/no) and if
yes, the results.
Thank you.
Oct-09-2020
13:07:40
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Cl
osedResponse
satisfies query
Oct-09-2020
11:53:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: An
sweredThe CRF was
updated to
include
Hydronephrosis.
Oct-08-2020
16:32:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Giselle Castillo Query 1: Op
enedOn review of the
SAE report for
nephrolithiasis,
an event of
hydronephrosis
has been
mentioned, yet it
does not appear
in the CRF.
Please review for
safety and update
AE log CRF
accordingly. If
safety update is
required, submit
a follow-up SAE
Form.
Oct-07-2020
11:16:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
nephrolithia
sisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-28-2020 10:12:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815680
Page 186 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-28-2020 08:13:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered the subject did not
meet the TDV criteria
at V2.
Oct-27-2020 10:50:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm the subject
did not meet TDV
criteria at V2 listed in
protocol section 5.5 as
a result of
Nephrolithiasis and
Hydronephrosis.
Thanks.
Oct-07-2020 11:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/6/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-08-2020 06:48:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815681
Page 187 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-07-2020 11:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
nephrolithiasis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Oct-07-2020 11:16:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated wi
th congenital anomaly or birth de
fect?
NO
Did this serious event result in de
ath?
NO
Did this serious event require or
prolong hospitalization?
YES
Did this serious event result in pe
rsistent or significant disability/in
capacity?
NO
Is this serious event life threateni
ng?
NO
Other medically important seriou
s event
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815682
Page 188 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-13-2020
02:25:30
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Clos
edResponse
satisfies query
Oct-12-2020
11:34:34
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Query 1: Ans
weredHistory of
nephrolithiasis
Oct-08-2020
08:17:52
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query 1: Ope
nedPlease review
"If not related to
study treatment
other" field, the
following text
was indicated in
the comment
field
[Intercurrent
illness]. Any
symptoms, AEs
or other key
data should be
collected on the
appropriate
page. Please
review and
update as
necessary.
Oct-07-2020
11:30:39
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELAT
ED
If Not Relat
ed to study t
reatment(s),
this event isNew
Information
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0815683
Page 189 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
due to:
OTHER
If Other,
specify:
Intercur
rent illn
ess
Oct-07-2020
11:16:04
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELAT
EDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (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-2021-5683-0815684
Page 190 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Date Location User Value Reason
Oct-07-2020 11:16:04
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-08-2020 06:48:27
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2020389747Initial Entry
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815685
Page 191 of 200
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Back to Form
1. Category:
Date Location User Value Reason
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HydronephrosisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/6/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3d42\Final\Final On: 01-Apr-2021 04:28 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0815686
Page 192 of 200
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1174 Site Name: (1174) Clinical Alliance for Research and Education - Infectious
Diseases, LLC CARE-ID
Subject No: 11741042 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 12:55
Oct-09-2020 11:51:36
(UTC-05:00) Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital an
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