125742 S1 M5 CRF c4591001 1223 12231159

Document text

Page 1 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827378
Page 2 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/10/2020
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827379
Page 3 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Demography
1.Subject ID [12231159]
2.Birth Date: /1947
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827380
Page 4 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/10/2020
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827381
Page 5 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827382
Page 6 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathSep/10/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827383
Page 7 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/2014
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cardiovascular prevention]
Start Date: UNK/UNK/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2008
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: UNK/UNK/2019
Ongoing: YES
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827384
Page 8 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Irritable bowl syndrome]
Start Date: UNK/UNK/2019
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2002
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Menopause]
Start Date: UNK/UNK/1998
Ongoing: YES
1.hLine/MH Number: [8] Comments
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Melanoma] Comments
Start Date: UNK/UNK/2007 Comments
Ongoing: NO
End Date:
UNK/UNK/2007Comments
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis]
Start Date: UNK/UNK/1996
Ongoing: YES
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827385
Page 9 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Eustachian Tube Dysfunction]
Start Date: UNK/UNK/2017
Ongoing: YES
1.kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Dyslipidemia]
Start Date: UNK/UNK/2014
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Monoclonal Gammopathy of Unknown Significance]
Start Date: Aug/17/2020
Ongoing: YES
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827386
Page 10 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Sep/10/2020
2.Weight: [50.3]
3.Unit: kg
4.Height: [154.0]
5.Unit: cm
6.Body Mass Index: [21.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827387
Page 11 of 234
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/10/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827388
Page 12 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/10/2020
2.Randomization Number: [257123]
3.Randomization Group: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827389
Page 13 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BPXXJZ]
5.bSample ID [BPXXK0]
5.cSample ID [BPXXK1]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827390
Page 14 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/10/2020
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 [BPXXJY]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827391
Page 15 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/10/2020 15:26
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
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827392
Page 16 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827393
Page 17 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/1/2020
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827394
Page 18 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Oct/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.4]
Unit: F
Temperature Location: FOREHEAD
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827395
Page 19 of 234
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Oct/1/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827396
Page 20 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/1/2020
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 [BPXXYY]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827397
Page 21 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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/1/2020 15:36
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
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827398
Page 22 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827399
Page 23 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Done Comments
2.Sample Type Not Done Comments
3.Sample Collected? Not Done Comments
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:Not Done
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Done
[ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827400
Page 24 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827401
Page 25 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827402
Page 26 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827403
Page 27 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827404
Page 28 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827405
Page 29 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827406
Page 30 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/29/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827407
Page 31 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/29/2021
2.Date of First Symptom Started: Jan/15/2021
3.Symptoms Ongoing? YES
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? YES
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827408
Page 32 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.aSymptoms - Other Text: [abdominal pain]
5.bSymptoms - Other Text: [enterocolitis ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827409
Page 33 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/16/20
21 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827410
Page 34 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Jan/16/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827411
Page 35 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject refused.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827412
Page 36 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[subject has been hospitalized and is unable to provide a sample at the site.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827413
Page 37 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
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?NO
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827414
Page 38 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827415
Page 39 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment Identifier? Not Done
[ ]Comments
2.Concomitant Non-drug Treatment
Pre-specified:Not Done Comments
3.Treatment: Not Done Comments
4.Treatment: Not Done
[ ]Comments
5.Start Date: Not Done
//Comments
6.Ongoing? Not Done Comments
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827416
Page 40 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Enterocolitis]
Date of Diagnosis:
Jan/16/2021
3.Toxicity Grade: 2
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827417
Page 41 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827418
Page 42 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827419
Page 43 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827420
Page 44 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827421
Page 45 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827422
Page 46 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827423
Page 47 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827424
Page 48 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827425
Page 49 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827426
Page 50 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827427
Page 51 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827428
Page 52 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827429
Page 53 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827430
Page 54 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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.Start Date: //
6.Ongoing?
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827431
Page 55 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827432
Page 56 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827433
Page 57 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827434
Page 58 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827435
Page 59 of 234
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827436
Page 60 of 234
***Confidential***
 
Header Text: C4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unplanned Assessments
1.Assessments
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827437
Page 61 of 234
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Nov/5/2020
2.Phase of Disposition: VACCINATION
3.Status: OTHER
4.Specify Status: [patient had medical condition which precluded her from coming to visit 3]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827438
Page 62 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827439
Page 63 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827440
Page 64 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827441
Page 65 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827442
Page 66 of 234
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 28-Mar-2021 02:28 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827443
Page 67 of 234
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827444
Page 68 of 234
***Confidential***
 
Header Text: C4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827445
Page 69 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827446
Page 70 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827447
Page 71 of 234
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827448
Page 72 of 234
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827449
Page 73 of 234
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827450
Page 74 of 234
***Confidential***
 
Header Text: C4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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 [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827451
Page 75 of 234
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827452
Page 76 of 234
***Confidential***
 
Header Text: C4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827453
Page 77 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#CategoryAE Identif
ierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Pancreatic Adenocarci
noma Nov/5/2020 11
:21 YES  Repeating
Pages
 2.ADVERSE EV
ENT 2  Enterocolitis  Jan/15/2021 0
0:00 YES  Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827454
Page 78 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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)[Pancreatic Adenocarcinoma]
4.Start Date Time: Nov/5/2020 11:21
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827455
Page 79 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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:
[New development of pancreatic mass]
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?:NOT RECOVERED/NOT 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[2020437831]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827456
Page 80 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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)[Enterocolitis]
4.Start Date Time: Jan/15/2021 00:00
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
CONCOMITANT DRUG TREATMENT
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827457
Page 81 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT 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[2021046126]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827458
Page 82 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827459
Page 83 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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[ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827460
Page 84 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827461
Page 85 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include
clarifying information in the
Medication text (e.g., Ingredient(s),
route, use, formulation).[ ]
5.Date: //
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827462
Page 86 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defi
ned Identifie
rCategory for MedicationConcomitant Medi
cations Pre-specifie
dName of
Medicatio
nDose De
scriptio
nForm Instan
ce
 1. DELETED           Repeating
Pages
 2. 2  CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y NO  Flourourac
il 3,500  Repeating
Pages
 3. 3  CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y NO  Irinotecan  180  Repeating
Pages
 4. 4  CONCOMITANT IMMUN
OSUPPRESSIVE THERAP
Y NO  Oxaliplatin
 115  Repeating
Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827463
Page 87 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
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?
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827464
Page 88 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [2]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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).[Flourouracil]
5.Dose: [3,500]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Jan/7/2021
10.Ongoing? YES
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827465
Page 89 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [3]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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).[Irinotecan]
5.Dose: [180]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Jan/7/2021
10.Ongoing? YES
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827466
Page 90 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [4]
2.Category: CONCOMITANT IMMUNOSUPPRESSIVE THERAPY
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).[Oxaliplatin]
5.Dose: [115]
6.Dose Unit: mg
7.Dose Frequency: ONCE
8.Route: INTRAVENOUS
9.Start Date: Jan/7/2021
10.Ongoing? YES
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827467
Page 91 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827468
Page 92 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
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?
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827469
Page 93 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827470
Page 94 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827471
Page 95 of 234
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827472
Page 96 of 234
***Confidential***
 
Header Text: C4591001
Visit: UNPLANNED_BOOSTER_CONTACT -
UnscheduledForm: BOOSTER DOSE TRIGGER FORM
Form Version: 20-Feb-2021 02:20 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Booster Dose Trigger Form
1.Select appropriate response - Will
the participant return for
consent/eligibility assessment for
the booster dose visit?
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827473
Page 97 of 234
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827474
Page 98 of 234
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827475
Page 99 of 234
***Confidential***
 
Header Text: C4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827476
Page 100 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/5/2020
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827477
Page 101 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827478
Page 102 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jessica Tuan  Approved Mar-19-2021 21:05:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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.
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827479
Page 103 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormSep-10-2020 19:41:38 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827480
Page 104 of 234
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1 hSep-14-2020 11:07:01 (UTC-05:00) Eastern
Time (US & Canada)S/P Excision 2007
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827481
Page 105 of 234
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1 hSep-14-2020 11:07:01 (UTC-05:00) Eastern
Time (US & Canada)S/P Excision 2007
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827482
Page 106 of 234
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1 hSep-14-2020 11:07:01 (UTC-05:00) Eastern
Time (US & Canada)S/P Excision 2007
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827483
Page 107 of 234
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1 hSep-14-2020 11:07:01 (UTC-05:00) Eastern
Time (US & Canada)S/P Excision 2007
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827484
Page 108 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormMar-04-2021 15:24:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827485
Page 109 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1Mar-04-2021 15:24:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827486
Page 110 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
2Mar-04-2021 15:24:43 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827487
Page 111 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormMar-09-2021 15:53:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827488
Page 112 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1Mar-09-2021 15:53:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827489
Page 113 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
2Mar-09-2021 15:53:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827490
Page 114 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
3Mar-09-2021 15:53:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827491
Page 115 of 234
***Confidential***
Header Text: C4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
4Mar-09-2021 15:53:40 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827492
Page 116 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormFeb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
FormFeb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827493
Page 117 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1Feb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
1Feb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827494
Page 118 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
2Feb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
2Feb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827495
Page 119 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
3Feb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
3Feb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827496
Page 120 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
4Feb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
4Feb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827497
Page 121 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
5Feb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
5Feb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827498
Page 122 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
6Feb-17-2021 11:56:22 (UTC-05:00) Eastern
Time (US & Canada)Not Done
6Feb-17-2021 11:56:05 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0827499
Page 123 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Jessica Tuan  Approved Mar-19-2021 21:05:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, 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-16-2020 14:13:59 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan  Approved Nov-16-2020 12:12:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-11-2020 10:12:05 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) 
(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827500
Page 124 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Onyema
Ogbuagu Approved Nov-10-2020 09:09:05 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, OnyemaOgbuagu, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-09-2020 16:01:58 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan  Approved Nov-09-2020 14:02:35 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, JessicaTuan, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-08-2020 10:20:28 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Onyema
Ogbuagu Approved Nov-07-2020 13:17:38 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) 
(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827501
Page 125 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Affidavit:
By my dated signature below, I, OnyemaOgbuagu, 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.
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827502
Page 126 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020 19:41:00
(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-10-2020 19:41:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827503
Page 127 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020 19:41:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/10/2020Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827504
Page 128 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Subject ID
Date Location User Value Reason
Nov-09-2020
05:33:37 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-08-2020
10:21:04 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Nov-07-2020 11:57:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020437831
mass at pancreatic
head(onset
date:05Oct2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Sep-10-2020 19:40:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12231159Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020 19:40:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1947Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020 19:41:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827505
Page 129 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 19:41:18
(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-10-2020 19:41:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827506
Page 130 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 19:41:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827507
Page 131 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 19:41:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827508
Page 132 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Sep-10-2020 19:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Hypothyroidi
sm
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:42:14
(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-10-2020 19:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-10-2020 19:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-10-2020 19:42:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827509
Page 133 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.b
Date Location User Value Reason
Sep-10-2020 19:42:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Cardiovascular p
revention
Start Date: UNK/UNK/2018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:42:43
(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-10-2020 19:42:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cardiovascular preventionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-10-2020 19:42:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-10-2020 19:42:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827510
Page 134 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-10-2020 19:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:3
Medical History T
erm:Hypertension
Start Date: UNK/UNK/2
008
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-10-2020 19:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-10-2020 19:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-10-2020 19:43:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-10-2020 19:43:22
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 4Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827511
Page 135 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada) :
Medical History T
erm:Osteoporosis
Start Date: UNK/UNK/2
019
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:43:22
(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-10-2020 19:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OsteoporosisInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-10-2020 19:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-10-2020 19:43:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-14-2020 09:24:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:5Transcription Error
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b)(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827512
Page 136 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Medical Histo
ry Term:Irritable bowl
syndrome
Start Date: UNK/UNK/20
19
Ongoing: YES
Sep-10-2020 19:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:IBS
Start Date: UNK/UNK/
2019
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827513
Page 137 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.e Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:43:39
(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-14-2020
10:49:28
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Sep-14-2020
09:24:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: A
nsweredTranscription Error
Sep-14-2020
09:24:24
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Irritable bo
wl syndrom
eTranscription Error
Sep-11-2020
15:33:02
(UTC-05:00)
Eastern Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: O
penedClarify IBS as
follows...Please
expand the
abbreviation and
clarify are you
reporting
IRRITABLE
BOWEL
SYNDROME?
INFLAMMATORY
BOWEL
SYNDROME?
Other? If so, edit.
Otherwise clarify.
Thank you.
Sep-10-2020
19:43:39ACV0PFEINFP6000  Data Entry
:Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)(4),
(b)(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827514
Page 138 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00)
Eastern Time
(US & Canada)IBS
1.e Start Date:
Date Location User Value Reason
Sep-10-2020 19:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-10-2020 19:43:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Sep-10-2020 19:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:GERD
Start Date: UNK/UNK/2
002
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827515
Page 139 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.f Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:43:55
(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
Sep-10-2020 19:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GERDInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-10-2020 19:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2002Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-10-2020 19:43:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-10-2020 19:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:7
Medical History T
erm:Menopause
Start Date: UNK/UNK/1
998
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827516
Page 140 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.g Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:44:12
(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
Nov-11-2020 14:48:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the
prompt response.
Thank you.
Nov-11-2020 10:27:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Nov-11-2020 06:43:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Per case narrative
reported to safety,
there is additional
Med Hx of
Dyslipidemia and
monoclonal
gammopathy of
undetermined
significance
(MGUS) not
recorded on CRF.
Please revise and
update accordingly.
Nov-10-2020 23:28:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Candidate Per case narrative
reported to safety,
there is additional
Med Hx of
Dyslipidemia and
monoclonal
gammopathy of
undetermined
significance
(MGUS) not
recorded on CRF.
Please revise and
update accordingly.
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827517
Page 141 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-10-2020 19:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MenopauseInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-10-2020 19:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-10-2020 19:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Sep-14-2020 11:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numb
er:8
Medical Histor
y Term:Melanoma
Start Date: UNK/UNK/20
07
Ongoing: NO
End Date:
UNK/UNK
/2007Changed
Information
Sep-10-2020 19:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:Melanoma
Start Date: UNK/UNK/2
007
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827518
Page 142 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.h Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:44:32
(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-10-2020 19:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MelanomaInitial Entry
1.h Start Date:
Date Location User Value Reason
Sep-10-2020 19:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.h Ongoing:
Date Location User Value Reason
Sep-14-2020 16:19:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827519
Page 143 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.h Ongoing:
Date Location User Value Reason
Sep-14-2020 11:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Sep-14-2020 11:06:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007Changed
Information
Sep-11-2020 10:03:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Please
confirm if ongoing?
Sep-10-2020 19:44:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Sep-10-2020 19:44:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:9
Medical History T
erm:Osteoarthritis
Start Date: UNK/UNK/1
996
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827520
Page 144 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.i Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:44:52
(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
Sep-10-2020 19:44:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OsteoarthritisInitial Entry
1.i Start Date:
Date Location User Value Reason
Sep-10-2020 19:44:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1996Initial Entry
1.i Ongoing:
Date Location User Value Reason
Sep-10-2020 19:44:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Sep-10-2020 19:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Histo
ry Term:Eustachian Tube
Dysfunction
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827521
Page 145 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.j Line/MH Number:
Date Location User Value Reason
Sep-10-2020 19:45:22
(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
Sep-10-2020 19:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Eustachian Tube DysfunctionInitial Entry
1.j Start Date:
Date Location User Value Reason
Sep-10-2020 19:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.j Ongoing:
Date Location User Value Reason
Sep-10-2020 19:45:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Nov-11-2020 10:12:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:11
Medical History T
erm:Dyslipidemia
Start Date: UNK/UNK/2
014
Ongoing: YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827522
Page 146 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.k Line/MH Number:
Date Location User Value Reason
Nov-11-2020 10:12:05
(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
Feb-01-2021 11:39:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Jan-28-2021 12:50:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This is not medical
history prior to study
entry. AE term has
been updated
Jan-26-2021 12:04:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Per SAE report
subject has a MHx
of pancreatic
adenocarcinoma
from 05Nov2020 to
2021 which is
missing on CRF.
Please review and
update accordingly.
Nov-11-2020 10:12:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DyslipidemiaInitial Entry
1.k Start Date:
Date Location User Value Reason
Nov-11-2020 10:12:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.k Ongoing:
Date Location User Value Reason
Nov-11-2020 10:12:05
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827523
Page 147 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
1.l
Date Location User Value Reason
Nov-11-2020 10:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:12
Medical H
istory Ter
m:Monoclonal Gammop
athy of Unknown Sig
nificance
Start Date
:Aug/17/2020
Ongoing: YESInitial Entry
1.l Line/MH Number:
Date Location User Value Reason
Nov-11-2020 10:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Nov-11-2020 10:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Monoclonal Gammopathy of Un
known SignificanceInitial Entry
1.l Start Date:
Date Location User Value Reason
Nov-11-2020 10:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/17/2020Initial Entry
1.l Ongoing:
Date Location User Value Reason
Nov-11-2020 10:27:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827524
Page 148 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
50.3Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
154.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21.2Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827525
Page 149 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.6
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 19:46:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827526
Page 150 of 234
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827527
Page 151 of 234
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-10-2020 19:46:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827528
Page 152 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 19:47:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 19:47:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
257123Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827529
Page 153 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 19:47:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 19:47:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-14-2020 12:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 05:45:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 19:47:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 19:47:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827530
Page 154 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a
Date Location User Value Reason
Sep-14-2020 12:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXXJZInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 12:46:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXXJZInitial Entry
5.b
Date Location User Value Reason
Sep-14-2020 12:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXXK0Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-14-2020 12:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXXK0Initial Entry
5.c
Date Location User Value Reason
Sep-14-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXXK1Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-14-2020 12:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXXK1Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827531
Page 155 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 19:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 19:47:32
(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-14-2020 16:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 05:45:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 19:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 19:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/10/2020Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827532
Page 156 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a
Date Location User Value Reason
Sep-14-2020 16:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXXJYInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-14-2020 16:45:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXXJYInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827533
Page 157 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 19:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 19:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 19:47:55
(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-10-2020 19:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/10/2020 15:26Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 19:47:55
(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-10-2020 19:47:55
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827534
Page 158 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-10-2020 19:47:55
(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-10-2020 19:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 19:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827535
Page 159 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 19:48:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827536
Page 160 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021
09:46:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Query raised for the same in
SUBSTAT #1
Mar-01-2021
01:37:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Open
edDM: Please consider updating
tentative V3 date and subject
recent status or else clarify.
Thank you.
Feb-27-2021
12:54:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Visit is not planned and
subject is likely to be
discontinued at this point.
Feb-26-2021
09:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Open
edDM1 : Kindly provide planned
V3_MONTH1_POSTVAX2_L
visit. Thank you.
Feb-25-2021
13:09:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered this has not occurred yet.
Feb-22-2021
17:27:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened DM: Subject should have had
V3_MONTH1_POSTVAX2_L
visit. Please confirm if this
visit did or did not occur and
consider updating dates/CRFs
as necessary or as applicable
(e.g. End of Treatment, etc.).
Nov-11-2020
17:38:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies query
Nov-11-2020
13:56:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered DCF submitted in Trial
Manager. Subject explained
her throat pain was due to
intubation from having
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827537
Page 161 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
surgery.
Nov-11-2020
09:08:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Illness ediary: As per Illness
ediary records, subject
reported "Yes" for the
COVID-19 symptoms or
diagnosis on 07NOV2020. But
no corresponding COVID
Illness visit indicate symptoms
present at this date. Pls update
Covid illness visit or clarify.
Oct-01-2020
20:18:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827538
Page 162 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Oct-01-2020 20:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
2.a
Date Location User Value Reason
Oct-01-2020 20:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.4
Temperature Unit: F
Temperature Locati
on::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-01-2020 20:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-01-2020 20:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.4Initial Entry
2.a Unit:
Date Location User Value Reason
Oct-01-2020 20:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827539
Page 163 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Oct-01-2020 20:18:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827540
Page 164 of 234
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827541
Page 165 of 234
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Oct-01-2020 20:18:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827542
Page 166 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 20:18:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 20:18:31
(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-03-2020 12:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-02-2020 04:51:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-01-2020 20:18:31
(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-01-2020 20:18:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/1/2020Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) 
(4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827543
Page 167 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.a
Date Location User Value Reason
Oct-03-2020 12:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPXXYYInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-03-2020 12:44:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPXXYYInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827544
Page 168 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-01-2020 20:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-01-2020 20:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-01-2020 20:25:59
(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-01-2020 20:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/1/2020 15:36Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-01-2020 20:25:59
(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-01-2020 20:25:59
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
RIGHTInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827545
Page 169 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
7. Route:
Date Location User Value Reason
Oct-01-2020 20:25:59
(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-01-2020 20:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Oct-01-2020 20:25:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827546
Page 170 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 15:24:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Mar-04-2021 15:24:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827547
Page 171 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021 15:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-09-2021 15:53:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-04-2021 15:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 15:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Not DoneInitial Entry
Mar-09-2021 15:53:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Transcription Error
Mar-04-2021 15:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 15:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 15:53:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-04-2021 15:27:38 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827548
Page 172 of 234
***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: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)NO
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-09-2021 15:53:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Mar-09-2021 15:53:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription Error
Mar-04-2021 15:27:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
subject missed visitInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827549
Page 173 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-09-2021 02:16:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed As per site
confirmation -
updated PD tracker
Mar-08-2021 17:10:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered subject is not able
to come in for a
convalescent visit,
due to her
pancreatic cancer.
Mar-08-2021 07:20:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened PDQ: Convalescent
visit is missing and
35+ days (38) have
passed since
COVID Illness
Visit. If visit
occurred record
data as a matching
CONVA visit; if
visit did not occur
attempt to schedule
visit even if OOW
and obtain the
CONVA sample
else clarify.
Mar-01-2021 02:34:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed As per site
confirmation -
updated PD tracker
Feb-27-2021 12:51:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject refused self
swab, due to
ongoing medical
issues.
Feb-18-2021 23:27:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Feb-18-2021 16:08:10
(UTC-05:00) EasternACV0PFEINFP6000  Jessica Tuan Query 3: Answered Changed data per
query
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827550
Page 174 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada)
Feb-18-2021 07:02:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM: Kindly
consider to update
missing ILL
POTEN form or
else clarify. Thank
you.
Feb-18-2021 05:31:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ : Details of
Sample ID
(barcode) and
collection date for
either Nasal Swab
Self or Nasal Swab
expected to be
completed. Please
check and update
else clarify.
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-17-2021 11:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but Date
of Assessment in
the Signs and
Symptoms form is
missing. Please
review and update
as appropriate.
Feb-17-2021 11:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Feb-17-2021 11:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827551
Page 175 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-17-2021 11:46:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
FDA-CBER-2021-5683-0827552
Page 176 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/29/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827553
Page 177 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW OR INCREA
SED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COUG
HInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF
BREATH
Sympto
m Prese
nt:NOInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827554
Page 178 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.c Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHORT
NESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED MUSCLE PAINInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827555
Page 179 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUSC
LE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms
:NEW LOSS OF TA
STE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR SM
ELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827556
Page 180 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SORE
THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Present
:YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827557
Page 181 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.h Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.i
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Present
:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-17-2021 11:47:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-17-2021 11:47:55 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827558
Page 182 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)Symptoms - Oth
er:abdominal pa
in
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-17-2021 11:47:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
abdominal painInitial Entry
5.b
Date Location User Value Reason
Feb-27-2021 12:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:enterocoliti
sTranscription Error
(DELETED)
Feb-17-2021 11:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Othe
r:enterocoliti
sInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827559
Page 183 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 14-Jan-2021 02:23 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Symptoms - Other Text:
Date Location User Value Reason
Mar-03-2021 02:09:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Closed Response satisfies
query
Feb-27-2021 12:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
enterocolitisTranscription Error
(DELETED)
Feb-27-2021 12:52:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-20-2021 19:59:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Salim
BouguermouhQuery 1: Opened Clin:
ENTEROCOLITIS is
already captured as a
diagnosis on the
ILLNESS DETAILS
CRF form and should
not be entered on the
SIGNS AND
SYMPTOMS OF
POTENTIAL
COVID-19 CRF
form. Please review
and update
Feb-17-2021 11:49:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
enterocolitisInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827560
Page 184 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827561
Page 185 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/16/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Feb-17-2021 11:52:07
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
CEPHEID XPERT XPRESS SAInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827562
Page 186 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada) RS-COV-2 TEST
7. Test Result:
Date Location User Value Reason
Feb-17-2021 11:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827563
Page 187 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 11:53:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 11:53:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 11:53:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-17-2021 11:53:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
subject refused.Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827564
Page 188 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-17-2021 11:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-17-2021 11:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-17-2021 11:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Feb-17-2021 11:54:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
subject has been hospitalized and
is unable to provide a sample at t
he site.Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827565
Page 189 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits
or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:EMERGENCY
ROOM
Occurrence of
Visits or Conta
cts:YES
Number of Vis
its or Contact
s:
1Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827566
Page 190 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
1.c
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:PRIMARY C
ARE PHYSIC
IAN
Occurrence of
Visits or Conta
cts:NOInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827567
Page 191 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.d
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:URGENT
CARE
Occurrence of Visit
s or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827568
Page 192 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATIO
NInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-17-2021 11:55:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Feb-17-2021 11:55:20 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827569
Page 193 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 14-Jan-2021 02:24 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)NO
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0827570
Page 194 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. What is the treatment Identifier?
Date Location User Value Reason
Feb-17-2021 11:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-17-2021 11:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Feb-17-2021 11:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-17-2021 11:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Treatment:
Date Location User Value Reason
Feb-17-2021 11:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-17-2021 11:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Feb-17-2021 11:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-17-2021 11:56:05 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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) (6)
(b) (4)
FDA-CBER-2021-5683-0827571
Page 195 of 234
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)Not Applicable
5. Start Date:
Date Location User Value Reason
Feb-17-2021 11:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-17-2021 11:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6. Ongoing?
Date Location User Value Reason
Feb-17-2021 11:56:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
Feb-17-2021 11:56:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (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-2021-5683-0827572
Page 196 of 234
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Jan/29/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-18-2021 14:42:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-18-2021 14:42:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
TuanData Entry:
YES
Respiratory Illness Diagnosis:
Enterocolitis
Date of Diagnosis:
Jan/16/2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-18-2021 14:42:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
TuanData Entry:
2Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827573
Page 197 of 234
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Mar-09-2021 16:04:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
TuanData Entry:
Nov/5/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Mar-09-2021 16:04:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User ValueReason
Mar-11-2021
22:30:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Clo
sedAuto closed by
Validation Check:
VC_DS001_25
Mar-11-2021
15:35:42
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Clo
sedClose Auto Query
Mar-11-2021
15:35:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
4: Op
enedResponse to "Status"
is OTHER but
"Specify Status" is
missing.
Mar-11-2021
15:35:02
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  auto query
(autoquery)Query
3: An
swere
dPatient had medical
condition at the time
that precluded her
from coming to Visit
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827574
Page 198 of 234
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(US &
Canada)3.
Mar-11-2021
15:35:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Jessica Tuan Data
Entry
:
OTH
ERPatient had medical
condition at the time
that precluded her
from coming to Visit
3.
Mar-10-2021
18:28:52
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
3: Op
enedDMW7665967;Status
is reported as
Adverse Event, but
there is no Adverse
Event with 'Latest
Action Taken with
Study Treatment'
reported as DRUG
WITHDRAWN.
Please review and
update as
appropriate.
Mar-10-2021
14:01:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query
1: Clo
sedResponse satisfies
query
Mar-10-2021
12:52:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Clo
sedClose Auto Query
Mar-10-2021
12:41:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
2: Op
enedResponse to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Mar-10-2021
12:41:02
(UTC-05:00)
Eastern TimeACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dShe had adverse
event of other
medical
comordibities at that
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827575
Page 199 of 234
***Confidential***
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(US &
Canada)time which prevented
her to go to visit 3.
Mar-10-2021
12:41:02
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Jessica Tuan Data
Entry
:
ADV
ERSE
EVE
NTShe had adverse
event of other
medical
comordibities at that
time which prevented
her to go to visit 3.
Mar-10-2021
04:40:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query
1: Op
enedCLINQUERY: Per
comment subject had
ongoing AE at time
of V3. Please review
if status ADVERSE
EVENT better
reflects reason for
missed V3
Mar-09-2021
16:04:46
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Jessica Tuan Data
Entry
:
OTH
ERInitial Entry
4. Specify Status:
Date Location User Value Reason
Mar-11-2021 15:35:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
TuanData Entry:
patient had medical condition whi
ch precluded her from coming to v
isit 3Initial Entry
Mar-10-2021 12:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
TuanData Entry: Changed
Information
Mar-09-2021 16:04:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica
TuanData Entry:
Subject has missed Visit 3 due to o
ngoing AE but wants to remain in
the study.Initial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827576
Page 200 of 234
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827577
Page 201 of 234
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-01-2021 13:14:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827578
Page 202 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Category:
Date Location User Value Reason
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-08-2020 10:20:28
(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
Feb-08-2021
10:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Query on Diarrhea
Feb-04-2021
13:10:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies query
Feb-01-2021
12:56:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered SAE form amended and
resubmitted
Feb-01-2021
12:13:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 5: Closed Response satisfies query
Jan-29-2021
11:42:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Ope
nedSAE RECON 2: Thanks for
your response. Please confirm
submission of updated SAE
form.
Jan-28-2021 ACV0PFEINFP6000  Query 4: Reissued:Ope Response does not satisfy
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827579
Page 203 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
12:51:19
(UTC-05:00) Eastern
Time (US & Canada)ned query
Jan-28-2021
12:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4: Answered UPdated report to be submitted
Jan-28-2021
12:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered UPdated report to be submitted
Jan-28-2021
12:46:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Pancreatic Adenocarcin
omaUPdated report to be submitted
Jan-28-2021
11:58:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered data will be updated
Jan-24-2021
09:33:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 5: Opened CLINICAL_
AER#2021046126, If the
subject will be receiving
treatment with chemotherapy,
per CRF CG V12, section
8.53., details of prohibited
medications should be
recorded on CRF. Kindly
reassess and update the
PROHIB CM accordingly.
Thank you.
Jan-21-2021
05:27:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SAE
RECON:AER#2021046126,the
following events 'abdominal
pain, fever, enterocolitis on CT
scan, likely chemotherapy-
induced diarrhea' were
recorded as serious in SDB but
missing in AE CRF. Please
confirm and update
accordingly.
Jan-21-2021 ACV0PFEINFP6000  Query 3: Reissued:Ope SAE RECON 1:The term in
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827580
Page 204 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
05:17:03
(UTC-05:00) Eastern
Time (US & Canada)ned SDB was still recorded as
'mass at pancreatic head'.
Please submit a follow up
AEM form to indicate ductal
carcinoma as updated term of
mass at panreactic head
Jan-20-2021
15:45:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Safety update has been
submitted
Dec-18-2020
08:36:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE
RECON:AER#2020437831,
the term in AE CRF was
updated to 'Ductal
Adenocarcinoma' while
retained as 'mass at pancreatic
head' in SDB. Please confirm
correct term. If safety update is
required, please submit a
follow-up form.
Dec-17-2020
10:29:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response satisfies query
Dec-16-2020
14:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Dec-16-2020
14:13:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Ductal AdenocarcinomaNew Information
Nov-24-2020
12:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened Per narrative, the subject
underwent an "endoscopic
ultrasound (EUS) with biopsy
was performed on
06Nov2020". Kindly provide
results for a final diagnosis.
Thank you.
Nov-12-2020
07:28:05ACV0PFEINFP6000  Query 1: Closed Per PSSR confirmation 'Event
term updated to Pancreatic
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) 
(4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827581
Page 205 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)Mass in the Argus Database.
Issue has been reconcilied'
Nov-11-2020
02:32:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Can
didateSAE RECON: For PSSR
review
Nov-10-2020
10:21:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered The term carcinoma was not
used in the narrative of the
SAE. The mass was described
as a "neoplasm" which can be
benign or malignant. The
biopsy is pending and the term
will be updated, as indicated,
upon receiving biopsy results.
Nov-10-2020
07:12:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020437831,the
term was reported as 'Mass at
Pancreatic Head' in both
database.Per narrative of the
case this is a pancreatic
carcinoma.Please confirmed
and update the event term in
the AE log and submit a fu
SAE form.
Nov-08-2020
10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mass at Pancreatic Hea
dInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-10-2020 12:03:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-09-2020 16:01:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-09-2020 16:01:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/5/2020 11:21Transcription Error
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4), 
(b) (6)
(b)
(4),
(b)(6)
(b) (4)
FDA-CBER-2021-5683-0827582
Page 206 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Nov-09-2020 12:32:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Please verify start
date. EMR records
indicate subject was
admitted
05Nov2020
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/5/2020 11:21Initial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-08-2020 10:20:28
(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
Dec-17-2020 10:42:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response satisfies
query
Dec-16-2020 14:00:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered COVID test was
done on
05NOV2020 and
was negative. Will
add this to an
updated SAE form.
Nov-19-2020 14:34:27 ACV0PFEINFP6000  Giselle Query 2: Opened As per the request
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b) 
(4), 
(b) (6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827583
Page 207 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)Castillo of our Data
Monitoring
Committee, please
include in a
follow-up SAE form
whether COVID
testing was
conducted during
hospitalization –
yes/no including not
available/not
performed. If
COVID testing was
performed, include
the results.
Nov-09-2020 04:55:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Mass at
Pancreatic Head:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associated
with congenital anomaly or bi
rth defect?
NO
Did this serious event result in
death?
NO
Did this serious event require
or prolong hospitalization?
YESInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0827584
Page 208 of 234
***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, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Did this serious event result in
persistent or significant disabil
ity/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important seri
ous event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-08-2020 10:20:28
(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
Nov-08-2020 10:20:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatme
nt(s), this event is due to:
OTHER
If Other, specify:
New development of pancr
eatic massInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-08-2020 10:20:28
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
090177e196ae301b\Final\Final On: 01-Apr-2021 04:01 (GMT)
(b)
(4),
(b)(6)
(b)
(4),
(b)(6)
(b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0827585
Page 209 of 234
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