125742 S1 M5 CRF c4591001 1223 12231252

Document text

Page 1 of 250
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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 version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828067
Page 2 of 250
***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: 12231252 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
Oct/16/2020
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828068
Page 3 of 250
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Demography
1.Subject ID [12231252]
2.Birth Date: /1972
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828069
Page 4 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/16/2020
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828070
Page 5 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828071
Page 6 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathOct/16/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828072
Page 7 of 250
***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: 12231252 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:[Hypertension]
Start Date: UNK/UNK/2015
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: Aug/UNK/2020
Ongoing: YES
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828073
Page 8 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828074
Page 9 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Oct/16/2020
2.Weight: [180.0]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [25.8]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828075
Page 10 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition
1.Randomization Date : Oct/16/2020
2.Randomization Number: [108817]
3.Randomization Group: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828076
Page 11 of 250
***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: 12231252 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:
Oct/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR37P5]
5.bSample ID [BR37P4]
5.cSample ID [BR37P3]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828077
Page 12 of 250
***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: 12231252 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/16/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR37P2]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828078
Page 13 of 250
***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: 12231252 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/16/2020 12:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828079
Page 14 of 250
***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: 12231252 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
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828080
Page 15 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/4/2020
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828081
Page 16 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Vital Signs
1.Date: Nov/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.0]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828082
Page 17 of 250
***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: 12231252 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:
Nov/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR376F]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828083
Page 18 of 250
***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: 12231252 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: Nov/4/2020 14:51
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828084
Page 19 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828085
Page 20 of 250
***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: 12231252 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:
Dec/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPW1YR]
5.bSample ID [BPW1YS]
5.cSample ID [BPW1YT]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828086
Page 21 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828087
Page 22 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828088
Page 23 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828089
Page 24 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828090
Page 25 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828091
Page 26 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828092
Page 27 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828093
Page 28 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Jan/19/2021
2.Date of First Symptom Started: Jan/10/2021
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Jan/25/2021
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? NO
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828094
Page 29 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [seizures]
5.bSymptoms - Other Text: [fatigue]
5.cSymptoms - Other Text: [nausea]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828095
Page 30 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Jan/20/20
21 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
 2.Jan/15/20
21 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828096
Page 31 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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/20/2021
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: HOLOGIC PANTHER FUSION SARS-COV-2
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828097
Page 32 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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/15/2021
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: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [CLIA certified lab]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828098
Page 33 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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? YES
Date of Collection:
Jan/11/2021
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 [CV44706]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828099
Page 34 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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 was hospitalized and had a swab done there]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828100
Page 35 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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:[ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828101
Page 36 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
YES
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828102
Page 37 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  ICU  Jan/19/2021  NO
Discharge Date:
Jan/26/2021
 Repeating Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828103
Page 38 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: ICU
3.Admission Date: Jan/19/2021
4.Ongoing? NO
Discharge Date:
Jan/26/2021
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828104
Page 39 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Treatment I
dentifierCon Non-Drug Treatme
nts Pre-specifiedTreatment TreatmentStart D
ateForm Instan
ce
 1.1  YES  MECHANICAL VE
NTILATION MECHANICAL VE
NTILATION Jan/19/
2021 Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828105
Page 40 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Respiratory Treatment
1.What is the treatment Identifier? [1]
2.Concomitant Non-drug Treatment
Pre-specified:YES
3.Treatment: MECHANICAL VENTILATION
4.Treatment: [MECHANICAL VENTILATION]
5.Start Date: Jan/19/2021
6.Ongoing? NO
End Date:
Jan/21/2021
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828106
Page 41 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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:
[COVID-19 ILLNESS]
Date of Diagnosis:
Jan/15/2021
3.Toxicity Grade: 3
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828107
Page 42 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category of Clini
cal Event:Subcategory of Clinical EventDiagnosis Obt
ainedToxicity
GradeForm Instan
ce
 1. DELETED SEVERE COVID-
19 ILLNESS SIGNIFICANT ACUTE NEUROL
OGIC DYSFUNCTION YES
Diagnosis:
seizures
Start Date:
Jan/19/202
1
Ongoing?:
NO
End Date:
Jan/19/2
021
 3  Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828108
Page 43 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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
Illness Details
1.Category of Clinical Event: SEVERE COVID-19 ILLNESS
2.Subcategory of Clinical Event: SIGNIFICANT ACUTE NEUROLOGIC DYSFUNCTION
3.Was a diagnosis obtained? YES
Diagnosis:
[seizures]
Start Date:
Jan/19/2021
Ongoing?:
NO
End Date:
Jan/19/2021
4.Toxicity Grade: 3
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828109
Page 44 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category fo
r Lab TestVendor NameCollecti
on Date
:Specim
en Typ
eLab ResultForm Insta
nce
 1.CLINICAL
CHEMISTR
Y YALE NEW HAVEN
HOSPITAL LABORA
TORY Jan/19/
2021 BLOO
D Sponsor-De
fined Identi
fierTest:Res
ult:
329  C Reactive Prot
ein_PX329 9.7 
30  Alanine Amino
transferase_PX
30 19 
28  Aspartate Amin
otransferase_P
X28 34 
35  Alkaline Phosp
hatase_PX35 59 
21  Bilirubin_PX21
 0.5 
47  Blood Urea Nit
rogen_PX47 14 
48  Creatinine_PX
48 1.0
7 Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828110
Page 45 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [YALE NEW HAVEN HOSPITAL LABORATORY]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [329]
Test: C Reactive Protein_PX329
Result: [9.7]
Not Done:
LNMT Low
[<1.0]
High
[1.0]
Unit
mg/L
5.bSponsor ID: [30]
Test: Alanine Aminotransferase_PX30
Result: [19]
Not Done:
LNMT Low
[9]
High
[59]
Unit
U/L
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828111
Page 46 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.cSponsor ID: [28]
Test: Aspartate Aminotransferase_PX28
Result: [34]
Not Done:
LNMT Low
[10]
High
[35]
Unit
U/L
5.dSponsor ID: [35]
Test: Alkaline Phosphatase_PX35
Result: [59]
Not Done:
LNMT Low
[9]
High
[122]
Unit
U/L
5.eSponsor ID: [21]
Test: Bilirubin_PX21
Result: [0.5]
Not Done:
LNMT Low
[0.0]
High
[1.2]
Unit
mg/dL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828112
Page 47 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5 fSponsor ID: [47]
Test: Blood Urea Nitrogen_PX47
Result: [14]
Not Done:
LNMT Low
[6]
High
[20]
Unit
mg/dL
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [1.07]
Not Done:
LNMT Low
[0.40]
High
[1.30]
Unit
mg/dL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828113
Page 48 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Category fo
r Lab TestVendor Name (D
ERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.HEMATOL
OGY YALE NEW HAV
EN HOSPITAL Jan/19/20
21 BLOOD Sponsor-Defin
ed IdentifierTest:Res
ult:
1  Hemoglobin
_PX1 13.5
 
2  Hematocrit_
PX2 40.2
 
3  Erythrocyte
s_PX3 [ ] 
5  Platelets_P
X5 208 
7  Leukocytes
_PX7 [ ] 
608  Neutrophils
_PX608 6.9 
609  Eosinophils
_PX609 0.0 
612  Monocytes_
PX612 13.1
 
610  Basophils_P
X610 0.3 
611  Lymphocyte
s_PX611 11.8
 Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828114
Page 49 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Laboratory Data Hematology
1.Lab Panel: HEMATOLOGY
2.Laboratory Name and Address [YALE NEW HAVEN HOSPITAL]
3.Collection Date: Jan/19/2021
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [1]
Test: Hemoglobin_PX1
Result: [13.5]
Not Done:
LNMT Low
[12.0]
High
[18.0]
Unit
g/dL
5.bSponsor ID: [2]
Test: Hematocrit_PX2
Result: [40.2]
Not Done:
LNMT Low
[37.0]
High
[52.0]
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828115
Page 50 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.cSponsor ID: [3]
Test: Erythrocytes_PX3
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [5]
Test: Platelets_PX5
Result: [208]
Not Done:
LNMT Low
[140]
High
[440]
Unit
10^3/uL
5.eSponsor ID: [7]
Test: Leukocytes_PX7
Result: [ ]
Not Done: NOT DONE
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828116
Page 51 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5 fSponsor ID: [608]
Test: Neutrophils_PX608
Result: [6.9]
Not Done:
LNMT Low
[1.0]
High
[11.0]
Unit
10^3/uL
5.gSponsor ID: [609]
Test: Eosinophils_PX609
Result: [0.0]
Not Done:
LNMT Low
[0.0]
High
[7.0]
Unit
%
5 hSponsor ID: [612]
Test: Monocytes_PX612
Result: [13.1]
Not Done:
LNMT Low
[4.0]
High
[15.0]
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828117
Page 52 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.iSponsor ID: [610]
Test: Basophils_PX610
Result: [0.3]
Not Done:
LNMT Low
[0.0]
High
[4.0]
Unit
%
5.jSponsor ID: [611]
Test: Lymphocytes_PX611
Result: [11.8]
Not Done:
LNMT Low
[8.0]
High
[49.0]
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828118
Page 53 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Date: Vital Signs Details Form Instance
 1.Jan/19/2021 Record Identifier: Systolic: Diastolic:
1  125  72 Repeating Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828119
Page 54 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: VITAL SIGNS - COVID
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/19/2021
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [125]
Diastolic: [72]
Respiratory Rate in
respirations/minute:[29]
Heart Rate in beats/minute: [102]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828120
Page 55 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Date: Vital Signs Details Form Instance
 1.Jan/19/2021 Record Identifier: Oxygen Saturation
1  97.0 Repeating Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828121
Page 56 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Jan/19/2021
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [97.0]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828122
Page 57 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxygen
)Form Instance
 1.Jan/19/2021 10:31  162  1.00  Repeating Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828123
Page 58 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Oxygenation Parameters
1.Date Time of Assessment: Jan/19/2021 10:31
2.Arterial Blood Gases PaO2
(mmHg):[162]
3.FiO2 (Fraction of Inhaled
Oxygen):[1.00]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828124
Page 59 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medications
Pre-specifiedName of Med
icationStart Dat
eForm Instanc
e
 1.Not Applicable  Not Applicable  Not Applicable  Not Applicabl
e Not Appli
cable Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828125
Page 60 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Form Comments
eCRF Audit Trail History
Concomitant Medications
1.What is the medication identifier? Not Applicable
[ ]Comments
2.Category: Not Applicable Comments
3.Concomitant Medications
Pre-specified:Not Applicable Comments
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).Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828126
Page 61 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Date of Assess
mentLocation of Asses
smentImaging Me
thodOverall AssessmentForm Instanc
e
 1.Jan/19/2021  CHEST  X-RAY  ABNORMAL
If abnormal, specify findings:
SMALL bilateral pleural effusion and bi
basilar opacity
 Repeating
Pages
 2.Jan/20/2021  HEAD  MRI  NORMAL  Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828127
Page 62 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/19/2021
2.Location of Assessment: CHEST
3.Type of Imaging Exam: X-RAY
4.Assessment: ABNORMAL
If abnormal, specify findings:
[SMALL bilateral pleural effusion and bibasilar opacity]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828128
Page 63 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Jan/20/2021
2.Location of Assessment: HEAD
3.Type of Imaging Exam: MRI
4.Assessment: NORMAL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828129
Page 64 of 250
***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: 12231252 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:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828130
Page 65 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828131
Page 66 of 250
***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: 12231252 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:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828132
Page 67 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828133
Page 68 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828134
Page 69 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unplanned Assessments
1.Assessments
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828135
Page 70 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828136
Page 71 of 250
***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: 12231252 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:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828137
Page 72 of 250
***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: 12231252 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?
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828138
Page 73 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828139
Page 74 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828140
Page 75 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828141
Page 76 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828142
Page 77 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828143
Page 78 of 250
***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: 12231252 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 [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828144
Page 79 of 250
***Confidential***
 
Header Text: C4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Dec/4/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828145
Page 80 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828146
Page 81 of 250
***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: 12231252 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?
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828147
Page 82 of 250
***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: 12231252 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: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828148
Page 83 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#CategoryAE Identif
ierAdverse Ev
entStart DateIs the Adverse Event Still O
ngoingForm Instance
 1.ADVERSE EVE
NT 1  left arm pain
 Nov/4/2020 19
:00 NO
End Date Time:
Nov/6/2020 09:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  malaise  Nov/5/2020 08
:00 NO
End Date Time:
Nov/6/2020 09:00
 Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828149
Page 84 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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)[left arm pain]
4.Start Date Time: Nov/4/2020 19:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 09:00
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828150
Page 85 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828151
Page 86 of 250
***Confidential***
 
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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)[malaise]
4.Start Date Time: Nov/5/2020 08:00
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/6/2020 09:00
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828152
Page 87 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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?NO
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828153
Page 88 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828154
Page 89 of 250
***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: 12231252 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[ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828155
Page 90 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828156
Page 91 of 250
***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: 12231252 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: //
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828157
Page 92 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828158
Page 93 of 250
***Confidential***
Header Text: C4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828159
Page 94 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828160
Page 95 of 250
***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: 12231252 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?
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828161
Page 96 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828162
Page 97 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828163
Page 98 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828164
Page 99 of 250
***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: 12231252 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?
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828165
Page 100 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828166
Page 101 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828167
Page 102 of 250
***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: 12231252 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: [ ]
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828168
Page 103 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Dec/4/2020
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828169
Page 104 of 250
***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: 12231252 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
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828170
Page 105 of 250
***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: 12231252 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 21:44:34 (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.
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828171
Page 106 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 10-Oct-2020 16:00 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormOct-16-2020 18:01:22 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828172
Page 107 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
FormFeb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828173
Page 108 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
1Feb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828174
Page 109 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
2Feb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828175
Page 110 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
3Feb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828176
Page 111 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
4Feb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828177
Page 112 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
5Feb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828178
Page 113 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS -
Comments
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Frozen
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
ItemDate User Comment
6Feb-17-2021 12:53:50 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828179
Page 114 of 250
***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: 12231252 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 21:44:34 (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 Feb-01-2021 13:41:38 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Jessica Tuan  Approved Jan-21-2021 14:23:01 (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.
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828180
Page 115 of 250
***Confidential***
Header Text: C4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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
Oct-16-2020 18:00:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Oct-16-2020 18:00:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828181
Page 116 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Consent Was:
Date Location User Value Reason
Oct-16-2020 18:00:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Oct/16/2020Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828182
Page 117 of 250
***Confidential***
 
Header Text: C4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Subject ID
Date Location User Value Reason
Oct-16-2020 18:00:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12231252Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Oct-16-2020 18:00:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1972Enrollment Entry
3. Sex:
Date Location User Value Reason
Oct-16-2020 18:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Oct-16-2020 18:01:07
(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
Oct-16-2020 18:01:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828183
Page 118 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-16-2020 18:01:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828184
Page 119 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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
Oct-16-2020 18:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-16-2020 18:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Oct-16-2020 18:01:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828185
Page 120 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Oct-16-2020 18:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Hypertensio
n
Start Date: UNK/UNK/
2015
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Oct-16-2020 18:01:53
(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
Oct-16-2020 18:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Oct-16-2020 18:01:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2015Initial Entry
1.a Ongoing:
Date Location User Value Reason
Oct-16-2020 18:01:53 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828186
Page 121 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)YES
1.b
Date Location User Value Reason
Oct-16-2020 18:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:2
Medical History
Term:Hyperlipide
mia
Start Date: Aug/UNK/2
020
Ongoing: YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828187
Page 122 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.b Line/MH Number:
Date Location User Value Reason
Oct-16-2020 18:02:28
(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
Feb-04-2021 16:45:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-03-2021 13:52:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This information
is not pertinent for
PI and will be
removed
Feb-02-2021 16:23:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Clinical_ Per
report the subject
has " of opioid use
disorder, history of
substance abuse in
remission and
smoking tobacco."
However, this
additional
information is
missing on CRF.
Please revise and
update form
accordingly.
Thanks.
Oct-16-2020 18:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Oct-16-2020 18:02:28 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828188
Page 123 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)Aug/UNK/2020
1.b Ongoing:
Date Location User Value Reason
Oct-16-2020 18:02:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828189
Page 124 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Oct-16-2020 18:02:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to b
e HIV POSITIVEInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828190
Page 125 of 250
***Confidential***
 
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Weight:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
180.0Initial Entry
3. Unit:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828191
Page 126 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.8Initial Entry
7.a
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 98.3
Temperature Unit
:F
Temperature Loc
ation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
7.a Unit:
Date Location User Value Reason
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828192
Page 127 of 250
***Confidential***
Header Text: C4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-16-2020 18:03:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828193
Page 128 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Randomization Date :
Date Location User Value Reason
Oct-16-2020 18:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Oct-16-2020 18:03:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
108817Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828194
Page 129 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 18:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 18:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-20-2020 14:31:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-19-2020 06:38:54
(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-16-2020 18:03:32
(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.
Oct-16-2020 18:03:32
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828195
Page 130 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada) Date of Collection:
Oct/16/2020
5.a
Date Location User Value Reason
Oct-20-2020 14:31:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37P5Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020 14:31:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR37P5Initial Entry
5.b
Date Location User Value Reason
Oct-20-2020 14:31:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37P4Initial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020 14:31:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR37P4Initial Entry
5.c
Date Location User Value Reason
Oct-20-2020 14:32:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37P3Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828196
Page 131 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.c Sample ID
Date Location User Value Reason
Oct-20-2020 14:32:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR37P3Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828197
Page 132 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-16-2020 18:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-16-2020 18:03:39
(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-21-2020 08:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-19-2020 06:38:54
(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-16-2020 18:03:39
(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-16-2020 18:03:39
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828198
Page 133 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Time (US & Canada) Date of Collection:
Oct/16/2020
5.a
Date Location User Value Reason
Oct-21-2020 08:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR37P2Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 08:30:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR37P2Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828199
Page 134 of 250
***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: 12231252 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-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/16/2020 12:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828200
Page 135 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Oct-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-16-2020 18:03:55
(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
Oct-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION 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-16-2020 18:03:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828201
Page 136 of 250
***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: 12231252 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
Oct-16-2020 18:04:00
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E-
DIARY NOT COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0828202
Page 137 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-04-2020 16:04:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828203
Page 138 of 250
***Confidential***
 
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date:
Date Location User Value Reason
Nov-04-2020 16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2.a
Date Location User Value Reason
Nov-04-2020 16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 98.0
Temperature Uni
t:F
Temperature Loc
ation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Nov-04-2020 16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Nov-04-2020 16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.0Initial Entry
2.a Unit:
Date Location User Value Reason
Nov-04-2020 16:04:47 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828204
Page 139 of 250
***Confidential***
Header Text: C4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
(UTC-05:00) Eastern
Time (US & Canada)F
2.a Temperature Location:
Date Location User Value Reason
Nov-04-2020 16:04:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828205
Page 140 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 16:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 16:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-05-2020 15:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-04-2020 16:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Nov-04-2020 16:05:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828206
Page 141 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Nov-05-2020 15:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR376FInitial Entry
5.a Sample ID
Date Location User Value Reason
Nov-05-2020 15:24:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR376FInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828207
Page 142 of 250
***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: 12231252 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
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020 14:51Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828208
Page 143 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Nov-04-2020 16:07:05
(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
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Nov-04-2020 16:07:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828209
Page 144 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-07-2020 09:39:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/4/2020Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828210
Page 145 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Dec-04-2020 13:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-04-2020 13:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Dec-04-2020 13:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Dec-04-2020 13:56:44
(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.
Dec-04-2020 13:56:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
YES
Date of Collection:
Dec/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828211
Page 146 of 250
***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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Dec-04-2020 13:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
Sample ID: BPW1YRInitial Entry
5.a Sample ID
Date Location User Value Reason
Dec-04-2020 13:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
BPW1YRInitial Entry
5.b
Date Location User Value Reason
Dec-04-2020 13:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
Sample ID: BPW1YSInitial Entry
5.b Sample ID
Date Location User Value Reason
Dec-04-2020 13:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
BPW1YSInitial Entry
5.c
Date Location User Value Reason
Dec-04-2020 13:58:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
Sample ID: BPW1YTInitial Entry
5.c Sample ID
Date Location User Value Reason
Dec-04-2020 13:58:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
BPW1YTInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828212
Page 147 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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-08-2021 01:29:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed As per site
confirmation -
updated PD tracker
Mar-05-2021 12:56:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered subject has been
contacted and
refuses to come in
for a convalescent
visit at this time.
Mar-04-2021 02:27:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened PDQ RQ1:Thank
you for the
response, however
Please confirm
whether subject
was contacted and
accordingly, enter
corresponding
CONVA visit else
provide planned
CONVA visit date.
Feb-26-2021 03:03:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Candidate PDQ RQ1: Thank
you for the
response, please
confirm the date
scheduled in query
response and
requesting to
respond to query
once data
available. Else
clarify.
Feb-25-2021 12:48:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered Subject is coming
in for a
convalescent visit
next week.
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828213
Page 148 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-24-2021 06:16:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened PDQ:
Convalescent visit
is missing and 35
days (36) 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.
Feb-03-2021 11:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Feb-02-2021 04:23:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 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-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Feb-01-2021 13:41:36
(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.
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0828214
Page 149 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-01-2021 13:41:36
(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-01-2021 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Feb-01-2021 13:41:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828215
Page 150 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Feb-03-2021 13:40:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/10/2021Changed
Information
Feb-03-2021 11:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/11/2021Transcription Error
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-01-2021 13:49:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Resol
ved:
Jan/25/2021Initial Entry
4.a
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828216
Page 151 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.a Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828217
Page 152 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Pres
ent:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828218
Page 153 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.d Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE P
AIN
Sympto
m Prese
nt:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828219
Page 154 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.f
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE THR
OAT
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828220
Page 155 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
4.g Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828221
Page 156 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Feb-01-2021 13:49:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Feb-01-2021 13:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: seizuresInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Feb-01-2021 13:56:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
seizuresInitial Entry
5.b
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828222
Page 157 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-01-2021 13:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: fatigueInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Feb-01-2021 13:56:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
fatigueInitial Entry
5.c
Date Location User Value Reason
Feb-01-2021 13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Other: nauseaInitial Entry
5.c Symptoms - Other Text:
Date Location User Value Reason
Feb-01-2021 13:56:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
nauseaInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828223
Page 158 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828224
Page 159 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828225
Page 160 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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-15-2021 15:07:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/20/2021Transcription Error
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828226
Page 161 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
6. Trade Name:
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HOLOGIC PANTHER FUSI
ON SARS-COV-2Initial Entry
7. Test Result:
Date Location User Value Reason
Feb-01-2021 13:50:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828227
Page 162 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/15/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Feb-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Feb-15-2021 15:16:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Feb-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Feb-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
6. Trade Name:
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828228
Page 163 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Feb-15-2021 15:16:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User ValueReason
Feb-18-2021
07:48:03
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse
satisfies query
Feb-17-2021
12:51:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dChanged
Information
Feb-17-2021
12:51:14
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
CLIA
certifi
ed labChanged
Information
Feb-17-2021
03:13:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedTrade name
Manufacturer
test kit name
provided as "
PCR test" does
not uniquely
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828229
Page 164 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
match with the
FDA List.
Kindly update
data as
requested else
please confirm
and add text
"CLIA certified
lab", Thank
you
Feb-15-2021
15:16:06
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
PCR t
estInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828230
Page 165 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-03-2021 11:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-03-2021 11:58:50
(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-03-2021 11:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Feb-03-2021 11:59:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Feb-03-2021 11:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of Collection
is before Date of
First Symptom
Started on the
Signs and
Symptoms form in
the same visit.
Please review and
update as
appropriate.
Feb-03-2021 11:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828231
Page 166 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
barcodes are
entered. Please
review and correct
as appropriate.
Feb-03-2021 11:58:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Jan/11/2021Initial Entry
5.a
Date Location User Value Reason
Feb-03-2021 11:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
Sample ID: CV44706Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-03-2021 11:59:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Suzana
MuticData Entry:
CV44706Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828232
Page 167 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-01-2021 13:51:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-01-2021 13:51:26
(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-01-2021 13:51:26
(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-01-2021 13:51:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
subject was hospitalized and h
ad a swab done thereInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828233
Page 168 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1.a
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:SPECI
ALIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 13:52:16
(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-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:EMERGENC
Y ROOM
Occurrence o
f Visits or Co
ntacts:YES
Number of V
isits or Cont
acts:
1Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828234
Page 169 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 13:52:16
(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-01-2021 13:52:16
(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-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828235
Page 170 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGEN
T CARE
Occurrence of Vis
its or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 13:52:16
(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-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828236
Page 171 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Pract
itioner:TELEPHON
E CONSULT
ATION
Occurrence o
f Visits or Co
ntacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Feb-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828237
Page 172 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Feb-01-2021 13:52:16
(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-01-2021 13:52:16
(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-01-2021 13:52:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Has the subject been in inten
sive care due to potential CO
VID-19 illness?
YESInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828238
Page 173 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: HOSPITALIZATION DETAILS - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-01-2021 13:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828239
Page 174 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Hospitalization Category:
Date Location User Value Reason
Feb-01-2021 13:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HOSPITALIZATION STATUSInitial Entry
2. Hospitalization Term:
Date Location User Value Reason
Feb-01-2021 13:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ICUInitial Entry
3. Admission Date:
Date Location User Value Reason
Feb-18-2021 16:07:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 14:51:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica Tuan Query 1: Answered Changed data per
query
Feb-16-2021 09:56:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY:
Please complete
the Vasopress CRF
in this visit.
Feb-15-2021 15:14:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Feb-02-2021 10:03:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Please complete
the Oxygen,
Vasopress &
Imaging CRF's in
this visit.
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828240
Page 175 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: HOSPITALIZATION DETAILS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-01-2021 13:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
4. Ongoing?
Date Location User Value Reason
Feb-01-2021 13:53:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Jan/26/2021Transcription Error
Feb-01-2021 13:53:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Discharge Date:
Jan/25/2021Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828241
Page 176 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: RESPIRATORY TREATMENT - Audit Trail
Form Version: 06-Jul-2020 21:53 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828242
Page 177 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 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-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Feb-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
YESInitial Entry
3. Treatment:
Date Location User Value Reason
Feb-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MECHANICAL VENTILATI
ONInitial Entry
4. Treatment:
Date Location User Value Reason
Feb-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
MECHANICAL VENTILATIO
NInitial Entry
5. Start Date:
Date Location User Value Reason
Feb-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
6. Ongoing?
Date Location User Value Reason
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828243
Page 178 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: RESPIRATORY TREATMENT - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-01-2021 14:05:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jan/21/2021New Information
Feb-01-2021 13:55:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828244
Page 179 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 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-01-2021 14:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Feb-15-2021
16:38:25
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 4:
ClosedDiscrepancy has
been closed.
Feb-15-2021
15:00:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 4:
AnsweredTranscription
Error
Feb-15-2021
15:00:21
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
YES
Respirat
ory Illne
ss Diagn
osis:
COVI
D-19 I
LLNE
SS
Date of
Diagnosi
s:Transcription
Error
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828245
Page 180 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Jan/15/
2021
Feb-03-2021
16:56:26
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 4:
OpenedClarify COVID
ILLNESS as
follows....The
term appears
incomplete. Are
you reporting
COVID-19
ILLNESS? If so,
update the
verbatim term as
such. Otherwise,
clarify and
update the term
as appropriate.
Thank you.
Feb-03-2021
13:53:59
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 3:
ClosedResponse
satisfies query
Feb-03-2021
13:36:15
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2:
ClosedDiscrepancy has
been closed.
Feb-03-2021
12:01:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3:
AnsweredTranscription
Error
Feb-03-2021
12:01:05
(UTC-05:00)ACV0PFEINFP6000  auto query
(autoquery)Query 2:
AnsweredTranscription
Error
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828246
Page 181 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Eastern Time
(US &
Canada)
Feb-03-2021
12:01:05
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
YES
Respirat
ory Illne
ss Diagn
osis:
COVI
D ILL
NESS
Date of
Diagnosi
s:
Jan/15/
2021Transcription
Error
Feb-02-2021
09:55:23
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Query 3:
OpenedCLIQUERY:
Subject has
confirmed
COVID-19
(symptoms and
positive test),
please update
diagnosis to
COVID-19.
Feb-01-2021
16:29:01
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 2:
OpenedClarify NO
RESPIRATORY
SYMPTOMS
OR
DIAGNOSIS
PRESENT as
follows¿Cannot
code the lack of
an event or
diagnosis.
Specify
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828247
Page 182 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
symptom,
diagnosis or
procedure being
reported. Thank
you.
Feb-01-2021
14:07:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
ClosedClose Auto
Query
Feb-01-2021
14:07:20
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
YES
Respirat
ory Illne
ss Diagn
osis:
no resp
iratory
sympto
ms or d
iagnosi
s prese
nt
Date of
Diagnosi
s:
Jan/15/
2021New Information
Feb-01-2021
14:06:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1:
OpenedYes is selected,
however, either
the diagnosis
details or date of
diagnosis is
missing. Please
correct.
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828248
Page 183 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: 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: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Feb-01-2021
14:06:22
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data Entr
y:
YES
Date of
Diagnosi
s:
Jan/15/
2021Initial Entry
3. Toxicity Grade:
Date Location User Value Reason
Feb-16-2021 09:57:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-15-2021 15:17:13
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered initial test for
COVID 19 done
on 15Jan2021.
Results entered.
Feb-04-2021 11:51:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
COVID-19 Date of
Diagnosis is
15Jan2021
however Local
positive
COVID-19 test
date was
19Jan2021. Date
of Diagnosis
should match
positive test date
in Local or
Central. Please
update or clarify.
Feb-01-2021 14:06:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (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-2021-5683-0828249
Page 184 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: ILLNESS DETAILS - SEVERE - Audit Trail
Form Version: 17-Jul-2020 21:55 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Feb-18-2021 16:49:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted Transcription
Error
Feb-01-2021 14:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828250
Page 185 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Feb-01-2021 14:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE COVID-19 ILLNESSInitial Entry
2. Subcategory of Clinical Event:
Date Location User Value Reason
Feb-01-2021 14:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SIGNIFICANT ACUTE NEU
ROLOGIC DYSFUNCTIONInitial Entry
3. Was a diagnosis obtained?
Date Location User Value Reason
Feb-19-2021 09:58:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Feb-18-2021 16:49:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Feb-18-2021 16:10:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY:
Please make
required updates
then respond to
discrepancy once
updates made.
Feb-18-2021 15:00:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Jessica Tuan Query 1: Answered Seizures reported
within symptoms
of disease, will
delete
Feb-16-2021 10:08:57
(UTC-05:00) EasternACV0PFEINFP6000  Query 1: Reissued:Opened CLIQUERY:
Seizures cannot be
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0828251
Page 186 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada) recorded on this
CRF as this is for
renal, hepatic, and
neurologic
dysfunction.
Please remove and
add the AE CRF in
Log visit.
Feb-15-2021 15:18:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered may be a
complication of
COVID 19, but
definitive cause
unknown.
Feb-02-2021 10:54:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLIQUERY:
Diagnosis should
be given for events
caused by
significant acute
renal, hepatic, or
neurologic
dysfunction.
Please update.
Feb-01-2021 14:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Diagnosis:
seizures
Start Date:
Jan/19/2021
Ongoing?:
NO
End Date:
Jan/19/2021Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828252
Page 187 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: ILLNESS DETAILS - SEVERE - eCRF Audit Trail History
Form Version: 17-Jul-2020 21:55 Form Status: Data Complete, Deleted
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
*** THIS REPEATING FORM HAS BEEN DELETED ***
4. Toxicity Grade:
Date Location User Value Reason
Feb-01-2021 14:08:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828253
Page 188 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- Audit Trail
Form Version: 10-Oct-2020 15:58 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828254
Page 189 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
CLINICAL CHEMISTRYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YALE NEW HAVEN HOSPI
TAL LABORATORYInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:329
Test:: C Reactive Pro
tein_PX329
Result:: 9.7Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828255
Page 190 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Not Done::
Lab Normal R
ange:Low
<1.0
High
1.0
Unit
mg/L
5.a Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
329Initial Entry
5.a Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
C Reactive Protein_PX329Initial Entry
5.a Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
9.7Initial Entry
5.a LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
<1.0
High
1.0Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828256
Page 191 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unit
mg/L
5.b
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifier
:30
Test:: Alanine Aminotr
ansferase_PX30
Result:: 19
Not Done::
Lab Normal
Range:Low
9
High
59
Unit
U/LInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828257
Page 192 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
5.b Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Alanine Aminotransferase_PX
30Initial Entry
5.b Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
19Initial Entry
5.b LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
9
High
59
Unit
U/LInitial Entry
5.c
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defi
ned Identifie28Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828258
Page 193 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
r:
Test:: Aspartate Amino
transferase_PX2
8
Result:: 34
Not Done::
Lab Normal
Range:Low
10
High
35
Unit
U/L
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828259
Page 194 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.c Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
5.c Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aspartate Aminotransferase_P
X28Initial Entry
5.c Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
34Initial Entry
5.c LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
10
High
35
Unit
U/LInitial Entry
5.d
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:35Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828260
Page 195 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Alkaline Phosp
hatase_PX35
Result:: 59
Not Done::
Lab Normal R
ange:Low
9
High
122
Unit
U/L
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828261
Page 196 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.d Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
5.d Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Alkaline Phosphatase_PX35Initial Entry
5.d Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
59Initial Entry
5.d LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
9
High
122
Unit
U/LInitial Entry
5.e
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:21Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828262
Page 197 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Bilirubin_P
X21
Result:: 0.5
Not Done::
Lab Normal Rang
e:Low
0.0
High
1.2
Unit
mg/dL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828263
Page 198 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.e Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
5.e Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bilirubin_PX21Initial Entry
5.e Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
0.5Initial Entry
5.e LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.0
High
1.2
Unit
mg/dLInitial Entry
5.f
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:47Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828264
Page 199 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Blood Urea Nit
rogen_PX47
Result:: 14
Not Done::
Lab Normal R
ange:Low
6
High
20
Unit
mg/dL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828265
Page 200 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.f Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
5.f Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Blood Urea Nitrogen_PX47Initial Entry
5.f Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
14Initial Entry
5.f LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
6
High
20
Unit
mg/dLInitial Entry
5.g
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:48Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828266
Page 201 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Creatinine_
PX48
Result:: 1.07
Not Done::
Lab Normal Rang
e:Low
0.40
High
1.30
Unit
mg/dL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828267
Page 202 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
- eCRF Audit Trail History
Form Version: 10-Oct-2020 15:58 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.g Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
5.g Test:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Creatinine_PX48Initial Entry
5.g Result:
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1.07Initial Entry
5.g LNMT
Date Location User Value Reason
Feb-01-2021 14:54:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.40
High
1.30
Unit
mg/dLInitial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828268
Page 203 of 250
***Confidential***
 
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
Audit Trail
Form Version: 10-Oct-2020 16:02 Form Status:
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828269
Page 204 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Back to Form
1. Lab Panel:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
HEMATOLOGYInitial Entry
2. Laboratory Name and Address
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YALE NEW HAVEN HOSPI
TALInitial Entry
3. Collection Date:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2021Initial Entry
4. Specimen Type:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLOODInitial Entry
5.a
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:1
Test:: Hemoglobin
_PX1
Result:: 13.5Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828270
Page 205 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Not Done::
Lab Normal Ran
ge:Low
12.0
High
18.0
Unit
g/dL
5.a Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
5.a Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hemoglobin_PX1Initial Entry
5.a Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
13.5Initial Entry
5.a LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
12.0
High
18.0Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828271
Page 206 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Unit
g/dL
5.b
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:2
Test:: Hematocrit
_PX2
Result:: 40.2
Not Done::
Lab Normal Rang
e:Low
37.0
High
52.0
Unit
%Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828272
Page 207 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.b Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
5.b Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hematocrit_PX2Initial Entry
5.b Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
40.2Initial Entry
5.b LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
37.0
High
52.0
Unit
%Initial Entry
5.c
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:3Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828273
Page 208 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Erythrocyte
s_PX3
Result::
Not Done:: NOT DON
E
Lab Normal Ran
ge:
5.c Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
5.c Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Erythrocytes_PX3Initial Entry
5.c Not Done:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.d
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined Id
entifier:5
Test:: Platelets_
PX5
Result:: 208
Not Done::Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828274
Page 209 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Lab Normal Range
:Low
140
High
440
Unit
10^3/uL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828275
Page 210 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.d Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
5.d Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Platelets_PX5Initial Entry
5.d Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
208Initial Entry
5.d LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
140
High
440
Unit
10^3/uLInitial Entry
5.e
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined I
dentifier:7Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828276
Page 211 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Leukocytes
_PX7
Result::
Not Done:: NOT DON
E
Lab Normal Rang
e:
5.e Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
5.e Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Leukocytes_PX7Initial Entry
5.e Not Done:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
5.f
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:608
Test:: Neutrophils_
PX608
Result:: 6.9
Not Done::Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828277
Page 212 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Lab Normal Ran
ge:Low
1.0
High
11.0
Unit
10^3/uL
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828278
Page 213 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.f Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
608Initial Entry
5.f Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Neutrophils_PX608Initial Entry
5.f Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
6.9Initial Entry
5.f LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
1.0
High
11.0
Unit
10^3/uLInitial Entry
5.g
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:609Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828279
Page 214 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Eosinophils_
PX609
Result:: 0.0
Not Done::
Lab Normal Ran
ge:Low
0.0
High
7.0
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828280
Page 215 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.g Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
609Initial Entry
5.g Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Eosinophils_PX609Initial Entry
5.g Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
0.0Initial Entry
5.g LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.0
High
7.0
Unit
%Initial Entry
5.h
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:612Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828281
Page 216 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Monocytes_
PX612
Result:: 13.1
Not Done::
Lab Normal Ran
ge:Low
4.0
High
15.0
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828282
Page 217 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.h Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
612Initial Entry
5.h Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Monocytes_PX612Initial Entry
5.h Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
13.1Initial Entry
5.h LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
4.0
High
15.0
Unit
%Initial Entry
5.i
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:610Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828283
Page 218 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Basophils_P
X610
Result:: 0.3
Not Done::
Lab Normal Ran
ge:Low
0.0
High
4.0
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828284
Page 219 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.i Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
610Initial Entry
5.i Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Basophils_PX610Initial Entry
5.i Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
0.3Initial Entry
5.i LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
0.0
High
4.0
Unit
%Initial Entry
5.j
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defined
Identifier:611Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0828285
Page 220 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
Test:: Lymphocytes
_PX611
Result:: 11.8
Not Done::
Lab Normal Ra
nge:Low
8.0
High
49.0
Unit
%
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4)
FDA-CBER-2021-5683-0828286
Page 221 of 250
***Confidential***
Header Text: C4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Jan/19/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology -
eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete
Site No: 1223 Site Name: (1223) Yale New Haven Medical Center
Subject No: 12231252 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 13:30
5.j Sponsor ID:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
611Initial Entry
5.j Test:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Lymphocytes_PX611Initial Entry
5.j Result:
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
11.8Initial Entry
5.j LNMT
Date Location User Value Reason
Feb-01-2021 14:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Low
8.0
High
49.0
Unit
%Initial Entry
090177e196ae3019\Final\Final On: 01-Apr-2021 04:00 (GMT)
(b) (4),
…[truncated]