125742 S1 M5 CRF c4591001 1090 10901300

Document text

Page 1 of 243
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920780
Page 2 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/2/2020
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920781
Page 3 of 243
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Demography
1.Subject ID [10901300]
2.Birth Date: 1952
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:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920782
Page 4 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920783
Page 5 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920784
Page 6 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/2/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920785
Page 7 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep Apnea]
Start Date: UNK/UNK/1990
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Elevated Lipids]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[chronic kidney disease, mild]
Start Date: Aug/UNK/2019
Ongoing: YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920786
Page 8 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prostate Cancer]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Myeloid Leukemia]
Start Date: UNK/UNK/1991
Ongoing: YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920787
Page 9 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
2.Weight: [102.0]
3.Unit: kg
4.Height: [175.0]
5.Unit: cm
6.Body Mass Index: [33.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920788
Page 10 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/2/2020
2.Randomization Number: [249966]
3.Randomization Group: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920789
Page 11 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BN680W]
5.bSample ID [BN680X]
5.cSample ID [BN680Y]
5.dSample ID [BPLGRN]
5.eSample ID [BPLGRP]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920790
Page 12 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
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 [BN680P]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920791
Page 13 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 13:30
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920792
Page 14 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920793
Page 15 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/21/2020
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920794
Page 16 of 243
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920795
Page 17 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/21/2020
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 [BP8FRJ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920796
Page 18 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/21/2020 10:13
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920797
Page 19 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/19/2020
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920798
Page 20 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/19/2020
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 [BP8FMW]
5.bSample ID [BS7JJS]
5.cSample ID [BS7JJT]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920799
Page 21 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920800
Page 22 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/22/2020
2.Date of First Symptom Started: Oct/21/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/6/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? YES
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? YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920801
Page 23 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [sinus drainage]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920802
Page 24 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Colle
ctionSpecimen
TypeSpecimen Collection
LocationAssay Code and Des
criptionDevice T
ypeForm Instanc
e
 1.Not Done  Not Done  Not Done  Not Done  Not Don
e Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920803
Page 25 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920804
Page 26 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Oct/22/2020
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 [CV23120]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920805
Page 27 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:[self swab collected]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920806
Page 28 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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:NO
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
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920807
Page 29 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?NO
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920808
Page 30 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Treatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatment Treatment Start DateForm Instanc
e
 1.Not Applicable
 Not Applicable  Not Applic
able Not Applic
able Not Applic
able Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920809
Page 31 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Form Comments
eCRF Audit Trail History
Respiratory Treatment
1.What is the treatment
Identifier?Not Applicable
[ ]Comments
2.Concomitant Non-drug
Treatment Pre-specified:Not Applicable Comments
3.Treatment: Not Applicable Comments
4.Treatment: Not Applicable
[ ]Comments
5.Start Date: Not Applicable
//Comments
6.Ongoing? Not Applicable Comments
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920810
Page 32 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?NO
3.Toxicity Grade: 1
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920811
Page 33 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category of Clinical E
vent:Subcategory of Clinical
EventDiagnosis Obtai
nedToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920812
Page 34 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920813
Page 35 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for
Lab TestVendor
NameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920814
Page 36 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920815
Page 37 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Category for
Lab TestVendor Name (
DERIVED)Collectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.       Sponsor-Define
d IdentifierTe
st:Res
ult:Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920816
Page 38 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: LOCAL LABORATORY DATA - REPEATING
Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920817
Page 39 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920818
Page 40 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920819
Page 41 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920820
Page 42 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920821
Page 43 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date Time of Assessm
entArterial Blood Gases Pa
O2FiO2 (Fraction of Inhaled Oxy
gen)Form Instance
 1.      Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920822
Page 44 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920823
Page 45 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920824
Page 46 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where
generic name is unknown, enter
the full trade or proprietary
name. Include clarifying
information in the Medication
text (e.g., Ingredient(s), route,
use, formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920825
Page 47 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Date of Assessmen
tLocation of Assessmen
tImaging Metho
dOverall Assessmen
tForm Instance
 1.        Repeating Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920826
Page 48 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920827
Page 49 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/23/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920828
Page 50 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/23/2020
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 [BRCY08]
5.bSample ID [BSHBFJ]
5.cSample ID [BSHBFK]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920829
Page 51 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920830
Page 52 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Unplanned Assessments
1.Assessments
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920831
Page 53 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/19/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920832
Page 54 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920833
Page 55 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920834
Page 56 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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 [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920835
Page 57 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# CategoryAE Ide
ntifierAdverse E
ventStart DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  anaphylacti
c shock Oct/9/2020 U
NK:UNK NO
End Date Time:
Oct/9/2020 UNK:
UNK
 Repeating
Pages
 2. ADVERSE
EVENT 2  ant bite, lef
t ankle Oct/9/2020 15
:00 NO
End Date Time:
Oct/10/2020 UNK:
UNK
 Repeating
Pages
 3. DELETED ADVERSE
EVENT 3  Sore throat  Oct/21/2020
UNK:UNK YES  Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920836
Page 58 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[anaphylactic shock]
4.Start Date Time: Oct/9/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/9/2020 UNK:UNK
6.Toxicity Grade: 4
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening;
Inpatient hospitalization or
prolongation of existing
hospitalization; Persistent or
significant
disability/incapacity;
Congenital anomaly/birth
defect; Important medical event
(i.e. may jeopardize subject and
may require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth
defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
YES
Other medically important serious event
YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920837
Page 59 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[anaphylactic shock to ant bite]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?: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[2020405611]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920838
Page 60 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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)[ant bite, left ankle]
4.Start Date Time: Oct/9/2020 15:00
5.Is the adverse event still
ongoing?NO
End Date Time:
Oct/10/2020 UNK:UNK
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
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920839
Page 61 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
8.Is this adverse event the result
of a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[NA]
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[ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920840
Page 62 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis,
not individual symptoms)[Sore throat ]
4.Start Date Time: Oct/21/2020 UNK:UNK
5.Is the adverse event still
ongoing?YES
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
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920841
Page 63 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
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
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?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event
Number: For Pfizer Use Only[ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920842
Page 64 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Categ
oryMedication
ErrorStart D
ateIs the medication error St
ill OngoingStudy Medication Err
ors ActionForm Instanc
e
 1.         Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920843
Page 65 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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[ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920844
Page 66 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medicatio
ns Pre-specifiedName of Me
dicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920845
Page 67 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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: //
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920846
Page 68 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Sponsor-Define
d IdentifierCategory for
MedicationConcomitant Medicati
ons Pre-specifiedName of Me
dicationDose Desc
riptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920847
Page 69 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920848
Page 70 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
#Catego
ryTreatment Identi
fierCon Non-Drug Treatments Pre-s
pecifiedTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920849
Page 71 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920850
Page 72 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920851
Page 73 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920852
Page 74 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920853
Page 75 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920854
Page 76 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
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?
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920855
Page 77 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920856
Page 78 of 243
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920857
Page 79 of 243
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/19/2021
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920858
Page 80 of 243
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have
received only placebo at Vaccination 1/2
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920859
Page 81 of 243
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/20/2021
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920860
Page 82 of 243
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920861
Page 83 of 243
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Death Details
1.Date of Collection /
Notification of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920862
Page 84 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/28/2021
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920863
Page 85 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/28/2021
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920864
Page 86 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920865
Page 87 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation
/Death :Jan/28/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920866
Page 88 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BMN9GH]
5.bSample ID [BMN9GG]
5.cSample ID [BP8G4D]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920867
Page 89 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/28/2021
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 [BP8G4G]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920868
Page 90 of 243
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/28/2021 15:55
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920869
Page 91 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/19/2021
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920870
Page 92 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Feb/19/2021
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 [BV0F78]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920871
Page 93 of 243
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/19/2021 10:22
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was
Observed30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920872
Page 94 of 243
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920873
Page 95 of 243
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920874
Page 96 of 243
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920875
Page 97 of 243
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920876
Page 98 of 243
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920877
Page 99 of 243
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920878
Page 100 of 243
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Not Started
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920879
Page 101 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/19/2020
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920880
Page 102 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920881
Page 103 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Matthew
Hong Approved Feb-22-2021 16:54:06 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920882
Page 104 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormSep-03-2020 14:11:56 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920883
Page 105 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920884
Page 106 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920885
Page 107 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920886
Page 108 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920887
Page 109 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920888
Page 110 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920889
Page 111 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920890
Page 112 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
7Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920891
Page 113 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
8Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920892
Page 114 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
9Oct-26-2020 16:14:07 (UTC-05:00)
Eastern Time (US & Canada)Not Done
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920893
Page 115 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormOct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920894
Page 116 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
1Oct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920895
Page 117 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
2Oct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920896
Page 118 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
3Oct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920897
Page 119 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
4Oct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920898
Page 120 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
5Oct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920899
Page 121 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - Comments
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
6Oct-26-2020 16:15:36 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920900
Page 122 of 243
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
ItemDate User Comment
FormJan-28-2021 16:31:55 (UTC-05:00)
Eastern Time (US & Canada)Not Applicable
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920901
Page 123 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Matthew
Hong Approved Feb-22-2021 16:54:06 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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-22-2021 15:37:48 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Feb-19-2021 15:43:39 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920902
Page 124 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
 N/A Feb-19-2021 14:12:11 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Jan-29-2021 12:24:50 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-29-2021 12:01:05 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Jan-28-2021 17:29:54 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920903
Page 125 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
 N/A Jan-28-2021 16:30:23 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Nov-24-2020 13:22:47 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-24-2020 12:53:14 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Nov-24-2020 10:08:34 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920904
Page 126 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
 N/A Nov-23-2020 16:20:20 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Nov-23-2020 12:01:32 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that
this electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-23-2020 10:53:42 (UTC-05:00)
Eastern Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew
Hong Approved Oct-28-2020 14:19:15 (UTC-05:00)
Eastern Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewHong, 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.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0920905
Page 127 of 243
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-03-2020
14:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-03-2020
14:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920906
Page 128 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-03-2020
14:10:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obt
ained
Sep/2/2020Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920907
Page 129 of 243
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 14:10:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10901300Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-03-2020 14:10:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1952Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-03-2020
14:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-03-2020
14:11:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATI
NO(A) OR OF SPANISH
ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-03-2020
14:11:31ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920908
Page 130 of 243
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920909
Page 131 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020
01:50:50
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM:
PM.
Sep-09-2020
16:10:40
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Sep-07-2020
05:35:34
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened IVRS
Reconciliation:
Randomization
date and
randomization
number recorded
at Impala but not
recorded at
Inform. Please
review and
update data as
appropriate. Else
clarify. Thank
you.
Sep-03-2020
14:11:48
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920910
Page 132 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-03-2020
14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-03-2020 14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-03-2020
14:12:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920911
Page 133 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Sep-03-2020 14:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Sleep Apn
ea
Start Date: UNK/UNK
/1990
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
14:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sleep ApneaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020
14:13:25
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920912
Page 134 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
1.a Ongoing:
Date Location User Value Reason
Sep-03-2020
14:13:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-03-2020 14:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:Hypertensi
on
Start Date: UNK/UNK
/2000
Ongoing: YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920913
Page 135 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
14:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020
14:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020
14:13:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-03-2020 14:14:19
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num 3Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920914
Page 136 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) ber:
Medical Histor
y Term:Elevated L
ipids
Start Date: UNK/UNK
/2019
Ongoing: YES
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920915
Page 137 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-03-2020
14:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Elevated LipidsInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020
14:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020
14:14:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-09-2020
16:15:48ACV0PFEINFP6000  Data Entry:
Line/MH N 4New Information
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0920916
Page 138 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)umber:
Medical Hi
story Term
:chronic kidne
y disease, mil
d
Start Date: Aug/UNK/20
19
Ongoing: YES
Sep-03-2020
14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:4
Medical His
tory Term:Elevated Kid
ney Levels
Start Date: Aug/UNK/2
019
Ongoing: YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920917
Page 139 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.d Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User ValueReason
Sep-09-2020
20:48:55
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy
has been
closed.
Sep-09-2020
16:15:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dNew
Information
Sep-09-2020
16:15:48
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
chroni
c kidn
ey dis
ease,
mildNew
Information
Sep-04-2020
05:43:30
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedClarify
ELEVATED
KIDNEY
LEVELS as
follows...The
term is unclear.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0920918
Page 140 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Are you
reporting
KIDNEY
FUNCTION
ABNORMAL?
KIDNEY
FUNCTION
TEST
ABNORMAL?
KIDNEY
DISORDER?
Other? If so,
edit the term as
such.
Otherwise
clarify and edit
the term as
appropriate.
Thank you.
Sep-03-2020
14:16:11
(UTC-05:00)
Eastern Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Elevat
ed Ki
dney
Level
sInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020
14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/UNK/2019Initial Entry
1.d Ongoing:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920919
Page 141 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-03-2020
14:16:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-03-2020 14:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:5
Medical Hist
ory Term:Prostate Can
cer
Start Date: UNK/UNK/1
988
Ongoing: NO
End Date:
UNK/UN
K/1988Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920920
Page 142 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.e Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020
15:18:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Query closed;
will follow for
SAE update with
the med Hx
discussed
Oct-26-2020
13:16:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Oct-20-2020
13:11:02
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL
please submit a
SAE safety
update with the
additional Past
medical history
conditions of
prostate cancer
and chronic
kidney disease
reported in the
SAE Medical
history
Sep-03-2020
14:16:43
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
Prostate CancerInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920921
Page 143 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US &
Canada)
1.e Start Date:
Date Location User Value Reason
Sep-03-2020
14:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-03-2020
14:16:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.f
Date Location User Value Reason
Sep-03-2020 14:19:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:6
Medical His
tory Term:Chronic Myel
oid Leukemia
Start Date: UNK/UNK/1
991
Ongoing: YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920922
Page 144 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.f Line/MH Number:
Date Location User Value Reason
Sep-03-2020 14:19:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Oct-26-2020
21:36:05
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-26-2020
16:42:21
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Answered Corrected on med
hx pages that CML
has a stop date of
1991. We can
upload to Florence
again
Oct-26-2020
15:17:06
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL - Prior
Med Hx condition
CML is ongoing;
however, in SAE
report there is an
end date 1991
(same as onset
date). Please review
and update ongoing
status if correct in a
SAE safety update
Sep-10-2020
16:03:21
(UTC-05:00)
Eastern Time (USACV0PFEINFP6000  Patricia
BancheroQuery 1: Closed Closed per site
response.
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920923
Page 145 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
& Canada)
Sep-09-2020
16:09:47
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered per Pfizer ok to
enroll this pt with
imatinib
Sep-04-2020
18:29:42
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Patricia
BancheroQuery 1: Opened GPDCLIN: Please
confirm if
individual is
receiving or
planning to receive
immunosuppressive
therapy due to this
condition.
Sep-03-2020
14:19:56
(UTC-05:00)
Eastern Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Chronic Myeloid Leuk
emiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-03-2020
14:19:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1991Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-03-2020
14:19:56
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0920924
Page 146 of 243
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
102.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
175.0Initial Entry
5. Unit:
Date Location User Value Reason
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920925
Page 147 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-03-2020 14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33.3Initial Entry
7.a
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 97.8
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-03-2020
14:23:49ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920926
Page 148 of 243
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)
7.a Unit:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-03-2020
14:23:49
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920927
Page 149 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-09-2020 16:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-09-2020 16:10:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
249966Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920928
Page 150 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 16:51:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 16:51:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
16:51:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
16:51:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-08-2020
16:51:23
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920929
Page 151 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US &
Canada) Sep/2/2020
5.a
Date Location User Value Reason
Sep-08-2020
16:51:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN680WInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
16:51:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN680WInitial Entry
5.b
Date Location User Value Reason
Sep-08-2020
16:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN680XInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-08-2020
16:51:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN680XInitial Entry
5.c
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920930
Page 152 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Sep-08-2020
16:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN680YInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-08-2020
16:51:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN680YInitial Entry
5.d
Date Location User Value Reason
Sep-08-2020
16:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPLGRNInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-08-2020
16:52:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGRNInitial Entry
5.e
Date Location User Value Reason
Sep-08-2020
16:52:14
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Sample ID: BPLGRPInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (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-2021-5683-0920931
Page 153 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
5.e Sample ID
Date Location User Value Reason
Sep-08-2020
16:52:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPLGRPInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920932
Page 154 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-08-2020 16:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-08-2020 16:52:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-08-2020
16:52:38
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-08-2020
16:52:26
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-08-2020
16:52:26
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920933
Page 155 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US &
Canada) Sep/2/2020
5.a
Date Location User Value Reason
Sep-08-2020
16:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BN680PInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-08-2020
16:52:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BN680PInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920934
Page 156 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-03-2020
14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-03-2020 14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-03-2020 14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-03-2020
14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 13:30Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-03-2020 14:25:23
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920935
Page 157 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Sep-03-2020
14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-03-2020 14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-03-2020 14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-03-2020
14:25:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920936
Page 158 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-04-2020
11:15:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICIT
Y E-DIARY NOT COLLE
CTED FOR THIS SUBJE
CTTranscription
Error
Sep-03-2020
14:25:28
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICIT
Y E-DIARY COLLECTE
D FOR THIS SUBJECTInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920937
Page 159 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-21-2020
14:54:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920938
Page 160 of 243
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date:
Date Location User Value Reason
Sep-21-2020
14:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020
14:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identif
ier::1
Temperature: 98.1
Temperature
Unit:F
Temperature
Location::ORAL C
AVITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020
14:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020
14:55:10
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
98.1Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920939
Page 161 of 243
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
2.a Unit:
Date Location User Value Reason
Sep-21-2020
14:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020
14:55:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920940
Page 162 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-22-2020 10:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-22-2020 10:04:23
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-22-2020
10:04:32
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-22-2020
10:04:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Sep-22-2020
10:04:23
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920941
Page 163 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US &
Canada) Sep/21/2020
5.a
Date Location User Value Reason
Sep-22-2020
10:04:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8FRJInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-22-2020
10:04:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8FRJInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920942
Page 164 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-21-2020
14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-21-2020 14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-21-2020
14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/21/2020 10:13Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 14:55:47
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920943
Page 165 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
6. Body Side:
Date Location User Value Reason
Sep-21-2020
14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-21-2020 14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-21-2020 14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFI
ED OBSERVATION PERIO
DInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational
product administration?
Date Location User Value Reason
Sep-21-2020
14:55:47
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920944
Page 166 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-19-2020 14:21:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920945
Page 167 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-20-2020 07:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 07:58:32
(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
07:58:41
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-20-2020
07:58:32
(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-20-2020
07:58:32
(UTC-05:00)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920946
Page 168 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Eastern Time (US &
Canada) Oct/19/2020
5.a
Date Location User Value Reason
Oct-20-2020
07:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8FMWInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-20-2020
07:58:41
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8FMWInitial Entry
5.b
Date Location User Value Reason
Oct-20-2020
07:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7JJSInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-20-2020
07:58:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS7JJSInitial Entry
5.c
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920947
Page 169 of 243
***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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-20-2020
07:58:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS7JJTInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-20-2020
07:58:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BS7JJTInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920948
Page 170 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-26-2020
16:14:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-26-2020
16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto
Query
Oct-26-2020
16:13:10
(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.
Oct-26-2020
16:13:10
(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.
Oct-26-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920949
Page 171 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
16:13:10
(UTC-05:00) Eastern
Time (US & Canada)Oct/22/2020
3. COVID-19 Illness Visit:
Date Location User Value Reason
Oct-26-2020 16:13:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920950
Page 172 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/22/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Nov-23-2020
11:22:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Re
solved:
Nov/6/2020New Information
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVE
RInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920951
Page 173 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Symptom Present
:NO
4.a Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCR
EASED COUG
H
Symptom
Present:YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920952
Page 174 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.b Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED CO
UGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.c
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympt
oms:NEW OR INCRE
ASED SHORTNE
SS OF BREATH
Sympt
om Pre
sent:NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920953
Page 175 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.c Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SH
ORTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILL
S
Symptom Present
:NOInitial Entry
4.d Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920954
Page 176 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.e
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE
PAIN
Sympto
m Prese
nt:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED M
USCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF
TASTE OR SME
LL
Sympto
m Prese
nt:NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920955
Page 177 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.f Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR
SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE TH
ROAT
Sympto
m Prese
nt:YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920956
Page 178 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.g Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SO
RE THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRH
EA
Symptom Pres
ent:NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920957
Page 179 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
4.i
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITI
NG
Symptom Pres
ent:NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Oct-26-2020 16:13:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Oct-26-2020 16:13:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms - Ot
her:sinus drain
ageInitial Entry
5.a Symptoms - Other Text:
Date Location User Value Reason
Oct-26-2020 16:13:58
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
sinus drainageInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920958
Page 180 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
- eCRF Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada)
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920959
Page 181 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920960
Page 182 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
6. Trade Name:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
7. Test Result:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Oct-26-2020 16:14:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920961
Page 183 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: 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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 16:14:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 16:14:31
(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
Oct-26-2020
16:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-26-2020
16:14:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however no
barcodes are
entered. Please
review and
correct as
appropriate.
Oct-26-2020
16:14:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920962
Page 184 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: 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: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct/22/2020
5.a
Date Location User Value Reason
Oct-26-2020 16:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: CV23120Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-26-2020 16:14:43
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CV23120Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920963
Page 185 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
- eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-26-2020 16:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-26-2020 16:14:58
(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-26-2020 16:14:58
(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
Oct-26-2020 16:14:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
self swab collectedInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920964
Page 186 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1.a
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:SPECI
ALIST
Occurrence of Vis
its or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practit
ioner:EMERGE
NCY ROO
M
Occurrence of
Visits or Conta
cts:NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920965
Page 187 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 16:15:26
(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
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Prac
titioner:PRIMARY
CARE PHY
SICIAN
Occurrence
of Visits or C
ontacts:NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920966
Page 188 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICI
ANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitio
ner:URGEN
T CARE
Occurrence of V
isits or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 16:15:26
(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
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920967
Page 189 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
1.e
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Sabine
Ucik
(pfe.sucik)Data Entry:
Type of Prac
titioner:TELEPHON
E CONSULT
ATION
Occurrence
of Visits or C
ontacts:NOInitial Entry
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTA
TIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Oct-26-2020 16:15:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner
:OTH
ER
Occurrence of Visits
or Contacts:NOInitial Entry
Oct-26-2020 16:15:26
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
Type of Practitioner OTHInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0920968
Page 190 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail
History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Time (US & Canada) : ER
Occurrence of Visits
or Contacts:
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Oct-26-2020 16:15:53
(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
Oct-26-2020 16:15:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920969
Page 191 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. What is the treatment Identifier?
Date Location User Value Reason
Oct-26-2020 16:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Concomitant Non-drug Treatment Pre-specified:
Date Location User Value Reason
Oct-26-2020 16:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Treatment:
Date Location User Value Reason
Oct-26-2020 16:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Treatment:
Date Location User Value Reason
Oct-26-2020 16:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Start Date:
Date Location User Value Reason
Oct-26-2020 16:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920970
Page 192 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: RESPIRATORY TREATMENT - eCRF Audit Trail
History
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
6. Ongoing?
Date Location User Value Reason
Oct-26-2020 16:15:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920971
Page 193 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Oct/22/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Oct-26-2020 16:18:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 IL
LNESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Oct-26-2020 16:18:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Oct-26-2020 16:18:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920972
Page 194 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-23-2020
10:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/23/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-23-2020
10:53:42
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COVID_A1Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920973
Page 195 of 243
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-23-2020
16:20:20 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-23-2020
16:20:20 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-23-2020
16:20:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Nov-23-2020
16:20:20
(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-23-2020
16:20:20ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920974
Page 196 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)Date of Collection:
Nov/23/2020
5.a
Date Location User Value Reason
Nov-23-2020
16:20:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BRCY08Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-23-2020
16:20:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BRCY08Initial Entry
5.b
Date Location User Value Reason
Nov-23-2020
16:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHBFJInitial Entry
5.b Sample ID
Date Location User Value Reason
Nov-23-2020
16:20:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSHBFJInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920975
Page 197 of 243
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 -
Unscheduled Visit on Nov/23/2020Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5.c
Date Location User Value Reason
Nov-23-2020
16:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHBFKInitial Entry
5.c Sample ID
Date Location User Value Reason
Nov-23-2020
16:20:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSHBFKInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920976
Page 198 of 243
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail
History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-19-2020 14:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/19/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-19-2020 14:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-19-2020 14:21:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920977
Page 199 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920978
Page 200 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920979
Page 201 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Oct-27-2020
10:15:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Deleted New
Information
Oct-23-2020
11:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920980
Page 202 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-26-2020
19:32:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020
15:19:43
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Oct-21-2020
18:05:23
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered New Information
Oct-21-2020
18:05:23ACV0PFEINFP6000  Data Entry:
anaphylactic shockNew Information
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920981
Page 203 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US &
Canada)
Oct-21-2020
11:13:57
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened Clinical - Ant bite
as the cause for
anaphylactic
shock is reported
in the etiology
(Other = ant bite).
Consider single
term for SAE, and
ant bit still as a
separate term
Oct-21-2020
09:23:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered New Information
Oct-21-2020
09:23:25
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
anaphylactic shock, due
to ant biteNew Information
Oct-20-2020
21:26:16
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Ant
bite, left ankle:
Please enter a
separate AE
term(s) for the
signs/symptoms
that are observed.
For example, if
the insect bite
caused macular
lesions and
pruritus of the left
ankle, then record
a separate one for
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920982
Page 204 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
each event.
Oct-19-2020
14:25:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
ant bite, left ankleInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/9/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920983
Page 205 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Oct-21-2020
11:12:09
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Closed anaphylactic
shock entered as
a SAE
Oct-20-2020
13:04:20
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 2: Opened CLINICAL Per
SAE report, the
med
significant/life
threatening event
was anaphylactic
shock
(tongue/throat
swelling)
following this
insect bite. Please
enter the
additional
adverse event and
submit a SAE
safety update
with the modified
SAE event term.
Oct-20-2020
05:35:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Oct-19-2020
17:48:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NONew Information
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920984
Page 206 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
NO
Did this serious event r
esult in persistent or si
gnificant disability/inca
pacity?
NO
Is this serious event lif
e threatening?
YES
Other medically import
ant serious event
YES
Oct-19-2020
14:25:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE ant bite,
left ankle:
Response to "Is
the adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is
blank.
Oct-19-2020
14:25:22ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920985
Page 207 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00)
Eastern Time (US &
Canada)Is this serious event ass
ociated with congenital
anomaly or birth defect
?
NO
Did this serious event r
esult in death?
NO
Did this serious event r
equire or prolong hospi
talization?
YES
Did this serious event r
esult in persistent or si
gnificant disability/inca
pacity?
NO
Is this serious event lif
e threatening?
YES
Other medically import
ant serious event
YES
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
FDA-CBER-2021-5683-0920986
Page 208 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
anaphylactic shock to
ant biteInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920987
Page 209 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-19-2020 14:25:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Oct-20-2020 05:35:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020405611Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0920988
Page 210 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Back to Form
1. Category:
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ant bite, left ankleInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-24-2020
12:53:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/9/2020 15:00Transcription
Error
Oct-21-2020
18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020 15:00Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920989
Page 211 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
5. Is the adverse event still ongoing?
Date Location User Value Reason
Nov-24-2020
12:53:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Nov-24-2020
12:53:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/10/2020 UNK:U
NKTranscription
Error
Nov-24-2020
12:53:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For ant bite, left
ankle End Date
& Time
10/Sep/2020
UNK:UNK is
before the Start
Date & Time
09/Oct/2020
15:00.
Oct-21-2020
18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Sep/10/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-24-2020
02:27:04
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920990
Page 212 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Oct-23-2020
11:01:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Oct-23-2020
11:01:42
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
1Changed
Information
Oct-23-2020
04:25:24
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please
complete this
item. Thank you.
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920991
Page 213 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study trea
tment(s), this event is due t
o:
OTHER
If Other, specify:
NAInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-21-2020 18:13:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0920992
Page 214 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
Date Location User Value Reason
Nov-24-2020
15:20:55
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed Response satisfies
query
Nov-24-2020
12:54:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-24-2020
12:54:18
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOL
VEDTranscription Error
Nov-24-2020
12:10:22
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY: Ant
bite is reported to
have
Recovered/Resolved
with SEQUELAE.
Please review if this
selection is correct
for this event;
clarify sequelae in
query response
Oct-21-2020
18:13:11
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOL
VED WITH SEQUEL
AEInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-21-2020 18:13:11 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0920993
Page 215 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
(UTC-05:00) Eastern
Time (US & Canada)NO
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0920994
Page 216 of 243
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-23-2020 11:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-23-2020 11:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-28-2020
08:31:17
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response
satisfies query
Oct-27-2020
10:14:59
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Oct-27-2020
07:58:13
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Reissued:Open
edCLIQUERY: Per
protocol, section
8.3.7,
COVID-19
related event
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920995
Page 217 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
SORE THROAT
does not qualify
as AE and
should ONLY be
documented on
the COVID
Illness CRF page
and should not
be duplicated on
the AE CRF
page. Please
clarify or update.
Oct-26-2020
16:39:51
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Changed data
per query
Oct-26-2020
14:30:19
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened Clin: Per
protocol section
8.1., COVID-19
listed symptom
SORE THROAT
should trigger a
COVID Visit
irrespective of
perceived
etiology or
clinical
significance and
should be
captured on the
CRF SOD form
only. Please
collect Nasal
Swab.
Oct-23-2020
11:03:39ACV0PFEINFP6000  Data Entry:
Sore throatInitial Entry
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (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-2021-5683-0920996
Page 218 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-05:00)
Eastern Time (US &
Canada)
4. Start Date Time:
Date Location User Value Reason
Oct-23-2020
11:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/21/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-23-2020
12:56:21
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
YESChanged
Information
Oct-23-2020
11:03:39
(UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Oct/23/2020 UNK:U
NKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-23-2020
11:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7. Is the adverse event serious?
090177e196ae3d7f\Final\Final On: 01-Apr-2021 04:35 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0920997
Page 219 of 243
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1090 Site Name: (1090) Wake Research Associates, LLC
Subject No: 10901300 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:31
*** THIS REPEATING FORM HAS BEEN DELETED ***
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may
jeopardize subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-23-2020
11:03:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0P
…[truncated]