125742 S1 M5 CRF c4591001 1087 10871150

Document text

Page 1 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963555
Page 2 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/21/2020
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963556
Page 3 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10871150]
2.Birth Date: /1949
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963557
Page 4 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/21/2020
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963558
Page 5 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963559
Page 6 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/21/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963560
Page 7 of 365
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO CODEINE]
Start Date: UNK/UNK/2010
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ALLERGY TO CORTISONE]
Start Date: UNK/UNK/2010
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERCHOLESTEROLEMIA]
Start Date: UNK/UNK/2019
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NEUROPATHY (BILATERAL LEGS)]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963561
Page 8 of 365
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/2018
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC BACK PAIN]
Start Date: UNK/UNK/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEEP VEIN THROMBOSIS]
Start Date: UNK/UNK/1994
Ongoing: YES
1.hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Atrial Fibrillation]
Start Date: Jun/6/2017
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Coronary Artery Disease]
Start Date: Jun/6/2017
Ongoing: YES
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963562
Page 9 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/21/2020
2.Weight: [127.7]
3.Unit: kg
4.Height: [182.9]
5.Unit: cm
6.Body Mass Index: [38.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963563
Page 10 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/21/2020
2.Randomization Number: [236081]
3.Randomization Group: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963564
Page 11 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/21/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[inadvertently sent 4 sends instead of 3]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP1JWP]
5.bSample ID [BP1JWS]
5.cSample ID [BP1JWT]
5.dSample ID [BPHBSH]
5.eSample ID [BPHBSJ]
5.fSample ID [BP1JWR]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963565
Page 12 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/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 [BP1JW3]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963566
Page 13 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/21/2020 11:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963567
Page 14 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963568
Page 15 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963569
Page 16 of 365
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.9]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963570
Page 17 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP89SY]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963571
Page 18 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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/9/2020 16:59
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963572
Page 19 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963573
Page 20 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Oct/7/2020
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 [BR24X3]
5.bSample ID [BSJ1SF]
5.cSample ID [BSJ1SR]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963574
Page 21 of 365
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/3/2021
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963575
Page 22 of 365
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Mar/3/2021
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 [BMBBH7]
5.bSample ID [BSFRLT]
5.cSample ID [BSFRLM]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963576
Page 23 of 365
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963577
Page 24 of 365
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963578
Page 25 of 365
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963579
Page 26 of 365
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963580
Page 27 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963581
Page 28 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Aug/25/2020
2.Date of First Symptom Started: Aug/24/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Aug/25/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? YES
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963582
Page 29 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
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Page 30 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Collect
ionSpecimen Ty
peSpecimen Collection Loc
ationAssay Code and Descri
ptionDevice Ty
peForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating
Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Aug/25/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Nasal self-swab will be shipped to Pfizer lab on 27-Aug-2020]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW87941]
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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:[Sample was collected by subject and documented as such. Visit was a
Telehealth Visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW87941 ]
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: HEALTH CARE UTILIZATION
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Sep/1/2020  NO
Discharge Date:
Sep/5/2020
 Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Sep/1/2020
4.Ongoing? NO
Discharge Date:
Sep/5/2020
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[STREP THROAT]
Date of Diagnosis:
Sep/1/2020
3.Toxicity Grade: 3 Comments
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0963594
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
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Page 42 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0963596
Page 43 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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(b) (4)
FDA-CBER-2021-5683-0963597
Page 44 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0963598
Page 45 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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(b) (4)
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Page 46 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
 1.Sep/5/2020 Record Identifier: Systolic: Diastolic:
1  162  96 Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [162]
Diastolic: [96]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [71]
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***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
 1.Sep/5/2020 Record Identifier: Oxygen Saturation
1  94.0 Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Vital Signs
1.Date: Sep/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [94.0]
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0963606
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assess
mentLocation of Assess
mentImaging Met
hodOverall Assessment Form Instance
 1.Sep/1/2020  OTHER
If other, specify:
Cervical Soft Tis
sues
 CT SCAN  ABNORMAL
If abnormal, specify findings:
Confirmed right tonsillar abscess that wa
s draining.
 Repeating
Pages
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(b) (4)
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Page 55 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Imaging
1.Date of Assessment: Sep/1/2020
2.Location of Assessment: OTHER
If other, specify:
[Cervical Soft Tissues]
3.Type of Imaging Exam: CT SCAN
4.Assessment: ABNORMAL
If abnormal, specify findings:
[Confirmed right tonsillar abscess that was draining.]
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(b) (4)
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Page 56 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_B
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Page 57 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/9/2020
2.Date of First Symptom Started: Sep/1/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Sep/5/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4.fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
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(b) (4)
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Page 58 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [Strep Throat]
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FDA-CBER-2021-5683-0963612
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Colle
ctionSpecimen
TypeSpecimen Collection
LocationAssay Code and Des
criptionDevice T
ypeForm Instanc
e
 1. DELETED Not Applicabl
e Not Applic
able Not Applicable      Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0963613
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Not Applicable
//Comments
2.Specimen Type: Not Applicable Comments
3.Specimen Collection Location: Not Applicable Comments
4.Assay Code and Description:
5.Device Type:
6.Trade Name: Not Applicable Comments
7.Test Result: Not Applicable Comments
8.Comments/Findings/Details: Not Applicable
[ ]Comments
9.Trade Name Other, Specify: [Novant Health PCR ]
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(b) (4)
FDA-CBER-2021-5683-0963614
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject did not report sx to site so no illness visit performed and no self swab
collected.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0963615
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[Subject did not report sx to site so no illness visit performed and no self swab
collected.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
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(b) (4)
FDA-CBER-2021-5683-0963616
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?YES
Has the subject been in intensive care due to potential COVID-19 illness?
NO
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(b) (4)
FDA-CBER-2021-5683-0963617
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Hospitalization Category Hospitalization Term Admission Date Ongoing Form Instance
 1.HOSPITALIZATION STATUS  HOSPITAL   Sep/1/2020  NO
Discharge Date:
Sep/5/2020
 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0963618
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Hospitalization Details
1.Hospitalization Category: HOSPITALIZATION STATUS
2.Hospitalization Term: HOSPITAL
3.Admission Date: Sep/1/2020
4.Ongoing? NO
Discharge Date:
Sep/5/2020
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(b) (4)
FDA-CBER-2021-5683-0963619
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0963620
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
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(b) (4)
FDA-CBER-2021-5683-0963621
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?YES
Respiratory Illness Diagnosis:
[Strep Throat]
Date of Diagnosis:
Sep/1/2020
3.Toxicity Grade: 3
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(b) (4)
FDA-CBER-2021-5683-0963622
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0963623
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
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(b) (4)
FDA-CBER-2021-5683-0963624
Page 71 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963625
Page 72 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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(b) (4)
FDA-CBER-2021-5683-0963626
Page 73 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963627
Page 74 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
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(b) (4)
FDA-CBER-2021-5683-0963628
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0963629
Page 76 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
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(b) (4)
FDA-CBER-2021-5683-0963630
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963631
Page 78 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
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(b) (4)
FDA-CBER-2021-5683-0963632
Page 79 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963633
Page 80 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
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(b) (4)
FDA-CBER-2021-5683-0963634
Page 81 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963635
Page 82 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
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(b) (4)
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Page 83 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 2 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963637
Page 84 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963638
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Sep/22/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/22/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963639
Page 86 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Sep/22/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/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 [BM95YR]
5.bSample ID [BRT112]
5.cSample ID [BRT116]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963640
Page 87 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/25/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/25/2020
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963641
Page 88 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/25/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Unplanned Assessments
1.Assessments CONTACT OUTCOME
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963642
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Aug/25/2020Form: CONTACT OUTCOME - UNPLANNED
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Aug/25/2020
Contact Outcome:
VISIT NOT REQUIRED, INVESTIGATOR DECISION
3.Comments: [Subject called & reported fever and chills. Pt to collect self-swab and get tested
locally.]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963643
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***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963644
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***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963645
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***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963646
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***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963647
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***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 1. DELETED       Aug/24/2020
UNK:UNK NO
End Date Time:
Aug/25/2020 UN
K:UNK
 Repeating
Pages
 2. DELETED ADVERSE
EVENT 2  CHILLS  Aug/24/2020
UNK:UNK NO
End Date Time:
Aug/25/2020 UN
K:UNK
 Repeating
Pages
 3. ADVERSE
EVENT 3  STREP THROAT  Aug/25/2020
UNK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 4. ADVERSE
EVENT 4  Tonsillar Abscess - Right  Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 5. ADVERSE
EVENT 5  Odynophagia  Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 6. ADVERSE
EVENT 6  Femoral Hernia - Right  Sep/1/2020 U
NK:UNK YES  Repeating
Pages
 7. ADVERSE
EVENT 7  Hypokalemia  Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963648
Page 95 of 365
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
 8. ADVERSE
EVENT 8  Urinary Frequency  Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 9. ADVERSE
EVENT 9  Urinary Tract Infection  Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 10. ADVERSE
EVENT 10  Worsening of Hypertension
 Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/3/2020 UNK:
UNK
 Repeating
Pages
 11. ADVERSE
EVENT 11  Prominent Reactive Lymph
nodes in Cervical Area Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 12. ADVERSE
EVENT 12  Right Anterior Cervical Te
nderness Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 13. ADVERSE
EVENT 13  Right Anterior Cervical Sw
elling Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:
UNK
 Repeating
Pages
 14. ADVERSE
EVENT 14  Abdominal Pain  Sep/1/2020 U
NK:UNK NO
End Date Time:
Sep/5/2020 UNK:Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963649
Page 96 of 365
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
UNK
 
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963650
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category:
2.AE ID: [ ]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[ ]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963651
Page 98 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Incomplete, Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963652
Page 99 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[CHILLS]
4.Start Date Time: Aug/24/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/25/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963653
Page 100 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963654
Page 101 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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)[STREP THROAT]
4.Start Date Time: Aug/25/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[BACTERIAL INFECTION]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963655
Page 102 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963656
Page 103 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Tonsillar Abscess - Right]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963657
Page 104 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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:
[Strep Throat]
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[2020352363]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963658
Page 105 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Odynophagia]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Tonsillar Abscess]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963659
Page 106 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963660
Page 107 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Femoral Hernia - Right]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Idiopathic]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963661
Page 108 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:NOT RECOVERED/NOT RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963662
Page 109 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Hypokalemia]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Urinary Frequency]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963663
Page 110 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963664
Page 111 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [8]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Urinary Frequency]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Urinary Tract Infection]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963665
Page 112 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963666
Page 113 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [9]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Urinary Tract Infection]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Idiopathic]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963667
Page 114 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963668
Page 115 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Not Verified, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [10]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Worsening of Hypertension]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Tonsillar Abscess]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963669
Page 116 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Not Verified, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963670
Page 117 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [11]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Prominent Reactive Lymph nodes in Cervical Area]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Tonsillar Abscess]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963671
Page 118 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963672
Page 119 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [12]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right Anterior Cervical Tenderness]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Tonsillar Abscess]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963673
Page 120 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963674
Page 121 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [13]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Right Anterior Cervical Swelling]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Tonsillar Abscess]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963675
Page 122 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963676
Page 123 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [14]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Abdominal Pain]
4.Start Date Time: Sep/1/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/5/2020 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Urinary Tract Infection]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963677
Page 124 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963678
Page 125 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963679
Page 126 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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[ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963680
Page 127 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963681
Page 128 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: //
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963682
Page 129 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963683
Page 130 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963684
Page 131 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963685
Page 132 of 365
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963686
Page 133 of 365
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963687
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963688
Page 135 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963689
Page 136 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963690
Page 137 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963691
Page 138 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963692
Page 139 of 365
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963693
Page 140 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963694
Page 141 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963695
Page 142 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963696
Page 143 of 365
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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 [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963697
Page 144 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/15/2021
2.Erroneous Visit
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963698
Page 145 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963699
Page 146 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/15/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963700
Page 147 of 365
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963701
Page 148 of 365
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963702
Page 149 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/7/2020
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963703
Page 150 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963704
Page 151 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin Cannon  Approved Mar-10-2021 14:42:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963705
Page 152 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-21-2020 15:39:09 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963706
Page 153 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormSep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963707
Page 154 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963708
Page 155 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963709
Page 156 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963710
Page 157 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963711
Page 158 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963712
Page 159 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963713
Page 160 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963714
Page 161 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963715
Page 162 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Sep-22-2020 09:26:00 (UTC-05:00) Eastern
Time (US & Canada)Not Done
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963716
Page 163 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Oct-23-2020 16:48:02 (UTC-05:00) Eastern
Time (US & Canada)
3Aug-27-2020 12:13:00 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963717
Page 164 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
1Nov-23-2020 08:39:40 (UTC-05:00) Eastern
Time (US & Canada)No mention of COVID testing performed in
hospital records.
Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963718
Page 165 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
2Nov-23-2020 08:39:57 (UTC-05:00) Eastern
Time (US & Canada)No mention of COVID testing performed in
hospital records.
Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963719
Page 166 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
3Nov-23-2020 08:40:07 (UTC-05:00) Eastern
Time (US & Canada)No mention of COVID testing performed in
hospital records.
Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963720
Page 167 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
6Nov-23-2020 08:40:19 (UTC-05:00) Eastern
Time (US & Canada)No mention of COVID testing performed in
hospital records.
Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963721
Page 168 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
7Nov-23-2020 08:40:30 (UTC-05:00) Eastern
Time (US & Canada)No mention of COVID testing performed in
hospital records.
Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963722
Page 169 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 2 - Unscheduled Visit
on Sep/09/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Deleted, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
ItemDate User Comment
8Nov-23-2020 08:40:41 (UTC-05:00) Eastern
Time (US & Canada)No mention of COVID testing performed in
hospital records.
Not Applicable
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963723
Page 170 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Kevin Cannon  Approved Mar-10-2021 14:42:28 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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 Mar-08-2021 09:03:07 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Mar-05-2021 12:55:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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 Mar-04-2021 16:48:24 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963724
Page 171 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Kevin Cannon  Approved Mar-04-2021 11:35:06 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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 Mar-04-2021 09:57:27 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Mar-03-2021 16:53:04 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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-26-2021 17:07:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Jan-26-2021 08:28:21 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963725
Page 172 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, KevinCannon, 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-25-2021 15:16:04 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Jan-22-2021 16:03:02 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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 08:25:00 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-17-2020 19:44:34 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963726
Page 173 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, KevinCannon, 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-17-2020 16:05:10 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-13-2020 14:03:43 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Nov-09-2020 10:49:44 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-04-2020 20:09:42 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963727
Page 174 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, KevinCannon, 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-04-2020 12:05:48 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Oct-27-2020 17:51:07 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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 Oct-27-2020 17:21:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Oct-23-2020 17:51:35 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963728
Page 175 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, KevinCannon, 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 Oct-23-2020 16:48:02 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Oct-21-2020 18:13:52 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, KevinCannon, 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.
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963729
Page 176 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-21-2020 15:38:27
(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
Aug-21-2020 15:38:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963730
Page 177 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-21-2020 15:38:36
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Aug/21/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963731
Page 178 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-15-2020 05:55:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event entered in AE CRF
Sep-11-2020 06:32:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020352363
strep throat(onset
date:01Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-21-2020 15:38:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10871150Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-21-2020 15:38:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1949Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-21-2020 15:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-21-2020 15:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORIInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963732
Page 179 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
GIN
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-21-2020 15:38:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AM
ERICANInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963733
Page 180 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-21-2020 15:39:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963734
Page 181 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-21-2020 15:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-21-2020 15:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-21-2020 15:39:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963735
Page 182 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-21-2020 15:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:ALLERGY TO
CODEINE
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:46:32
(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
Aug-21-2020 15:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO CODEINEInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-21-2020 15:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-21-2020 15:46:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963736
Page 183 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b
Date Location User Value Reason
Aug-21-2020 15:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Histo
ry Term:ALLERGY TO C
ORTISONE
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:46:50
(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
Aug-21-2020 15:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO CORTISONEInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-21-2020 15:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-21-2020 15:46:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963737
Page 184 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-21-2020 15:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:HYPERCHOLES
TEROLEMIA
Start Date: UNK/UNK/2019
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:47:03
(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
Aug-21-2020 15:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERCHOLESTEROLEM
IAInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-21-2020 15:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-21-2020 15:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-21-2020 15:47:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:4Transcription Error
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963738
Page 185 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Medical
History T
erm:NEUROPATHY
(BILATERAL L
EGS)
Start Date
:UNK/UNK/201
8
Ongoing: YES
Aug-21-2020 15:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc (autocalc) Data Entry:
Line/MH Num
ber:4
Medical Histor
y Term:NEUROPA
THY
Start Date: UNK/UN
K/2018
Ongoing: YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4)
FDA-CBER-2021-5683-0963739
Page 186 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 15:47:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEUROPATHY (BILATER
AL LEGS)Transcription Error
Aug-21-2020 15:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEUROPATHYInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-21-2020 15:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-21-2020 15:47:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-21-2020 15:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:HYPERTENS
ION
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963740
Page 187 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.e Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 15:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-21-2020 15:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-21-2020 15:47:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-21-2020 15:47:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:CHRONIC BAC
K PAIN
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963741
Page 188 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.f Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:47:50
(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
Aug-21-2020 15:47:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHRONIC BACK PAINInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-21-2020 15:47:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-21-2020 15:47:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-21-2020 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:DEEP VEIN THR
OMBOSIS
Start Date: UNK/UNK/1994
Ongoing: YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963742
Page 189 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.g Line/MH Number:
Date Location User Value Reason
Aug-21-2020 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-21-2020 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEEP VEIN THROMBOSISInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-21-2020 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-21-2020 15:48:07
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Mar-08-2021 12:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:8
Medical Histor
y Term:Chronic Atrial Fi
brillation
Start Date: Jun/6/2017
Ongoing: YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963743
Page 190 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.h Line/MH Number:
Date Location User Value Reason
Mar-08-2021 12:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-08-2021 12:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic Atrial FibrillationInitial Entry
1.h Start Date:
Date Location User Value Reason
Mar-08-2021 12:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/6/2017Initial Entry
1.h Ongoing:
Date Location User Value Reason
Mar-08-2021 12:47:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Mar-08-2021 12:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:Coronary Artery
Disease
Start Date: Jun/6/2017
Ongoing: YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963744
Page 191 of 365
***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, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.i Line/MH Number:
Date Location User Value Reason
Mar-08-2021 12:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Mar-08-2021 12:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Coronary Artery DiseaseInitial Entry
1.i Start Date:
Date Location User Value Reason
Mar-08-2021 12:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/6/2017Initial Entry
1.i Ongoing:
Date Location User Value Reason
Mar-08-2021 12:47:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963745
Page 192 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
127.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
182.9Initial Entry
5. Unit:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) EasternACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38.2Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963746
Page 193 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
7.a
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 98.7
Temperature U
nit:F
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.7Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-21-2020 15:39:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963747
Page 194 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-21-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-21-2020 15:40:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
236081Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963748
Page 195 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 15:44:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 15:44:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 14:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-22-2020 10:35:57
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-21-2020 15:44:06
(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.
Aug-21-2020 15:44:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963749
Page 196 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-28-2020 10:24:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inadvertently sent 4 sends inste
ad of 3Transcription Error
Aug-28-2020 10:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-28-2020 10:23:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inadvertently sent 4 sends inste
ad of 3 retainsTranscription Error
Aug-28-2020 10:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Entered text has
either a carriage
return (line break)
or extra spaces at
the end of the text
or between words.
Please correct by
removing all data in
the field and
re-enter without
adding extra spaces
or using enter or tab
keys.
Aug-28-2020 10:22:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inadvertently sent 4 sends inste
ad of 3 retains.Initial Entry
5.a
Date Location User Value Reason
Aug-22-2020 14:45:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1JWPInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 14:45:10
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
BP1JWPInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963750
Page 197 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
5.b
Date Location User Value Reason
Aug-22-2020 14:45:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1JWSInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-22-2020 14:45:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1JWSInitial Entry
5.c
Date Location User Value Reason
Aug-22-2020 14:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1JWTInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-22-2020 14:45:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1JWTInitial Entry
5.d
Date Location User Value Reason
Aug-22-2020 14:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHBSHInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963751
Page 198 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Aug-22-2020 14:46:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPHBSHInitial Entry
5.e
Date Location User Value Reason
Aug-22-2020 14:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPHBSJInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-22-2020 14:46:19
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPHBSJInitial Entry
5.f
Date Location User Value Reason
Aug-28-2020 10:00:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1JWRInitial Entry
5.f Sample ID
Date Location User Value Reason
Aug-28-2020 10:00:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1JWRInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963752
Page 199 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-21-2020 15:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-21-2020 15:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-22-2020 14:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-22-2020 10:50:54
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Balaji Prabu R Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-21-2020 15:44:12
(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.
Aug-21-2020 15:44:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/21/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0963753
Page 200 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a
Date Location User Value Reason
Aug-22-2020 14:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP1JW3Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-22-2020 14:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1JW3Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963754
Page 201 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/21/2020 11:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963755
Page 202 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
7. Route:
Date Location User Value Reason
Aug-21-2020 15:45:45
(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
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-21-2020 15:45:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963756
Page 203 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-21-2020 15:44:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963757
Page 204 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-10-2020 20:17:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963758
Page 205 of 365
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 20:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020Initial Entry
2.a
Date Location User Value Reason
Sep-10-2020 20:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 36.9
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 20:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-10-2020 20:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.9Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-10-2020 20:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963759
Page 206 of 365
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 20:18:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963760
Page 207 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 20:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 20:18:16
(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-12-2020 13:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 00:51:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 20:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-10-2020 20:18:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963761
Page 208 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a
Date Location User Value Reason
Sep-12-2020 13:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP89SYInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-12-2020 13:12:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP89SYInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963762
Page 209 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/9/2020 16:59Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963763
Page 210 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
7. Route:
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-10-2020 20:18:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0963764
Page 211 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-12-2020 14:02:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/7/2020Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963765
Page 212 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-12-2020 14:02:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-12-2020 14:02:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-12-2020 16:49:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-12-2020 14:02:10
(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-12-2020 14:02:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-12-2020 16:49:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR24X3Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963766
Page 213 of 365
***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: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Oct-12-2020 16:49:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR24X3Initial Entry
5.b
Date Location User Value Reason
Oct-12-2020 16:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJ1SFInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-12-2020 16:50:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSJ1SFInitial Entry
5.c
Date Location User Value Reason
Oct-12-2020 16:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSJ1SRInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-12-2020 16:50:33
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSJ1SRInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963767
Page 214 of 365
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-04-2021 09:57:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/3/2021Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963768
Page 215 of 365
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-04-2021 09:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-04-2021 09:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-04-2021 09:57:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-04-2021 09:57:37
(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.
Mar-04-2021 09:57:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Mar/3/2021Initial Entry
5.a
Date Location User Value Reason
Mar-04-2021 09:57:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BMBBH7Initial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963769
Page 216 of 365
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Mar-04-2021 09:57:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BMBBH7Initial Entry
5.b
Date Location User Value Reason
Mar-04-2021 09:58:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSFRLTInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-04-2021 09:58:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSFRLTInitial Entry
5.c
Date Location User Value Reason
Mar-04-2021 09:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSFRLMInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-04-2021 09:58:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSFRLMInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963770
Page 217 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021 08:40:18
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed per updated data
Jan-26-2021 17:16:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Changed data per
query
Dec-15-2020 07:11:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Kindly review
and complete
‘Hospitalization
Details form' at this
visit. Thank you.
Oct-07-2020 15:36:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Oct-07-2020 13:14:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered DATA UPDATED
PER QUERY
Sep-28-2020 06:39:26
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened DM Query: Kindly
review and
complete ‘Health
Care Utilization
form' at this visit.
Thank you.
Aug-27-2020 12:14:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Aug-27-2020 12:11:27
(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
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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)
FDA-CBER-2021-5683-0963771
Page 218 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Symptoms form is
missing. Please
review and update
as appropriate.
Aug-27-2020 12:11:27
(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.
Aug-27-2020 12:11:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Aug-27-2020 12:11:27
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963772
Page 219 of 365
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/24/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
Date of Last Symptom Reso
lved:
Aug/25/2020Initial Entry
4.a
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: YESInitial Entry
4.a Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963773
Page 220 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.b
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
4.b Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(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
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Pres
ent:NOInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963774
Page 221 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4.c Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED MUSCLE PInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (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-2021-5683-0963775
Page 222 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
AIN
Sympto
m Prese
nt:NO
4.e Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MU
SCLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW LOSS OF T
ASTE OR SMEL
L
Sympto
m Presen
t:NOInitial Entry
090177e196ae4034\Final\Final On: 01-Apr-2021 05:33 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0963776
Page 223 of 365
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Aug/25/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 21-Aug-2020 02:52 Form Status: Data Complete, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871150 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4.f Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(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
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCRE
ASED SORE THR
OAT
Sympto
m Prese
nt:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Aug-27-2020 12:12:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR 
…[truncated]