125742 S1 M5 CRF c4591001 1087 10871029

Collection
Pfizer Documents (PHMPT/FDA)
Case
Pfizer Bla Submission
Sub-case
Pfizer 16 Plus Documents
Pages
337
Download PDF ↗ Live URL (may be dead)
Document text

Page 1 of 337
***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: 10871029 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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962741
Page 2 of 337
***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: 10871029 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/7/2020
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962742
Page 3 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10871029]
2.Birth Date: /1940
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962743
Page 4 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/7/2020
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962744
Page 5 of 337
***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: 10871029 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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962745
Page 6 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/7/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962746
Page 7 of 337
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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/1970
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[FOOD ALLERGY TO SHRIMP]
Start Date: UNK/UNK/1990
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[FOOD ALLERGY TO ALCOHOL]
Start Date: UNK/UNK/1980
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HEARING PROBLEMS (BILATERAL EARS)]
Start Date: UNK/UNK/1990
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962747
Page 8 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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:[SEASONAL ALLERGIC RHINITIS]
Start Date: UNK/UNK/2000
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SHORTNESS OF BREATH]
Start Date: UNK/UNK/1995
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC OBSTRUCTIVE PULMONARY DISEASE]
Start Date: UNK/UNK/1995
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[SLEEP APNEA]
Start Date: UNK/UNK/2005
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MITRAL VALVE DISORDER]
Start Date: UNK/UNK/1998
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962748
Page 9 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CORONARY ARTERY DISEASE]
Start Date: UNK/UNK/1995
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CONGESTIVE HEART FAILURE (CLASS 2)]
Start Date: UNK/UNK/1995
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERTENSION]
Start Date: UNK/UNK/1992
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[HYPERLIPIDEMIA]
Start Date: UNK/UNK/1992
Ongoing: YES
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GASTROESOPHAGEAL REFLUX DISEASE]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962749
Page 10 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[RECURRENT CONSTIPATION]
Start Date: UNK/UNK/2010
Ongoing: YES
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[NAUSEA]
Start Date: UNK/UNK/1980
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[CHRONIC KIDNEY DISEASE (STAGE 3)]
Start Date: UNK/UNK/2000
Ongoing: YES
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[POST MENOPAUSAL]
Start Date: UNK/UNK/2000
Ongoing: YES
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[ANEMIA]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962750
Page 11 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MIGRAINE HEADACHES]
Start Date: UNK/UNK/1980
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DIABETIC NEUROPATHY]
Start Date: UNK/UNK/2010
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TYPE 2 DIABETES]
Start Date: UNK/UNK/2010
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS (BILATERAL LEGS)]
Start Date: UNK/UNK/2000
Ongoing: YES
1.xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS (BILATERAL FEET)]
Start Date: UNK/UNK/2000
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962751
Page 12 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOARTHRITIS (BILATERAL HANDS)]
Start Date: UNK/UNK/2000
Ongoing: YES
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OSTEOPOROSIS]
Start Date: UNK/UNK/2000
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GOUT]
Start Date: UNK/UNK/1990
Ongoing: YES
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[DEPRESSION]
Start Date: UNK/UNK/2000
Ongoing: YES
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[OBESITY]
Start Date: UNK/UNK/1980
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962752
Page 13 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[TREMOR (BILATERAL ARMS)]
Start Date: UNK/UNK/2016
Ongoing: YES
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[MEMORY LOSS]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962753
Page 14 of 337
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/7/2020
2.Weight: [80.8]
3.Unit: kg
4.Height: [160.0]
5.Unit: cm
6.Body Mass Index: [31.6]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [35.6]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962754
Page 15 of 337
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962755
Page 16 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/7/2020
2.Randomization Number: [224387]
3.Randomization Group: [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962756
Page 17 of 337
***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: 10871029 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? NO
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[After multiple unsuccessful attempts at blood draw a sample was unable to be
obtained. Pt did not wish to try for any further attempts.]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962757
Page 18 of 337
***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: 10871029 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/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 [BP1K3Y]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962758
Page 19 of 337
***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: 10871029 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/7/2020 17:04
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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962759
Page 20 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962760
Page 21 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/26/2020
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962761
Page 22 of 337
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Aug/14/2020
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962762
Page 23 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962763
Page 24 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/26/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.0]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962764
Page 25 of 337
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: Not Done
//Comments
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.aSponsor ID: [113] Comments
Test: Choriogonadotropin Beta_PX113
Result: Comments
Not Done: NOT DONE Comments
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962765
Page 26 of 337
***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: 10871029 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/26/2020
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 [BP9ZMM]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962766
Page 27 of 337
***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: 10871029 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/26/2020 14:23
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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962767
Page 28 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/23/2020
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962768
Page 29 of 337
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day the
Subject Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.bSymptom: FATIGUE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/2/2020
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?YES
Ongoing?
NO
Stop Date:
Sep/2/2020
2.dSymptom: CHILLS
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.eSymptom: VOMITING
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962769
Page 30 of 337
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/2/2020
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962770
Page 31 of 337
***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: 10871029 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/23/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRT11B]
5.bSample ID [BRT11M]
5.cSample ID [BM95YW]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962771
Page 32 of 337
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/17/2021
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962772
Page 33 of 337
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_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: 10871029 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:
Feb/17/2021
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 [BMBBCZ]
5.bSample ID [BNS86G]
5.cSample ID [BRW720]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962773
Page 34 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962774
Page 35 of 337
***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: 10871029 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 [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962775
Page 36 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962776
Page 37 of 337
***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: 10871029 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 [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962777
Page 38 of 337
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/29/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962778
Page 39 of 337
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Oct/29/2020
2.Date of First Symptom Started: Oct/28/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/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? YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962779
Page 40 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Not Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
4.iSymptoms: VOMITING
Was symptom present? YES
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962780
Page 41 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Date of C
ollectionSpecimen Ty
peSpecimen Colle
ction LocationAssay Code and Description Device TypeForm Instan
ce
 1.Oct/28/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYN
DROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962781
Page 42 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Form Comments
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Oct/28/2020 Comments
2.Specimen Type: SWABBED MATERIAL Comments
3.Specimen Collection Location: NASOPHARYNX Comments
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2 Comments
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST Comments
6.Trade Name: CEPHEID XPERT XPRESS SARS-COV-2 TEST Comments
7.Test Result: NEGATIVE Comments
8.Comments/Findings/Details: [ ] Comments
9.Trade Name Other, Specify: [ ] Comments
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962782
Page 43 of 337
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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:
Oct/29/2020
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 [RR08372]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962783
Page 44 of 337
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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:[Kindly refer to SELF SWAB eCRF]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962784
Page 45 of 337
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962785
Page 46 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
NOComments
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962786
Page 47 of 337
***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: 10871029 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   Oct/28/2020  NO
Discharge Date:
Nov/5/2020
 Repeating Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962787
Page 48 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: HOSPITALIZATION DETAILS
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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: Oct/28/2020
4.Ongoing? NO
Discharge Date:
Nov/5/2020
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962788
Page 49 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Treatment Identifi
erCon Non-Drug Treatments Pre-speci
fiedTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962789
Page 50 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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?
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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?NO
3.Toxicity Grade: 1
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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: 10871029 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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FDA-CBER-2021-5683-0962792
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for
Lab TestVendor
NameCollectio
n Date:Specime
n TypeLab ResultForm Instan
ce
 1.CLINICAL CH
EMISTRY [ ]  Nov/2/20
20 BLOOD Sponsor-Defin
ed IdentifierTest:Result
:
[ ]  C Reactive Protein
_PX329 [ ] 
[ ]  Alanine Aminotran
sferase_PX30 [ ] 
[ ]  Aspartate Aminotra
nsferase_PX28 [ ] 
[ ]  Alkaline Phosphata
se_PX35 [ ] 
[ ]  Bilirubin_PX21  [ ] 
[ ]  Blood Urea Nitroge
n_PX47 [ ] 
48  Creatinine_PX48  .96 m
g/dL Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0962794
Page 55 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Lab Chemistry Details
1.Lab Panel: CLINICAL CHEMISTRY
2.Laboratory Name and Address [ ]
3.Collection Date: Nov/2/2020
4.Specimen Type: BLOOD
Lab Result
5.aSponsor ID: [ ]
Test: C Reactive Protein_PX329
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.bSponsor ID: [ ]
Test: Alanine Aminotransferase_PX30
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0962795
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.cSponsor ID: [ ]
Test: Aspartate Aminotransferase_PX28
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.dSponsor ID: [ ]
Test: Alkaline Phosphatase_PX35
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.eSponsor ID: [ ]
Test: Bilirubin_PX21
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
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(b) (4)
FDA-CBER-2021-5683-0962796
Page 57 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.fSponsor ID: [ ]
Test: Blood Urea Nitrogen_PX47
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
5.gSponsor ID: [48]
Test: Creatinine_PX48
Result: [.96 mg/dL]
Not Done:
LNMT Low
[.55]
High
[1.02]
Unit
mg/dL
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FDA-CBER-2021-5683-0962797
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Category for L
ab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0962798
Page 59 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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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FDA-CBER-2021-5683-0962799
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
 1.Nov/5/2020 Record Identifier: Systolic: Diastolic:
1  116  75 Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
Systolic: [116]
Diastolic: [75]
Respiratory Rate in
respirations/minute:[16]
Heart Rate in beats/minute: [87]
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Date: Vital Signs Details Form Instance
 1.Nov/5/2020 Record Identifier: Oxygen Saturation
1  98.0 Repeating Pages
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(b) (4)
FDA-CBER-2021-5683-0962802
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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: Nov/5/2020
Vital Signs Details
2.aRecord Identifier: 1
SPO2 Pulse Oximetry % [98.0]
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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: 10871029 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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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
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(b) (4)
FDA-CBER-2021-5683-0962806
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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: 10871029 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
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(b) (4)
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***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: 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: 10871029 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:
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: 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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/30/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
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(b) (4)
FDA-CBER-2021-5683-0962810
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***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Nov/30/2020Form: 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: 10871029 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:
Nov/30/2020
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 [BSH9HK]
5.bSample ID [BSH9J2]
5.cSample ID [BR1STZ]
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(b) (4)
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962812
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***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
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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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Sep/23/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
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(b) (4)
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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: 10871029 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: [ ]
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(b) (4)
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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: 10871029 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:
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(b) (4)
FDA-CBER-2021-5683-0962816
Page 77 of 337
***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: 10871029 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 [ ]
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(b) (4)
FDA-CBER-2021-5683-0962817
Page 78 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1. ADVERSE
EVENT 1  Acute Toxic Metaboli
c Encephalopathy Oct/28/2020 U
NK:UNK NO
End Date Time:
Nov/5/2020 UNK:
UNK
 Repeating
Pages
 2. ADVERSE
EVENT 2  Functional Abdominal
Pain Oct/28/2020 U
NK:UNK NO
End Date Time:
Nov/5/2020 UNK:
UNK
 Repeating
Pages
 3. ADVERSE
EVENT 3  Diverticulosis  Oct/28/2020 U
NK:UNK YES  Repeating
Pages
 4. ADVERSE
EVENT 4  Urinary Tract Infectio
n Oct/28/2020 U
NK:UNK NO
End Date Time:
Nov/5/2020 UNK:
UNK
 Repeating
Pages
 5. ADVERSE
EVENT 5  Distended Gallbladder
 Oct/28/2020 U
NK:UNK YES  Repeating
Pages
 6. ADVERSE
EVENT 6  Small Hiatal Hernia  Oct/28/2020 U
NK:UNK YES  Repeating
Pages
 7. DELETED ADVERSE
EVENT 7  Fatigue  Aug/31/2020
UNK:UNK NO
End Date Time:
Sep/1/2020 UNK:
UNK
 Repeating
Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962818
Page 79 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Acute Toxic Metabolic Encephalopathy]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962819
Page 80 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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:
CONCOMITANT DRUG TREATMENT
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[2020422217]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962820
Page 81 of 337
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Functional Abdominal Pain]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/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:
[Diverticulosis]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962821
Page 82 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962822
Page 83 of 337
***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: 10871029 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)[Diverticulosis]
4.Start Date Time: Oct/28/2020 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:
[Poor Diet]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962823
Page 84 of 337
***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: 10871029 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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962824
Page 85 of 337
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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)[Urinary Tract Infection]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Nov/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:
[Probable Bacterial Infection]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962825
Page 86 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962826
Page 87 of 337
***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: 10871029 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)[Distended Gallbladder]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962827
Page 88 of 337
***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: 10871029 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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962828
Page 89 of 337
***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: 10871029 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)[Small Hiatal Hernia]
4.Start Date Time: Oct/28/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962829
Page 90 of 337
***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: 10871029 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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962830
Page 91 of 337
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 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: [7]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fatigue]
4.Start Date Time: Aug/31/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/1/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962831
Page 92 of 337
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
*** THIS REPEATING FORM HAS BEEN DELETED ***
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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962832
Page 93 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962833
Page 94 of 337
***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: 10871029 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[ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962834
Page 95 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962835
Page 96 of 337
***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: 10871029 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: //
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962836
Page 97 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962837
Page 98 of 337
***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: 10871029 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?
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962838
Page 99 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962839
Page 100 of 337
***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: 10871029 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?
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962840
Page 101 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962841
Page 102 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962842
Page 103 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962843
Page 104 of 337
***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: 10871029 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:
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962844
Page 105 of 337
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962845
Page 106 of 337
***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: 10871029 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?
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962846
Page 107 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962847
Page 108 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962848
Page 109 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962849
Page 110 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962850
Page 111 of 337
***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: 10871029 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 [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962851
Page 112 of 337
***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: 10871029 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 [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962852
Page 113 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/11/2021
2.Erroneous Visit
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962853
Page 114 of 337
***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: 10871029 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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962854
Page 115 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/11/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962855
Page 116 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962856
Page 117 of 337
***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: 10871029 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: [ ]
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962857
Page 118 of 337
***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: 10871029 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 Sep/23/2020
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962858
Page 119 of 337
***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: 10871029 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
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962859
Page 120 of 337
***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: 10871029 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-11-2021 15:38:31 (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.
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962860
Page 121 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-10-2020 11:40:37 (UTC-05:00) Eastern
Time (US & Canada)Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962861
Page 122 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-08-2020 10:47:09 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962862
Page 123 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Aug-08-2020 10:47:03 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
Not Done
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962863
Page 124 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-08-2020 10:46:56 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962864
Page 125 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-08-2020 10:46:56 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962865
Page 126 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-08-2020 10:46:56 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962866
Page 127 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormAug-27-2020 10:26:58 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962867
Page 128 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Aug-27-2020 10:26:51 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
Not Done
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962868
Page 129 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-27-2020 10:26:44 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962869
Page 130 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-27-2020 10:26:44 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962870
Page 131 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6.aAug-27-2020 10:26:44 (UTC-05:00) Eastern
Time (US & Canada)NOT OF CHILDBEARING POTENTIAL
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962871
Page 132 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
FormNov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
FormNov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962872
Page 133 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
1Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
1Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962873
Page 134 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
2Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
2Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962874
Page 135 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
3Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962875
Page 136 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
4Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
4Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962876
Page 137 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
5Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
5Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962877
Page 138 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
6Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
6Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962878
Page 139 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
7Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
7Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962879
Page 140 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
8Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
8Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962880
Page 141 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Oct/29/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
9Nov-09-2020 16:01:05 (UTC-05:00) Eastern
Time (US & Canada)
9Nov-04-2020 17:41:06 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
Not Applicable
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962881
Page 142 of 337
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Not Complete
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
ItemDate User Comment
3Nov-04-2020 17:39:02 (UTC-05:00) Eastern
Time (US & Canada)Update pending receipt of medical records
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962882
Page 143 of 337
***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: 10871029 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-11-2021 15:38:31 (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-11-2021 09:38:46 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Feb-26-2021 12:29:29 (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 Feb-21-2021 11:57:18 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962883
Page 144 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Kevin Cannon  Approved Jan-22-2021 10:37:46 (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-24-2020 16:26:15 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-13-2020 13:59:37 (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 15:59:11 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-06-2020 10:29:03 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962884
Page 145 of 337
***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: 10871029 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-05-2020 02:03:27 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-04-2020 20:05:23 (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-04-2020 11:46:32 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-04-2020 11:14:12 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962885
Page 146 of 337
***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: 10871029 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-03-2020 20:14:34 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-03-2020 16:31:34 (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-03-2020 16:30:54 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Nov-03-2020 16:29:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962886
Page 147 of 337
***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: 10871029 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-03-2020 15:50:56 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Oct-09-2020 15:18:10 (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 Sep-24-2020 13:19:21 (UTC-05:00) Eastern
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Kevin Cannon  Approved Sep-14-2020 16:06:19 (UTC-05:00) Eastern
Time (US & Canada)BOOK Signed
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962887
Page 148 of 337
***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: 10871029 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.
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962888
Page 149 of 337
***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: 10871029 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-08-2020 10:43:16
(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-08-2020 10:43:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962889
Page 150 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-08-2020 10:43:24
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obta
ined
Aug/7/2020Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962890
Page 151 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-08-2020 10:43:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10871029Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-08-2020 10:43:06
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1940Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-08-2020 10:43:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-08-2020 10:43:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-08-2020 10:43:34
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962891
Page 152 of 337
***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: 10871029 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-08-2020 10:43:45
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962892
Page 153 of 337
***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: 10871029 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-08-2020 10:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-08-2020 10:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-08-2020 10:44:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962893
Page 154 of 337
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-08-2020 10:54:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:ALLERGY TO
CODEINE
Start Date: UNK/UNK/197
0
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:54:51
(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-08-2020 10:54:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO CODEINEInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-08-2020 10:54:51
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-08-2020 10:54:51
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962894
Page 155 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
1.b
Date Location User Value Reason
Aug-08-2020 10:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:2
Medical H
istory Ter
m:FOOD ALLE
RGY TO SHR
IMP
Start Date
:UNK/UNK/19
90
Ongoing: YESTranscription
Error
Aug-08-2020 10:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc (autocalc) Data Entry:
Line/MH N
umber:2
Medical His
tory Term:ALLERGY
TO SHRIMP
Start Date: UNK/UNK/
1990
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962895
Page 156 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:55:11
(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-08-2020 10:55:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOOD ALLERGY TO SH
RIMPTranscription
Error
Aug-08-2020 10:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ALLERGY TO SHRIMPInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-08-2020 10:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-08-2020 10:55:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-08-2020 10:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:FOOD ALLERGY
TO ALCOHOL
Start Date: UNK/UNK/1980Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962896
Page 157 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:55:32
(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-08-2020 10:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOOD ALLERGY TO ALC
OHOLInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-08-2020 10:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-08-2020 10:55:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-08-2020 10:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical H
istory Ter
m:HEARING PROBL
EMS (BILATERAL
EARS)
Start Date
:UNK/UNK/1990Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962897
Page 158 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:56:08
(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-08-2020 10:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEARING PROBLEMS (BI
LATERAL EARS)Initial Entry
1.d Start Date:
Date Location User Value Reason
Aug-08-2020 10:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-08-2020 10:56:08
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Aug-08-2020 10:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:5
Medical His
tory Term:SEASONAL ALL
ERGIC RHINITIS
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962898
Page 159 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.e Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:56:37
(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-08-2020 10:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SEASONAL ALLERGIC R
HINITISInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-08-2020 10:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-08-2020 10:56:37
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
Aug-08-2020 10:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:6
Medical Histo
ry Term:SHORTNESS O
F BREATH
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962899
Page 160 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.f Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:56:58
(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-12-2020
13:20:44 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-12-2020 11:00:50
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per PI no
significant change
in therapy or
hospitalization for
worsening of
disease occurred
during the 6 weeks
before enrollment.
Aug-11-2020 15:33:17
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN:
Regarding
shortness of breath
medical history,
please confirm
stability of
symptoms of prior
to study enrolment
and that no
significant change
in therapy or
hospitalization for
worsening of
disease occurred
during the 6 weeks
before enrolment.
Aug-08-2020
10:56:58 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
SHORTNESS OF BREAT
HInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962900
Page 161 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.f Start Date:
Date Location User Value Reason
Aug-08-2020 10:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-08-2020 10:56:58
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-08-2020 10:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:CHRONIC OBSTRU
CTIVE PULMONAR
Y DISEASE
Start Dat
e:UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962901
Page 162 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.g Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:57:15
(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-13-2020
07:09:44 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Aug-12-2020 11:11:04
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per PI no
significant change
in therapy or
hospitalization for
worsening of
disease occurred
during the 6 weeks
before enrollment.
EC13 confirmed,
subject eligible for
enrollment.
Aug-12-2020 07:57:11
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin: Per
IC3, please
confirm stability of
symptoms prior to
study enrolment;
that no significant
change in therapy
or hospitalization
for worsening of
disease within 6
weeks of
enrolment. Also,
confirm EC13
reviewed (systemic
corticosteroid use)
Aug-08-2020
10:57:15 (UTC-05:00)ACV0PFEINFP6000  Data Entry:
CHRONIC OBSTRUCTIVInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0962902
Page 163 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Eastern Time (US &
Canada)E PULMONARY DISEAS
E
1.g Start Date:
Date Location User Value Reason
Aug-08-2020 10:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-08-2020 10:57:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-08-2020 10:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:8
Medical History
Term:SLEEP APN
EA
Start Date: UNK/UNK/2
005
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962903
Page 164 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.h Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:57:30
(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
Aug-08-2020 10:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SLEEP APNEAInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-08-2020 10:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2005Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-08-2020 10:57:30
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-08-2020 10:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:MITRAL VALVE
DISORDER
Start Date: UNK/UNK/1998
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962904
Page 165 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.i Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:57:46
(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
Aug-08-2020 10:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MITRAL VALVE DISORD
ERInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-08-2020 10:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1998Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-08-2020 10:57:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-08-2020 10:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:10
Medical Hist
ory Term:CORONARY AR
TERY DISEASE
Start Date: UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962905
Page 166 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.j Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10Initial Entry
1.j Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 10:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CORONARY ARTERY DIS
EASEInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-08-2020 10:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-08-2020 10:57:59
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
Date Location User Value Reason
Aug-08-2020 10:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:11
Medical H
istory Ter
m:CONGESTIVE HE
ART FAILURE (CL
ASS 2)
Start Date
:UNK/UNK/1995
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962906
Page 167 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.k Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 10:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CONGESTIVE HEART FAI
LURE (CLASS 2)Initial Entry
1.k Start Date:
Date Location User Value Reason
Aug-08-2020 10:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1995Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-08-2020 10:58:20
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-08-2020 10:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History
Term:HYPERTEN
SION
Start Date: UNK/UNK/1
992
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962907
Page 168 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.l Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 10:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERTENSIONInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-08-2020 10:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-08-2020 10:58:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-08-2020 10:58:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:13
Medical History
Term:HYPERLIPID
EMIA
Start Date: UNK/UNK/19
92
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962908
Page 169 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.m Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:58:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 10:58:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HYPERLIPIDEMIAInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-08-2020 10:58:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1992Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-08-2020 10:58:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.n
Date Location User Value Reason
Aug-08-2020 10:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:14
Medical H
istory Ter
m:GASTROESOPHA
GEAL REFLUX DI
SEASE
Start Date
:UNK/UNK/1980
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962909
Page 170 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.n Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
14Initial Entry
1.n Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 10:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GASTROESOPHAGEAL R
EFLUX DISEASEInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-08-2020 10:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-08-2020 10:59:01
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.o
Date Location User Value Reason
Aug-08-2020 10:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:15
Medical Hist
ory Term:RECURRENT C
ONSTIPATION
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962910
Page 171 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.o Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
15Initial Entry
1.o Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 10:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECURRENT CONSTIPAT
IONInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-08-2020 10:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-08-2020 10:59:15
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.p
Date Location User Value Reason
Aug-08-2020 10:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:16
Medical History
Term:NAUSEA
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962911
Page 172 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.p Line/MH Number:
Date Location User Value Reason
Aug-08-2020 10:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
16Initial Entry
1.p Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020
07:09:44 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response satisfies
query
Aug-12-2020 11:01:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Per PI no
significant change
in therapy or
hospitalization for
worsening of
disease occurred
during the 6 weeks
before enrollment.
Aug-12-2020
10:03:43 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin: Per IC3
and Criteria for
Temporary Delay
of Enrolment
(Protocol 5.5),
please confirm
stability of
symptoms within 6
weeks of
enrolment and no
acute event within
48h before study
intervention
administration
Aug-08-2020
10:59:52 (UTC-05:00)
Eastern Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
NAUSEAInitial Entry
1.p Start Date:
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0962912
Page 173 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-08-2020 10:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-08-2020 10:59:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Aug-08-2020 11:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:17
Medical
History
Term:CHRONIC KID
NEY DISEASE
(STAGE 3)
Start Dat
e:UNK/UNK/200
0
Ongoing
:YESTranscription
Error
Aug-08-2020 11:00:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc (autocalc) Data Entry:
Line/MH
Number:17
Medical H
istory Ter
m:CHRONIC KI
DNEY DISE
ASE
Start Date
:UNK/UNK/20
00
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962913
Page 174 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.q Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:00:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
17Initial Entry
1.q Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:00:22
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHRONIC KIDNEY DISE
ASE (STAGE 3)Transcription
Error
Aug-08-2020 11:00:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHRONIC KIDNEY DISE
ASEInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-08-2020 11:00:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-08-2020 11:00:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.r
Date Location User Value Reason
Aug-08-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:18
Medical Histor
y Term:POST MENOP
AUSAL
Start Date: UNK/UNK/200
0Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962914
Page 175 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Ongoing: YES
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4)
FDA-CBER-2021-5683-0962915
Page 176 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.r Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
18Initial Entry
1.r Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POST MENOPAUSALInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-08-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-08-2020 11:00:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.s
Date Location User Value Reason
Aug-08-2020 11:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:19
Medical History
Term:ANEMIA
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962916
Page 177 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.s Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
19Initial Entry
1.s Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-11-2020 04:58:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Closed Response
satisfies query
Aug-10-2020 17:47:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered No treatment for
this condition per
patient
Aug-10-2020 13:03:16
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Hayley Wyper Query 1: Opened GPD Clin:
Anemia reported:
Please can you
confirm if subject
has received any
blood products in
the past 60 days
for this medhx?
Aug-08-2020 11:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ANEMIAInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-08-2020 11:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-08-2020 11:00:53
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0962917
Page 178 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.t
Date Location User Value Reason
Aug-08-2020 11:01:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:20
Medical Histo
ry Term:MIGRAINE HE
ADACHES
Start Date: UNK/UNK/1980
Ongoing: YESInitial Entry
1.t Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:01:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
20Initial Entry
1.t Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:01:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MIGRAINE HEADACHESInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-08-2020 11:01:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-08-2020 11:01:10
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.u
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962918
Page 179 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-08-2020 11:01:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:21
Medical Histo
ry Term:DIABETIC NEU
ROPATHY
Start Date: UNK/UNK/2010
Ongoing: YESInitial Entry
1.u Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:01:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
21Initial Entry
1.u Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:01:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIABETIC NEUROPATHYInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-08-2020 11:01:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-08-2020 11:01:35
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962919
Page 180 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:22
Medical History
Term:TYPE 2 DIAB
ETES
Start Date: UNK/UNK/20
10
Ongoing: YESInitial Entry
1.v Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
22Initial Entry
1.v Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TYPE 2 DIABETESInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-08-2020 11:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-08-2020 11:01:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962920
Page 181 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:23
Medical Hi
story Term
:OSTEOARTHRITI
S (BILATERAL LE
GS)
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.w Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23Initial Entry
1.w Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS (BILA
TERAL LEGS)Initial Entry
1.w Start Date:
Date Location User Value Reason
Aug-08-2020 11:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.w Ongoing:
Date Location User Value Reason
Aug-08-2020 11:02:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.x
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962921
Page 182 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:24
Medical Hi
story Term
:OSTEOARTHRITI
S (BILATERAL FE
ET)
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.x Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
24Initial Entry
1.x Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS (BILA
TERAL FEET)Initial Entry
1.x Start Date:
Date Location User Value Reason
Aug-08-2020 11:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.x Ongoing:
Date Location User Value Reason
Aug-08-2020 11:02:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.y
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962922
Page 183 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:25
Medical Hi
story Term
:OSTEOARTHRITIS
(BILATERAL HAN
DS)
Start Date: UNK/UNK/2000
Ongoing: YESInitial Entry
1.y Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25Initial Entry
1.y Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOARTHRITIS (BILA
TERAL HANDS)Initial Entry
1.y Start Date:
Date Location User Value Reason
Aug-08-2020 11:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.y Ongoing:
Date Location User Value Reason
Aug-08-2020 11:02:39
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.z
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962923
Page 184 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:26
Medical History
Term:OSTEOPOR
OSIS
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.z Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
26Initial Entry
1.z Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OSTEOPOROSISInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-08-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.z Ongoing:
Date Location User Value Reason
Aug-08-2020 11:02:52
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962924
Page 185 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:27
Medical History
Term:GOUT
Start Date: UNK/UNK/1
990
Ongoing: YESInitial Entry
1.aa Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
27Initial Entry
1.aa Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GOUTInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962925
Page 186 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.aa Start Date:
Date Location User Value Reason
Aug-08-2020 11:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Aug-08-2020 11:03:02
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ab
Date Location User Value Reason
Aug-08-2020 11:03:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:28
Medical History
Term:DEPRESSIO
N
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962926
Page 187 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.ab Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:03:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28Initial Entry
1.ab Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:03:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DEPRESSIONInitial Entry
1.ab Start Date:
Date Location User Value Reason
Aug-08-2020 11:03:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Aug-08-2020 11:03:21
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ac
Date Location User Value Reason
Aug-08-2020 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:29
Medical History
Term:OBESITY
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962927
Page 188 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.ac Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
29Initial Entry
1.ac Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBESITYInitial Entry
1.ac Start Date:
Date Location User Value Reason
Aug-08-2020 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Aug-08-2020 11:03:32
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ad
Date Location User Value Reason
Aug-08-2020 13:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH
Number:30
Medical H
istory Ter
m:TREMOR (BI
LATERAL A
RMS)
Start Date
:UNK/UNK/20
16
Ongoing: YESTranscription
Error
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962928
Page 189 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 11:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc (autocalc) Data Entry:
Line/MH Nu
mber:30
Medical Histo
ry Term:TREMOR
Start Date: UNK/UN
K/2016
Ongoing: YESInitial Entry
1.ad Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
30Initial Entry
1.ad Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 13:31:09
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TREMOR (BILATERAL A
RMS)Transcription
Error
Aug-08-2020 11:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TREMORInitial Entry
1.ad Start Date:
Date Location User Value Reason
Aug-08-2020 11:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Aug-08-2020 11:04:40
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ae
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962929
Page 190 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-08-2020 11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:31
Medical History
Term:MEMORY L
OSS
Start Date: UNK/UNK/2
018
Ongoing: YESInitial Entry
1.ae Line/MH Number:
Date Location User Value Reason
Aug-08-2020 11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31Initial Entry
1.ae Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-08-2020 11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MEMORY LOSSInitial Entry
1.ae Start Date:
Date Location User Value Reason
Aug-08-2020 11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.ae Ongoing:
Date Location User Value Reason
Aug-08-2020 11:04:55
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962930
Page 191 of 337
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
80.8Initial Entry
3. Unit:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
160.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (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-2021-5683-0962931
Page 192 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
31.6Initial Entry
7.a
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifi
er::1
Temperature: 35.6
Temperature U
nit:C
Temperature L
ocation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-10-2020 09:36:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM:
Aug-08-2020 10:46:29
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Correct as entered
per sponsor
provided device
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 35.6
C is outside of
Normal Range
36.1 - 37.5 C.
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
35.6Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (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)
FDA-CBER-2021-5683-0962932
Page 193 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:28 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a Unit:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-08-2020 10:46:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962933
Page 194 of 337
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
3. Collection Date:
Date Location User Value Reason
Aug-08-2020 10:47:03
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
6.a
Date Location User Value Reason
Aug-08-2020 10:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-08-2020 10:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-08-2020 10:46:44
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_P
X113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-08-2020 10:46:44
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962934
Page 195 of 337
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada)
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0962935
Page 196 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-08-2020 10:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-08-2020 10:50:31
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
224387Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962936
Page 197 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-08-2020 10:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-08-2020 10:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-08-2020 10:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Aug-08-2020 10:48:25
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
After multiple unsuccessful
attempts at blood draw a sa
mple was unable to be obtai
ned. Pt did not wish to try fo
r any further attempts.Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962937
Page 198 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-08-2020 10:48:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-08-2020 10:48:38
(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-08-2020 11:06:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-08-2020 10:48:38
(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-08-2020 10:48:38
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/7/2020Initial Entry
5.a
Date Location User Value Reason
Aug-08-2020 11:06:46
(UTC-05:00) EasternACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962938
Page 199 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) Sample ID: BP1K3Y
5.a Sample ID
Date Location User Value Reason
Aug-08-2020 11:06:46
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP1K3YInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962939
Page 200 of 337
***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: 10871029 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-08-2020 10:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-08-2020 10:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-08-2020 10:51:12
(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-08-2020 10:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/7/2020 17:04Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-08-2020 10:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962940
Page 201 of 337
***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: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-08-2020 10:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-08-2020 10:51:12
(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-08-2020 10:51:12
(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-08-2020 10:51:12
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962941
Page 202 of 337
***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: 10871029 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-08-2020 10:49:48
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY
E-DIARY COLLECTED F
OR THIS SUBJECTInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962942
Page 203 of 337
***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: 10871029 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-27-2020 10:24:05
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/26/2020Initial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962943
Page 204 of 337
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
V
ER
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?
:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962944
Page 205 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEADA
CHEInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962945
Page 206 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Were fever or sys
temic symptoms
present on the la
st day the Subjec
t Diary was com
pleted?:YES
Ongoin
g?
NO
Stop
Date
:
Au
g/1
4/2
02
0
2.c Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/14/2020Initial Entry
2.d
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: C
HIInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962946
Page 207 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
LL
S
Were fever or systemi
c symptoms present o
n the last day the Subj
ect Diary was complet
ed?:N
O
2.d Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TIN
G
Were fever or system
ic symptoms present
on the last day the Su
bject Diary was comp
leted?:NOInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962947
Page 208 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.e Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemi
c symptoms present o
n the last day the Sub
ject Diary was compl
eted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (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-2021-5683-0962948
Page 209 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.g
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was compl
eted?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MU
SCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT
PAINInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962949
Page 210 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM
RESOLVED DATES - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:30 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1087 Site Name: (1087) PMG Research of Wilmington, LLC
Subject No: 10871029 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Were fever or sys
temic symptoms
present on the las
t day the Subject
Diary was comple
ted?:NO
2.h Symptom:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOI
NT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-27-2020 10:25:14
(UTC-05:00) Eastern
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio REInitial Entry
090177e196ae403f\Final\Final On: 01-Apr-2021 05:34 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0962950
Page 211 of 337
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION SYMPTOMS DIARY - SYMPTOM

…[truncated]
Related across Profoundd

Epstein Files

EFTA02705217 — Partners Management Group, Inc. FF&E Purchasing • Project Management • Consulting
Partners Management Group, Inc. FF&E Purchasing • Project Management • Consulting for the Hospitality Industry PURCHASING AGENT PROPOSAL THIS AGREEMENT, made and effective as of November 15, 2013, between Partners Manage…
EFTA01080666 — Partners Management Group, Inc. FF&E Purchasing • Project Management • Consulting
Partners Management Group, Inc. FF&E Purchasing • Project Management • Consulting for the HospaaIlly Industry PURCHASING AGENT PROPOSAL THIS AGREEMENT, made and effective as of November 15, 2013, between Partners Managem…
EFTA00122329 — SELECT APPLICATION CONTROLS
SELECT APPLICATION CONTROLS REVIEW OF THE FEDERAL BUREAU OF PRISONS'S SENTRY DATABASE SYSTEM U.S. Department of Justice Office of the Inspector General Audit Division Audit Report 03-25 July 2003 EFTA00122329 SELECT APPL…
Federal Writers' Project

[Early-Day Portland]
Accession no. WPA L C. PROJECT Writers' Foim—S UNIT NIN 9629 Date received 10/10/40 Consignment no. Shipped from cash. Office Label Amount 87). Wan" Collection (or Type) lienderin' all of Indian wars Place of origin_RQ P…
[Mining Lore of Waldo]
WPI L. C. PROJE'CT UNIT e-Ife ,:f-S Accession n3. W 9.0 Date received /y 0 Consignment no. Shipped from Label Amount AA. Form -3 0.%Lee(7,e. Collection (or Type) Title.. Place of origin Date atel Project worker e Project…
[Early Portland Folkways]
Pee -Ors 4"J er,i7vAls -retA",10**ErS, Amnion no. WPA L. C. PROJECT UNIT Form -3 /J-F'd Date received 47, Consignment no. Shipped from Label AV:al-4 514 Amount olv Collection (or Type) Title Date...11,4/ Place of origin …
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Pfizer, CDC Withheld Evidence of Myocarditis After COVID Shots, New Documents Reveal
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