125742 S1 M5 CRF c4591001 1018 10181132

Document text

Page 1 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787570
Page 2 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787571
Page 3 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10181132]
2.Birth Date: 1948
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): BLACK OR AFRICAN AMERICAN
6.Racial Designation:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787572
Page 4 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787573
Page 5 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787574
Page 6 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787575
Page 7 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: UNK/UNK/1999
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hyperlipidemia]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Asthma]
Start Date: UNK/UNK/1990
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Foot fracture]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787576
Page 8 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Surgery - Foot fracture repair]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Codeine Allergy]
Start Date: UNK/UNK/1988
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy]
Start Date: UNK/UNK/2018
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iodine Allergy]
Start Date: UNK/UNK/1970
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergic Rhinitis]
Start Date: UNK/UNK/1988
Ongoing: YES
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787577
Page 9 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Generalized Osteoarthritis]
Start Date: UNK/UNK/1988
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Postmenopausal]
Start Date: UNK/UNK/1990
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Uterine fibroids]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hysterectomy]
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1990
1 nLine/MH Number: [14]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Partial Left knee replacement]
Start Date: May/14/2007
Ongoing: NO
End Date:
May/14/2007
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787578
Page 10 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.oLine/MH Number: [15]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Gastroesophageal reflux disease]
Start Date: UNK/UNK/1994
Ongoing: NO
End Date:
UNK/UNK/2004
1.pLine/MH Number: [16]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Barrett's esophagus]
Start Date: UNK/UNK/2004
Ongoing: YES
1.qLine/MH Number: [17]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nissen fundoplication - Surgery]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
1 rLine/MH Number: [18]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right stenosing tenosynovitis]
Start Date: Dec/9/2016
Ongoing: NO
End Date:
Dec/9/2016
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787579
Page 11 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.sLine/MH Number: [19]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right trigger finger release]
Start Date: Dec/9/2016
Ongoing: NO
End Date:
Dec/9/2016
1.tLine/MH Number: [20]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colonic polyps]
Start Date: Apr/28/2017
Ongoing: YES
1.uLine/MH Number: [21]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep apnea]
Start Date: UNK/UNK/2008
Ongoing: YES
1.vLine/MH Number: [22]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: Jun/UNK/2008
Ongoing: YES
1.wLine/MH Number: [23]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypothyroidism]
Start Date: UNK/UNK/1994
Ongoing: YES
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787580
Page 12 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 xLine/MH Number: [24]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fatigue]
Start Date: UNK/UNK/2012
Ongoing: YES
1.yLine/MH Number: [25]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Lumbar radiculopathy]
Start Date: UNK/UNK/2010
Ongoing: YES
1.zLine/MH Number: [26]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acquired deformities of second toe of right foot]
Start Date: UNK/UNK/2007
Ongoing: YES
1.aaLine/MH Number: [27]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Prediabetes]
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2014
1.abLine/MH Number: [28]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vertigo]
Start Date: UNK/UNK/1988
Ongoing: YES
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787581
Page 13 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.acLine/MH Number: [29]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin B12 deficiency]
Start Date: UNK/UNK/2016
Ongoing: YES
1.adLine/MH Number: [30]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin D deficiency]
Start Date: UNK/UNK/2009
Ongoing: YES
1.aeLine/MH Number: [31]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acute bronchitis]
Start Date: Dec/15/2016
Ongoing: NO
End Date:
UNK/UNK/2016
1.afLine/MH Number: [32]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Motor Vehicle Accident ]
Start Date: Jun/14/2017
Ongoing: NO
End Date:
Jun/14/2017
1.agLine/MH Number: [33]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Jaw pain]
Start Date: Jun/14/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787582
Page 14 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ahLine/MH Number: [34]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Neck strain]
Start Date: Jun/14/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.aiLine/MH Number: [35]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Accidental fall ]
Start Date: May/28/2019
Ongoing: NO
End Date:
May/28/2019
1.ajLine/MH Number: [36]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Pre-syncope]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.akLine/MH Number: [37]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acute rhinitis]
Start Date: Dec/11/2018
Ongoing: NO
End Date:
UNK/UNK/2018
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787583
Page 15 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.alLine/MH Number: [38]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Acute bronchitis]
Start Date: Mar/19/2019
Ongoing: NO
End Date:
Mar/UNK/2019
1.amLine/MH Number: [39]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left hand inflammatory arthropathy]
Start Date: Mar/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.anLine/MH Number: [40]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Urinary tract infection]
Start Date: Aug/14/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.aoLine/MH Number: [41]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Intermittent lower extremities edema]
Start Date: UNK/UNK/2016
Ongoing: YES
1.apLine/MH Number: [42]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Telangiectasias on lower extremities]
Start Date: UNK/UNK/2016
Ongoing: YES
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787584
Page 16 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aqLine/MH Number: [43]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Airplane accident ]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.arLine/MH Number: [44]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Facial injuries]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.asLine/MH Number: [45]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Nasal surgery]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
1.atLine/MH Number: [46]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Jaw surgery]
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1988
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787585
Page 17 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.auLine/MH Number: [47]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Periorbital hematoma]
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.avLine/MH Number: [48]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Frontal Scalp contusion]
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.awLine/MH Number: [49]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Closed nasal bone fracture]
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/2019
1.axLine/MH Number: [50]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Concussion]
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/2019
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787586
Page 18 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [155.6]
3.Unit: LB
4.Height: [62.0]
5.Unit: in
6.Body Mass Index: [28.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.0]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787587
Page 19 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787588
Page 20 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [226222]
3.Randomization Group: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787589
Page 21 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BHTY28]
5.bSample ID [BHTY29]
5.cSample ID [BHTY2B]
5.dSample ID [BPG6J0]
5.eSample ID [BPG6J1]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787590
Page 22 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
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 [BP69FH]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787591
Page 23 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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/12/2020 11:09
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787592
Page 24 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787593
Page 25 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787594
Page 26 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?NO
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
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787595
Page 27 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787596
Page 28 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [96.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787597
Page 29 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787598
Page 30 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/1/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BN5NP1]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787599
Page 31 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/1/2020 12:18
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787600
Page 32 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/14/2021
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787601
Page 33 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?NO
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
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787602
Page 34 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787603
Page 35 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/14/2021
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 [BR94NT]
5.bSample ID [BR94NV]
5.cSample ID [BMNJRN]
5.dSample ID [BMNJRP]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787604
Page 36 of 228
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787605
Page 37 of 228
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787606
Page 38 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787607
Page 39 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787608
Page 40 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787609
Page 41 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787610
Page 42 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787611
Page 43 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom Started: //
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787612
Page 44 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787613
Page 45 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787614
Page 46 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or Contacts:
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787615
Page 47 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled Visit Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for Potential
COVID-19 Illness?
3.Toxicity Grade:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787616
Page 48 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787617
Page 49 of 228
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New Unscheduled
VisitForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787618
Page 50 of 228
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/09/2020Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787619
Page 51 of 228
***Confidential***
 
Header Text: c4591001
Visit: Unplanned 1 - Unscheduled Visit on
Sep/09/2020Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787620
Page 52 of 228
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Jan/14/2021
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787621
Page 53 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787622
Page 54 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787623
Page 55 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787624
Page 56 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event S
till OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  CARDIAC STRESS TEST ABNORMA
L, HOSPITALIZED Sep/8/2020 UN
K:UNK YES  Repeating
Pages
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787625
Page 57 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[CARDIAC STRESS TEST ABNORMAL, HOSPITALIZED]
4.Start Date Time: Sep/8/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study treatment: NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Believed related to chronic conditions including hypertension and hyperlipidemia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication given? NO
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787626
Page 58 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[2020350081]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787627
Page 59 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Act
ionForm Instance
 1.          Repeating
Pages
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787628
Page 60 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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[ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787629
Page 61 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-s
pecifiedName of Medica
tionStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787630
Page 62 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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: //
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787631
Page 63 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationDose Descrip
tionForm Instanc
e
 1.          Repeating
Pages
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787632
Page 64 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787633
Page 65 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787634
Page 66 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787635
Page 67 of 228
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787636
Page 68 of 228
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787637
Page 69 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787638
Page 70 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787639
Page 71 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787640
Page 72 of 228
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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?
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787641
Page 73 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787642
Page 74 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787643
Page 75 of 228
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787644
Page 76 of 228
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787645
Page 77 of 228
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787646
Page 78 of 228
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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 [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787647
Page 79 of 228
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/5/2021
2.Erroneous Visit
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787648
Page 80 of 228
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787649
Page 81 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/5/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787650
Page 82 of 228
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787651
Page 83 of 228
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787652
Page 84 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Jan/14/2021
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787653
Page 85 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787654
Page 86 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Jan-25-2021 20:47:20 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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.
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787655
Page 87 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-13-2020 08:01:24 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787656
Page 88 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787657
Page 89 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Aug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787658
Page 90 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Aug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787659
Page 91 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Aug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787660
Page 92 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Aug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787661
Page 93 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Aug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787662
Page 94 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787663
Page 95 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787664
Page 96 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aAug-13-2020 09:13:39 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787665
Page 97 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787666
Page 98 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Sep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787667
Page 99 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Sep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787668
Page 100 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Sep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787669
Page 101 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Sep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787670
Page 102 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
5Sep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787671
Page 103 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787672
Page 104 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787673
Page 105 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
6.aSep-01-2020 14:32:48 (UTC-06:00) Central Time
(US & Canada)Total Hysterectomy in 1996
Not Applicable
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787674
Page 106 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
 Approved Jan-25-2021 20:47:20 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature
is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-16-2021 09:17:57 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-16-2020 16:24:39 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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-16-2020 12:43:45 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-16-2020 09:16:19 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787675
Page 107 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I, , 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-16-2020 08:44:51 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-15-2020 15:48:43 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, , 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-15-2020 13:07:54 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Sep-14-2020 15:12:42 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  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.
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787676
Page 108 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-13-2020 07:59:53
(UTC-06:00) Central 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-13-2020 07:59:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787677
Page 109 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-13-2020 08:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-13-2020 08:01:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date Informed
Consent Obtained is
not the same as the
Date of Visit. Please
correct as necessary.
Aug-13-2020 08:00:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787678
Page 110 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-11-2020 04:56:43
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed event added in AE CRF
Sep-10-2020 11:34:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Will update when full
details are collected from pt
Sep-10-2020 05:59:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020350081
abnormal stress test(onset
date:08Sep2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-13-2020 07:59:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10181132Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-13-2020 07:59:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1948Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-13-2020 08:01:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 16:51:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787679
Page 111 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-10-2020 10:39:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered NOT Hispanic, SAE,
will be updated.
Sep-10-2020 08:29:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL Ethnicity
reported here as NOT
Hispanic; on SAE
report ethnicity is
Blank. Please update
SAE report with NOT
Hispanic ethnicity.
Aug-13-2020 08:01:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 16:51:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-10-2020 10:38:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Race is correct, SAE
will be updated
Sep-10-2020 08:28:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Race
reported here as
Black or African
American; however
SAE report race was
reported as
Caucasian. Please
correct RACE in the
necessary location
(here, or update SAE
report)
Aug-13-2020 08:01:03
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLACK OR AFRICAN AMERICA
NInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787680
Page 112 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-13-2020 08:53:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Transcription Error
Aug-13-2020 08:01:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787681
Page 113 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-13-2020 00:59:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-12-2020 09:53:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-12-2020 09:53:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Transcription Error
Sep-11-2020 22:48:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Erica Weaver Query 1: Opened *DM: Please confirm
date as DOV was
completed on 12/Aug,
please correct if
necessary. Thank you.
Aug-13-2020 08:01:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/13/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-13-2020 08:01:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-13-2020 08:01:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787682
Page 114 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-13-2020 08:04:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 1
Medical History Ter
m:Hypertension
Start Date: UNK/UNK/19
99
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:04:29
(UTC-06:00) Central 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-13-2020 08:04:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-13-2020 08:04:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1999Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-13-2020 08:04:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Aug-13-2020 08:05:29 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787683
Page 115 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central Time
(US & Canada)(autocalc) Line/MH Number: 2
Medical History Ter
m:Hyperlipidemia
Start Date: UNK/UNK/20
00
Ongoing: YES
1.b Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:05:29
(UTC-06:00) Central 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-13-2020 08:05:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HyperlipidemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-13-2020 08:05:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-13-2020 08:05:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Aug-13-2020 08:07:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Ter
m:Asthma
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787684
Page 116 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:07:07
(UTC-06:00) Central 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-13-2020 08:07:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
AsthmaInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-13-2020 08:07:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-13-2020 08:07:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Aug-13-2020 08:07:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 4
Medical History Te
rm:Foot fracture
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2
017Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787685
Page 117 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:07:46
(UTC-06:00) Central 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-13-2020 08:07:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Foot fractureInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-13-2020 08:07:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-13-2020 08:07:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.e
Date Location User Value Reason
Aug-13-2020 08:09:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical Histor
y Term:Surgery - Foot fractu
re repair
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787686
Page 118 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:09:34
(UTC-06:00) Central 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-13-2020 08:09:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Surgery - Foot fracture repairInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-13-2020 08:09:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-13-2020 08:09:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.f
Date Location User Value Reason
Aug-13-2020 08:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Ter
m:Codeine Allerg
y
Start Date: UNK/UNK/19
88
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787687
Page 119 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:10:50
(UTC-06:00) Central 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-13-2020 08:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Codeine AllergyInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-13-2020 08:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-13-2020 08:10:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-13-2020 08:12:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Ter
m:Penicillin Aller
gy
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0787688
Page 120 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.g Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:12:04
(UTC-06:00) Central 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 08:12:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Penicillin AllergyInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-13-2020 08:12:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-13-2020 08:12:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-13-2020 08:12:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Ter
m:Iodine Allergy
Start Date: UNK/UNK/19
70
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787689
Page 121 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:12:36
(UTC-06:00) Central 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-13-2020 08:12:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Iodine AllergyInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-13-2020 08:12:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1970Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-13-2020 08:12:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-13-2020 08:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:9
Medical History
Term:Seasonal Allergic
Rhinitis
Start Date: UNK/UNK/1988
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787690
Page 122 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:13:12
(UTC-06:00) Central 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-13-2020 08:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal Allergic RhinitisInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-13-2020 08:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-13-2020 08:13:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.j
Date Location User Value Reason
Aug-13-2020 08:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:10
Medical History
Term:Generalized Osteoa
rthritis
Start Date: UNK/UNK/1988
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787691
Page 123 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:13:59
(UTC-06:00) Central 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-13-2020 08:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Generalized OsteoarthritisInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-13-2020 08:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-13-2020 08:13:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787692
Page 124 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k
Date Location User Value Reason
Aug-13-2020 08:14:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History Ter
m:Postmenopausa
l
Start Date: UNK/UNK/19
90
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:14:30
(UTC-06:00) Central 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-13-2020 08:14:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PostmenopausalInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-13-2020 08:14:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-13-2020 08:14:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-13-2020 08:16:24
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 12Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787693
Page 125 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Medical History Te
rm:Uterine fibroids
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1
990
1.l Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:16:24
(UTC-06:00) Central 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-13-2020 08:16:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Uterine fibroidsInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-13-2020 08:16:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-13-2020 08:16:24
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.m
Date Location User Value Reason
Aug-13-2020 08:17:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 13
Medical History Te
rm:HysterectomyInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787694
Page 126 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/1990
Ongoing: NO
End Date:
UNK/UNK/1
990
1.m Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:17:11
(UTC-06:00) Central 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-13-2020 08:17:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HysterectomyInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-13-2020 08:17:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1990Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-13-2020 08:17:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1990Initial Entry
1.n
Date Location User Value Reason
Aug-13-2020 08:28:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:14
Medical Histor
y Term:Partial Left knee repl
acement
Start Date: May/14/2007Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787695
Page 127 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
May/14/2007
1.n Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:28:32
(UTC-06:00) Central 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-13-2020 08:28:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Partial Left knee replacementInitial Entry
1.n Start Date:
Date Location User Value Reason
Aug-13-2020 08:28:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/14/2007Initial Entry
1.n Ongoing:
Date Location User Value Reason
Aug-13-2020 08:28:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/14/2007Initial Entry
1.o
Date Location User Value Reason
Aug-13-2020 08:29:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:15
Medical Histor
y Term:Gastroesophageal refl
ux disease
Start Date: UNK/UNK/1994Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787696
Page 128 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/2004
1.o Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:29:42
(UTC-06:00) Central 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-13-2020 08:29:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Gastroesophageal reflux diseaseInitial Entry
1.o Start Date:
Date Location User Value Reason
Aug-13-2020 08:29:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.o Ongoing:
Date Location User Value Reason
Aug-13-2020 08:29:42
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.p
Date Location User Value Reason
Aug-13-2020 08:32:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 16
Medical History Te
rm:Barrett's esopha
gus
Start Date: UNK/UNK/200
4
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787697
Page 129 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.p Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:32:13
(UTC-06:00) Central 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 08:32:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Barrett's esophagusInitial Entry
1.p Start Date:
Date Location User Value Reason
Aug-13-2020 08:32:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.p Ongoing:
Date Location User Value Reason
Aug-13-2020 08:32:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.q
Date Location User Value Reason
Aug-13-2020 08:33:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:17
Medical Histor
y Term:Nissen fundoplicatio
n - Surgery
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787698
Page 130 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.q Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:33:12
(UTC-06:00) Central 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-13-2020 08:33:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nissen fundoplication - SurgeryInitial Entry
1.q Start Date:
Date Location User Value Reason
Aug-13-2020 08:33:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.q Ongoing:
Date Location User Value Reason
Aug-13-2020 08:33:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
1.r
Date Location User Value Reason
Aug-13-2020 08:34:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:18
Medical Histor
y Term:Right stenosing teno
synovitis
Start Date: Dec/9/2016
Ongoing: NO
End Date:
Dec/9/2016Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787699
Page 131 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.r Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:34:21
(UTC-06:00) Central 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-13-2020 08:34:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Right stenosing tenosynovitisInitial Entry
1.r Start Date:
Date Location User Value Reason
Aug-13-2020 08:34:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2016Initial Entry
1.r Ongoing:
Date Location User Value Reason
Aug-13-2020 08:34:21
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/9/2016Initial Entry
1.s
Date Location User Value Reason
Aug-13-2020 08:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:19
Medical History
Term:Right trigger finger
release
Start Date: Dec/9/2016
Ongoing: NO
End Date:
Dec/9/2016Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787700
Page 132 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.s Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:36:13
(UTC-06:00) Central 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-13-2020 08:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Right trigger finger releaseInitial Entry
1.s Start Date:
Date Location User Value Reason
Aug-13-2020 08:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/9/2016Initial Entry
1.s Ongoing:
Date Location User Value Reason
Aug-13-2020 08:36:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Dec/9/2016Initial Entry
1.t
Date Location User Value Reason
Aug-13-2020 08:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 20
Medical History Ter
m:Colonic polyp
s
Start Date: Apr/28/2017
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787701
Page 133 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.t Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:36:57
(UTC-06:00) Central 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-13-2020 08:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Colonic polypsInitial Entry
1.t Start Date:
Date Location User Value Reason
Aug-13-2020 08:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/28/2017Initial Entry
1.t Ongoing:
Date Location User Value Reason
Aug-13-2020 08:36:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787702
Page 134 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.u
Date Location User Value Reason
Aug-13-2020 08:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 21
Medical History Ter
m:Sleep apnea
Start Date: UNK/UNK/20
08
Ongoing: YESInitial Entry
1.u Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:38:10
(UTC-06:00) Central 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-13-2020 08:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sleep apneaInitial Entry
1.u Start Date:
Date Location User Value Reason
Aug-13-2020 08:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.u Ongoing:
Date Location User Value Reason
Aug-13-2020 08:38:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.v
Date Location User Value Reason
Aug-13-2020 08:38:52
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 22Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787703
Page 135 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) Medical History Ter
m:Osteoporosis
Start Date: Jun/UNK/200
8
Ongoing: YES
1.v Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:38:52
(UTC-06:00) Central 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-13-2020 08:38:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OsteoporosisInitial Entry
1.v Start Date:
Date Location User Value Reason
Aug-13-2020 08:38:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/UNK/2008Initial Entry
1.v Ongoing:
Date Location User Value Reason
Aug-13-2020 08:38:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.w
Date Location User Value Reason
Aug-13-2020 08:41:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 23
Medical History Ter
m:Hypothyroidis
m
Start Date: UNK/UNK/19
94
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787704
Page 136 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.w Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:41:25
(UTC-06:00) Central 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-13-2020 08:41:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypothyroidismInitial Entry
1.w Start Date:
Date Location User Value Reason
Aug-13-2020 08:41:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1994Initial Entry
1.w Ongoing:
Date Location User Value Reason
Aug-13-2020 08:41:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.x
Date Location User Value Reason
Aug-13-2020 08:42:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 24
Medical History Ter
m:Fatigue
Start Date: UNK/UNK/20
12
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787705
Page 137 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.x Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:42:00
(UTC-06:00) Central 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-18-2020 21:37:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-17-2020 08:44:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Fatigue is due to her
age
Aug-16-2020 02:09:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Fatigue: Please can
you confirm if there is
a diagnosis available
for this MedHx?
Aug-13-2020 08:42:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FatigueInitial Entry
1.x Start Date:
Date Location User Value Reason
Aug-13-2020 08:42:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.x Ongoing:
Date Location User Value Reason
Aug-13-2020 08:42:00
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.y
Date Location User Value Reason
Aug-13-2020 08:42:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:25Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787706
Page 138 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History T
erm:Lumbar radiculop
athy
Start Date: UNK/UNK/2010
Ongoing: YES
1.y Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:42:52
(UTC-06:00) Central 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-13-2020 08:42:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Lumbar radiculopathyInitial Entry
1.y Start Date:
Date Location User Value Reason
Aug-13-2020 08:42:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.y Ongoing:
Date Location User Value Reason
Aug-13-2020 08:42:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.z
Date Location User Value Reason
Aug-13-2020 08:43:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:26
Medical His
tory Term:Acquired deformities of
second toe of right foot
Start Date: UNK/UNK/2007
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787707
Page 139 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.z Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:43:23
(UTC-06:00) Central 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-13-2020 08:43:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Acquired deformities of second toe of r
ight footInitial Entry
1.z Start Date:
Date Location User Value Reason
Aug-13-2020 08:43:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.z Ongoing:
Date Location User Value Reason
Aug-13-2020 08:43:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aa
Date Location User Value Reason
Aug-13-2020 08:45:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 27
Medical History Te
rm:Prediabetes
Start Date: UNK/UNK/2012
Ongoing: NO
End Date:
UNK/UNK/2
014Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787708
Page 140 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aa Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:45:57
(UTC-06:00) Central 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-13-2020 08:45:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
PrediabetesInitial Entry
1.aa Start Date:
Date Location User Value Reason
Aug-13-2020 08:45:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2012Initial Entry
1.aa Ongoing:
Date Location User Value Reason
Aug-13-2020 08:45:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.ab
Date Location User Value Reason
Aug-13-2020 08:46:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 28
Medical History Ter
m:Vertigo
Start Date: UNK/UNK/19
88
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787709
Page 141 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ab Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:46:49
(UTC-06:00) Central 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-13-2020 08:46:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
VertigoInitial Entry
1.ab Start Date:
Date Location User Value Reason
Aug-13-2020 08:46:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.ab Ongoing:
Date Location User Value Reason
Aug-13-2020 08:46:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ac
Date Location User Value Reason
Aug-13-2020 08:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:29
Medical History
Term:Vitamin B12 defic
iency
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787710
Page 142 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ac Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:47:39
(UTC-06:00) Central 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-13-2020 08:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin B12 deficiencyInitial Entry
1.ac Start Date:
Date Location User Value Reason
Aug-13-2020 08:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.ac Ongoing:
Date Location User Value Reason
Aug-13-2020 08:47:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ad
Date Location User Value Reason
Aug-13-2020 08:48:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 30
Medical History T
erm:Vitamin D defici
ency
Start Date: UNK/UNK/2009
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787711
Page 143 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.ad Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:48:07
(UTC-06:00) Central 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-13-2020 08:48:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin D deficiencyInitial Entry
1.ad Start Date:
Date Location User Value Reason
Aug-13-2020 08:48:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
1.ad Ongoing:
Date Location User Value Reason
Aug-13-2020 08:48:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ae
Date Location User Value Reason
Aug-13-2020 08:48:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 31
Medical History Te
rm:Acute bronchitis
Start Date: Dec/15/2016
Ongoing: NO
End Date:
UNK/UNK/2
016Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787712
Page 144 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ae Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:48:54
(UTC-06:00) Central 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-13-2020 08:48:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Acute bronchitisInitial Entry
1.ae Start Date:
Date Location User Value Reason
Aug-13-2020 08:48:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2016Initial Entry
1.ae Ongoing:
Date Location User Value Reason
Aug-13-2020 08:48:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2016Initial Entry
1.af
Date Location User Value Reason
Aug-17-2020 08:32:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Numbe
r:32
Medical History
Term:Motor Vehicle Acc
ident
Start Date: Jun/14/2017
Ongoing: NO
End Date:
Jun/14/2017per query clarification
(DELETED)
Aug-13-2020 08:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:32Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787713
Page 145 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Motor Vehicle Acc
ident
Start Date: Jun/14/2017
Ongoing: NO
End Date:
Jun/14/2017
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787714
Page 146 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.af Line/MH Number:
Date Location User Value Reason
Aug-17-2020 08:32:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
32per query clarification
(DELETED)
Aug-13-2020 08:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
32Initial Entry
1.af Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 21:37:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-17-2020 08:32:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Motor Vehicle Accidentper query clarification
(DELETED)
Aug-17-2020 08:32:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered per query clarification
Aug-16-2020 02:05:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Motor Vehicle
Accident: Please note
this is not a medical
history. If there is a
symptom/diagnosis
/procedure please
reference, else remove.
Thanks
Aug-13-2020 08:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Motor Vehicle AccidentInitial Entry
1.af Start Date:
Date Location User Value Reason
Aug-17-2020 08:32:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/14/2017per query clarification
(DELETED)
Aug-13-2020 08:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/14/2017Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787715
Page 147 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.af Ongoing:
Date Location User Value Reason
Aug-17-2020 08:32:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/14/2017per query clarification
(DELETED)
Aug-13-2020 08:49:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Jun/14/2017Initial Entry
1.ag
Date Location User Value Reason
Aug-13-2020 08:50:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 33
Medical History Te
rm:Right Jaw pain
Start Date: Jun/14/2017
Ongoing: NO
End Date:
UNK/UNK/2
017Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787716
Page 148 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ag Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:50:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
33Initial Entry
1.ag Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:50:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Right Jaw painInitial Entry
1.ag Start Date:
Date Location User Value Reason
Aug-13-2020 08:50:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/14/2017Initial Entry
1.ag Ongoing:
Date Location User Value Reason
Aug-13-2020 08:50:27
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.ah
Date Location User Value Reason
Aug-13-2020 08:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 34
Medical History Te
rm:Neck strain
Start Date: Jun/14/2017
Ongoing: NO
End Date:
UNK/UNK/2
017Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787717
Page 149 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ah Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
34Initial Entry
1.ah Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Neck strainInitial Entry
1.ah Start Date:
Date Location User Value Reason
Aug-13-2020 08:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jun/14/2017Initial Entry
1.ah Ongoing:
Date Location User Value Reason
Aug-13-2020 08:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.ai
Date Location User Value Reason
Aug-17-2020 08:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 35
Medical History Ter
m:Accidental fall
Start Date: May/28/2019
Ongoing: NO
End Date:
May/28/201
9per query clarification
(DELETED)
Aug-13-2020 08:55:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 35Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787718
Page 150 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History Ter
m:Accidental fall
Start Date: May/28/2019
Ongoing: NO
End Date:
May/28/201
9
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787719
Page 151 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ai Line/MH Number:
Date Location User Value Reason
Aug-17-2020 08:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
35per query clarification
(DELETED)
Aug-13-2020 08:55:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
35Initial Entry
1.ai Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 21:37:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-17-2020 08:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Accidental fallper query clarification
(DELETED)
Aug-17-2020 08:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered per query clarification
Aug-16-2020 02:01:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Accidental fall: Please
note this is not a
medical history. If there
is a symptom/diagnosis
/procedure please
reference, else clarify.
Thanks
Aug-13-2020 08:55:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Accidental fallInitial Entry
1.ai Start Date:
Date Location User Value Reason
Aug-17-2020 08:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/28/2019per query clarification
(DELETED)
Aug-13-2020 08:55:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/28/2019Initial Entry
1.ai Ongoing:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787720
Page 152 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-17-2020 08:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/28/2019per query clarification
(DELETED)
Aug-13-2020 08:55:22
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
May/28/2019Initial Entry
1.aj
Date Location User Value Reason
Aug-13-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 36
Medical History Te
rm:Pre-syncope
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787721
Page 153 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aj Line/MH Number:
Date Location User Value Reason
Aug-13-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36Initial Entry
1.aj Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Pre-syncopeInitial Entry
1.aj Start Date:
Date Location User Value Reason
Aug-13-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.aj Ongoing:
Date Location User Value Reason
Aug-13-2020 08:59:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787722
Page 154 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.ak
Date Location User Value Reason
Aug-13-2020 09:00:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 37
Medical History Te
rm:Acute rhinitis
Start Date: Dec/11/2018
Ongoing: NO
End Date:
UNK/UNK/2
018Initial Entry
1.ak Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:00:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
37Initial Entry
1.ak Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:00:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Acute rhinitisInitial Entry
1.ak Start Date:
Date Location User Value Reason
Aug-13-2020 09:00:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/11/2018Initial Entry
1.ak Ongoing:
Date Location User Value Reason
Aug-13-2020 09:00:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.al
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787723
Page 155 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020 09:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 38
Medical History Te
rm:Acute bronchitis
Start Date: Mar/19/2019
Ongoing: NO
End Date:
Mar/UNK/20
19Initial Entry
1.al Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
38Initial Entry
1.al Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Acute bronchitisInitial Entry
1.al Start Date:
Date Location User Value Reason
Aug-13-2020 09:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/19/2019Initial Entry
1.al Ongoing:
Date Location User Value Reason
Aug-13-2020 09:02:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Mar/UNK/2019Initial Entry
1.am
Date Location User Value Reason
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787724
Page 156 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-13-2020 09:03:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:39
Medical Histo
ry Term:Left hand inflammator
y arthropathy
Start Date: Mar/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019Initial Entry
1.am Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:03:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
39Initial Entry
1.am Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:03:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Left hand inflammatory arthropathyInitial Entry
1.am Start Date:
Date Location User Value Reason
Aug-13-2020 09:03:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/UNK/2019Initial Entry
1.am Ongoing:
Date Location User Value Reason
Aug-13-2020 09:03:45
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.an
Date Location User Value Reason
Aug-13-2020 09:04:39
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number 40Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787725
Page 157 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada) :
Medical History T
erm:Urinary tract infec
tion
Start Date: Aug/14/2019
Ongoing: NO
End Date:
UNK/UNK/20
19
1.an Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:04:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
40Initial Entry
1.an Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:04:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Urinary tract infectionInitial Entry
1.an Start Date:
Date Location User Value Reason
Aug-13-2020 09:04:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2019Initial Entry
1.an Ongoing:
Date Location User Value Reason
Aug-13-2020 09:04:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.ao
Date Location User Value Reason
Aug-13-2020 09:05:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:41Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787726
Page 158 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histo
ry Term:Intermittent lower ext
remities edema
Start Date: UNK/UNK/2016
Ongoing: YES
1.ao Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:05:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
41Initial Entry
1.ao Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:05:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Intermittent lower extremities edemaInitial Entry
1.ao Start Date:
Date Location User Value Reason
Aug-13-2020 09:05:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.ao Ongoing:
Date Location User Value Reason
Aug-13-2020 09:05:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.ap
Date Location User Value Reason
Aug-13-2020 09:06:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:42
Medical Histo
ry Term:Telangiectasias on lo
wer extremities
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787727
Page 159 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ap Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:06:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
42Initial Entry
1.ap Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:06:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Telangiectasias on lower extremitiesInitial Entry
1.ap Start Date:
Date Location User Value Reason
Aug-13-2020 09:06:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.ap Ongoing:
Date Location User Value Reason
Aug-13-2020 09:06:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.aq
Date Location User Value Reason
Aug-17-2020 08:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Number: 43
Medical History T
erm:Airplane acciden
t
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1
988Per query clarification
(DELETED)
Aug-13-2020 09:07:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 43
Medical History T
erm:Airplane acciden
tInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787728
Page 160 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1
988
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787729
Page 161 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aq Line/MH Number:
Date Location User Value Reason
Aug-17-2020 08:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
43Per query clarification
(DELETED)
Aug-13-2020 09:07:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
43Initial Entry
1.aq Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-18-2020 21:37:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-17-2020 08:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Airplane accidentPer query clarification
(DELETED)
Aug-17-2020 08:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Per query clarification
Aug-16-2020 02:01:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened Airplane accident:
Please note this is not a
medical history. If there
is a symptom/diagnosis
/procedure please
reference, else clarify.
Thanks
Aug-13-2020 09:07:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Airplane accidentInitial Entry
1.aq Start Date:
Date Location User Value Reason
Aug-17-2020 08:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Per query clarification
(DELETED)
Aug-13-2020 09:07:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.aq Ongoing:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0787730
Page 162 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-17-2020 08:30:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Per query clarification
(DELETED)
Aug-13-2020 09:07:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.ar
Date Location User Value Reason
Aug-13-2020 09:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 44
Medical History Te
rm:Facial injuries
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1
988Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787731
Page 163 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ar Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
44Initial Entry
1.ar Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Facial injuriesInitial Entry
1.ar Start Date:
Date Location User Value Reason
Aug-13-2020 09:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.ar Ongoing:
Date Location User Value Reason
Aug-13-2020 09:07:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.as
Date Location User Value Reason
Aug-13-2020 09:08:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 45
Medical History Te
rm:Nasal surgery
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1
988Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787732
Page 164 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.as Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:08:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
45Initial Entry
1.as Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:08:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Nasal surgeryInitial Entry
1.as Start Date:
Date Location User Value Reason
Aug-13-2020 09:08:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.as Ongoing:
Date Location User Value Reason
Aug-13-2020 09:08:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.at
Date Location User Value Reason
Aug-13-2020 09:09:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 46
Medical History Te
rm:Jaw surgery
Start Date: UNK/UNK/1988
Ongoing: NO
End Date:
UNK/UNK/1
988Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787733
Page 165 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.at Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:09:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
46Initial Entry
1.at Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:09:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jaw surgeryInitial Entry
1.at Start Date:
Date Location User Value Reason
Aug-13-2020 09:09:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1988Initial Entry
1.at Ongoing:
Date Location User Value Reason
Aug-13-2020 09:09:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1988Initial Entry
1.au
Date Location User Value Reason
Aug-13-2020 09:38:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:47
Medical History T
erm:Periorbital hemat
oma
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/20
19Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787734
Page 166 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.au Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:38:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
47Initial Entry
1.au Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:38:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Periorbital hematomaInitial Entry
1.au Start Date:
Date Location User Value Reason
Aug-13-2020 09:38:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/28/2019Initial Entry
1.au Ongoing:
Date Location User Value Reason
Aug-13-2020 09:38:04
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.av
Date Location User Value Reason
Aug-13-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:48
Medical History
Term:Frontal Scalp cont
usion
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/201
9Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787735
Page 167 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.av Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
48Initial Entry
1.av Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Frontal Scalp contusionInitial Entry
1.av Start Date:
Date Location User Value Reason
Aug-13-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/28/2019Initial Entry
1.av Ongoing:
Date Location User Value Reason
Aug-13-2020 09:42:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.aw
Date Location User Value Reason
Aug-13-2020 09:43:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:49
Medical History
Term:Closed nasal bone f
racture
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787736
Page 168 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.aw Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:43:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
49Initial Entry
1.aw Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:43:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Closed nasal bone fractureInitial Entry
1.aw Start Date:
Date Location User Value Reason
Aug-13-2020 09:43:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/28/2019Initial Entry
1.aw Ongoing:
Date Location User Value Reason
Aug-13-2020 09:43:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
1.ax
Date Location User Value Reason
Aug-13-2020 09:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 50
Medical History Te
rm:Concussion
Start Date: May/28/2019
Ongoing: NO
End Date:
UNK/UNK/2
019Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787737
Page 169 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.ax Line/MH Number:
Date Location User Value Reason
Aug-13-2020 09:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
50Initial Entry
1.ax Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-13-2020 09:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ConcussionInitial Entry
1.ax Start Date:
Date Location User Value Reason
Aug-13-2020 09:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/28/2019Initial Entry
1.ax Ongoing:
Date Location User Value Reason
Aug-13-2020 09:44:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787738
Page 170 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
155.6Initial Entry
3. Unit:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
62.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.5Initial Entry
7.a
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (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-2021-5683-0787739
Page 171 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.0
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.0Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-13-2020 09:13:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (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-2021-5683-0787740
Page 172 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sponsor-Defined Identi
fier:Not Applica
ble
Test:: Not Applica
bleInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787741
Page 173 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Result:: Not Applica
ble
Not Done:: Not Applica
ble
6.a Sponsor ID:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-13-2020 09:13:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787742
Page 174 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-13-2020 09:14:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-13-2020 09:14:07
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
226222Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787743
Page 175 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 09:14:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 09:14:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 09:14:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 09:14:20
(UTC-06:00) Central 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-13-2020 09:14:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 09:14:30
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTY28Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 09:14:30
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
BHTY28Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0787744
Page 176 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
5.b
Date Location User Value Reason
Aug-13-2020 09:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTY29Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-13-2020 09:14:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHTY29Initial Entry
5.c
Date Location User Value Reason
Aug-13-2020 09:14:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BHTY2BInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-13-2020 09:14:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BHTY2BInitial Entry
5.d
Date Location User Value Reason
Aug-13-2020 10:12:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG6J0Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-13-2020 10:12:41
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPG6J0Initial Entry
5.e
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0787745
Page 177 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020 10:12:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG6J1Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-13-2020 10:12:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPG6J1Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787746
Page 178 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-13-2020 09:18:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-13-2020 09:18:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-13-2020 09:18:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-13-2020 09:18:34
(UTC-06:00) Central 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-13-2020 09:18:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-13-2020 09:18:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP69FHInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-13-2020 09:18:54
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
BP69FHInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787747
Page 179 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(US & Canada)
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787748
Page 180 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 11:09Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787749
Page 181 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION 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-13-2020 09:19:23
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787750
Page 182 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-13-2020 09:19:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787751
Page 183 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-01-2020 14:31:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787752
Page 184 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central 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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IGU
E
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NOInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (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-2021-5683-0787753
Page 185 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.b Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central 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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central 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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CHInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787754
Page 186 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
ILL
S
Were fever or systemic sympto
ms present on the last day the S
ubject Diary was completed?:NO
2.d Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central 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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MITI
NG
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central 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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (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-2021-5683-0787755
Page 187 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central 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
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NOInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787756
Page 188 of 228
***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: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181132 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE PAI
NInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020 14:31:51
(UTC-06:00) Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae4013\Final\Final On: 01-Apr-2021 05:30 (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-2021-5683-0787757
Page 189 of 228
***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: 1018 Site Name: (10
…[truncated]