125742 S1 M5 CRF c4591001 1018 10181159

Document text

Page 1 of 191
***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: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787798
Page 2 of 191
***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: 10181159 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/14/2020
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787799
Page 3 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10181159]
2.Birth Date: 1967
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787800
Page 4 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/14/2020
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787801
Page 5 of 191
***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: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787802
Page 6 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation/DeathAug/14/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787803
Page 7 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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:[Obstructive breathing due to deviated septum]
Start Date: /1967
Ongoing: NO
End Date:
UNK/UNK/2017
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rhinoplasty]
Start Date: UNK/UNK/2008
Ongoing: NO
End Date:
UNK/UNK/2008
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Rhinoplasty]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787804
Page 8 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[right shoulder dislocation]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Right Shoulder Repair]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2014
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Breast augmentation]
Start Date: UNK/UNK/2010
Ongoing: NO
End Date:
UNK/UNK/2010
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Fibrocystic Breast Disease]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787805
Page 9 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines once or twice a month]
Start Date: UNK/UNK/2008
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin D deficiency]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2014
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[benign cyst removed]
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/2009
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Occipital Neuralgia R>L]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787806
Page 10 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Chronic Neck Pain]
Start Date: UNK/UNK/2008
Ongoing: YES
1 mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vitamin B12 Deficiency ]
Start Date: UNK/UNK/2009
Ongoing: YES
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787807
Page 11 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/14/2020
2.Weight: [137.0]
3.Unit: LB
4.Height: [69.5]
5.Unit: in
6.Body Mass Index: [19.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [95.5]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787808
Page 12 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/14/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787809
Page 13 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/14/2020
2.Randomization Number: [50249]
3.Randomization Group: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787810
Page 14 of 191
***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: 10181159 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/14/2020
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 [BP69J3]
5.bSample ID [BP69J4]
5.cSample ID [BP69J5]
5.dSample ID [BPG680]
5.eSample ID [BPG681]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787811
Page 15 of 191
***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: 10181159 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/14/2020
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 [BP69HX]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787812
Page 16 of 191
***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: 10181159 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/14/2020 11:33
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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787813
Page 17 of 191
***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: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787814
Page 18 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787815
Page 19 of 191
***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: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787816
Page 20 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787817
Page 21 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [95.2] Comments
Unit: F Comments
Temperature Location: ORAL CAVITY Comments
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787818
Page 22 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/4/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787819
Page 23 of 191
***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: 10181159 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/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BHTYD9]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787820
Page 24 of 191
***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: 10181159 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/4/2020 16:07
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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787821
Page 25 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/7/2020
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787822
Page 26 of 191
***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: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787823
Page 27 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last day
the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787824
Page 28 of 191
***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: 10181159 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:
Oct/7/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9FVK]
5.bSample ID [BP9FVL]
5.cSample ID [BLB1PG]
5.dSample ID [BLB1PH]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787825
Page 29 of 191
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Mar/1/2021
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787826
Page 30 of 191
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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:
Mar/1/2021
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 [BR1387]
5.bSample ID [BR1388]
5.cSample ID [BS7GRN]
5.dSample ID [BS7GRP]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787827
Page 31 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787828
Page 32 of 191
***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: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787829
Page 33 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787830
Page 34 of 191
***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: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787831
Page 35 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10181159 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:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787832
Page 36 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10181159 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: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787833
Page 37 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787834
Page 38 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787835
Page 39 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10181159 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?
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787836
Page 40 of 191
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New Unscheduled
VisitForm: 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: 10181159 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:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787837
Page 41 of 191
***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: 10181159 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:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787838
Page 42 of 191
***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: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787839
Page 43 of 191
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787840
Page 44 of 191
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787841
Page 45 of 191
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation/Death
:Oct/7/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787842
Page 46 of 191
***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: 10181159 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: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787843
Page 47 of 191
***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: 10181159 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:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787844
Page 48 of 191
***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: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787845
Page 49 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Identi
fierAdverse Event Start DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Right Leg Parest
hesia Oct/20/2020 UNK:
UNK YES  Repeating
Pages
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787846
Page 50 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Form Comments
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)[Right Leg Paresthesia]
4.Start Date Time: Oct/20/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
NO
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
YES
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787847
Page 51 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020447492]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787848
Page 52 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still
OngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787849
Page 53 of 191
***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: 10181159 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[ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787850
Page 54 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787851
Page 55 of 191
***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: 10181159 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: //
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787852
Page 56 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787853
Page 57 of 191
***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: 10181159 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?
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787854
Page 58 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-specif
iedTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787855
Page 59 of 191
***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: 10181159 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?
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787856
Page 60 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787857
Page 61 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787858
Page 62 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787859
Page 63 of 191
***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: 10181159 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:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787860
Page 64 of 191
***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: 10181159 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:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787861
Page 65 of 191
***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: 10181159 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?
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787862
Page 66 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787863
Page 67 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787864
Page 68 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787865
Page 69 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787866
Page 70 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787867
Page 71 of 191
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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 [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787868
Page 72 of 191
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/16/2020
2.Erroneous Visit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787869
Page 73 of 191
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787870
Page 74 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787871
Page 75 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787872
Page 76 of 191
***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: 10181159 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: [ ]
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787873
Page 77 of 191
***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: 10181159 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 Oct/7/2020
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787874
Page 78 of 191
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787875
Page 79 of 191
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787876
Page 80 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormAug-14-2020 12:41:33 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787877
Page 81 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-04-2020 16:08:46 (UTC-06:00) Central
Time (US & Canada)per source - not clinically significant
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787878
Page 82 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-04-2020 16:08:46 (UTC-06:00) Central
Time (US & Canada)per source - not clinically significant
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787879
Page 83 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - Comments
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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2.aSep-04-2020 16:08:46 (UTC-06:00) Central
Time (US & Canada)per source - not clinically significant
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787880
Page 84 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormJan-22-2021 16:41:24 (UTC-06:00) Central
Time (US & Canada)Vitamin b12 deficiency was deleted from
medical history after consolation with patient.
Patient denies having b12 deficiency or
received treatment.
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787881
Page 85 of 191
***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, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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
CRF_Sign_1
Name Signature
MeaningDate Type Action
William
Fernandez N/A Mar-02-2021 23:11:18 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-25-2021 21:02:26 (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-06-2021 13:46:41 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-18-2020 11:28:57 (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.
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787882
Page 86 of 191
***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, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
 N/A Nov-17-2020 19:59:55 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-13-2020 12:09:49 (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 Nov-12-2020 11:13:02 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Oct-12-2020 19:59:35 (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.
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787883
Page 87 of 191
***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: 10181159 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-14-2020 12:40:38
(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-14-2020 12:40:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787884
Page 88 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-14-2020 12:40:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/14/2020Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787885
Page 89 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-14-2020 12:40:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10181159Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-14-2020 12:40:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1967Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-14-2020 12:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-14-2020 12:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO(
A) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-14-2020 12:41:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae401b\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)
FDA-CBER-2021-5683-0787886
Page 90 of 191
***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: 10181159 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-14-2020 12:41:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787887
Page 91 of 191
***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: 10181159 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
Aug-14-2020 12:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-14-2020 12:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-14-2020 12:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787888
Page 92 of 191
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Aug-14-2020 12:42:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:Obstructive breathing
due to deviated septu
m
Start Date
:/1967
Ongoing: NO
End Date:
UNK/UNK/2017Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:42:47
(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-14-2020 12:42:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Obstructive breathing due to dev
iated septumInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-14-2020 12:42:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1967Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787889
Page 93 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Aug-14-2020 12:42:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.b
Date Location User Value Reason
Aug-14-2020 12:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:2
Medical History
Term:Rhinoplasty
Start Date: UNK/UNK/20
08
Ongoing: NO
End Date:
UNK/UNK/
2008Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787890
Page 94 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:43:34
(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-14-2020 12:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RhinoplastyInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-14-2020 12:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-14-2020 12:43:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2008Initial Entry
1.c
Date Location User Value Reason
Aug-14-2020 12:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:3
Medical History
Term:Rhinoplasty
Start Date: UNK/UNK/20
17Initial Entry
090177e196ae401b\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-2021-5683-0787891
Page 95 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
2017
1.c Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:44:14
(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-14-2020 12:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RhinoplastyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-14-2020 12:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-14-2020 12:44:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.d
Date Location User Value Reason
Aug-17-2020 12:01:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:4Transcription Error
090177e196ae401b\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-2021-5683-0787892
Page 96 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Hist
ory Term:right shoulder d
islocation
Start Date: UNK/UNK/201
4
Ongoing: NO
End Date:
UNK/UNK/
2014
Aug-14-2020 17:30:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Right Shoulder
Dislocation
Start Date: UNK/UNK/201
4
Ongoing: NO
End Date:
UNK/UNK/2
014Transcription Error
Aug-14-2020 12:44:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:4
Medical Hi
story Term
:Right Shoulder Di
slocation due to fal
l
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/201
4Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787893
Page 97 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:44:42
(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
Jan-22-2021
15:53:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Cl
osedResponse
satisfies query
Jan-22-2021
15:26:49
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: An
sweredChanged data per
query
Jan-22-2021
12:45:13
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edClinical /
Unfrozen: On
review of SAE
report for
Paresthesia, Med
Hx of Neck Pain
was mentioned,
yet it does not
appear in Med
Hx CRF. Please
review for
clinical relevance
to safety event
and update Med
Hx log CRF if
appropriate
Jan-22-2021
10:39:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: An
sweredPlease unfreeze
Hx CRF
090177e196ae401b\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-2021-5683-0787894
Page 98 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Dec-06-2020
12:42:33
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Re
issued:Open
edClinical On
review of SAE
report for
Paresthesia, Med
Hx of Neck Pain
was mentioned,
yet it does not
appear in Med
Hx CRF. Please
review for
clinical relevance
to safety event
and update Med
Hx log CRF if
appropriate.
Dec-03-2020
12:13:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: An
sweredWaiting on PI
review.
Nov-24-2020
07:39:55
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Op
enedClinical On
review of SAE
report for
Paresthesia, Med
Hx of Neck Pain
was mentioned,
yet it does not
appear in Med
Hx CRF. Please
review for
clinical relevance
to safety event
and update Med
Hx log CRF if
appropriate.
Aug-18-2020
02:37:25
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Cl
osedResponse
satisfies query
Aug-17-2020
12:01:00
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 2: An
sweredTranscription
Error
090177e196ae401b\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-2021-5683-0787895
Page 99 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Central Time
(US & Canada)
Aug-17-2020
12:01:00
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
right should
er dislocatio
nTranscription
Error
Aug-17-2020
11:46:52
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Op
enedDM QUERY: A
trailing space is
identified. To
avoid processing
errors, please
remove the
identified
character by
deleting the entry
and re-entering
the data (without
using copy and
paste).
Aug-14-2020
18:35:19
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Aug-14-2020
17:30:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredTranscription
Error
Aug-14-2020
17:30:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Right Shoul
der Dislocat
ionTranscription
Error
Aug-14-2020
14:35:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Op
enedMultiple
concepts in the
term RIGHT
SHOULDER
DISLOCATION
DUE TO FALL.
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787896
Page 100 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Split the term
into RIGHT
SHOULDER
DISLOCATION
and FALL and
submit
separately. Thank
you.
Aug-14-2020
12:44:42
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry
:
Right Shoul
der Dislocat
ion due to fa
llInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-14-2020 12:44:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-14-2020 12:44:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.e
Date Location User Value Reason
Aug-14-2020 12:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:5
Medical Histor
y Term:Right Shoulder
Repair
Start Date: UNK/UNK/201
4Initial Entry
090177e196ae401b\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-2021-5683-0787897
Page 101 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: NO
End Date:
UNK/UNK/
2014
1.e Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:45:10
(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-14-2020 12:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Right Shoulder RepairInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-14-2020 12:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-14-2020 12:45:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.f
Date Location User Value Reason
Aug-14-2020 12:45:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:6Initial Entry
090177e196ae401b\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-2021-5683-0787898
Page 102 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical History
Term:Breast augment
ation
Start Date: UNK/UNK/20
10
Ongoing: NO
End Date:
UNK/UNK/
2010
1.f Line/MH Number:
Date Location User Value Reason
Aug-14-2020 12:45:34
(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-14-2020 12:45:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Breast augmentationInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-14-2020 12:45:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-14-2020 12:45:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2010Initial Entry
1.g
090177e196ae401b\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-2021-5683-0787899
Page 103 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-17-2020 08:37:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:7
Medical Histo
ry Term:Fibrocystic Brea
st Disease
Start Date: UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1
993Clarification
Aug-14-2020 17:29:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:7
Medical
History T
erm:Fibrocystic Breast Di
sease, benign cyst re
moved
Start Dat
e:UNK/UNK/1993
Ongoing: NO
End Date:
UNK/UNK/1993Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787900
Page 104 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.g Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:29:28
(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-17-2020
09:49:44
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Cl
osedDiscrepancy has
been closed.
Aug-17-2020
08:37:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: An
sweredClarification
Aug-17-2020
08:37:31
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Fibrocystic
Breast Disea
seClarification
Aug-14-2020
20:10:11
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Op
enedMultiple
concepts in the
term
FIBROCYSTIC
BREAST
DISEASE,
BENIGN CYST
REMOVED.
Split the term
into
FIBROCYSTIC
BREAST
DISEASE and
BENIGN CYST
REMOVED and
submit
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787901
Page 105 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
separately.
Thank you.
Aug-14-2020
17:29:28
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Fibrocystic
Breast Disea
se, benign c
yst removedInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-14-2020 17:29:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-14-2020 17:29:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
1.h
Date Location User Value Reason
Aug-17-2020 09:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH N
umber:8
Medical His
tory Term:Migraines once o
r twice a month
Start Date: UNK/UNK/2008
Ongoing: YESTranscription Error
Aug-14-2020 17:29:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:8
Medical History
Term:Migraines
Start Date: UNK/UNK/
2008Initial Entry
090177e196ae401b\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-2021-5683-0787902
Page 106 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Ongoing: YES
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787903
Page 107 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.h Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:29:51
(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
Jan-22-2021 15:53:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 15:27:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-22-2021 12:46:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical Unfrozen:
On review of SAE
report for
Paresthesia, Med
Hx of R>L
occipital neuralgia
was mentioned, yet
it does not appear
in Med Hx CRF.
Please review for
clinical relevance
to safety event and
update Med Hx log
CRF if appropriate.
Jan-22-2021 10:38:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze Hx
CRF
Dec-06-2020 12:43:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical On review
of SAE report for
Paresthesia, Med
Hx of R>L
occipital neuralgia
was mentioned, yet
it does not appear
in Med Hx CRF.
Please review for
090177e196ae401b\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-2021-5683-0787904
Page 108 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
clinical relevance
to safety event and
update Med Hx log
CRF if appropriate.
Dec-03-2020 12:13:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Waiting on PI
review.
Nov-24-2020 07:38:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical On review
of SAE report for
Paresthesia, Med
Hx of R>L
occipital neuralgia
was mentioned, yet
it does not appear
in Med Hx CRF.
Please review for
clinical relevance
to safety event and
update Med Hx log
CRF if appropriate.
Aug-17-2020 09:44:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Migraines once or twice a mon
thTranscription Error
Aug-14-2020 17:29:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MigrainesInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-14-2020 17:29:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-14-2020 17:29:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae401b\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-2021-5683-0787905
Page 109 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i
Date Location User Value Reason
Aug-14-2020 17:30:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:9
Medical History
Term:Vitamin D defic
iency
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2014Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787906
Page 110 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.i Line/MH Number:
Date Location User Value Reason
Aug-14-2020 17:30:16
(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
Jan-22-2021 20:56:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-22-2021 16:01:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject did not
have Vit B-12, SAE
report is being
amended and will
be updated
Jan-22-2021 15:55:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical Vit B12
deficiency was
added as a Med Hx
condition, but then
crossed out. Please
clarify if subject
never had Vit B12
deficiency (then,
remove this history
from SAE). Or
re-add if subj did
have Vit B12 def on
study day 1
Jan-22-2021 15:27:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Jan-22-2021 12:45:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical Unfrozen:
On review of SAE
for Paresthesia,
Med Hx of Vitamin
B12 deficiency was
reported, yet is not
on Med Hx CRF. Is
subj on B12
090177e196ae401b\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-2021-5683-0787907
Page 111 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
injections/was
subject assessed for
Pernicious anemia?
Please review,
update Med Hx and
SAE if appropriate
Jan-22-2021 09:01:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Please unfreeze
medical Hx so it
can be updated
Dec-06-2020 12:41:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Event of osteopenia
reported after V3
Dec-06-2020 12:40:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical On review
of SAE report for
Paresthesia, Med
Hx of Vitamin B12
deficiency was
reported, yet is not
on Med Hx CRF. Is
subj on B12
injections/was
subject assessed for
Pernicious anemia?
Please review,
update Med Hx and
SAE if appropriate
Dec-03-2020 12:13:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Waiting on PI
review.
Dec-03-2020 12:13:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered Waiting on PI
review.
Nov-24-2020 07:39:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical On review
of SAE report for
Paresthesia, Med
Hx of Osteopena
was mentioned, yet
it does not appear in
Med Hx CRF.
Please review for
clinical relevance to
090177e196ae401b\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-2021-5683-0787908
Page 112 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
safety event and
update Med Hx log
CRF if appropriate.
Nov-24-2020 07:36:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical On review
of SAE report for
Paresthesia, Med
Hx of Vitamin B12
deficiency was
reported, yet is not
on Med Hx CRF. Is
subj on B12
injections/was
subject assessed for
Pernicious anemia?
Please review,
update Med Hx and
SAE if appropriate
Aug-14-2020 17:30:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin D deficiencyInitial Entry
1.i Start Date:
Date Location User Value Reason
Aug-14-2020 17:30:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-14-2020 17:30:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2014Initial Entry
1.j
Date Location User Value Reason
Jan-22-2021 15:26:10
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Line/MH Num 10Transcription Error
090177e196ae401b\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), 
(b) (6)
FDA-CBER-2021-5683-0787909
Page 113 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) ber:
Medical Histor
y Term:benign cyst re
moved
Start Date: UNK/UNK/19
93
Ongoing: NO
End Date:
UNK/UNK/
2009
Aug-17-2020 08:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:10
Medical Histor
y Term:benign cyst re
moved
Start Date: UNK/UNK/19
93
Ongoing: NO
End Date:
UNK/UNK/
1993Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787910
Page 114 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.j Line/MH Number:
Date Location User Value Reason
Aug-17-2020 08:39:27
(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-17-2020 08:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
benign cyst removedInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-17-2020 08:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1993Initial Entry
1.j Ongoing:
Date Location User Value Reason
Jan-22-2021 15:26:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2009Transcription Error
Aug-17-2020 08:39:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1993Initial Entry
1.k
Date Location User Value Reason
Jan-22-2021 15:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:11Initial Entry
090177e196ae401b\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-2021-5683-0787911
Page 115 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histor
y Term:Occipital Neural
gia R>L
Start Date: UNK/UNK/201
4
Ongoing: YES
1.k Line/MH Number:
Date Location User Value Reason
Jan-22-2021 15:22:54
(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
Jan-22-2021 15:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Occipital Neuralgia R>LInitial Entry
1.k Start Date:
Date Location User Value Reason
Jan-22-2021 15:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787912
Page 116 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.k Ongoing:
Date Location User Value Reason
Jan-22-2021 15:22:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Jan-22-2021 15:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:12
Medical History
Term:Chronic Neck
Pain
Start Date: UNK/UNK/2
008
Ongoing: YESInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787913
Page 117 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.l Line/MH Number:
Date Location User Value Reason
Jan-22-2021 15:24:12
(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
Jan-22-2021 15:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Chronic Neck PainInitial Entry
1.l Start Date:
Date Location User Value Reason
Jan-22-2021 15:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2008Initial Entry
1.l Ongoing:
Date Location User Value Reason
Jan-22-2021 15:24:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Jan-22-2021 15:48:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:13
Medical Histor
y Term:Vitamin B12 D
eficiency
Start Date: UNK/UNK/20
09
Ongoing: YESSpoke with subject
directly, she denies
any history and
treatment for
Vitamin B12
Deficiency
(DELETED)
Jan-22-2021 15:25:40
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num 13Initial Entry
090177e196ae401b\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-2021-5683-0787914
Page 118 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) ber:
Medical Histor
y Term:Vitamin B12 D
eficiency
Start Date: UNK/UNK/20
09
Ongoing: YES
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787915
Page 119 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Line/MH Number:
Date Location User Value Reason
Jan-22-2021 15:48:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
13Spoke with subject
directly, she denies
any history and
treatment for
Vitamin B12
Deficiency
(DELETED)
Jan-22-2021 15:25:40
(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
Jan-22-2021 15:48:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin B12 DeficiencySpoke with subject
directly, she denies
any history and
treatment for
Vitamin B12
Deficiency
(DELETED)
Jan-22-2021 15:25:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Vitamin B12 DeficiencyInitial Entry
1.m Start Date:
Date Location User Value Reason
Jan-22-2021 15:48:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Spoke with subject
directly, she denies
any history and
treatment for
Vitamin B12
Deficiency
(DELETED)
Jan-22-2021 15:25:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2009Initial Entry
090177e196ae401b\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-2021-5683-0787916
Page 120 of 191
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.m Ongoing:
Date Location User Value Reason
Jan-22-2021 15:48:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESSpoke with subject
directly, she denies
any history and
treatment for
Vitamin B12
Deficiency
(DELETED)
Jan-22-2021 15:25:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787917
Page 121 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
137.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
69.5Initial Entry
5. Unit:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-14-2020 12:53:32 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae401b\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-2021-5683-0787918
Page 122 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) 19.9
7.a
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier
::1
Temperature: 95.5
Temperature Uni
t:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-17-2020 07:37:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed by DM: AT.
Aug-14-2020 12:54:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered per source
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 95.5 F
is outside of
Normal Range 97 -
99.5 F.
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
95.5Initial Entry
7.a Unit:
090177e196ae401b\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-2021-5683-0787919
Page 123 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-14-2020 12:53:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787920
Page 124 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-18-2020 09:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-18-2020 09:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Date of collection
is reported, but
result is missing.
Please review and
update as
appropriate.
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787921
Page 125 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-18-2020 09:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
Aug-18-2020 09:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done::Clarification, Test
was performed
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result::
Not Done:: NOT DONEInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Aug-18-2020 09:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
Aug-18-2020 09:27:20
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry: Clarification, Test
was performed
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787922
Page 126 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX11
3Initial Entry
6.a Result:
Date Location User Value Reason
Aug-18-2020 09:27:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
6.a Not Done:
Date Location User Value Reason
Aug-19-2020 21:14:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-18-2020 09:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Clarification, Test
was performed
Aug-18-2020 09:27:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Clarification, Test
was performed
Aug-17-2020 20:26:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened please can you
confirm why a
pregnancy test was
not done for this
subject? There is
nothing in her
medhx to indicate
she is not a woman
of child bearing
090177e196ae401b\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-2021-5683-0787923
Page 127 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
potential? Thanks
Aug-14-2020 12:54:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787924
Page 128 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-14-2020 12:55:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-14-2020 12:55:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
50249Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787925
Page 129 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 12:55:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 12:55:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-14-2020 12:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 12:55:29
(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-14-2020 12:55:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 12:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP69J3Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787926
Page 130 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 12:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP69J3Initial Entry
5.b
Date Location User Value Reason
Aug-14-2020 12:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP69J4Initial Entry
5.b Sample ID
Date Location User Value Reason
Aug-14-2020 12:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP69J4Initial Entry
5.c
Date Location User Value Reason
Aug-14-2020 12:56:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP69J5Initial Entry
5.c Sample ID
Date Location User Value Reason
Aug-14-2020 12:56:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP69J5Initial Entry
5.d
Date Location User Value Reason
Aug-14-2020 12:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG680Initial Entry
090177e196ae401b\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-2021-5683-0787927
Page 131 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d Sample ID
Date Location User Value Reason
Aug-14-2020 12:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG680Initial Entry
5.e
Date Location User Value Reason
Aug-14-2020 12:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPG681Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-14-2020 12:56:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPG681Initial Entry
090177e196ae401b\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-2021-5683-0787928
Page 132 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-14-2020 12:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-14-2020 12:56:57
(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-14-2020 12:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-14-2020 12:56:57
(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-14-2020 12:56:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/14/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 12:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP69HXInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787929
Page 133 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Sample ID
Date Location User Value Reason
Aug-14-2020 12:57:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP69HXInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0787930
Page 134 of 191
***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: 10181159 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-14-2020 12:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-14-2020 12:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-14-2020 12:57:39
(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-14-2020 12:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/14/2020 11:33Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-14-2020 12:57:39
(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-14-2020 12:57:39 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae401b\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-2021-5683-0787931
Page 135 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Aug-14-2020 12:57:39
(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-14-2020 12:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-14-2020 12:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0787932
Page 136 of 191
***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: 10181159 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-14-2020 12:57:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-
DIARY COLLECTED FOR TH
IS SUBJECTInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787933
Page 137 of 191
***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: 10181159 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-04-2020 16:04:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787934
Page 138 of 191
***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: 10181159 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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Symptom:: FAInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787935
Page 139 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) TI
GU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787936
Page 140 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Diar
y was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787937
Page 141 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787938
Page 142 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE P
AIN
Were fever or syste
mic symptoms pre
sent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787939
Page 143 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787940
Page 144 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOIN
T 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-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:RE
DN
ES
S
Were injection site react
ions present on the last
day the Subject Diary w
as completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787941
Page 145 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:SW
ELL
ING
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787942
Page 146 of 191
***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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SITE
Were injection site r
eactions present on t
he last day the Subje
ct Diary was comple
ted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:05:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787943
Page 147 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 95.2
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-08-2020 09:55:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Closed as per site
response.
Sep-08-2020 08:34:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered not clinically
significant
Sep-07-2020 03:58:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened DM1: Thanks for
the response.
Kindly confirm if
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787944
Page 148 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
the value is not
clinically
significant.
Sep-04-2020 16:08:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Temperature 95.2 F
is outside of
Normal Range 97 -
99.5 F.
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
95.2Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 16:06:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787945
Page 149 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787946
Page 150 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-Defin
ed Identifier:113
Test:: Choriogonadotro
pin Beta_PX113
Result:: NEGATIVE
Not Done::Initial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin Beta_PX1
13Initial Entry
6.a Result:
Date Location User Value Reason
Sep-04-2020 16:06:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEGATIVEInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787947
Page 151 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 16:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 16:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 16:07:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 16:06:58
(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.
Sep-04-2020 16:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
Sep-04-2020 16:07:03
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Sample ID: BHTYD9Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787948
Page 152 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 16:07:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BHTYD9Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787949
Page 153 of 191
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 16:07Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-04-2020 16:07:45 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0787950
Page 154 of 191
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)LEFT
7. Route:
Date Location User Value Reason
Sep-04-2020 16:07:45
(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
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 16:07:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0787951
Page 155 of 191
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 10:23:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Oct/7/2020Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787952
Page 156 of 191
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: FE
VE
R
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) CentralACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: FAInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787953
Page 157 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada) TI
GU
E
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NO
2.b Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787954
Page 158 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.c Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: CH
IL
LS
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.e
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787955
Page 159 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787956
Page 160 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.f Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData 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
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: NEW O
R WORS
ENED M
USCLE
PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787957
Page 161 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.g Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syste
mic symptoms pres
ent on the last day
the Subject Diary
was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787958
Page 162 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2.h Symptom:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Injection Site Reaction:
:RE
DN
ES
S
Were injection site reac
tions present on the last
day the Subject Diary
was completed?:NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787959
Page 163 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site rea
ctions present on the la
st day the Subject Diar
y was completed?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
5.c
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787960
Page 164 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on t
he last day the Subj
ect Diary was compl
eted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-07-2020 10:23:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
NOInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787961
Page 165 of 191
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-07-2020 10:23:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-07-2020 10:23:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-07-2020 10:23:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-07-2020 10:23:47
(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.
Oct-07-2020 10:23:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
YES
Date of Collection:
Oct/7/2020Initial Entry
5.a
Date Location User Value Reason
Oct-07-2020 10:23:52
(UTC-06:00) CentralACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BP9FVKInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787962
Page 166 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Oct-07-2020 10:23:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BP9FVKInitial Entry
5.b
Date Location User Value Reason
Oct-07-2020 10:23:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BP9FVLInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-07-2020 10:23:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BP9FVLInitial Entry
5.c
Date Location User Value Reason
Oct-07-2020 10:24:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BLB1PGInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-07-2020 10:24:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BLB1PGInitial Entry
5.d
Date Location User Value Reason
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787963
Page 167 of 191
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-07-2020 10:24:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BLB1PHInitial Entry
5.d Sample ID
Date Location User Value Reason
Oct-07-2020 10:24:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BLB1PHInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787964
Page 168 of 191
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-02-2021 23:11:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Mar/1/2021Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787965
Page 169 of 191
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-02-2021 23:11:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-02-2021 23:11:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-02-2021 23:12:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-02-2021 23:11:34
(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.
Mar-02-2021 23:11:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
YES
Date of Collection:
Mar/1/2021Initial Entry
5.a
Date Location User Value Reason
Mar-02-2021 23:12:55
(UTC-06:00) CentralACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BR1387Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787966
Page 170 of 191
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Time (US & Canada)
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 23:12:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BR1387Initial Entry
5.b
Date Location User Value Reason
Mar-02-2021 23:13:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BR1388Initial Entry
5.b Sample ID
Date Location User Value Reason
Mar-02-2021 23:13:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BR1388Initial Entry
5.c
Date Location User Value Reason
Mar-02-2021 23:13:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BS7GRNInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-02-2021 23:13:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BS7GRNInitial Entry
5.d
Date Location User Value Reason
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787967
Page 171 of 191
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-02-2021 23:13:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Sample ID: BS7GRPInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-02-2021 23:13:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
BS7GRPInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787968
Page 172 of 191
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 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
Oct-07-2020 10:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
Oct/7/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-07-2020 10:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-07-2020 10:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  William
FernandezData Entry:
COMPLETEDInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787969
Page 173 of 191
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787970
Page 174 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Dec-06-2020
12:40:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Clo
sedEvent of disc
protrusion
occurred after
V3
Dec-03-2020
12:13:45
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
5: An
swere
dWaiting on PI
review.
Nov-24-2020
13:41:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
5: Op
enedClinical SAE
report for
Paresthesia
reports event
'Small Lt central
disc protrusion
T5-T6 with
minimal thecal
sac indentation'.
If subject's MRI
occurred by V3
090177e196ae401b\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-2021-5683-0787971
Page 175 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(reporting
window), please
review for safety
relevance &
update AE CRF
as appropriate
Nov-24-2020
13:39:12
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Clo
sedreworded
Nov-24-2020
13:06:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Clo
sedQuery Closed;
this reported
adverse event
occurred after
V3; not in
reporting period
Nov-24-2020
07:43:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
4: Op
enedClinical On
review of SAE
report for
Paresthesia, an
event 'Small Lt
central disc
protrusion
T5-T6 with
minimal thecal
sac indentation'
was report, yet is
not on AE CRF.
Please review
for clinical
relevance and
update AE CRF
if appropriate
Nov-23-2020
07:57:13
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Rei
ssued:
Open
edCLINICAL -
Currently no
new entry has
been entered for
an AE pertaining
to "large mobile
inguinal lymph
nodes palpable"
090177e196ae401b\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-2021-5683-0787972
Page 176 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-19-2020
17:31:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: An
swere
dWill have PI
update AE log in
source and will
update
accordingly.
Nov-19-2020
15:14:16
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
3: Op
enedCLINICAL On
review of the
SAE report for
Rt. Leg
Paresthesia, an
event of "large
mobile inguinal
lymph nodes
palpable
bilaterally" has
been mentioned,
yet it does not
appear in the
CRF. Please
review for safety
and update AE
log CRF
accordingly.
Nov-17-2020
21:26:33
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Clo
sedDiscrepancy has
been closed.
Nov-17-2020
19:59:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query (autoquery) Query
1: An
swere
dChanged
Information
Nov-17-2020
19:59:55
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Right
Leg P
aresth
esiaChanged
Information
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787973
Page 177 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-17-2020
06:55:34
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Open
edAs per previous
query, please
split the term
into LOWER
BACK PAIN
and
BILATERAL
LOWER
EXTREMITY
PAIN and
RADICULAR
PARESTHESIA
and report as
separate entries
so they can be
coded and
analyzed.
Nov-16-2020
18:59:08
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Candi
dateWaiting for
patient records
Nov-16-2020
17:40:27
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dwaiting for
patient records
Nov-14-2020
14:23:30
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query
2: Clo
sedAppreciate the
prompt
response. Thank
you.
Nov-14-2020
09:52:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Rei
ssued:
Open
edPlease leave
query open until
term is clarified
with patient's
records.
090177e196ae401b\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-2021-5683-0787974
Page 178 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-13-2020
13:06:48
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dWill update
when medical
records are
received and
reviewed.
Nov-13-2020
13:05:42
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dWaiting on
medical records.
Updated SAE
form was sent.
Nov-13-2020
12:37:26
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Giselle Castillo Query
2: Op
enedCLINICAL_
Multiple terms
recorded. Kindly
provide a
final/underlying
diagnosis based
on MRI results
or clinical
assessment if
available. Thank
you.
Nov-12-2020
15:40:03
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS Oracle Query
1: Op
enedMultiple
concepts in the
term LOWER
BACK PAIN
AND
BILATERAL
LOWER
EXTREMITY
PAIN WITH
RADICULAR
PARESTHESIA.
Split the term
into LOWER
BACK PAIN
and
BILATERAL
LOWER
EXTREMITY
PAIN and
RADICULAR
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787975
Page 179 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
PARESTHESIA
and report as
separate entries.
Thank you.
Nov-12-2020
11:13:02
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Lowe
r back
pain a
nd bil
ateral
lower
extre
mity p
ain wi
th radi
cular
parest
hesiaInitial Entry
4. Start Date Time:
Date Location User Value Reason
Nov-16-2020 14:34:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Closed Response satisfies
query
Nov-16-2020 14:29:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered PI feels possible
due to no other
obvious potential
etiologies.
Nov-14-2020 06:14:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Reissued:Opened Please can you
confirm why the PI
felt this was related
to IP? It has began
46 days post dose
2. thanks
Nov-13-2020 13:04:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Start date is
correct.
Nov-13-2020 05:48:45 ACV0PFEINFP6000  Ahmed Query 1: Opened Clin: Lower back
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787976
Page 180 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)Hassan pain and bilateral
lower extremity
pain with radicular
paresthesia: Please
can you review the
start date of this
AE, as currently it
is listed as related
to IP but began 46
days PD2. Thanks
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-05-2021 06:20:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen
GayedQuery 1: Closed Response satisfies
query
Mar-03-2021 16:01:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Still ongoing.
Mar-03-2021 13:45:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Juleen
GayedQuery 1: Opened Clin: Please
confirm if this AE
is still ongoing
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
090177e196ae401b\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)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0787977
Page 181 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Nov-21-2020 14:43:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
Nov-19-2020 17:25:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Answered Test was performed
on 23Oct2020 and
was reported
negative. We will
update the SAE
form.
Nov-19-2020 15:18:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 5: Opened Clinical COVID
test status (yes/no)
during Hosp was
not submitted to the
SAE, as state
13Nov20. Please
submit the
follow-up SAE
form to document
if COVID testing
was performed
(YES/NO or info
not available) and
if yes, the date and
results.
Nov-13-2020 18:08:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for SAE
update with the
requested IP
injection dates
Nov-13-2020 18:07:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Query closed; will
follow for SAE
update with the
requested COVID
test info
090177e196ae401b\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-2021-5683-0787978
Page 182 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-13-2020 13:06:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered SAE form was
corrected.
Nov-13-2020 13:03:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered SAE form updated
Nov-13-2020 08:01:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened Clinical COVID
test status (yes/no)
during Hosp was
not reported in the
SAE. Please submit
a follow-up SAE
form [#10181159]
to document if
COVID testing was
performed
(YES/NO or info
not available) and
if yes, the date and
results.
Nov-13-2020 08:00:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened CLINICAL - Per
CRF, Inj #1 given
on 8/14 and Inj #2
on 9/4; however, in
SAE Inj #1 given
on 8/12 and Inj #2
on 9/1. Please
review, harmonize
reporting and
update in
appropriate
location.
Nov-13-2020 04:07:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 11:13:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Nov-12-2020 11:13:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associateNew Information
090177e196ae401b\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), 
(b) (6)
FDA-CBER-2021-5683-0787979
Page 183 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
d with congenital anomaly or
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
NO
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threa
tening?
NO
Other medically important se
rious event
YES
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes', but
at least one
seriousness criteria
is missing. Please
review and update
as appropriate.
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Lower back
pain and bilateral
lower extremity
pain with radicular
paresthesia:
Response to "Is the
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787980
Page 184 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Other medically important se
rious event
YESInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0787981
Page 185 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae401b\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-2021-5683-0787982
Page 186 of 191
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Nov-12-2020 11:13:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Nov-13-2020 04:07:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020447492Initial Entry
090177e196ae401b\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-2021-5683-0787983
Page 187 of 191
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-06-2021 13:47:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787984
Page 188 of 191
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION - eCRF Audit
Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Jan-22-2021 12:02:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return for
Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2Transcription Error
Jan-06-2021 13:47:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR otherwi
se not eligibleInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787985
Page 189 of 191
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail History
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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-06-2021 13:46:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Jan-06-2021 13:46:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILITY FOR AD
DITIONAL VACCINATIONInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787986
Page 190 of 191
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
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: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-07-2020 10:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-14-2020 12:55:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-14-2020 12:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Oct-07-2020 10:26:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Oct/7/2020Initial Entry
Aug-14-2020 12:55:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
Aug-14-2020 12:41:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/14/2020Initial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4)
FDA-CBER-2021-5683-0787987
Page 191 of 191
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1018 Site Name: (1018) Texas Center For Drug Development, Inc.
Subject No: 10181159 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Oct-12-2020 14:16:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae401b\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0787988