125742 S1 M5 CRF c4591001 1084 10841141

Document text

Page 1 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5,
STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
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FDA-CBER-2021-5683-0960977
Page 2 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/12/2020
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FDA-CBER-2021-5683-0960978
Page 3 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Demography
1.Subject ID [10841141]
2.Birth Date: /1968
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
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(b) (6)
(b) (4)
FDA-CBER-2021-5683-0960979
Page 4 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
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(b) (4)
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Page 5 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Study eligibility requires subjects to meet all inclusion criteria (YES) and Not meet exclusion criteria (NO).
Inclusion Criteria
1.aInclusion Number: 1
Criterion Description: Male or female participants between the ages of 18 and 55 years, inclusive, 65 and
85 years, inclusive, or 18 and 85 years, inclusive, at randomization (dependent
upon study stage)
Criterion met? YES
Criterion ID: (For Pfizer use only) IN01A00
1.bInclusion Number: 2
Criterion Description: Participants who are willing and able to comply with all scheduled visits,
vaccination plan, laboratory tests, lifestyle considerations, and other study
procedures
Criterion met? YES
Criterion ID: (For Pfizer use only) IN02A00
1.cInclusion Number: 3
Criterion Description: Healthy participants who are determined by medical history, physical
examination, and clinical judgment of the investigator to be eligible for inclusion
in the study
Criterion met? YES
Criterion ID: (For Pfizer use only) IN03A00
1.dInclusion Number: 4
Criterion Description: Capable of giving personal signed informed consent, which includes compliance
with the requirements and restrictions listed in the ICD and in this protocol
Criterion met? YES
Criterion ID: (For Pfizer use only) IN04A00
Exclusion Criteria
2.aExclusion Number: 1
Criterion Description: Other medical or psychiatric condition incl. recent (within past year) or active
suicidal ideation/behavior/lab abnormality that may increase the risk of study
participation
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Page 6 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
2.bExclusion Number: 2
Criterion Description: Known infection with human immunodeficiency virus (HIV), hepatitis C virus
(HCV), or hepatitis B virus (HBV)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX02A00
2.cExclusion Number: 3
Criterion Description: History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s)
Criterion met? NO
Criterion ID: (For Pfizer use only) EX03A00
2.dExclusion Number: 4
Criterion Description: Receipt of medications intended to prevent COVID-19
Criterion met? NO
Criterion ID: (For Pfizer use only) EX04A00
2.eExclusion Number: 8
Criterion Description: Immunocompromised individuals with known or suspected immunodeficiency, as
determined by history and/or laboratory/physical examination
Criterion met? NO
Criterion ID: (For Pfizer use only) EX08A00
2.fExclusion Number: 10
Criterion Description: Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection
Criterion met? NO
Criterion ID: (For Pfizer use only) EX10A00
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(b) (4)
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Page 7 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
2 hExclusion Number: 12
Criterion Description: Previous vaccination with any coronavirus vaccine
Criterion met? NO
Criterion ID: (For Pfizer use only) EX12A00
2.iExclusion Number: 13
Criterion Description: Subjects who receive immunosuppressive therapy, such as cytotoxic agents or
systemic corticosteroids
Criterion met? NO
Criterion ID: (For Pfizer use only) EX13A01
2.jExclusion Number: 15
Criterion Description: Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study
Criterion met? NO
Criterion ID: (For Pfizer use only) EX14A01
2 kExclusion Number: 16
Criterion Description: Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation
Criterion met? NO
Criterion ID: (For Pfizer use only) EX15A01
2.lExclusion Number: 17
Criterion Description: Previous participation in other studies involving study intervention containing
lipid nanoparticles
Criterion met? NO
Criterion ID: (For Pfizer use only) EX16A01
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(b) (4)
FDA-CBER-2021-5683-0960983
Page 8 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.mExclusion Number: 22
Criterion Description: Investigator site staff or Pfizer employees directly involved in the conduct of the
study, site staff otherwise supervised by the investigator, and their respective
family members
Criterion met? NO
Criterion ID: (For Pfizer use only) EX21A01
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(b) (4)
FDA-CBER-2021-5683-0960984
Page 9 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
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FDA-CBER-2021-5683-0960985
Page 10 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Seasonal Allergies]
Start Date: UNK/UNK/2000
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[GERD]
Start Date: UNK/UNK/2000
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colonoscopy]
Start Date: UNK/UNK/2013
Ongoing: NO
End Date:
UNK/UNK/2013
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Colonoscopy]
Start Date: UNK/UNK/2019
Ongoing: NO
End Date:
UNK/UNK/2019
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(b) (4)
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Page 11 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Vasectomy]
Start Date: UNK/UNK/2007
Ongoing: NO
End Date:
UNK/UNK/2007
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Myopia]
Start Date: UNK/UNK/1980
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Biliary Hyperkinesis]
Start Date: May/UNK/2020
Ongoing: YES
1 hLine/MH Number: [8]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hemorrhoids]
Start Date: UNK/UNK/2000
Ongoing: YES
1.iLine/MH Number: [9]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left foot 4th metatarsal fracture]
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/2004
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(b) (4)
FDA-CBER-2021-5683-0960987
Page 12 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.jLine/MH Number: [10]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[acne]
Start Date: UNK/UNK/1980
Ongoing: YES
1 kLine/MH Number: [11]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[dry skin]
Start Date: UNK/UNK/1980
Ongoing: YES
1.lLine/MH Number: [12]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[athletes foot]
Start Date: UNK/UNK/1980
Ongoing: YES
1.mLine/MH Number: [13]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[prostatitis]
Start Date: Oct/UNK/2017
Ongoing: NO
End Date:
Oct/UNK/2017
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(b) (4)
FDA-CBER-2021-5683-0960988
Page 13 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [87.1]
3.Unit: kg
4.Height: [185.4]
5.Unit: cm
6.Body Mass Index: [25.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [36.6]
Unit: C
Temperature Location: ORAL CAVITY
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Page 14 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [47794]
3.Randomization Group: [ ]
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(b) (4)
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Page 15 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BPFTBC]
5.bSample ID [BPFTBD]
5.cSample ID [BP6RNN]
5.dSample ID [BP6RNP]
5.eSample ID [BP6RNR]
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(b) (4)
FDA-CBER-2021-5683-0960991
Page 16 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/12/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP6RMX]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960992
Page 17 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/12/2020 14:29
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
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(b) (4)
FDA-CBER-2021-5683-0960993
Page 18 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
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(b) (4)
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Page 19 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/2/2020
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960995
Page 20 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960996
Page 21 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960997
Page 22 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vital Signs
1.Date: Sep/2/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [36.7]
Unit: C
Temperature Location: ORAL CAVITY
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960998
Page 23 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/2/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKMZJT]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0960999
Page 24 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/2/2020 12:01
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
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961000
Page 25 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/30/2020
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961001
Page 26 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961002
Page 27 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961003
Page 28 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/30/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BKZ9MH]
5.bSample ID [BKZ9MJ]
5.cSample ID [BP8PRN]
5.dSample ID [BP8PRP]
5.eSample ID [BP8PRR]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961004
Page 29 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961005
Page 30 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Feb/24/2021
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 [BR0T9P]
5.bSample ID [BR0T9R]
5.cSample ID [BR0T9S]
5.dSample ID [BSDKMS]
5.eSample ID [BSDKMT]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961006
Page 31 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961007
Page 32 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961008
Page 33 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961009
Page 34 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961010
Page 35 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961011
Page 36 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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: [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961012
Page 37 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961013
Page 38 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961014
Page 39 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
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?
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961015
Page 40 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained for
Potential COVID-19 Illness?
3.Toxicity Grade:
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961016
Page 41 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961017
Page 42 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961018
Page 43 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961019
Page 44 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Unplanned Assessments
1.Assessments
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961020
Page 45 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/30/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961021
Page 46 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961022
Page 47 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961023
Page 48 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961024
Page 49 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#CategoryAE Identifi
erAdverse Ev
entStart DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Appendicitis
 Dec/20/2020 UNK:U
NK NO
End Date Time:
Dec/22/2020 UNK:UNK
 Repeating
Pages
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961025
Page 50 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Appendicitis]
4.Start Date Time: Dec/20/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Dec/22/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961026
Page 51 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment s), this event is due to:
OTHER
If Other, specify:
[Appendicitis]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[2020509001]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961027
Page 52 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm Instance
 1.          Repeating
Pages
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961028
Page 53 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961029
Page 54 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medic
ationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961030
Page 55 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961031
Page 56 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961032
Page 57 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961033
Page 58 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifie
dTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961034
Page 59 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961035
Page 60 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961036
Page 61 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961037
Page 62 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961038
Page 63 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961039
Page 64 of 185
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961040
Page 65 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961041
Page 66 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961042
Page 67 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961043
Page 68 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961044
Page 69 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961045
Page 70 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961046
Page 71 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/22/2021
2.Erroneous Visit
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961047
Page 72 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination 1/2
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961048
Page 73 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/22/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961049
Page 74 of 185
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961050
Page 75 of 185
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961051
Page 76 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/30/2020
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961052
Page 77 of 185
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961053
Page 78 of 185
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Douglas
Denham Approved Mar-11-2021 11:02:08 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DouglasDenham, 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.
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961054
Page 79 of 185
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
Name Signature
MeaningDate Type Action
Douglas
Denham Approved Mar-11-2021 11:02:08 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DouglasDenham, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Jan-25-2021 16:14:31 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Jan-22-2021 18:29:55 (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-07-2021 17:17:09 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Douglas
Denham Approved Oct-09-2020 13:41:22 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961055
Page 80 of 185
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Affidavit:
By my dated signature below, I, DouglasDenham, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Oct-05-2020 12:08:42 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Douglas
Denham Approved Oct-02-2020 08:33:12 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DouglasDenham, verify that all case report form pages accurately display the results of the
examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic
signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-30-2020 11:49:50 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Douglas
Denham Approved Sep-10-2020 14:40:57 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, DouglasDenham, 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.
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961056
Page 81 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-12-2020 16:45:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
30 JUN 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-12-2020 16:45:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961057
Page 82 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 16:45:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/12/2020Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961058
Page 83 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-12-2020 16:44:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10841141Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 16:44:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1968Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-12-2020 16:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 16:45:36
(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-12-2020 16:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961059
Page 84 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-12-2020 16:45:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961060
Page 85 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclus
ion N
umbe
r:1
Criter
ion D
escrip
tion:Male or female participa
nts between the ages of 1
8 and 55 years, inclusive,
65 and 85 years, inclusiv
e, or 18 and 85 years, inc
lusive, at randomization (
dependent upon study sta
ge)
Criter
ion m
et?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants betw
een the ages of 18 and 55 years, i
nclusive, 65 and 85 years, inclusi
ve, or 18 and 85 years, inclusive,Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961061
Page 86 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
at randomization (dependent upo
n study stage)
1.a Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.a Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criter
ion De
scripti
on:Participants who are will
ing and able to comply
with all scheduled visits,
vaccination plan, laborat
ory tests, lifestyle consid
erations, and other study
procedures
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN02A00Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961062
Page 87 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b Inclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participants who are willing and
able to comply with all scheduled
visits, vaccination plan, laborator
y tests, lifestyle considerations, a
nd other study proceduresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclus
ion Nu
mber:3Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961063
Page 88 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Healthy participants who
are determined by medic
al history, physical exam
ination, and clinical judg
ment of the investigator t
o be eligible for inclusio
n in the study
Criter
ion me
t?:YES
Criter
ion ID
: (For
Pfizer
use on
ly):IN03A00
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961064
Page 89 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.c Inclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants who are dete
rmined by medical history, physic
al examination, and clinical judg
ment of the investigator to be elig
ible for inclusion in the studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:4Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961065
Page 90 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Capable of giving perso
nal signed informed con
sent, which includes co
mpliance with the requir
ements and restrictions l
isted in the ICD and in t
his protocol
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN04A00
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961066
Page 91 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.d Inclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signe
d informed consent, which includ
es compliance with the requireme
nts and restrictions listed in the I
CD and in this protocolInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
2.a
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclu
sion N
umbe
r:1Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961067
Page 92 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criter
ion De
scripti
on:Other medical or psychia
tric condition incl. recent
(within past year) or acti
ve suicidal ideation/beha
vior/lab abnormality that
may increase the risk of
study participation
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX01A00
2.a Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric con
dition incl. recent (within past ye
ar) or active suicidal ideation/beh
avior/lab abnormality that may in
crease the risk of study participati
onInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961068
Page 93 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:2
Criterio
n Descri
ption:Known infection with
human immunodeficie
ncy virus (HIV), hepati
tis C virus (HCV), or h
epatitis B virus (HBV)
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX02A00Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961069
Page 94 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.b Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human im
munodeficiency virus (HIV), hep
atitis C virus (HCV), or hepatitis
B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:3Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961070
Page 95 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:History of severe advers
e reaction associated wit
h a vaccine and/or sever
e allergic reaction (eg, a
naphylaxis) to any comp
onent of the study interv
ention(s)
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX03A00
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961071
Page 96 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.c Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
History of severe adverse reactio
n associated with a vaccine and/o
r severe allergic reaction (eg, ana
phylaxis) to any component of th
e study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion N
umber:4
Criterion D
escription:Receipt of medicat
ions intended to pr
event COVID-19
Criterion m
et?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961072
Page 97 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion ID
: (For Pfizer
use only):EX04A00
2.d Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended t
o prevent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:8Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961073
Page 98 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Immunocompromised in
dividuals with known or
suspected immunodefici
ency, as determined by
history and/or laborator
y/physical examination
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only)
:EX08A00
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961074
Page 99 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.e Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals
with known or suspected immuno
deficiency, as determined by hist
ory and/or laboratory/physical ex
aminationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:10Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961075
Page 100 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criteri
on Des
criptio
n:Bleeding diathesis or co
ndition associated with
prolonged bleeding that
would, in the opinion of
the investigator, contrain
dicate intramuscular inje
ction
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX10A00
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961076
Page 101 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.f Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition as
sociated with prolonged bleeding
that would, in the opinion of the i
nvestigator, contraindicate intram
uscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:11
Criterion Des
cription:Women who are
pregnant or brea
stfeeding
Criterion met
?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961077
Page 102 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion ID:
(For Pfizer us
e only):EX11A00
2.g Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or brea
stfeedingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion N
umber:12
Criterion De
scription:Previous vaccinat
ion with any coro
navirus vaccineInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961078
Page 103 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterion me
t?:NO
Criterion ID
: (For Pfizer
use only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any co
ronavirus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:13Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961079
Page 104 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n Descri
ption:Subjects who receive i
mmunosuppressive th
erapy, such as cytotoxi
c agents or systemic c
orticosteroids
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only
):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive immunosup
pressive therapy, such as cytotoxi
c agents or systemic corticosteroi
dsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.i Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961080
Page 105 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclus
ion Nu
mber:15
Criteri
on Des
criptio
n:Receipt of blood/plasma
products or immunoglob
ulin, from 60 days befor
e study intervention adm
inistration or planned re
ceipt throughout the stu
dy
Criteri
on met
?:NO
Criteri
on ID:
(For P
fizer u
se only
):EX14A01Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961081
Page 106 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.j Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products
or immunoglobulin, from 60 days
before study intervention adminis
tration or planned receipt through
out the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961082
Page 107 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
2.k
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:16
Criteri
on Desc
ription:Participation in other st
udies involving study i
ntervention within 28 d
ays prior to study entry
and/or during study par
ticipation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer use
only):EX15A01Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961083
Page 108 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.k Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participation in other studies inv
olving study intervention within
28 days prior to study entry and/
or during study participationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.k Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:17
Criterio
n Descri
ption:Previous participation
in other studies involv
ing study intervention
containing lipid nano
particlesInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961084
Page 109 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX16A01
2.l Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Previous participation in other st
udies involving study interventio
n containing lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.l Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) CentralACV0PFEINFP6000  Data Entry:
Exclu22Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0961085
Page 110 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) sion N
umbe
r:
Criter
ion D
escrip
tion:Investigator site staff or
Pfizer employees directl
y involved in the conduc
t of the study, site staff o
therwise supervised by t
he investigator, and their
respective family memb
ers
Criter
ion m
et?:NO
Criter
ion ID
: (For
Pfizer
use on
ly):EX21A01
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961086
Page 111 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - eCRF Audit Trail
History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.m Exclusion Number:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer e
mployees directly involved in the
conduct of the study, site staff ot
herwise supervised by the investi
gator, and their respective family
membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.m Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-12-2020 16:46:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961087
Page 112 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-12-2020 16:46:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-12-2020 16:46:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-12-2020 16:46:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961088
Page 113 of 185
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.a
Date Location User Value Reason
Aug-12-2020 16:46:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:1
Medical History T
erm:Seasonal Aller
gies
Start Date: UNK/UNK/20
00
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:46:51
(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-12-2020 16:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Seasonal AllergiesInitial Entry
1.a Start Date:
Date Location User Value Reason
Aug-12-2020 16:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.a Ongoing:
Date Location User Value Reason
Aug-12-2020 16:46:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961089
Page 114 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.b
Date Location User Value Reason
Aug-12-2020 16:47:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 2
Medical History Te
rm:GERD
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:47:06
(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-12-2020 16:47:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
GERDInitial Entry
1.b Start Date:
Date Location User Value Reason
Aug-12-2020 16:47:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.b Ongoing:
Date Location User Value Reason
Aug-12-2020 16:47:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961090
Page 115 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-12-2020 16:47:55
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:3
Medical History
Term:Colonoscopy
Start Date: UNK/UNK/201
3
Ongoing: NO
End Date:
UNK/UNK/
2013Initial Entry
1.c Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:47:55
(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-12-2020 16:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ColonoscopyInitial Entry
1.c Start Date:
Date Location User Value Reason
Aug-12-2020 16:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2013Initial Entry
1.c Ongoing:
Date Location User Value Reason
Aug-12-2020 16:47:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2013Initial Entry
1.d
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961091
Page 116 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-12-2020 16:48:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:4
Medical History
Term:Colonoscopy
Start Date: UNK/UNK/201
9
Ongoing: NO
End Date:
UNK/UNK/
2019Initial Entry
1.d Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:48:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 16:48:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ColonoscopyInitial Entry
1.d Start Date:
Date Location User Value Reason
Aug-12-2020 16:48:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Aug-12-2020 16:48:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2019Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961092
Page 117 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.e
Date Location User Value Reason
Aug-12-2020 16:49:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:5
Medical History
Term:Vasectomy
Start Date: UNK/UNK/200
7
Ongoing: NO
End Date:
UNK/UNK/
2007Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961093
Page 118 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.e Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:49:13
(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-12-2020 16:49:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VasectomyInitial Entry
1.e Start Date:
Date Location User Value Reason
Aug-12-2020 16:49:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2007Initial Entry
1.e Ongoing:
Date Location User Value Reason
Aug-12-2020 16:49:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2007Initial Entry
1.f
Date Location User Value Reason
Aug-12-2020 16:49:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Te
rm:Myopia
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961094
Page 119 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.f Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:49:44
(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-12-2020 16:49:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MyopiaInitial Entry
1.f Start Date:
Date Location User Value Reason
Aug-12-2020 16:49:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.f Ongoing:
Date Location User Value Reason
Aug-12-2020 16:49:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Aug-12-2020 16:50:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:7
Medical History
Term:Biliary Hyperki
nesis
Start Date: May/UNK/202
0
Ongoing: YESInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961095
Page 120 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.g Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:50:16
(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-12-2020 16:50:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Biliary HyperkinesisInitial Entry
1.g Start Date:
Date Location User Value Reason
Aug-12-2020 16:50:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
May/UNK/2020Initial Entry
1.g Ongoing:
Date Location User Value Reason
Aug-12-2020 16:50:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.h
Date Location User Value Reason
Aug-12-2020 16:50:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 8
Medical History Te
rm:Hemorrhoids
Start Date: UNK/UNK/2
000
Ongoing: YESInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961096
Page 121 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.h Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:50:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
8Initial Entry
1.h Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 16:50:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HemorrhoidsInitial Entry
1.h Start Date:
Date Location User Value Reason
Aug-12-2020 16:50:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2000Initial Entry
1.h Ongoing:
Date Location User Value Reason
Aug-12-2020 16:50:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.i
Date Location User Value Reason
Aug-14-2020 11:40:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Nu
mber:9
Medical Hist
ory Term:left foot 4th metat
arsal fracture
Start Date: UNK/UNK/2004
Ongoing: NO
End Date:
UNK/UNK/20
04Transcription Error
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961097
Page 122 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-12-2020 16:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:9
Medical Histor
y Term:left foot 4th met
atarsal
Start Date: UNK/UNK/200
4
Ongoing: NO
End Date:
UNK/UNK/
2004Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961098
Page 123 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
1.i Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:51:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
9Initial Entry
1.i Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-14-2020
13:00:58
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Clos
edDiscrepancy has
been closed.
Aug-14-2020
11:40:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredTranscription
Error
Aug-14-2020
11:40:29
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
left foot 4th m
etatarsal fractu
reTranscription
Error
Aug-13-2020
06:37:21
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery 1: Open
edClarify LEFT
FOOT 4TH
METATARSAL
as follows...Site
only term.
Specify the
corresponding
symptom,
diagnosis or
procedure being
reported and edit
the verbatim
accordingly.
Thank you.
Aug-12-2020
16:51:17
(UTC-06:00)
Central TimeACV0PFEINFP6000  Data Entry:
left foot 4th m
etatarsalInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961099
Page 124 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
(US & Canada)
1.i Start Date:
Date Location User Value Reason
Aug-12-2020 16:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2004Initial Entry
1.i Ongoing:
Date Location User Value Reason
Aug-12-2020 16:51:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2004Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961100
Page 125 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1.j
Date Location User Value Reason
Aug-12-2020 16:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 10
Medical History T
erm:acne
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.j Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:55:05
(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-12-2020 16:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
acneInitial Entry
1.j Start Date:
Date Location User Value Reason
Aug-12-2020 16:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.j Ongoing:
Date Location User Value Reason
Aug-12-2020 16:55:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.k
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961101
Page 126 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Aug-12-2020 16:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 11
Medical History T
erm:dry skin
Start Date: UNK/UNK/1
980
Ongoing: YESInitial Entry
1.k Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11Initial Entry
1.k Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 16:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
dry skinInitial Entry
1.k Start Date:
Date Location User Value Reason
Aug-12-2020 16:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.k Ongoing:
Date Location User Value Reason
Aug-12-2020 16:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.l
Date Location User Value Reason
Aug-12-2020 16:55:34
(UTC-06:00) CentralACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 12Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961102
Page 127 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Time (US & Canada) Medical History T
erm:athletes foot
Start Date: UNK/UNK/1
980
Ongoing: YES
1.l Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
12Initial Entry
1.l Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
athletes footInitial Entry
1.l Start Date:
Date Location User Value Reason
Aug-12-2020 16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.l Ongoing:
Date Location User Value Reason
Aug-12-2020 16:55:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.m
Date Location User Value Reason
Aug-12-2020 16:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:13
Medical History T
erm:prostatitisInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961103
Page 128 of 185
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Start Date: Oct/UNK/2017
Ongoing: NO
End Date:
Oct/UNK/2
017
1.m Line/MH Number:
Date Location User Value Reason
Aug-12-2020 16:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
13Initial Entry
1.m Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Aug-12-2020 16:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
prostatitisInitial Entry
1.m Start Date:
Date Location User Value Reason
Aug-12-2020 16:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/UNK/2017Initial Entry
1.m Ongoing:
Date Location User Value Reason
Aug-12-2020 16:56:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Oct/UNK/2017Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961104
Page 129 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
87.1Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
kgInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
185.4Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
cmInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
25.3Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961105
Page 130 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7.a
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.6
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-12-2020 16:56:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961106
Page 131 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 16:57:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 16:57:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
47794Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961107
Page 132 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 17:19:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 17:19:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 17:19:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 17:19:17
(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-12-2020 17:19:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 17:19:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPFTBCInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961108
Page 133 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 17:19:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPFTBCInitial Entry
5.b
Date Location User Value Reason
Aug-12-2020 17:19:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPFTBDInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020 17:19:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPFTBDInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020 17:20:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6RNNInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-12-2020 17:20:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6RNNInitial Entry
5.d
Date Location User Value Reason
Aug-12-2020 17:20:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6RNPInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961109
Page 134 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Aug-12-2020 17:20:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6RNPInitial Entry
5.e
Date Location User Value Reason
Aug-12-2020 17:20:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6RNRInitial Entry
5.e Sample ID
Date Location User Value Reason
Aug-12-2020 17:20:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP6RNRInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961110
Page 135 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 17:18:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 17:18:33
(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-12-2020 17:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 17:18:33
(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-12-2020 17:18:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
Aug-14-2020 09:17:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6RMXScanner
malfunction
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961111
Page 136 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-12-2020 17:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP6RMXInitial Entry
5.a Sample ID
Date Location User ValueReason
Aug-14-2020
13:29:43
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_BEETRK001_02
Aug-14-2020
09:17:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dScanner malfunction
Aug-14-2020
09:17:37
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP6R
MXScanner malfunction
Aug-14-2020
02:24:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Op
enedDMW4184431;Barcode
contains blank Space
which is not the correct
format. Please review
and correct as
appropriate.
Aug-12-2020
17:18:49
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
BP6R
MXInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0961112
Page 137 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-12-2020 16:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 16:57:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 16:57:39
(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-12-2020 16:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 14:29Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 16:57:39
(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-12-2020 16:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961113
Page 138 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Aug-12-2020 16:57:39
(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-12-2020 16:57:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-12-2020 16:57:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961114
Page 139 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-12-2020 16:57:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-D
IARY COLLECTED FOR THIS
SUBJECTInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961115
Page 140 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-02-2020 12:40:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961116
Page 141 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GUInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961117
Page 142 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961118
Page 143 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.c Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961119
Page 144 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961120
Page 145 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.f Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E 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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961121
Page 146 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.h
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961122
Page 147 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961123
Page 148 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-02-2020 12:41:18
(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-02-2020 12:41:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961124
Page 149 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date:
Date Location User Value Reason
Sep-02-2020 12:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Initial Entry
2.a
Date Location User Value Reason
Sep-02-2020 12:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:
:1
Temperature: 36.7
Temperature Unit
:C
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-02-2020 12:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-02-2020 12:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
36.7Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-02-2020 12:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961125
Page 150 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.a Temperature Location:
Date Location User Value Reason
Sep-02-2020 12:41:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961126
Page 151 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-02-2020 12:57:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-02-2020 12:57:31
(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-02-2020 12:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-02-2020 12:57:31
(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-02-2020 12:57:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/2/2020Initial Entry
5.a
Date Location User Value Reason
Sep-02-2020 12:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKMZJTInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961127
Page 152 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 12:57:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKMZJTInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961128
Page 153 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-02-2020 12:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-02-2020 12:42:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-02-2020 12:42:20
(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-02-2020 12:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020 12:01Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-02-2020 12:42:20
(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-02-2020 12:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961129
Page 154 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
7. Route:
Date Location User Value Reason
Sep-02-2020 12:42:20
(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-02-2020 12:42:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OB
SERVATION 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-02-2020 12:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961130
Page 155 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-30-2020 11:49:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961131
Page 156 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GUInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961132
Page 157 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
E
Were fever or systemic sy
mptoms present on the las
t day the Subject Diary w
as completed?:NO
2.b Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961133
Page 158 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.c Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic sy
mptoms present on the last
day the Subject Diary was
completed?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961134
Page 159 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RR
HE
A
Were fever or systemic sy
mptoms present on the la
st day the Subject Diary
was completed?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961135
Page 160 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.f Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED MU
SCLE PA
IN
Were fever or syste
mic symptoms prese
nt on the last day th
e Subject Diary was
completed?:NOInitial Entry
2.g Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCL
E 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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961136
Page 161 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
2.h
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSE
NED JOI
NT PAIN
Were fever or system
ic symptoms present
on the last day the S
ubject Diary was co
mpleted?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT P
AINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961137
Page 162 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactio
ns present on the last day
the Subject Diary was co
mpleted?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SW
ELL
ING
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961138
Page 163 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reactio
n::PAIN A
T INJE
CTION
SITE
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-30-2020 11:52:09
(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-30-2020 11:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961139
Page 164 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-01-2020 10:57:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-01-2020 10:57:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-01-2020 10:57:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-01-2020 10:57:50
(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-01-2020 10:57:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/30/2020Initial Entry
5.a
Date Location User Value Reason
Oct-01-2020 10:57:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKZ9MHInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961140
Page 165 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.a Sample ID
Date Location User Value Reason
Oct-01-2020 10:57:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKZ9MHInitial Entry
5.b
Date Location User Value Reason
Oct-01-2020 10:58:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BKZ9MJInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-01-2020 10:58:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BKZ9MJInitial Entry
5.c
Date Location User Value Reason
Oct-01-2020 12:03:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8PRNInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-01-2020 12:03:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8PRNInitial Entry
5.d
Date Location User Value Reason
Oct-01-2020 12:03:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8PRPInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961141
Page 166 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5.d Sample ID
Date Location User Value Reason
Oct-01-2020 12:03:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8PRPInitial Entry
5.e
Date Location User Value Reason
Oct-01-2020 12:04:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP8PRRInitial Entry
5.e Sample ID
Date Location User Value Reason
Oct-01-2020 12:04:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP8PRRInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961142
Page 167 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-26-2021 09:46:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961143
Page 168 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-26-2021 09:46:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-26-2021 09:46:53
(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 14:05:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-01-2021 05:14:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Feb-26-2021 09:46:53
(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.
Feb-26-2021 09:46:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Feb/24/2021Initial Entry
5.a
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0961144
Page 169 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-02-2021 14:05:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0T9PInitial Entry
5.a Sample ID
Date Location User Value Reason
Mar-02-2021 14:05:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0T9PInitial Entry
5.b
Date Location User Value Reason
Mar-02-2021 14:05:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0T9RInitial Entry
5.b Sample ID
Date Location User Value Reason
Mar-02-2021 14:05:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0T9RInitial Entry
5.c
Date Location User Value Reason
Mar-02-2021 14:05:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR0T9SInitial Entry
5.c Sample ID
Date Location User Value Reason
Mar-02-2021 14:05:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR0T9SInitial Entry
5.d
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961145
Page 170 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Date Location User Value Reason
Mar-02-2021 14:05:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSDKMSInitial Entry
5.d Sample ID
Date Location User Value Reason
Mar-02-2021 14:05:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSDKMSInitial Entry
5.e
Date Location User Value Reason
Mar-02-2021 14:05:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSDKMTInitial Entry
5.e Sample ID
Date Location User Value Reason
Mar-02-2021 14:05:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSDKMTInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961146
Page 171 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-05-2020 12:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Transcription Error
Sep-30-2020 12:06:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/2/2020Transcription Error
Sep-30-2020 12:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/30/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-30-2020 12:00:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Sep-30-2020 12:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) 
(6)
(b) (4)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961147
Page 172 of 185
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961148
Page 173 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Category:
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-07-2021 17:17:09
(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 Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
AppendicitisInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-07-2021 17:17:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-07-2021 17:17:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/20/2020 UNK:UNKTranscription Error
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Appendicitis
Start Date 20/Dec
/2021, is a future
date relative to when
it was entered on
07/Jan/2021. Please
correct.
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/20/2021 UNK:UNKInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961149
Page 174 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-07-2021 17:17:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Jan-07-2021 17:17:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/22/2020 UNK:UNKTranscription Error
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For Appendicitis
End Date 22/Dec
/2021, is a future
date relative to when
it was entered on
07/Jan/2021. Please
correct.
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or significant
disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize subject and may
require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Feb-25-2021 22:50:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0961150
Page 175 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Feb-22-2021 12:03:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered no
Jan-22-2021 07:49:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020509001] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Jan-21-2021 19:44:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Candidate Clinical COVID test
status (yes/no)
during Hosp was not
reported in the SAE.
Please submit a
follow-up SAE form
[#2020509001] to
document if COVID
testing was
performed (YES/NO
or info not available)
and if yes, the date
and results.
Jan-08-2021 03:18:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Appendicitis:
Response to "Is the
adverse event
serious?" is 'Yes' but
"Serious Adverse
Event Number" is
blank.
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associate
d with congenital anomaly orInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4), (b) 
(6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0961151
Page 176 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
birth defect?
NO
Did this serious event result i
n death?
NO
Did this serious event require
or prolong hospitalization?
YES
Did this serious event result i
n persistent or significant disa
bility/incapacity?
NO
Is this serious event life threat
ening?
NO
Other medically important ser
ious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-07-2021 17:17:09
(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
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treatment(
s), this event is due to:Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961152
Page 177 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
OTHER
If Other, specify:
Appendicitis
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Jan-07-2021 17:17:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-07-2021 17:17:09
(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
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (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-2021-5683-0961153
Page 178 of 185
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Jan-08-2021 03:18:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020509001Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961154
Page 179 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-02-2021 13:46:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961155
Page 180 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Feb-23-2021 15:07:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is willing to return fo
r Vaccination 3
Participant is:
eligible and NOT confirmed t
o have received only placebo
at Vaccination 1/2completed
Jan-25-2021 16:14:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Participant is NOT willing to ret
urn for Vaccination 3 OR otherw
ise not eligibleInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0961156
Page 181 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Jan-25-2021 16:14:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/22/2021Initial Entry
2. Primary Reason for Unblinding:
Date Location User ValueReason
Feb-23-2021
21:51:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Clo
sedAuto closed by
Validation Check:
VC_DS001_35
Feb-23-2021
15:08:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Ans
weredcompleted
Feb-22-2021
09:36:25
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  DMW QUERY Query
1: Ope
nedDMW7349701;Primary
Reason for Unblinding
is "ASSESS
ELIGIBILITY FOR
ADDITIONAL
VACCINATION", but
"Participant is willing
to return for
Vaccination 3" is not
selected in the Further
Vaccination
Confirmation CRF.
Please review and
update as appropriate.
Jan-25-2021
16:14:31
(UTC-06:00)
Central Time
(US &ACV0PFEINFP6000  Data
Entry
:
ASSE
SS ELInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) (6)
(b) (4), (b) 
(6)
(b) (4)
(b) (4)
(b) (4)
(b) 
(4), 
(b) (6)
FDA-CBER-2021-5683-0961157
Page 182 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Canada) IGIBI
LITY
FOR
ADDI
TION
AL V
ACCI
NATI
ON
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961158
Page 183 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Subject Status
Date Location User Value Reason
Jan-22-2021 22:07:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Jan-20-2021 14:12:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered complete
Dec-25-2020 10:12:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened CLINICAL A SAE
(#2020509001) of
Appendicitis has
been submitted;
please enter the
event on the AE
CRF
Sep-30-2020 12:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-12-2020 16:57:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-12-2020 16:46:16
(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-05-2020 12:08:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/30/2020Transcription Error
Sep-30-2020 12:06:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/2/2020Transcription Error
Sep-30-2020 12:00:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sep/30/2020Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), (b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) 
(6)
(b) (4)
FDA-CBER-2021-5683-0961159
Page 184 of 185
***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: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Aug-12-2020 16:57:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
Aug-12-2020 16:46:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4)
FDA-CBER-2021-5683-0961160
Page 185 of 185
***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, Signed, Verified
Site No: 1084 Site Name: (1084) Clinical Trials of Texas
Subject No: 10841141 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 10:22
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-10-2020 14:07:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Click Here to EnableInitial Entry
090177e196ae3f87\Final\Final On: 01-Apr-2021 05:18 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0961161