125742 S1 M5 CRF c4591001 1142 11421032

Document text

Page 1 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE 3
option is equivalent to PHASE 2/3.
1.Select appropriate response - Protocol
version30 JUN 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986279
Page 2 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Aug/3/2020
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986280
Page 3 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11421032]
2.Birth Date: /1950
3.Sex: MALE
4.Ethnicity: HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986281
Page 4 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/3/2020
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986282
Page 5 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
Criterion met? NO
Criterion ID: (For Pfizer use only) EX01A00
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986283
Page 6 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
2.gExclusion Number: 11
Criterion Description: Women who are pregnant or breastfeeding
Criterion met? NO
Criterion ID: (For Pfizer use only) EX11A00
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986284
Page 7 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
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
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986285
Page 8 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathAug/3/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986286
Page 9 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Paroxysmal atrial fibrillation]
Start Date: Jan/19/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypercholesterolemia]
Start Date: Jul/12/2018
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Migraines]
Start Date: Jul/12/2018
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Benign prostatic hyperplasia]
Start Date: May/20/2019
Ongoing: YES
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986287
Page 10 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cerebral vascular accident]
Start Date: Aug/25/2017
Ongoing: NO
End Date:
Aug/25/2017
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hiatal hernia]
Start Date: Apr/9/2018
Ongoing: YES
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Hypertension]
Start Date: Apr/9/2018
Ongoing: YES
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986288
Page 11 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/3/2020
2.Weight: [162.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [23.9]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986289
Page 12 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/3/2020
2.Randomization Number: [221743]
3.Randomization Group: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986290
Page 13 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
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 [BM7YHK]
5.bSample ID [BM7YHL]
5.cSample ID [BM7YHM]
5.dSample ID [BLCB73]
5.eSample ID [BLCB74]
5 fSample ID [BLCB75]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986291
Page 14 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/3/2020
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 [BM7YH7]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986292
Page 15 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/3/2020 13:58
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
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986293
Page 16 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionYES - REACTOGENICITY E-DIARY COLLECTED FOR THIS SUBJECT
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986294
Page 17 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/28/2020
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986295
Page 18 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?NO
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Aug/10/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986296
Page 19 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions present
on the last day the Subject Diary
was completed?NO
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986297
Page 20 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/28/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.1]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986298
Page 21 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Aug/28/2020
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 [BPBZ3T]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986299
Page 22 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Aug/28/2020 11:48
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
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986300
Page 23 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/25/2020
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986301
Page 24 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat fever/pain
given on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/3/2020
2.aSymptom: FEVER
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.bSymptom: FATIGUE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/3/2020
2.cSymptom: HEADACHE
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?YES
Ongoing?
NO
Stop Date:
Sep/3/2020
2.dSymptom: CHILLS
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2.eSymptom: VOMITING
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
2 fSymptom: DIARRHEA
Were fever or systemic symptoms
present on the last day the Subject
Diary was completed?NO
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986302
Page 25 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986303
Page 26 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/25/2020
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 [BS6SBD]
5.bSample ID [BS6SBF]
5.cSample ID [BS6SBG]
5.dSample ID [BR918T]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986304
Page 27 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/4/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986305
Page 28 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Dec/4/2020
2.Date of First Symptom Started: Dec/2/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Dec/10/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? YES
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986306
Page 29 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Dec-2020 02:29 Form Status: Data Complete, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.aSymptoms - Other Text: [Nasal congestion]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986307
Page 30 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Collectio
nSpecimen Typ
eSpecimen Collection Locati
onAssay Code and Descripti
onDevice Typ
eForm Instance
 1.Not Done  Not Done  Not Done  Not Done  Not Done  Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986308
Page 31 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986309
Page 32 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? YES
Date of Collection:
Dec/4/2020
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [CV28493]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986310
Page 33 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Self swab ordered]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986311
Page 34 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986312
Page 35 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
 1.[ ]      [ ]    Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986313
Page 36 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug Treatment
Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986314
Page 37 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for Potential
COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986315
Page 38 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
 1.        Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986316
Page 39 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986317
Page 40 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen Ty
peLab Result Form Instance
 1.       Sponsor-Defined Iden
tifierTest
:Resul
t:Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986318
Page 41 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986319
Page 42 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category for La
b TestVendor Name (DER
IVED)Collection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986320
Page 43 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986321
Page 44 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986322
Page 45 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: VITAL SIGNS - COVID
Form Version: 30-Jul-2020 21:27 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986323
Page 46 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986324
Page 47 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 30-Jul-2020 21:28 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986325
Page 48 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
 1.      Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986326
Page 49 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986327
Page 50 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986328
Page 51 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986329
Page 52 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986330
Page 53 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986331
Page 54 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/04/2021Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986332
Page 55 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled Visit
on Jan/04/2021Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BRR5F4]
5.bSample ID [BRR5F5]
5.cSample ID [BLGBWH]
5.dSample ID [BLGBW5]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986333
Page 56 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986334
Page 57 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986335
Page 58 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/25/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986336
Page 59 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986337
Page 60 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986338
Page 61 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986339
Page 62 of 258
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identifi
erAdverse Event Start DateIs the Adverse Event Still On
goingForm Instance
 1.ADVERSE EVE
NT 1  Possible postural hypote
nsion Aug/31/2020 14
:00 NO
End Date Time:
Aug/31/2020 16:00
 Repeating
Pages
 2.ADVERSE EVE
NT 2  injection site pain  Jan/4/2021 21:0
0 NO
End Date Time:
Jan/6/2021 UNK:UNK
 Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986340
Page 63 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [1]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Possible postural hypotension]
4.Start Date Time: Aug/31/2020 14:00
5.Is the adverse event still ongoing? NO
End Date Time:
Aug/31/2020 16:00
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Neurology noted indicated likely postural hypoperfusion]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986341
Page 64 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?: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[2020339650]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986342
Page 65 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[injection site pain]
4.Start Date Time: Jan/4/2021 21:00
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/6/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent or
significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this adverse
event?:RECOVERED/RESOLVED
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986343
Page 66 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986344
Page 67 of 258
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yMedication Err
orStart Dat
eIs the medication error Still Ong
oingStudy Medication Errors Ac
tionForm Instance
 1.          Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986345
Page 68 of 258
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of Medication
Error):[ ]
3.Start Date: //
4.Is the medication error still ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment given?
8.Did the Medication Error cause the
subject to be discontinued from the
study?
9.Was this medication error associated
with any adverse events?
10.Serious Adverse Event Number: For
Pfizer Use Only[ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986346
Page 69 of 258
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Ide
ntifierCategory for Medic
ationConcomitant Medications Pre-
specifiedName of Medic
ationStart D
ateForm Instance
 1.          Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986347
Page 70 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986348
Page 71 of 258
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined Id
entifierCategory for Medi
cationConcomitant Medications Pr
e-specifiedName of Medic
ationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986349
Page 72 of 258
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Concomitant Medications
1.What is the medication identifier? [ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic drug
name (including salt form, where
applicable). Where generic name is
unknown, enter the full trade or
proprietary name. Include clarifying
information in the Medication text
(e.g., Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986350
Page 73 of 258
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
 1.          Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986351
Page 74 of 258
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug Treatment
Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986352
Page 75 of 258
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986353
Page 76 of 258
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986354
Page 77 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986355
Page 78 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986356
Page 79 of 258
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986357
Page 80 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986358
Page 81 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986359
Page 82 of 258
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/30/2020
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986360
Page 83 of 258
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact - Unscheduled Form: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per local/national recommendations and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986361
Page 84 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/4/2021
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986362
Page 85 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/4/2021
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986363
Page 86 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986364
Page 87 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of Completion/Discontinuation
/Death :Jan/4/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986365
Page 88 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[collected as convalescent sera on the same date]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BRR5F5]
5.bSample ID [BRR5F4]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986366
Page 89 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/4/2021
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 [BRR5FH]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986367
Page 90 of 258
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/4/2021 14:38
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986368
Page 91 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/31/2020
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986369
Page 92 of 258
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986370
Page 93 of 258
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986371
Page 94 of 258
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Jan/25/2021
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986372
Page 95 of 258
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Jan/25/2021
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 [BR17D4]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986373
Page 96 of 258
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/25/2021 13:17
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986374
Page 97 of 258
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/25/2021
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986375
Page 98 of 258
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Feb/25/2021
3.Comments: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986376
Page 99 of 258
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986377
Page 100 of 258
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986378
Page 101 of 258
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986379
Page 102 of 258
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986380
Page 103 of 258
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Feb/25/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986381
Page 104 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Sep/25/2020
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986382
Page 105 of 258
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986383
Page 106 of 258
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986384
Page 107 of 258
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: GENERAL MEDICAL HISTORY - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-07-2020 09:51:35 (UTC-06:00) Central Time
(US & Canada)No significant medical history.
FormAug-06-2020 18:53:32 (UTC-06:00) Central Time
(US & Canada)No significant medical history.
Not Applicable
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986385
Page 108 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormDec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986386
Page 109 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986387
Page 110 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986388
Page 111 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
3Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986389
Page 112 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
4Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986390
Page 113 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986391
Page 114 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
6Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986392
Page 115 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
7Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986393
Page 116 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
8Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986394
Page 117 of 258
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
9Dec-15-2020 08:35:29 (UTC-06:00) Central Time
(US & Canada)Not Done
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986395
Page 118 of 258
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER VACCINATION
- Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormJan-05-2021 10:14:54 (UTC-06:00) Central Time
(US & Canada)Not Applicable
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986396
Page 119 of 258
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-10-2021 15:21:52 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp  Approved Mar-09-2021 13:46:23 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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-27-2021 09:30:53 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp  Approved Jan-26-2021 10:29:07 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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 13:27:00 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986397
Page 120 of 258
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
N/A
Richard Rupp  Approved Jan-22-2021 07:53:39 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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 Dec-14-2020 18:20:53 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp  Approved Oct-07-2020 10:02:40 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, 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-25-2020 13:52:50 (UTC-06:00) Central Time
(US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp  Approved Sep-18-2020 15:46:46 (UTC-06:00) Central Time
(US & Canada)BOOK Signed
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986398
Page 121 of 258
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
By my dated signature below, I, RichardRupp, 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.
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0986399
Page 122 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Aug-03-2020 13:50:19
(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-03-2020 13:50:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986400
Page 123 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-03-2020 13:50:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/3/2020Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986401
Page 124 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-03-2020 05:57:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed event added in Inform.
Sep-02-2020 10:58:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Sep-02-2020 07:15:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020339650
dizziness(onset
date:31Aug2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-03-2020 13:50:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11421032Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Sep-07-2020 05:20:39
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed resolved
Sep-04-2020 17:49:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered resent with birth date
Sep-03-2020 05:59:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened SAE RECON:AER#
2020339650 for
Dizziness,the date of
birth was missing in
SAE form but was
recorded as
1950. Please
confirm if date of birth
was reported. If safety
update is required,
please submit a
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986402
Page 125 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
follow-up form.
Aug-03-2020 13:50:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1950Enrollment Entry
3. Sex:
Date Location User Value Reason
Aug-03-2020 13:50:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-03-2020 13:50:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HISPANIC OR LATINO(A) OR OF S
PANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-03-2020 13:50:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986403
Page 126 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Aug-10-2020 03:22:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed form level comment
present on MH page
Aug-07-2020 10:01:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-07-2020 04:23:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Form marked as not
applicable
Aug-06-2020 18:53:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-06-2020 08:19:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM Query: Please
report any medical
histories for this
subject, if present on
GENERAL
MEDICAL
HISTORY' page else
indicate a form level
comment.
Aug-03-2020 13:50:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986404
Page 127 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Male or female participants b
etween the ages of 18 and 55
years, inclusive, 65 and 85 ye
ars, inclusive, or 18 and 85 ye
ars, inclusive, at randomizatio
n (dependent upon study stag
e)
Criteri
on met
?:YES
Criteri
on ID:
(For P
fizer u
se only
):IN01A00Initial Entry
1.a Inclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
1.a Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Male or female participants between th
e ages of 18 and 55 years, inclusive, 65
and 85 years, inclusive, or 18 and 85 y
ears, inclusive, at randomization (depe
ndent upon study stage)Initial Entry
1.a Criterion met?
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986405
Page 128 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN01A00Initial Entry
1.b
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:2
Criteri
on Desc
ription:Participants who are willing
and able to comply with all s
cheduled visits, vaccination
plan, laboratory tests, lifestyl
e considerations, and other st
udy procedures
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN02A00Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986406
Page 129 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Inclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
1.b Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participants who are willing and able t
o comply with all scheduled visits, vac
cination plan, laboratory tests, lifestyle
considerations, and other study proced
uresInitial Entry
1.b Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN02A00Initial Entry
1.c
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu
mber:3
Criteri
on Des
criptio
n:Healthy participants who are
determined by medical histor
y, physical examination, and
clinical judgment of the inve
stigator to be eligible for incl
usion in the studyInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986407
Page 130 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on met
?:YES
Criteri
on ID:
(For Pf
izer use
only):IN03A00
1.c Inclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
1.c Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Healthy participants who are determin
ed by medical history, physical examin
ation, and clinical judgment of the inve
stigator to be eligible for inclusion in t
he studyInitial Entry
1.c Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN03A00Initial Entry
1.d
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Inclusi
on Nu4Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986408
Page 131 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
mber:
Criteri
on Desc
ription:Capable of giving personal si
gned informed consent, whic
h includes compliance with t
he requirements and restricti
ons listed in the ICD and in t
his protocol
Criteri
on met
?:YES
Criteri
on ID: (
For Pfi
zer use
only):IN04A00
1.d Inclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
1.d Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Capable of giving personal signed info
rmed consent, which includes complia
nce with the requirements and restricti
ons listed in the ICD and in this protoc
olInitial Entry
1.d Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
IN04A00Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986409
Page 132 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.a
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:1
Criteri
on Des
criptio
n:Other medical or psychiatric
condition incl. recent (within
past year) or active suicidal i
deation/behavior/lab abnorm
ality that may increase the ris
k of study participation
Criteri
on met
?:NO
Criteri
on ID:
(For Pf
izer us
e only):EX01A00Initial Entry
2.a Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric condition
incl. recent (within past year) or active
suicidal ideation/behavior/lab abnorma
lity that may increase the risk of study
participationInitial Entry
2.a Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a Criterion ID: (For Pfizer use only)
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986410
Page 133 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX01A00Initial Entry
2.b
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numbe
r:2
Criterion
Descripti
on:Known infection with hum
an immunodeficiency virus
(HIV), hepatitis C virus (H
CV), or hepatitis B virus (
HBV)
Criterion
met?:NO
Criterion
ID: (For
Pfizer us
e only):EX02A00Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986411
Page 134 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.b Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial Entry
2.b Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Known infection with human immuno
deficiency virus (HIV), hepatitis C vir
us (HCV), or hepatitis B virus (HBV)Initial Entry
2.b Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX02A00Initial Entry
2.c
Date Location User Value Reason
Aug-03-2020 14:14:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)
Criteri
on met
?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986412
Page 135 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on ID: (
For Pfi
zer use
only):EX03A00
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:3
Criteri
on Desc
ription:History of severe adverse rea
ction associated with a vacci
ne and/or severe allergic reac
tion (eg, anaphylaxis) to any
component of the study inter
vention(s)
Criteri
on met
?:
Criteri
on ID: (
For Pfi
zer use
only):EX03A00Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986413
Page 136 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
2.c Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
History of severe adverse reaction asso
ciated with a vaccine and/or severe alle
rgic reaction (eg, anaphylaxis) to any c
omponent of the study intervention(s)Initial Entry
2.c Criterion met?
Date Location User Value Reason
Aug-03-2020 14:14:35
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX03A00Initial Entry
2.d
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Nu
mber:4
Criterion Desc
ription:Receipt of medication
s intended to prevent
COVID-19
Criterion met
?:NO
Criterion ID:
(For Pfizer us
e only):EX04A00Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986414
Page 137 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.d Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
2.d Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of medications intended to pre
vent COVID-19Initial Entry
2.d Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX04A00Initial Entry
2.e
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:8
Criterio
n Descri
ption:Immunocompromised indivi
duals with known or suspect
ed immunodeficiency, as det
ermined by history and/or la
boratory/physical examinati
on
Criterio
n met?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986415
Page 138 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criterio
n ID: (F
or Pfize
r use on
ly):EX08A00
2.e Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
8Initial Entry
2.e Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Immunocompromised individuals with
known or suspected immunodeficiency
, as determined by history and/or labor
atory/physical examinationInitial Entry
2.e Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX08A00Initial Entry
2.f
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num
ber:10Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986416
Page 139 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on Desc
ription:Bleeding diathesis or conditi
on associated with prolonged
bleeding that would, in the o
pinion of the investigator, co
ntraindicate intramuscular in
jection
Criteri
on met?
:NO
Criteri
on ID: (
For Pfi
zer use
only):EX10A00
2.f Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
10Initial Entry
2.f Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Bleeding diathesis or condition associa
ted with prolonged bleeding that would
, in the opinion of the investigator, con
traindicate intramuscular injectionInitial Entry
2.f Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX10A00Initial Entry
2.g
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986417
Page 140 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion Numb
er:11
Criterion Descri
ption:Women who are pr
egnant or breastfee
ding
Criterion met?: NO
Criterion ID: (F
or Pfizer use onl
y):EX11A00Initial Entry
2.g Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
11Initial Entry
2.g Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Women who are pregnant or breastfeed
ingInitial Entry
2.g Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX11A00Initial Entry
2.h
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
Exclusion Nu 12Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0986418
Page 141 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) mber:
Criterion Desc
ription:Previous vaccination
with any coronavirus
vaccine
Criterion met?
:NO
Criterion ID: (
For Pfizer use
only):EX12A00
2.h Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
12Initial Entry
2.h Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous vaccination with any coronav
irus vaccineInitial Entry
2.h Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX12A00Initial Entry
2.i
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:13Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986419
Page 142 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criterion
Descripti
on:Subjects who receive imm
unosuppressive therapy, su
ch as cytotoxic agents or s
ystemic corticosteroids
Criterion
met?:NO
Criterion
ID: (For
Pfizer use
only):EX13A01
2.i Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
13Initial Entry
2.i Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Subjects who receive immunosuppress
ive therapy, such as cytotoxic agents or
systemic corticosteroidsInitial Entry
2.i Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX13A01Initial Entry
2.j
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Num15Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986420
Page 143 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
ber:
Criterio
n Descr
iption:Receipt of blood/plasma pro
ducts or immunoglobulin, fr
om 60 days before study inte
rvention administration or pl
anned receipt throughout the
study
Criterio
n met?:NO
Criterio
n ID: (F
or Pfize
r use on
ly):EX14A01
2.j Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
15Initial Entry
2.j Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Receipt of blood/plasma products or i
mmunoglobulin, from 60 days before s
tudy intervention administration or pla
nned receipt throughout the studyInitial Entry
2.j Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986421
Page 144 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
2.j Criterion ID: (For Pfizer use only)
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX14A01Initial Entry
2.k
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusio
n Numb
er:16
Criterio
n Descri
ption:Participation in other studie
s involving study interventi
on within 28 days prior to st
udy entry and/or during stu
dy participation
Criterio
n met?:NO
Criterio
n ID: (F
or Pfizer
use only)
:EX15A01Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986422
Page 145 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.k Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
16Initial Entry
2.k Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Participation in other studies involving
study intervention within 28 days prior
to study entry and/or during study parti
cipationInitial Entry
2.k Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX15A01Initial Entry
2.l
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusion
Number:17
Criterion
Descriptio
n:Previous participation in o
ther studies involving stud
y intervention containing l
ipid nanoparticles
Criterion
met?:NO
Criterion
ID: (For P
fizer use o
nly):EX16A01Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986423
Page 146 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.l Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
17Initial Entry
2.l Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Previous participation in other studies i
nvolving study intervention containing
lipid nanoparticlesInitial Entry
2.l Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX16A01Initial Entry
2.m
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Exclusi
on Nu
mber:22
Criteri
on Des
criptio
n:Investigator site staff or Pfize
r employees directly involved
in the conduct of the study, si
te staff otherwise supervised
by the investigator, and their
respective family members
Criteri
on met
?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986424
Page 147 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Criteri
on ID:
(For Pf
izer us
e only)
:EX21A01
2.m Exclusion Number:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
22Initial Entry
2.m Criterion Description:
Date Location User Value Reason
Aug-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Investigator site staff or Pfizer employ
ees directly involved in the conduct of
the study, site staff otherwise supervise
d by the investigator, and their respecti
ve family membersInitial Entry
2.m Criterion met?
Date Location User Value Reason
Aug-03-2020 13:51:06
(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-03-2020 13:51:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
EX21A01Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986425
Page 148 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Aug-03-2020 13:51:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-03-2020 13:51:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-03-2020 13:51:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-17-2020 06:59:14
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Sep-16-2020 17:33:35
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Sep-16-2020 15:42:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Subject has MedHx of
hypercholesterolemia,
migraine and Atrial
Fibrillation reported on
SDB, significant
medical history is to be
reported in the CRF.
Please review/update
accordingly. Thank
you.
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0986426
Page 149 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 17:27:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Paroxysmal atrial f
ibrillation
Start Date: Jan/19/2018
Ongoing: YESTranscription Error
Sep-16-2020 17:25:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:Paroxysmal atrial f
ibrillation
Start Date: Dec/21/2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:25:59
(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
Sep-16-2020 17:25:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Paroxysmal atrial fibrillationInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 17:27:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jan/19/2018Transcription Error
Sep-16-2020 17:25:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/21/2018Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986427
Page 150 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 17:25:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-16-2020 17:28:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Hypercholesterol
emia
Start Date: Jul/12/2018
Ongoing: YESInitial Entry
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:28:19
(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
Sep-16-2020 17:28:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypercholesterolemiaInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020 17:28:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/12/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020 17:28:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986428
Page 151 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.c
Date Location User Value Reason
Sep-16-2020 17:28:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 3
Medical History Term: Migraines
Start Date: Jul/12/2018
Ongoing: YESInitial Entry
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:28:57
(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
Sep-16-2020 17:28:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
MigrainesInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020 17:28:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Jul/12/2018Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020 17:28:57
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-16-2020 17:29:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:4
Medical History
Term:Benign prostatic hy
perplasiaInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986429
Page 152 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Start Date: May/20/2019
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:29:48
(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
Sep-16-2020 17:29:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Benign prostatic hyperplasiaInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-16-2020 17:29:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
May/20/2019Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020 17:29:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-16-2020 17:31:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numb
er:5
Medical History
Term:Cerebral vascular a
ccident
Start Date: Aug/25/2017
Ongoing: NO
End Date:
Aug/25/2017Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986430
Page 153 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.e Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:31:16
(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
Sep-16-2020 17:31:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Cerebral vascular accidentInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-16-2020 17:31:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/25/2017Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-16-2020 17:31:16
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
Aug/25/2017Initial Entry
1.f
Date Location User Value Reason
Sep-16-2020 17:32:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 6
Medical History Term: Hiatal hernia
Start Date: Apr/9/2018
Ongoing: YESInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986431
Page 154 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:32:06
(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
Sep-16-2020 17:32:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Hiatal herniaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-16-2020 17:32:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/9/2018Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-16-2020 17:32:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.g
Date Location User Value Reason
Sep-16-2020 17:33:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number: 7
Medical History Term
:Hypertensio
n
Start Date: Apr/9/2018
Ongoing: YESInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986432
Page 155 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.g Line/MH Number:
Date Location User Value Reason
Sep-16-2020 17:33:26
(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
Sep-16-2020 17:33:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
HypertensionInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-16-2020 17:33:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Apr/9/2018Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-16-2020 17:33:26
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986433
Page 156 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
162.0Initial Entry
3. Unit:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.9Initial Entry
7.a
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986434
Page 157 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 97.8
Temperature Unit: F
Temperature Locatio
n::ORAL CAVIT
YInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
97.8Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Aug-03-2020 14:15:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986435
Page 158 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-03-2020 14:15:18
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-04-2020 13:45:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
221743Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986436
Page 159 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-03-2020 14:15:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2020 14:15:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-04-2020 07:33:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-04-2020 03:20:32
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DQ: Please review the
'Sample Collected?' is
reported as Yes
however no any
barcodes are entered.
Kindly review and
correct the data as
appropriate. Thank
you.
Aug-03-2020 14:15:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-03-2020 14:15:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986437
Page 160 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-04-2020 07:33:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YHKInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020 07:33:15
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YHKInitial Entry
5.b
Date Location User Value Reason
Aug-04-2020 07:33:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YHLInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-04-2020 07:33:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YHLInitial Entry
5.c
Date Location User Value Reason
Aug-04-2020 07:33:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YHMInitial Entry
5.c Sample ID
Date Location User Value Reason
Aug-04-2020 07:33:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YHMInitial Entry
5.d
Date Location User Value Reason
Aug-04-2020 07:33:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCB73Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986438
Page 161 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.d Sample ID
Date Location User Value Reason
Aug-04-2020 07:33:51
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLCB73Initial Entry
5.e
Date Location User Value Reason
Aug-04-2020 07:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCB74Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-04-2020 07:34:02
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLCB74Initial Entry
5.f
Date Location User Value Reason
Aug-04-2020 07:34:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCB75Initial Entry
5.f Sample ID
Date Location User Value Reason
Aug-04-2020 07:34:11
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BLCB75Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986439
Page 162 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-03-2020 14:15:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-03-2020 14:15:38
(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-04-2020 07:34:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-04-2020 03:19:49
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DQ: Please review the
'Sample Collected?' is
reported as Yes
however no any
barcodes are entered.
Kindly review and
correct the data as
appropriate. Thank
you.
Aug-03-2020 14:15:38
(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-03-2020 14:15:38
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/3/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986440
Page 163 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-04-2020 07:34:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YH7Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-04-2020 07:34:37
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YH7Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986441
Page 164 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-03-2020 14:16:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-03-2020 14:16:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-03-2020 14:16:13
(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-03-2020 14:16:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/3/2020 13:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-03-2020 14:16:13
(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-03-2020 14:16:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986442
Page 165 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-03-2020 14:16:13
(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-03-2020 14:16:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-03-2020 14:16:13
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986443
Page 166 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Aug-03-2020 14:16:19
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E-DIARY
COLLECTED FOR THIS SUBJECTInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986444
Page 167 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-03-2020 03:56:17
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-02-2020 10:55:52
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Answered Please indicate where
you want a deviation
written - the IRB?
Sep-01-2020 20:10:28
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery: Per
protocol, visit 2
should occur 19-23
days after V1. This
visit occurred-25 days
after V1. Please can
you confirm a PD will
be written for the out
of window
vaccination? Thanks
Sep-01-2020 01:38:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Per site confirmation
Aug-31-2020 10:24:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered Out of window visit
due to hurricane
evacuation.
Aug-31-2020 03:52:10
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: Date of visit at
this visit is out of
window (2 day) from
Date of visit
(03-Aug-20) at
V1D1VX1L visit.
Please reconcile and
update accordingly.
Else clarify.
Aug-28-2020 15:33:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986445
Page 168 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
R
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NOInitial Entry
2.a Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-04-2020 17:59:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGUETranscription Error
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986446
Page 169 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:YES
Ongoing
?
NO
Stop
Date:
Aug
/10/
202
0
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986447
Page 170 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.b Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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-07-2020 09:13:36
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Data updated
Sep-04-2020 17:59:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-04-2020 17:59:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Aug/10/2020Transcription Error
Sep-03-2020 06:00:56
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Thanks for the
response, form has
been unfreeze, please
update as per below
query
Sep-01-2020 10:06:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Answered please unfreeze record
so that entry can be
corrected
Aug-31-2020 11:04:34
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened e-Diary: Per eDiary
records, FATIGUE is
reported on Last day
(Day 7) however the
last day in inform is
entered as 'No' for the
same. Please verify
and update. Else,
clarify. Thanks.
Aug-28-2020 15:34:08
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0986448
Page 171 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
2.c
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.c Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986449
Page 172 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.d Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
Symptom:: DIAInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986450
Page 173 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) RRH
EA
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:NO
2.f Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986451
Page 174 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.g Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.h Symptom:
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986452
Page 175 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NGInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986453
Page 176 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NO
5.b Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
5.c Injection Site Reaction:
Date Location User Value Reason
Aug-28-2020 15:34:08
(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
Aug-28-2020 15:34:08
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986454
Page 177 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-28-2020 15:34:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020Initial Entry
2.a
Date Location User Value Reason
Aug-28-2020 15:34:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifier:: 1
Temperature: 98.1
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Aug-28-2020 15:34:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Aug-28-2020 15:34:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
98.1Initial Entry
2.a Unit:
Date Location User Value Reason
Aug-28-2020 15:34:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Aug-28-2020 15:34:20
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986455
Page 178 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986456
Page 179 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-28-2020 15:34:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-28-2020 15:34:29
(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-28-2020 17:46:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-28-2020 15:34:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample Collected?' is
Yes, however no
barcodes are entered.
Please review and
correct as appropriate.
Aug-28-2020 15:34:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/28/2020Initial Entry
5.a
Date Location User Value Reason
Aug-28-2020 17:46:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPBZ3TInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986457
Page 180 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-28-2020 17:46:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BPBZ3TInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986458
Page 181 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Aug-28-2020 15:34:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-28-2020 15:34:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-28-2020 15:34:44
(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-28-2020 15:34:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/28/2020 11:48Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-28-2020 15:34:44
(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-28-2020 15:34:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986459
Page 182 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-28-2020 15:34:44
(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-28-2020 15:34:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBSE
RVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product administration?
Date Location User Value Reason
Aug-28-2020 15:34:44
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986460
Page 183 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-25-2020 13:52:50
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986461
Page 184 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Were medications to treat fever/pain given on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-29-2020 05:16:47
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 18:00:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-28-2020 18:00:09
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/3/2020Transcription Error
Sep-28-2020 02:28:06
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per eDiary
Records, subject took
Fever/Pain
medication on the
Last day (Day 7),
however Inform CRF
data is indicated 'No'.
Please verify and
update the data as
appropriate. Else
clarify. SDQ
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
VE
RInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986462
Page 185 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever or systemic sympto
ms present on the last day the
Subject Diary was completed?
:NO
2.a Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-28-2020 18:00:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FATIGU
E
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:YES
Ongoin
g?
NO
Stop
Date:
Sep
/3/2
020Transcription Error
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FAT
IG
UE
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986463
Page 186 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.b Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-29-2020 05:17:12
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 18:00:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-28-2020 18:00:31
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/3/2020Transcription Error
Sep-28-2020 09:50:01
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records, FATIGUE
present on Last day
however inform
entered with 'No' for
the same. Please
verify and update. If
diary entered in error,
please enter stop date
as last date of diary.
Thanks.
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-28-2020 18:00:48
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry: Transcription Error
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986464
Page 187 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) Symptom:: HEADA
CHE
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:YES
Ongoin
g?
NO
Stop
Date:
Sep
/3/2
020
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HEA
DAC
HE
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986465
Page 188 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-29-2020 05:16:59
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Sep-28-2020 18:00:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Sep-28-2020 18:00:48
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Ongoing?
NO
Stop Date:
Sep/3/2020Transcription Error
Sep-28-2020 09:50:29
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened eDiary: Per diary
records,
HEADACHE present
on Last day however
inform entered with
'No' for the same.
Please verify and
update. If diary
entered in error,
please enter stop date
as last date of diary.
Thanks.
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986466
Page 189 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
ILL
S
Were fever or systemic sympt
oms present on the last day th
e Subject Diary was complete
d?:NOInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic symp
toms present on the last day
the Subject Diary was compl
eted?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986467
Page 190 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.e Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DIA
RRH
EA
Were fever or systemic symp
toms present on the last day t
he Subject Diary was comple
ted?:NOInitial Entry
2.f Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central TimeACV0PFEINFP6000  Data Entry:
Symptom:: NEW ORInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986468
Page 191 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada) WORSEN
ED MUSC
LE PAIN
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NO
2.g Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUSCLE P
AINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW OR
WORSEN
ED JOINT
PAIN
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986469
Page 192 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOINT PAI
NInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: RE
DN
ESS
Were injection site reactions
present on the last day the Su
bject Diary was completed?:NOInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986470
Page 193 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: SWE
LLI
NG
Were injection site reactions
present on the last day the S
ubject Diary was completed
?:NOInitial Entry
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:: PAIN A
T INJEC
TION SI
TE
Were injection site reacti
ons present on the last da
y the Subject Diary was c
ompleted?:NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (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-2021-5683-0986471
Page 194 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-25-2020 13:54:53
(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-25-2020 13:54:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0986472
Page 195 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 13:55:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 13:55:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-26-2020 02:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 13:55:05
(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-25-2020 13:55:05
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/25/2020Initial Entry
5.a
Date Location User Value Reason
Sep-26-2020 02:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6SBDInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986473
Page 196 of 258
***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: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-26-2020 02:31:25
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS6SBDInitial Entry
5.b
Date Location User Value Reason
Sep-26-2020 02:31:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6SBFInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-26-2020 02:31:33
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS6SBFInitial Entry
5.c
Date Location User Value Reason
Sep-26-2020 02:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BS6SBGInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-26-2020 02:31:40
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BS6SBGInitial Entry
5.d
Date Location User Value Reason
Sep-26-2020 05:02:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR918TInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-26-2020 05:02:54
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
BR918TInitial Entry
090177e196ae3e3f\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0986474
Page 197 of 258
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Dec/04/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421032 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-16-2020 23:30:20
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Closed Response satisfies
query
Dec-16-2020 19:04:46
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Answered Changed data per
query
Dec-15-2020 22:15:53
(UTC-06:00) Central Time
(US & Canada)ACV0PFEINFP6000  Query 3: Reissued:Opened DM1: Response is
provided as ‘Changed
data per query’,
however data on
Health Care
Utilization form not
entered. Please
consider completing
Health Care
U
…[truncated]