125742 S1 M5 CRF c4591001 1142 11421073

Document text

Page 1 of 181
***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: 11421073 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 version24 JUL 2020
2.Select appropriate response
- What cohort does the
subject belong to?STAGE 3 COHORTS
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987063
Page 2 of 181
***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: 11421073 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/11/2020
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987064
Page 3 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11421073]
2.Birth Date: 1958
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that
apply):WHITE
6.Racial Designation:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987065
Page 4 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/11/2020
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987066
Page 5 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987067
Page 6 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/11/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987068
Page 7 of 181
***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: 11421073 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:[History of smoking]
Start Date: UNK/UNK/1975
Ongoing: NO
End Date:
UNK/UNK/2006
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987069
Page 8 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/11/2020
2.Weight: [197.7]
3.Unit: LB
4.Height: [70.0]
5.Unit: in
6.Body Mass Index: [28.4]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987070
Page 9 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Aug/11/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987071
Page 10 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/11/2020
2.Randomization Number: [225059]
3.Randomization Group: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987072
Page 11 of 181
***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: 11421073 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/11/2020
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 [BM7YPF]
5.bSample ID [BM7YPG]
5.cSample ID [BM7YPH]
5.dSample ID [BLCBB8]
5.eSample ID [BLCBB9]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987073
Page 12 of 181
***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: 11421073 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/11/2020
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 [BM7YNV]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987074
Page 13 of 181
***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: 11421073 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/11/2020 10:28
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987075
Page 14 of 181
***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: 11421073 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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987076
Page 15 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/1/2020
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987077
Page 16 of 181
***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: 11421073 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?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987078
Page 17 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987079
Page 18 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987080
Page 19 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/1/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.3]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987081
Page 20 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/1/2020
4.Laboratory Name and
Address (Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result:
Not Done: NOT DONE
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987082
Page 21 of 181
***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: 11421073 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:
Sep/1/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9TX7]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987083
Page 22 of 181
***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: 11421073 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: Sep/1/2020 14:14
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
ObservedTHE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed
for at least the protocol
specified observation period
after investigational product
administration?YES
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987084
Page 23 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/2/2020
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987085
Page 24 of 181
***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: 11421073 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?NO
2.cSymptom: HEADACHE
Were fever or systemic
symptoms present on the
last day the Subject Diary
was completed?NO
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987086
Page 25 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987087
Page 26 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987088
Page 27 of 181
***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: 11421073 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:
Oct/2/2020
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR91DP]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987089
Page 28 of 181
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/24/2021
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987090
Page 29 of 181
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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:
Feb/24/2021
4.If no sample was collected
or sample was not collected
according to protocol,
please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR4782]
5.bSample ID [BRWKH9]
5.cSample ID [BRWKGW]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987091
Page 30 of 181
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987092
Page 31 of 181
***Confidential***
 
Header Text: c4591001
Visit: V5_MONTH12_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987093
Page 32 of 181
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987094
Page 33 of 181
***Confidential***
 
Header Text: c4591001
Visit: V6_MONTH24_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987095
Page 34 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987096
Page 35 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: SIGNS AND SYMPTOMS OF POTENTIAL
COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Signs and Symptoms
1.Date of Assessment: //
2.Date of First Symptom
Started://
3.Symptoms Ongoing?
Symptoms
4.Symptoms:
Was symptom present?
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987097
Page 36 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987098
Page 37 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987099
Page 38 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Health Care Utilization
1.Physician or Healthcare
Professional:
Occurrence of Visits or
Contacts:
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
Health Care Utilization
3.Has the subject been
hospitalized due to potential
COVID-19 illness?
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987100
Page 39 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL - New
Unscheduled VisitForm: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Illness Details
1.Category of Clinical Event:
2.Was a diagnosis obtained
for Potential COVID-19
Illness?
3.Toxicity Grade:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987101
Page 40 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987102
Page 41 of 181
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA - New
Unscheduled VisitForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987103
Page 42 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987104
Page 43 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled
VisitForm: 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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987105
Page 44 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Oct/2/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987106
Page 45 of 181
***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: 11421073 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: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987107
Page 46 of 181
***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: 11421073 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:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987108
Page 47 of 181
***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: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987109
Page 48 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Eve
nt Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Ascending Aorti
c Aneurysm Jan/4/2021 U
NK:UNK YES  Repeating
Pages
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987110
Page 49 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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)[Ascending Aortic Aneurysm]
4.Start Date Time: Jan/4/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 4
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987111
Page 50 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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?
YES
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:
[Unknown]
10.Latest Action Taken with
Study Treatment:NOT APPLICABLE
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987112
Page 51 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11.Was a Concomitant
Medication given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of
this adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause
the subject to be
discontinued from the
study?NO
15.Serious Adverse Event
Number: For Pfizer Use
Only[2021015979]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987113
Page 52 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categ
oryMedicatio
n ErrorStart
DateIs the medication erro
r Still OngoingStudy Medication
Errors ActionForm Instan
ce
 1.        Repeating
Pages
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987114
Page 53 of 181
***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: 11421073 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[ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987115
Page 54 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defin
ed IdentifierCategory for
MedicationConcomitant Medica
tions Pre-specifiedName of M
edicationStart
DateForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987116
Page 55 of 181
***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: 11421073 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: //
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987117
Page 56 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defi
ned IdentifierCategory for
MedicationConcomitant Medic
ations Pre-specifiedName of
Medicatio
nDose Des
criptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987118
Page 57 of 181
***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: 11421073 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?
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987119
Page 58 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categ
oryTreatment Ide
ntifierCon Non-Drug Treatments
Pre-specifiedTreatm
entStart D
ateForm Instanc
e
 1.         Repeating
Pages
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987120
Page 59 of 181
***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: 11421073 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?
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987121
Page 60 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987122
Page 61 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987123
Page 62 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987124
Page 63 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11421073 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:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987125
Page 64 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and
Address (Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987126
Page 65 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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?
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987127
Page 66 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987128
Page 67 of 181
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination -
UnscheduledForm: 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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987129
Page 68 of 181
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987130
Page 69 of 181
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: INFORMED CONSENT - ASYMPTOMATIC
SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987131
Page 70 of 181
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987132
Page 71 of 181
***Confidential***
 
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT -
UnscheduledForm: ELECTRONIC SAMPLE TRACKING - NASAL
SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987133
Page 72 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Dec/15/2020
2.Erroneous Visit
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987134
Page 73 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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 and NOT confirmed to have received only placebo at
Vaccination 1/2
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987135
Page 74 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Dec/16/2020
2.Primary Reason for
Unblinding:ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987136
Page 75 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent
Date ://
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987137
Page 76 of 181
***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: 11421073 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: [ ]
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987138
Page 77 of 181
***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: 11421073 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 Oct/2/2020
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987139
Page 78 of 181
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987140
Page 79 of 181
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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
Name Signature
MeaningDate Type Action
Richard
Rupp Approved Mar-09-2021 14:12:49 (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.
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987141
Page 80 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA -
Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-11-2020 13:07:30
(UTC-06:00) Central Time (US &
Canada)Not applicable
Not Applicable
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987142
Page 81 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormFeb-04-2021 17:46:43 (UTC-06:00)
Central Time (US & Canada)Not applicable
FormAug-11-2020 13:08:26
(UTC-06:00) Central Time (US &
Canada)Not applicable
Not Applicable
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987143
Page 82 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
Comments
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormAug-11-2020 13:14:34
(UTC-06:00) Central Time (US &
Canada)Pt is a post-menopausal female over
the age of 60.
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987144
Page 83 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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
Name Signature
MeaningDate Type Action
Richard
Rupp Approved Mar-09-2021 14:12:49 (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 15:30:51 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Rupp Approved Jan-22-2021 08:11:31 (UTC-06:00)
Central Time (US & Canada)BOOK Signed
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987145
Page 84 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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.
 N/A Dec-17-2020 16:08:22 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Rupp Approved Oct-12-2020 11:48:28 (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.
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987146
Page 85 of 181
***Confidential***
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - Signature
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
 N/A Oct-02-2020 11:15:55 (UTC-06:00)
Central Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard
Rupp Approved Sep-16-2020 17:38:06 (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.
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987147
Page 86 of 181
***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: 11421073 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-11-2020
13:06:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Aug-11-2020
13:06:17
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORT
SInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987148
Page 87 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-11-2020
13:06:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Cons
ent Obtained
Aug/11/2020Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987149
Page 88 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Aug-11-2020
13:06:06
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11421073Item copied
from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-11-2020
13:06:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1958Enrollment
Entry
3. Sex:
Date Location User Value Reason
Aug-11-2020
13:06:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987150
Page 89 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-11-2020
13:06:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC O
R LATINO(A) OR
OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-11-2020
13:06:32
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987151
Page 90 of 181
***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: 11421073 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-11-2020
13:06:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987152
Page 91 of 181
***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: 11421073 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-11-2020
13:07:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Aug-11-2020
13:07:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Aug-11-2020
13:07:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987153
Page 92 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Feb-04-2021
17:51:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH
Number:1
Medical H
istory Ter
m:History of
smoking
Start Date
:UNK/UN
K/1975
Ongoing: NO
End Date
:
UNK/U
NK/200
6Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Feb-04-2021
17:51:27
(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:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987154
Page 93 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Feb-04-2021
17:51:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
History of smokingInitial Entry
1.a Start Date:
Date Location User Value Reason
Feb-04-2021
17:51:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1975Initial Entry
1.a Ongoing:
Date Location User Value Reason
Feb-04-2021
17:51:27
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/2006Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987155
Page 94 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
197.7Initial Entry
3. Unit:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987156
Page 95 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
70.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.4Initial Entry
7.a
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Id
entifier::1
Temperat
ure:97.6Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987157
Page 96 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Temperat
ure Unit:F
Temperat
ure Locati
on::ORAL
CAVIT
Y
7.a Record Identifier:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987158
Page 97 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
7.a Temperature Location:
Date Location User Value Reason
Aug-11-2020
13:13:31
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987159
Page 98 of 181
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987160
Page 99 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987161
Page 100 of 181
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Aug-11-2020
13:13:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987162
Page 101 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-11-2020
13:15:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-11-2020
14:55:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
225059Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987163
Page 102 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020
13:15:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020
13:15:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-11-2020
14:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-11-2020
13:15:11
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987164
Page 103 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
13:15:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020
14:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM7YP
FInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020
14:09:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM7YPFInitial Entry
5.b
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987165
Page 104 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-11-2020
14:09:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM7YP
GInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-11-2020
14:09:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM7YPGInitial Entry
5.c
Date Location User Value Reason
Aug-11-2020
14:09:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BM7YP
HInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987166
Page 105 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Aug-11-2020
14:09:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM7YPHInitial Entry
5.d
Date Location User Value Reason
Aug-11-2020
14:10:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BLCBB
8Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-11-2020
14:10:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLCBB8Initial Entry
5.e
Date Location User Value Reason
Aug-11-2020
14:10:21ACV0PFEINFP6000  Data Entry:
Sample ID BLCBBInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987167
Page 106 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada): 9
5.e Sample ID
Date Location User Value Reason
Aug-11-2020
14:10:21
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BLCBB9Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987168
Page 107 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-11-2020
13:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-11-2020
13:15:19
(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-11-2020
14:11:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Aug-11-2020
13:15:19
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidat
e'Sample
Collected?' is
Yes, however
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987169
Page 108 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Aug-11-2020
13:15:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collectio
n:
Aug/11/2020Initial Entry
5.a
Date Location User Value Reason
Aug-11-2020
14:11:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample I
D:BM7YN
VInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-11-2020
14:11:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BM7YNVInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987170
Page 109 of 181
***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: 11421073 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-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987171
Page 110 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Aug/11/2020 10:28Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-11-2020
13:15:38
(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-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987172
Page 111 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N 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-11-2020
13:15:38
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987173
Page 112 of 181
***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: 11421073 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-11-2020
13:15:45
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGE
NICITY E-DIARY
COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987174
Page 113 of 181
***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: 11421073 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-01-2020
16:49:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987175
Page 114 of 181
***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: 11421073 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-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987176
Page 115 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987177
Page 116 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.b Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987178
Page 117 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-01-2020
16:49:49ACV0PFEINFP6000  Data Entry:
Symptom:: CInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987179
Page 118 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada)HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
O
2.d Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987180
Page 119 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987181
Page 120 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987182
Page 121 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987183
Page 122 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
2.g Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-01-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987184
Page 123 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
16:49:49
(UTC-06:00)
Central Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0987185
Page 124 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-01-2020
16:49:49
(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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987186
Page 125 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987187
Page 126 of 181
***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: 11421073 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-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987188
Page 127 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
16:49:49
(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-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987189
Page 128 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-01-2020
16:49:49
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987190
Page 129 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-01-2020
16:50:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
2.a
Date Location User Value Reason
Sep-01-2020
16:50:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Record Ide
ntifier::1
Temperatu
re:98.3
Temperatu
re Unit:F
Temperatu
re Locatio
n::ORAL
CAVIT
YInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-01-2020
16:50:04
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
1Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987191
Page 130 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
& Canada)
2.a Temperature:
Date Location User Value Reason
Sep-01-2020
16:50:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
98.3Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-01-2020
16:50:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-01-2020
16:50:04
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987192
Page 131 of 181
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-01-2020
16:50:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020
16:50:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020
16:50:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987193
Page 132 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-01-2020
16:50:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020
16:50:35
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-01-2020
16:50:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Sponsor-
Defined I
dentifier:113
Test:: Choriogon
adotropin
Beta_PX11
3
Result::
Not Done
::NOT DON
EInitial Entry
6.a Sponsor ID:
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987194
Page 133 of 181
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST -
eCRF Audit Trail History
Form Version: 30-Jul-2020 21:27 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-01-2020
16:50:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020
16:50:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Choriogonadotropin
Beta_PX113Initial Entry
6.a Not Done:
Date Location User Value Reason
Sep-01-2020
16:50:18
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT DONEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987195
Page 134 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-01-2020
16:50:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020
16:50:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-01-2020
18:23:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Sep-01-2020
16:50:26
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987196
Page 135 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Sep-01-2020
16:50:26
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Sep/1/2020Initial Entry
5.a
Date Location User Value Reason
Sep-01-2020
18:23:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9TX7Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-01-2020
18:23:14
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BP9TX7Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987197
Page 136 of 181
***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: 11421073 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
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987198
Page 137 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sep/1/2020 14:14Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987199
Page 138 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPE
CIFIED OBSERVATIO
N PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after
investigational product administration?
Date Location User Value Reason
Sep-01-2020
16:51:00
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987200
Page 139 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-02-2020
11:15:55
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987201
Page 140 of 181
***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: 11421073 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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: F
E
V
E
R
Were fever or s
ystemic sympto
ms present on t
he last day the S
ubject Diary wa
s completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987202
Page 141 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
G
U
E
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed?
:N
OInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987203
Page 142 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.b Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
A
D
AC
HEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987204
Page 143 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
O
2.c Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Oct-02-2020
11:16:11ACV0PFEINFP6000  Data Entry:
Symptom:: CInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987205
Page 144 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00)
Central Time (US
& Canada)HI
L
L
S
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary w
as completed?:N
O
2.d Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.e
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987206
Page 145 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MI
TI
NG
Were fever or s
ystemic sympt
oms present on
the last day the
Subject Diary
was completed
?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987207
Page 146 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
A
RR
HE
A
Were fever or s
ystemic sympto
ms present on t
he last day the
Subject Diary
was completed
?:N
OInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987208
Page 147 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW
OR W
ORSE
NED
MUS
CLE P
AINInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987209
Page 148 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were fever
or systemic
symptoms p
resent on th
e last day th
e Subject Di
ary was com
pleted?:NO
2.g Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED MUSCLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Oct-02-2020 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987210
Page 149 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
11:16:11
(UTC-06:00)
Central Time (US
& Canada)Symptom:: NEW
OR W
ORSE
NED
JOIN
T PAI
N
Were fever o
r systemic sy
mptoms pre
sent on the l
ast day the S
ubject Diary
was complet
ed?:NO
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0987211
Page 150 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSEN
ED JOINT PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987212
Page 151 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site R
eaction::RE
D
N
ES
S
Were injection
site reactions p
resent on the la
st day the Subj
ect Diary was c
ompleted?:N
OInitial Entry
5.a Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987213
Page 152 of 181
***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: 11421073 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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::SW
EL
LI
NG
Were injection
site reactions p
resent on the l
ast day the Su
bject Diary wa
s completed?:NOInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987214
Page 153 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
11:16:11
(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
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Injection Site
Reaction::PAI
N A
T IN
JEC
TIO
N SI
TEInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987215
Page 154 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were injectio
n site reactio
ns present on
the last day t
he Subject Di
ary was com
pleted?:NO
5.c Injection Site Reaction:
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTIO
N SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Oct-02-2020
11:16:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987216
Page 155 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-02-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-02-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-05-2020
13:55:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto
Query
Oct-03-2020
07:02:37
(UTC-06:00)ACV0PFEINFP6000  Query 1: Opened 'Sample
Collected?' is
Yes, however
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0987217
Page 156 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-02-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
no barcodes
are entered.
Please review
and correct as
appropriate.
Oct-02-2020
11:16:24
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Oct/2/2020Initial Entry
5.a
Date Location User Value Reason
Oct-05-2020
13:55:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BR91D
PInitial Entry
5.a Sample ID
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987218
Page 157 of 181
***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: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Oct-05-2020
13:55:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR91DPInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987219
Page 158 of 181
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Feb-24-2021
09:47:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Feb/24/2021Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987220
Page 159 of 181
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Feb-24-2021
09:47:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Feb-24-2021
09:47:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Feb-24-2021
16:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Feb-24-2021
09:47:23
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is
Yes, however
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987221
Page 160 of 181
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)no barcodes
are entered.
Please review
and correct as
appropriate.
Feb-24-2021
09:47:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection
:
Feb/24/2021Initial Entry
5.a
Date Location User Value Reason
Feb-24-2021
16:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR4782Initial Entry
5.a Sample ID
Date Location User Value Reason
Feb-24-2021
16:27:13
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BR4782Initial Entry
5.b
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987222
Page 161 of 181
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Feb-24-2021
16:27:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRWKH
9Initial Entry
5.b Sample ID
Date Location User Value Reason
Feb-24-2021
16:27:25
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRWKH9Initial Entry
5.c
Date Location User Value Reason
Feb-24-2021
16:27:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Sample ID
:BRWKG
WInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987223
Page 162 of 181
***Confidential***
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Feb-24-2021
16:27:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
BRWKGWInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987224
Page 163 of 181
***Confidential***
 
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit
Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 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
Oct-06-2020
16:45:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Oct/2/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020
16:45:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-06-2020
16:45:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987225
Page 164 of 181
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987226
Page 165 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Feb-07-2021
03:28:02
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Closed Response
satisfies query
Feb-04-2021
17:51:47
(UTC-06:00)ACV0PFEINFP6000  Query 2: Answered Changed data
per query
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987227
Page 166 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)
Feb-04-2021
16:45:08
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 2: Opened CLINICAL_
Per source, the
subject has
history of
smoking,
which
prompted the
need of
screening. This
information is
not recorded in
MedHx of
CRF. Pls revise
and update
accordingly.
Thanks
Jan-14-2021
18:23:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response
satisfies query
Jan-13-2021
10:53:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Answered No additional
conditions.
Screening only.
Jan-13-2021
08:16:37
(UTC-06:00)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened CLINICAL_
Per report,
subject went to
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987228
Page 167 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)"an incidental
screening for
lung cancer".
Are there any
additional
conditions or
MedHx that
precipitated
this screening?.
If so, please
update this
form. thank
you.
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Ascending Aortic A
neurysmInitial Entry
4. Start Date Time:
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Jan/4/2021 UNK:UN
KInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Jan-12-2021 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987229
Page 168 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
09:26:52
(UTC-06:00)
Central Time (US
& Canada)YES
6. Toxicity Grade:
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
4Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability/incapacity; Congenital anomaly/birth defect; Important
medical event (i.e. may jeopardize subject and may require medical/surgical intervention to
prevent above outcomes).
Date Location User Value Reason
Jan-12-2021
20:22:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto
Query
Jan-12-2021
09:26:52
(UTC-06:00)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE
Ascending
Aortic
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987230
Page 169 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Central Time (US
& Canada)Aneurysm:
Response to
"Is the adverse
event
serious?" is
'Yes' but
"Serious
Adverse Event
Number" is
blank.
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious even
t associated with c
ongenital anomaly
or birth defect?
NO
Did this serious ev
ent result in death?
NO
Did this serious ev
ent require or prol
ong hospitalization
?
YES
Did this serious ev
ent result in persist
ent or significant dInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987231
Page 170 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
isability/incapacity
?
NO
Is this serious even
t life threatening?
YES
Other medically i
mportant serious e
vent
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Jan-15-2021
00:53:07
(UTC-06:00)
Central TimeACV0PFEINFP6000  Query 1: Closed Response
satisfies query
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987232
Page 171 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
Jan-13-2021
10:59:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dQuery
resolution
Jan-13-2021
10:59:05
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to
study treatment(s
), this event is du
e to:
OTHER
If Other, specif
y:
UnknownQuery
resolution
Jan-12-2021
22:12:30
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Kindly
consider
updating 'If
Not Related to
study
treatment(s)'
missing field.
Thank you.
Jan-12-2021
09:26:52
(UTC-06:00)
Central TimeACV0PFEINFP6000  Data Entry:
NOT RELATEDInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987233
Page 172 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US & Canada)
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987234
Page 173 of 181
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERING/RES
OLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Jan-12-2021
09:26:52
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
15. Serious Adverse Event Number: For Pfizer Use Only
Date Location User Value Reason
Jan-12-2021
20:22:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
2021015979Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987235
Page 174 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Jan-27-2021
15:30:51
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/15/2020Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987236
Page 175 of 181
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Select appropriate response - Is participant willing to return for Vaccination 3?
Date Location User Value Reason
Mar-04-2021
14:27:10
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 1: Closed data updated
Mar-04-2021
11:28:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answere
dTranscription
Error
Mar-04-2021
11:28:42
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible and N
OT confirmed t
o have receive
d only placebo
at Vaccination
1/2Transcription
Error
Mar-03-2021
21:12:03
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Query 1: Opened DM:
Participant is
eligible and
confirmed to
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987237
Page 176 of 181
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION -
eCRF Audit Trail History
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
& Canada) have received
Placebo, but
Date Written
Consent
Obtained is
missing in
Informed
Consent -
Further
Vaccination
CRF. Please
review and
update as
appropriate.
Jan-27-2021
15:30:58
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Participant is willi
ng to return for Va
ccination 3
Participant is:
eligible per loc
al/national reco
mmendations a
nd confirmed t
o have receive
d only placebo
at Vaccination
1/2Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987238
Page 177 of 181
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date Treatment Unblinded :
Date Location User Value Reason
Dec-17-2020
16:08:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
Dec/16/2020Initial Entry
2. Primary Reason for Unblinding:
Date Location User Value Reason
Dec-17-2020
16:08:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
ASSESS ELIGIBILI
TY FOR ADDITION
AL VACCINATIONInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987239
Page 178 of 181
***Confidential***
 
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Oct-06-2020
16:45:22
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
Aug-11-2020
13:15:01
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDO
MIZEDInitial Entry
Aug-11-2020
13:07:56
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Jan-12-2021
20:23:51
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1: C
losedResponse satisfies query
Jan-12-2021 ACV0PFEINFP6000  Query 1: Changed data per query
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987240
Page 179 of 181
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
09:27:10
(UTC-06:00)
Central Time
(US &
Canada)Answered
Jan-11-2021
06:17:14
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query 1:
OpenedSAE
RECON:AER#2021015979
Ascending Aortic
Aneurysm(onset
date:04Jan2021)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.
Oct-06-2020
16:45:22
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
Oct/2/202
0Initial Entry
Aug-11-2020
13:15:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
Aug/11/20
20Initial Entry
Aug-11-2020
13:07:56
(UTC-06:00)
Central TimeACV0PFEINFP6000  auto calc
(autocalc)Data Entr
y:
Aug/11/20
20Initial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987241
Page 180 of 181
***Confidential***
Header Text: c4591001
Visit: Subject Status - Unscheduled Form: SUBJECT STATUS - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(US &
Canada)
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987242
Page 181 of 181
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature -
UnscheduledForm: CASEBOOK SIGNATURE FORM - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421073 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-16-2020
17:37:57
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Richard
RuppData Entry:
Click Here to EnableInitial Entry
090177e196ae3e30\Final\Final On: 01-Apr-2021 04:48 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987243