125742 S1 M5 CRF c4591001 1142 11421084

Document text

Page 1 of 153
***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: 11421084 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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987244
Page 2 of 153
***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: 11421084 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/12/2020
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987245
Page 3 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Demography
1.Subject ID [11421084]
2.Birth Date: /1979
3.Sex: MALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987246
Page 4 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Aug/12/2020
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987247
Page 5 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.aDescription of Exclusion
Criterion MetNot Applicable
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987248
Page 6 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathAug/12/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987249
Page 7 of 153
***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: 11421084 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:[Schizophrenia]
Start Date: UNK/UNK/2018
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Major Depressive Disorder]
Start Date: UNK/UNK/2018
Ongoing: YES
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987250
Page 8 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Aug/12/2020
2.Weight: [180.4]
3.Unit: LB
4.Height: [67.0]
5.Unit: in
6.Body Mass Index: [28.3]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987251
Page 9 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/12/2020
2.Randomization Number: [47124]
3.Randomization Group: [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987252
Page 10 of 153
***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: 11421084 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/12/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM7YPY]
5.bSample ID [BM7YPZ]
5.cSample ID [BM7YR0]
5.dSample ID [BLCBC1]
5.eSample ID [BLCBC2]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987253
Page 11 of 153
***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: 11421084 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/12/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BM7YR6]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987254
Page 12 of 153
***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: 11421084 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/12/2020 13:41
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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987255
Page 13 of 153
***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: 11421084 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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987256
Page 14 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/4/2020
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987257
Page 15 of 153
***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: 11421084 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
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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987258
Page 16 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2 fSymptom: DIARRHEA
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2.gSymptom: NEW OR WORSENED MUSCLE PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
2 hSymptom: NEW OR WORSENED JOINT PAIN
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?NO
3.Injection Site Location: DELTOID MUSCLE
4.Injection Site Body Side: LEFT
5.aInjection Site Reaction: REDNESS
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.bInjection Site Reaction: SWELLING
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
5.cInjection Site Reaction: PAIN AT INJECTION SITE
Were injection site reactions
present on the last day the
Subject Diary was completed?NO
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987259
Page 17 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/4/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [98.8]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987260
Page 18 of 153
***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: 11421084 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/4/2020
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9TZH]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987261
Page 19 of 153
***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: 11421084 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/4/2020 15:20
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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987262
Page 20 of 153
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Form Comments
eCRF Audit Trail History
Date of Visit
1.Date of Visit Not Done
//Comments
2.Erroneous Visit Not Done Comments
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987263
Page 21 of 153
***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: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Vaccination Symptoms Diary - Symptom Resolved Dates
1.Were medications to treat
fever/pain given on the last day
the Subject Diary was
completed?
2.Symptom:
Were fever or systemic
symptoms present on the last
day the Subject Diary was
completed?
3.Injection Site Location:
4.Injection Site Body Side:
5.Injection Site Reaction:
Were injection site reactions
present on the last day the
Subject Diary was completed?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987264
Page 22 of 153
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987265
Page 23 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987266
Page 24 of 153
***Confidential***
 
Header Text: c4591001
Visit: V4_MONTH6_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987267
Page 25 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987268
Page 26 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987269
Page 27 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987270
Page 28 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987271
Page 29 of 153
***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: 11421084 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:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987272
Page 30 of 153
***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: 11421084 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: [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987273
Page 31 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987274
Page 32 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987275
Page 33 of 153
***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: 11421084 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?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987276
Page 34 of 153
***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: 11421084 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:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987277
Page 35 of 153
***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: 11421084 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:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987278
Page 36 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987279
Page 37 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987280
Page 38 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned - New Unscheduled Visit Form: UNPLANNED VISIT
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Unplanned Assessments
1.Assessments
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987281
Page 39 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/4/2020
2.Phase of Disposition: VACCINATION
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [Discontinued d/t medical history discovered after enrollment per
instructions of CRA]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987282
Page 40 of 153
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death :Nov/4/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: NO LONGER MEETS ELIGIBILITY CRITERIA
4.Specify Status: [Discontinued d/t medical history discovered after enrollment per
instructions of CRA]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987283
Page 41 of 153
***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: 11421084 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:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987284
Page 42 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987285
Page 43 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#CategoryAE Identi
fierAdverse Eve
ntStart DateIs the Adverse Event Still
OngoingForm Instanc
e
 1.ADVERSE EV
ENT 1  Closed head i
njury Aug/19/2020 UNK
:UNK NO
End Date Time:
Aug/19/2020 UNK:UN
K
 Repeating
Pages
 2.ADVERSE EV
ENT 2  Suicidal Ideati
on Aug/19/2020 UNK
:UNK NO
End Date Time:
Aug/21/2020 UNK:UN
K
 Repeating
Pages
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987286
Page 44 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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)[Closed head injury]
4.Start Date Time: Aug/19/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/19/2020 UNK:UNKComments
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987287
Page 45 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
[Subject was in "an altercation"]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO Comments
12.Was a Non-Drug Treatment
given?NO Comments
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987288
Page 46 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Suicidal Ideation]
4.Start Date Time: Aug/19/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Aug/21/2020 UNK:UNK
6.Toxicity Grade: 4
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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987289
Page 47 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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:
[History of Major Depressive Disorder]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment
given?NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2020355765]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987290
Page 48 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987291
Page 49 of 153
***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: 11421084 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[ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987292
Page 50 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987293
Page 51 of 153
***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: 11421084 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: //
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987294
Page 52 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987295
Page 53 of 153
***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: 11421084 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?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987296
Page 54 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
#Categor
yTreatment Identifi
erCon Non-Drug Treatments Pre-spec
ifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987297
Page 55 of 153
***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: 11421084 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?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987298
Page 56 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987299
Page 57 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987300
Page 58 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987301
Page 59 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987302
Page 60 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987303
Page 61 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 1
Form Version: 10-Oct-2020 15:57 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987304
Page 62 of 153
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: CONTACT OUTCOME - MONTH 6
Form Version: 10-Oct-2020 16:01 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987305
Page 63 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987306
Page 64 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987307
Page 65 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987308
Page 66 of 153
***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: 11421084 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 [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987309
Page 67 of 153
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987310
Page 68 of 153
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987311
Page 69 of 153
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Treatment Unblinded
1.Date Treatment Unblinded : //
2.Primary Reason for Unblinding:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987312
Page 70 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987313
Page 71 of 153
***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: 11421084 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: [ ]
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987314
Page 72 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Nov/4/2020
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987315
Page 73 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987316
Page 74 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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 14:19:08 (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.
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987317
Page 75 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-04-2020 14:38:38 (UTC-06:00) Central
Time (US & Canada)Not Applicable
FormOct-26-2020 17:17:57 (UTC-06:00) Central
Time (US & Canada)
FormAug-12-2020 18:53:47 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987318
Page 76 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormSep-15-2020 11:52:35 (UTC-06:00) Central
Time (US & Canada)
FormAug-12-2020 19:01:54 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987319
Page 77 of 153
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
FormNov-12-2020 14:09:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987320
Page 78 of 153
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
1Nov-12-2020 14:09:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987321
Page 79 of 153
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - Comments
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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
2Nov-12-2020 14:09:58 (UTC-06:00) Central
Time (US & Canada)Not Done
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987322
Page 80 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
5Sep-14-2020 17:30:57 (UTC-06:00) Central
Time (US & Canada)
5Aug-28-2020 09:30:23 (UTC-06:00) Central
Time (US & Canada)Unknown
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987323
Page 81 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
11Sep-14-2020 17:49:02 (UTC-06:00) Central
Time (US & Canada)
11Aug-28-2020 09:29:55 (UTC-06:00) Central
Time (US & Canada)Unknown
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987324
Page 82 of 153
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Comments
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
ItemDate User Comment
12Sep-14-2020 17:49:28 (UTC-06:00) Central
Time (US & Canada)
12Aug-28-2020 09:30:07 (UTC-06:00) Central
Time (US & Canada)Unknown
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987325
Page 83 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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 14:19:08 (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 Nov-30-2020 17:11:55 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp  Approved Nov-16-2020 15:14:21 (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 Oct-26-2020 17:17:57 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987326
Page 84 of 153
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Affidavit:
N/A
Richard Rupp  Approved Oct-21-2020 12:36:21 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, RichardRupp, verify that all case report form pages accurately display the results of
the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Sep-23-2020 09:06:32 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Richard Rupp  Approved Sep-18-2020 15:47:59 (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.
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987327
Page 85 of 153
***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: 11421084 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-12-2020 18:53:22
(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-12-2020 18:53:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987328
Page 86 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Aug-12-2020 18:53:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtain
ed
Aug/12/2020Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987329
Page 87 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-16-2020
06:17:49
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Closed event entered in AE CRF
Sep-15-2020
11:44:25
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per query
Sep-15-2020
05:23:38
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2020355765
suicidal ideation(onset
date:19-Aug-2020)was
reported as serious in
Safety database but missing
in AE CRF. Please confirm
and update CRF. If safety
update is required, submit a
follow-up SAE Form.
Aug-12-2020
18:53:14
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
11421084Item copied from previous
form
2. Birth Date:
Date Location User Value Reason
Aug-12-2020 18:53:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1979Enrollment Entry
3. Sex:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987330
Page 88 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Aug-12-2020 18:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Aug-12-2020 18:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATINO
(A) OR OF SPANISH ORIGI
NInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Aug-12-2020 18:53:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987331
Page 89 of 153
***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: 11421084 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-27-2020 04:14:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Oct-26-2020 17:19:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject met
exclusion criteria
at time of
enrollment, but did
not disclose those
conditions when
asked during
interview and
those records were
not available at
time of enrollment.
Oct-26-2020 11:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery:
medical history
indicates ongoing
schizophrenia and
major depressive
disorder with
suicidal ideations
at the time of
enrollment. Please
review and clarify
if exclusion 1 is
met. Please update
CRF as needed.
Aug-12-2020 18:53:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987332
Page 90 of 153
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - 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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
2.a
Date Location User Value Reason
Nov-04-2020 14:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Criterion Description:Deleted upon
direction of CRA
Oct-26-2020 17:18:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Crit
erio
n D
escr
ipti
on:Other medical or psychi
atric condition incl. rece
nt (within past year) or
active suicidal ideation/
behavior/lab abnormalit
y that may increase the
risk of study participati
onInitial Entry
2.a Description of Exclusion Criterion Met
Date Location User Value Reason
Nov-16-2020 19:57:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Nov-04-2020 14:38:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Deleted upon
direction of CRA
Oct-30-2020 08:50:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Still awaiting
guidance from CRA.
Oct-30-2020 01:56:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened PDQ: RQ2: Please
consider to update
‘DISPOSITION –
TREATMENT’ CRF
details present under
EOT folder as
appropriate for this
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987333
Page 91 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - 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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
subject and respond
to query one data
updated. Please
connect with SITE
CRA for assistance.
Thank you.
Oct-29-2020 07:30:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered I requested guidance
about this subject a
month ago and have
not yet received
word about what to
do with him.
Oct-29-2020 02:26:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened PDQ: RQ1: As per
previous query
response, please
consider to update
‘DISPOSITION –
TREATMENT’ CRF
details as as
appropriate. Else
clarify.
Oct-28-2020 18:25:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered After subject was
vaccination, mental
health history was
discovered. Subject
denied in initial
interview.
Oct-28-2020 00:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened PDQ:RQ1:
Exclusion criteria
still added,
vaccination details
present.
Inclusion/Exclusion
is expected only for
Screen Failure and
subjects randomized
in error. Please add
Form level comment
“Not Applicable” if
Incl/Excl was added
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987334
Page 92 of 153
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - 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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
in error or confirm.
Oct-27-2020 08:26:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Detailes updated per
previous query.
Oct-27-2020 04:39:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened PDQ: Exclusion
criteria have been
added, vaccination
details present.
Inclusion/Exclusion
is expected only for
Screen Failure and
subjects randomized
in error. Please add
Form level comment
“Not Applicable” if
Incl/Excl was added
in error or confirm.
Oct-26-2020 17:18:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Other medical or psychiatric
condition incl. recent (withi
n past year) or active suicida
l ideation/behavior/lab abno
rmality that may increase th
e risk of study participationInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987335
Page 93 of 153
***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: 11421084 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-12-2020 18:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-17-2020 06:56:50
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Query placed in a
different form.
Sep-15-2020 12:29:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Based on the
missing MHx
(schizophrenia and
major depressive
disorder), please
re-assess eligibility
against Inclusion
#3 and Exclusion
#1
Aug-12-2020 18:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-15-2020 12:30:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Sep-15-2020 11:53:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Sep-15-2020 07:50:40 ACV0PFEINFP6000  Giselle Query 1: Opened Subject has a Med
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987336
Page 94 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)Castillo Hx of major
depressive disorder
and schizophrenia
(from 2018).
Please
revise/update
accordingly. Thank
you.
Aug-12-2020 18:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987337
Page 95 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1.a
Date Location User Value Reason
Sep-15-2020 11:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Numbe
r:1
Medical History
Term:Schizophren
ia
Start Date: UNK/UNK/
2018
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-15-2020 11:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
1.a Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-21-2020 14:17:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Response satisfies
query
Sep-17-2020 17:11:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject was not
eligible at time of
enrollment, but did
not report this
history when asked
in interview.
Sep-17-2020 06:57:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened Based on the
missing MHx
(schizophrenia and
major depressive
disorder), please
re-assess eligibility
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987338
Page 96 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
against Inclusion
#3 and Exclusion
#1.
Sep-15-2020 11:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SchizophreniaInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-15-2020 11:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-15-2020 11:53:06
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-15-2020 11:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Major Depressi
ve Disorder
Start Date: UNK/UNK/201
8
Ongoing: YESInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987339
Page 97 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-15-2020 11:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-15-2020 11:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Major Depressive DisorderInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-15-2020 11:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2018Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-15-2020 11:53:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987340
Page 98 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Weight:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
180.4Initial Entry
3. Unit:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
67.0Initial Entry
5. Unit:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987341
Page 99 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
28.3Initial Entry
7.a
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 97.6
Temperature U
nit:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.6Initial Entry
7.a Unit:
Date Location User Value Reason
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987342
Page 100 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-12-2020 19:02:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987343
Page 101 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Aug-12-2020 19:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Aug-12-2020 19:03:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
47124Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987344
Page 102 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 18:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 18:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 18:54:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 18:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-12-2020 18:54:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987345
Page 103 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-12-2020 18:55:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
5.a
Date Location User Value Reason
Aug-12-2020 18:54:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YPYInitial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 18:54:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YPYInitial Entry
5.b
Date Location User Value Reason
Aug-12-2020 18:54:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YPZInitial Entry
5.b Sample ID
Date Location User Value Reason
Aug-12-2020 18:54:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YPZInitial Entry
5.c
Date Location User Value Reason
Aug-12-2020 18:54:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YR0Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987346
Page 104 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Sample ID
Date Location User Value Reason
Aug-12-2020 18:54:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YR0Initial Entry
5.d
Date Location User Value Reason
Aug-12-2020 18:55:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCBC1Initial Entry
5.d Sample ID
Date Location User Value Reason
Aug-12-2020 18:55:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLCBC1Initial Entry
5.e
Date Location User Value Reason
Aug-12-2020 18:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BLCBC2Initial Entry
5.e Sample ID
Date Location User Value Reason
Aug-12-2020 18:55:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BLCBC2Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987347
Page 105 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Aug-12-2020 18:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Aug-12-2020 18:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Aug-12-2020 18:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Aug-12-2020 18:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Aug-12-2020 18:55:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Aug/12/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987348
Page 106 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Aug-12-2020 18:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM7YR6Initial Entry
5.a Sample ID
Date Location User Value Reason
Aug-12-2020 18:55:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM7YR6Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987349
Page 107 of 153
***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: 11421084 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-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Aug-12-2020 19:12:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 13:41Transcription Error
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/12/2020 18:56Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987350
Page 108 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
6. Body Side:
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Aug-12-2020 18:56:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987351
Page 109 of 153
***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: 11421084 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-12-2020 18:56:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES - REACTOGENICITY E
-DIARY COLLECTED FOR
THIS SUBJECTInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987352
Page 110 of 153
***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: 11421084 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-04-2020 16:17:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987353
Page 111 of 153
***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: 11421084 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-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.a
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FE
V
ER
Were fever or systemic s
ymptoms present on the
last day the Subject Dia
ry was completed?:N
OInitial Entry
2.a Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
2.a Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.b
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987354
Page 112 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: FA
TI
GU
E
Were fever or systemic
symptoms present on th
e last day the Subject D
iary was completed?:NOInitial Entry
2.b Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FATIGUEInitial Entry
2.b Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.c
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: HE
AD
AC
HE
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987355
Page 113 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.c Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
HEADACHEInitial Entry
2.c Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.d
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: CH
IL
LS
Were fever or systemic
symptoms present on th
e last day the Subject Di
ary was completed?:N
OInitial Entry
2.d Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
2.d Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987356
Page 114 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.e
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: VO
MIT
ING
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
2.e Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
2.e Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.f
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: DI
AR
RH
EA
Were fever or systemic
symptoms present on t
he last day the Subject
Diary was completed?:NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987357
Page 115 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.f Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
2.f Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.g
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
MUSCL
E PAIN
Were fever or syst
emic symptoms pr
esent on the last d
ay the Subject Dia
ry was completed?
:NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987358
Page 116 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.g Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED MUS
CLE PAINInitial Entry
2.g Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2.h
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom:: NEW O
R WOR
SENED
JOINT P
AIN
Were fever or syst
emic symptoms pr
esent on the last da
y the Subject Diar
y was completed?:NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987359
Page 117 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
2.h Symptom:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR WORSENED JOIN
T PAINInitial Entry
2.h Were fever or systemic symptoms present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Injection Site Location:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
4. Injection Site Body Side:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
5.a
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction:
:RE
DN
ES
SInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987360
Page 118 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Were injection site reac
tions present on the las
t day the Subject Diary
was completed?:NO
5.a Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
REDNESSInitial Entry
5.a Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.b
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reaction
::SW
ELL
ING
Were injection site rea
ctions present on the l
ast day the Subject Di
ary was completed?:NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987361
Page 119 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.b Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWELLINGInitial Entry
5.b Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
5.c
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injection Site Reacti
on::PAIN
AT INJ
ECTIO
N SIT
E
Were injection site r
eactions present on
the last day the Sub
ject Diary was comp
leted?:NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987362
Page 120 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
5.c Injection Site Reaction:
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PAIN AT INJECTION SITEInitial Entry
5.c Were injection site reactions present on the last day the Subject Diary was completed?
Date Location User Value Reason
Sep-04-2020 16:19:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987363
Page 121 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-04-2020 16:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020Initial Entry
2.a
Date Location User Value Reason
Sep-04-2020 16:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.8
Temperature Un
it:F
Temperature Lo
cation::ORAL CA
VITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-04-2020 16:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-04-2020 16:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.8Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987364
Page 122 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-04-2020 16:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Sep-04-2020 16:19:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
ORAL CAVITYInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987365
Page 123 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-04-2020 16:19:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-04-2020 16:19:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-04-2020 21:41:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-04-2020 16:19:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-04-2020 16:19:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/4/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987366
Page 124 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-04-2020 21:41:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BP9TZHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-04-2020 21:41:19
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BP9TZHInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987367
Page 125 of 153
***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: 11421084 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-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/4/2020 15:20Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987368
Page 126 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED
OBSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-04-2020 16:20:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987369
Page 127 of 153
***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, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Dec-01-2020 05:14:02
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Closed FUP tab completed
Nov-30-2020 17:28:01
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Subject did not
withdraw. Subject
was discontinued
due to not meeting
inclusion/exclusion
criteria.
Nov-30-2020 13:40:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Reissued:Opened CLINQUERY:
Query response
'subject withdrew': if
subject will not
attend any further
visits for study
please complete the
FUP tab capturing
reason for end of
study. Review also
completion the
WOC (Withdrawal
of Consent) page
under DISP tab, if
relevant
Nov-30-2020 08:22:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject withdrew
Nov-30-2020 05:49:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Hayley
WyperQuery 1: Opened CLINQUERY: Per
CRF subject
received both doses
of study vaccination.
Please clarify why
no follow up visit
has been performed
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987370
Page 128 of 153
***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, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
for this subject to
review
safety/efficacy
Nov-12-2020 14:09:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
2. Erroneous Visit
Date Location User Value Reason
Nov-12-2020 14:09:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not DoneInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987371
Page 129 of 153
***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: 11421084 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
Nov-04-2020 14:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-04-2020 14:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Nov-04-2020 14:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO LONGER MEETS ELIGI
BILITY CRITERIAInitial Entry
4. Specify Status:
Date Location User ValueReason
Nov-10-2020
15:43:50
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: Clo
sedResponse
satisfies query
Nov-10-2020
10:15:58
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
1: An
swere
dSchizophrenia
was already
added to
medical
history.
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987372
Page 130 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Nov-10-2020
02:34:06
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFE SDQ PROD Query
1: Op
enedPlease review
Specify Status
field, the
following text
was indicated
in the
comment field
[medical
history]
however
medical
history is not
updated with
details Please
review and
update as
necessary.
"[
]"
Nov-04-2020
14:37:40
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Disco
ntinue
d d/t
medic
al hist
ory di
scove
red af
ter en
rollm
ent pe
r instr
uction
s of C
RAInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987373
Page 131 of 153
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 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
Nov-30-2020 17:11:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/4/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Nov-30-2020 17:11:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
3. Status:
Date Location User Value Reason
Nov-30-2020 17:11:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO LONGER MEETS ELIGI
BILITY CRITERIAInitial Entry
4. Specify Status:
Date Location User Value Reason
Nov-30-2020 17:11:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Discontinued d/t medical histor
y discovered after enrollment p
er instructions of CRAInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987374
Page 132 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987375
Page 133 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987376
Page 134 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Aug-24-2020 17:57:36
(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
Sep-16-2020 08:06:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed Event updated to
suicidal ideation in
SDB
Sep-15-2020 11:43:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered Subject medical
records obtained -
event was not an
SAE, subject was
hospitalized for
suicidal ideations, for
which an SAE report
was submitted
14Sep2020
Sep-15-2020 05:32:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened SAE RECON:
AER#2020336447,the
term was updated in
AE CRF to CLOSED
HEAD INJURY
while in SDB it was
retained to as 'Injury
to right orbit'. Please
confirm correct term.
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987377
Page 135 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
If safety update is
required, please
submit a follow-up
SAE form.
Sep-14-2020 17:41:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Closed head injuryNew Information
Sep-12-2020 01:03:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Sandip
Namdeorao
SuryawanshiQuery 3: Closed Response satisfies
query
Sep-11-2020 15:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Answered New Information
Sep-11-2020 15:55:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Injury to right orbitNew Information
Sep-11-2020 05:18:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened SAE RECON:
AER#2020336447,the
term was updated in
Safety database to
'injury to right orbit.
Please confirm
correct term. If safety
update is required,
please submit a
follow-up SAE form.
Sep-03-2020 02:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Closed Response satisfies
query
Sep-02-2020 10:58:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered I have no additional
information at this
time. Have been
unable to reach
subject by phone.
Sep-02-2020 09:25:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Reissued:Opened please can you
confirm if there is any
additional
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987378
Page 136 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
information for this
AE? It is not clear
what the AE is.
Thanks
Sep-01-2020 05:08:37
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed reported under AER
2020336447
Aug-31-2020
05:56:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Reissued:Candid
ateSAE RECON: For
PSSR review to
confirm if AEM
forms were received.
Aug-28-2020
09:21:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered SAE Report form was
faxed 21Aug2020
Aug-28-2020
09:10:15
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered I have provided all of
the details I have. I do
not have a diagnosis
to provide at this
time.
Aug-26-2020
03:02:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened SAE RECON:
Hospitalized
following an
"altercation"(Onset
date:20Aug2020) is
not reported on SAE
Report Form but
marked serious on AE
CRF. Confirm
seriousness and report
to Pfizer immediately.
If this event is not
serious, downgrade
the event on AE CRF.
Aug-26-2020
02:57:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Opened Please can you
provide the
symptoms/disease
/diagnosis that
occurred?
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987379
Page 137 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Hospitalisation is not
an AE, it is the result
of an AE. Thanks
Aug-24-2020
17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Hospitalized following an
"altercation"Initial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-16-2020 08:52:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020 UNK:UNKNew Information
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/20/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-16-2020 08:53:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/19/2020 UNK:UNKNew Information
Sep-15-2020 08:49:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
Sep-14-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answered Initial Entry
Sep-14-2020 17:41:16
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/20/2020 UNK:UNKInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987380
Page 138 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-14-2020 17:30:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Sep-11-2020 23:04:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Erica Weaver Query 2: Opened DM: Please
remove
UNKNOWN and
report whether the
AE was ongoing at
the last
contact/report of
AE.
Aug-31-2020 09:00:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Aug-28-2020 11:04:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Aug-28-2020 09:30:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
Aug-25-2020 04:31:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened DM: Please review
and consider to
update the missing
response on item
number #5, #11
and #12. Thank
you.
Aug-24-2020 17:58:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Transcription
Error
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/21/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987381
Page 139 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-23-2020 11:16:23
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Ahmed
HassanQuery 1: Closed Response satisfies
query
Sep-23-2020 09:06:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Query resolution
Sep-23-2020 09:06:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Query resolution
Sep-22-2020 19:16:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened ClinQuery: as the
AE was deemed
non-serious, please
amend. Grade 4
pertains to 'life
threatening
consequences,
urgent intervention
needed'. thanks
Sep-21-2020 08:41:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered I was under the
impression that an
ER visit made it a
Grade 4. Please let
me know if it is
otherwise.
Sep-21-2020 00:35:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened ClinQuery: Closed
head injury: Please
can you review the
toxicity grade as
currently it is listed
as grade 4
indicating it is life
threatening.
Thanks
Sep-20-2020 19:08:41
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Candidate ClinQuery: Closed
head injury: Please
can you review the
toxicity grade as
currently it is listed
as grade 4
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987382
Page 140 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
indicating it is life
threatening.
Thanks
Aug-24-2020 17:57:36
(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
Sep-16-2020
08:06:45
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Close
dEvent updated to suicidal ideation in
SDB
Sep-15-2020
11:44:02
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Ans
weredSubject medical records obtained -
event not an SAE. Update form to be
submitted today.
Sep-15-2020
05:30:38
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 2: Open
edSAE
RECON:AER#2020336447,Seriousness
in AE CRF was updated to NO
however, the event was reported as
SERIOUS in Safety database. Please
confirm. If this event is serious,update
to yes.To downgrade the event in the
Safety Database,please submit SAE
form.
Sep-14-2020
17:44:23
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Cand
idateFor AE Closed head injury: Response
to "Is the adverse event serious?" is 'No'
but "Serious Adverse Event Number" is
present.
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987383
Page 141 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-14-2020
17:44:23
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Data Entry:
NONew Information
Aug-26-2020
04:37:34
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Close
dRaised in error
Aug-25-2020
00:21:47
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  Query 1: Open
edDM: For AE Hospitalized following an
"altercation": Response to "Is the
adverse event serious?" is 'Yes' but
"Serious Adverse Event Number" is
blank.
Aug-24-2020
17:57:36
(UTC-06:00)
Central Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Cand
idateFor AE Hospitalized following an
"altercation": Response to "Is the
adverse event serious?" is 'Yes' but
"Serious Adverse Event Number" is
blank.
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0987384
Page 142 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
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
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomaly
or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requir
e or prolong hospitalization?
YES
Did this serious event result
in persistent or significant di
sability/incapacity?
NO
Is this serious event life thre
atening?
NO
Other medically important s
erious eventInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987385
Page 143 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
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
Aug-24-2020 17:57:36
(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
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
Subject was in "an alter
cation"Initial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Aug-24-2020 17:57:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-14-2020 17:49:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Sep-14-2020 17:49:02 ACV0PFEINFP6000  Data Entry: Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987386
Page 144 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
(UTC-06:00) Central
Time (US & Canada)
Aug-28-2020 09:29:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-14-2020 17:49:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
Sep-14-2020 17:49:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: Initial Entry
Aug-28-2020 09:30:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UnknownInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-15-2020
05:24:11
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Closed resolved
Sep-14-2020
17:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Sep-14-2020
17:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Answe
redNew Information
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987387
Page 145 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-14-2020
17:47:54
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/
RESOLVEDNew Information
Sep-14-2020
17:41:30
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opene
dFor AE Closed head injury:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Sep-14-2020
17:41:16
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opene
dFor AE Injury to right orbit:
Response to "What was the outcome
of this adverse event?" is
'Recovering/Resolving' but AE End
Date/Time is present.
Sep-14-2020
04:03:19
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  Query 2: Opene
dSAE
RECON:AER#2020336447 ,outcome
was updated to
RECOVERED/RESOLVED in
Safety DB however, reported as
RECOVERING/RESOLVING on
AE CRF. Please confirm correct
outcome. If safety update is
required, please submit a follow-up
form
Aug-24-2020
17:58:23
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Aug-24-2020
17:57:36
(UTC-06:00)
Central Time (US
& Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opene
dFor AE Hospitalized following an
"altercation": Response to "What
was the outcome of this adverse
event?" is 'Recovering/Resolving'
but AE End Date/Time is present.
Aug-24-2020
17:57:36
(UTC-06:00)
Central Time (USACV0PFEINFP6000  Data Entry:
RECOVERING/
RESOLVINGInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987388
Page 146 of 153
***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, Locked, Frozen, Not Complete
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
& Canada)
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Aug-24-2020 17:57:36
(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
Sep-16-2020 08:07:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry: event deemed not
serious
Sep-01-2020 04:48:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020336447Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987389
Page 147 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Category:
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
2Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-23-2020 23:16:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Closed Appreciate the
prompt response.
Thank you.
Oct-23-2020 17:57:54
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Changed data per
query
Oct-22-2020 12:27:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Giselle
CastilloQuery 1: Opened COVID testing
has not been
recorded in the
SAE submitted to
safety. If test
performed = YES,
please provide FU
form with results.
If NOT test
performed or
available, please
submit FU form
as well so it is
reflected in the
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987390
Page 148 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
narrative.
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Suicidal IdeationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Aug/19/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Aug/21/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Sep-15-2020 11:42:20
(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
Sep-20-2020 17:46:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Closed Response satisfies
query
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987391
Page 149 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Sep-17-2020 17:01:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Answered SAE was reported
via fax as required
- Where is ID
incomplete?
Sep-16-2020 18:34:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 2: Opened ClinQuery:
Suicidal Ideation:
Question 7 states
subject was
hospitalised but
there is no SAE ID
listed. Please
review/update.
Thanks
Sep-16-2020 08:07:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Suicidal
Ideation: Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associa
ted with congenital anomal
y or birth defect?
NO
Did this serious event result
in death?
NO
Did this serious event requi
re or prolong hospitalizatio
n?
YESInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987392
Page 150 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
YES
Other medically important s
erious event
NO
8. Is this adverse event the result of a study Medication Error?
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Sep-15-2020 11:42:20
(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
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study treat
ment(s), this event is due to:
OTHER
If Other, specify:
History of Major Depres
sive DisorderInitial Entry
10. Latest Action Taken with Study Treatment:
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987393
Page 151 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Sep-15-2020 11:42:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Sep-15-2020 11:42:20
(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
Sep-16-2020 08:07:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2020355765Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0987394
Page 152 of 153
***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: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Subject Status
Date Location User Value Reason
Nov-30-2020 17:11:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Nov-04-2020 14:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DISCONTINUEDInitial Entry
Aug-12-2020 19:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ENROLLED/RANDOMIZEDInitial Entry
Aug-12-2020 18:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENEDInitial Entry
2. Subject Status Date
Date Location User Value Reason
Nov-30-2020 17:11:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/4/2020Initial Entry
Nov-04-2020 14:37:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Nov/4/2020Initial Entry
Aug-12-2020 19:02:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
Aug-12-2020 18:53:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Aug/12/2020Initial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
FDA-CBER-2021-5683-0987395
Page 153 of 153
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Signed, Verified
Site No: 1142 Site Name: (1142) University of Texas - Galveston
Subject No: 11421084 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 11:44
Back to Form
1. Casebook Signature
Date Location User Value Reason
Sep-18-2020 15:47:47
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Richard
RuppData Entry:
Click Here to EnableInitial Entry
090177e196ae3e31\Final\Final On: 01-Apr-2021 04:49 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-0987396