125742 S1 M5 CRF c4591001 1047 10471290

Document text

Page 1 of 221
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol
amendment 5, STAGE 3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version08 SEP 2020
2.Select appropriate response -
What cohort does the subject
belong to?STAGE 3 COHORTS
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913149
Page 2 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/24/2020
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913150
Page 3 of 221
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Demography
1.Subject ID [10471290]
2.Birth Date: 1964
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:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913151
Page 4 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/24/2020
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913152
Page 5 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion
Criterion Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion
Criterion MetNot Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913153
Page 6 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Screening
1.Date of
Completion/Discontinuation
/DeathSep/24/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913154
Page 7 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillitis]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left arm fracture]
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
UNK/UNK/1978
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[lumbar disc extrusion]
Start Date: UNK/UNK/2016
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[osteoarthrosis right foot]
Start Date: UNK/UNK/2014
Ongoing: YES
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913155
Page 8 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[left knee osteoarthritis]
Start Date: UNK/UNK/2010
Ongoing: YES
1 fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[tonsillectomy]
Start Date: UNK/UNK/1980
Ongoing: NO
End Date:
UNK/UNK/1980
1.gLine/MH Number: [7]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[correction of left arm fracture]
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
UNK/UNK/1978
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913156
Page 9 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
HIV Status
1.Select appropriate response -
What is the subject HIV status?The subject is NOT known to be HIV POSITIVE
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913157
Page 10 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Sep/24/2020
2.Weight: [300.0]
3.Unit: LB
4.Height: [76.0]
5.Unit: in
6.Body Mass Index: [36.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [98.6]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913158
Page 11 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/24/2020
2.Randomization Number: [265075]
3.Randomization Group: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913159
Page 12 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BK8YW1]
5.bSample ID [BM955J]
5.cSample ID [BM955K]
5.dSample ID [BM955L]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913160
Page 13 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/24/2020
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 [BM9561]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913161
Page 14 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Sep/24/2020 14:17
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
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913162
Page 15 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS
SUBJECT
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913163
Page 16 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Oct/13/2020
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913164
Page 17 of 221
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vital Signs
1.Date: Oct/13/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: FOREHEAD
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913165
Page 18 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Oct/13/2020
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 [BR8FP8]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913166
Page 19 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Vaccination
1.Was there a temporary delay of
vaccination?NO
2.Treatment Name [BLINDED THERAPY]
3.Formulation: INJECTION
4.Dose Date Time: Oct/13/2020 14:21
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
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913167
Page 20 of 221
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Nov/10/2020
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913168
Page 21 of 221
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Nov/10/2020
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 [BPSXR7]
5.bSample ID [BPSXR8]
5.cSample ID [BPSXR9]
5.dSample ID [BSHP34]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913169
Page 22 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913170
Page 23 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913171
Page 24 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913172
Page 25 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913173
Page 26 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913174
Page 27 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913175
Page 28 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/23/2021
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913176
Page 29 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Feb/23/2021
2.Date of First Symptom Started: Not Applicable
//Comments
3.Symptoms Ongoing? Not Applicable Comments
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? NO
4.eSymptoms: NEW OR INCREASED MUSCLE PAIN
Was symptom present? NO
4 fSymptoms: NEW LOSS OF TASTE OR SMELL
Was symptom present? NO
4.gSymptoms: NEW OR INCREASED SORE THROAT
Was symptom present? NO
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913177
Page 30 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913178
Page 31 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of C
ollectionSpecimen T
ypeSpecimen Coll
ection Locatio
nAssay Code and Description Device TypeForm Instan
ce
 1.Feb/23/20
21 SWABBED
MATERIAL NASOPHARY
NX SEVERE ACUTE RESP SY
NDROME CORONAVIRUS
2 SARS-COV-2 DI
AGNOSTIC TES
T Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913179
Page 32 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Feb/23/2021
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: POSITIVE
8.Comments/Findings/Details: [ ]
9.Trade Name Other, Specify: [Xpert Xpress SARS-Cov2 Assay CLIA certified lab]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913180
Page 33 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913181
Page 34 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Form Comments
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin Not Applicable Comments
2.Sample Type Not Applicable Comments
3.Sample Collected? Not Applicable Comments
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:Not Applicable
[ ]Comments
Aliquot
Please enter barcode for each aliquot.
5.Sample ID Not Applicable
[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913182
Page 35 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or
Contacts:NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or
Contacts:NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or
Contacts:NO
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or
Contacts:NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or
Contacts:NO
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or
Contacts:NO
Health Care Utilization Other
2.Other Type of Practitioner
Specify:[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913183
Page 36 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19
illness?NO
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913184
Page 37 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Treatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntTreatme
ntStart Da
teForm Instance
 1.          Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913185
Page 38 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Respiratory Treatment
1.What is the treatment Identifier? [ ]
2.Concomitant Non-drug
Treatment Pre-specified:
3.Treatment:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913186
Page 39 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 0
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913187
Page 40 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category of Clinical Eve
nt:Subcategory of Clinical Ev
entDiagnosis Obtain
edToxicity Gra
deForm Instance
 1.        Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913188
Page 41 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913189
Page 42 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for L
ab TestVendor N
ameCollection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913190
Page 43 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: LOCAL LABORATORY DATA - REPEATING
CHEMISTRY
Form Version: 15-Sep-2020 21:51 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Lab Chemistry Details
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913191
Page 44 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Category for
Lab TestVendor Name (D
ERIVED)Collection
Date:Specimen
TypeLab ResultForm Instan
ce
 1.       Sponsor-Defined
IdentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913192
Page 45 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 15-Sep-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Laboratory Data Hematology
1.Lab Panel:
2.Laboratory Name and Address [ ]
3.Collection Date: //
4.Specimen Type:
Lab Result
5.Sponsor ID: [ ]
Test:
Result: [ ]
Not Done:
LNMT Low
[ ]
High
[ ]
Unit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913193
Page 46 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913194
Page 47 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: VITAL SIGNS - COVID
Form Version: 15-Sep-2020 21:52 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Systolic: [ ]
Diastolic: [ ]
Respiratory Rate in
respirations/minute:[ ]
Heart Rate in beats/minute: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913195
Page 48 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date: Vital Signs Details Form Instance
 1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913196
Page 49 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 15-Sep-2020 21:54 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913197
Page 50 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date Time of Assessmen
tArterial Blood Gases PaO
2FiO2 (Fraction of Inhaled Oxyge
n)Form Instance
 1.      Repeating Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913198
Page 51 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2
(mmHg):[ ]
3.FiO2 (Fraction of Inhaled
Oxygen):[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913199
Page 52 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913200
Page 53 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Start Date: //
6.Ongoing?
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913201
Page 54 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
 1.        Repeating Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913202
Page 55 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913203
Page 56 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913204
Page 57 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913205
Page 58 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913206
Page 59 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913207
Page 60 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913208
Page 61 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Unplanned Assessments
1.Assessments
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913209
Page 62 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Event
Still OngoingForm Instan
ce
 1.ADVERSE
EVENT 1  Abdominal hernia  Dec/7/2020 U
NK:UNK NO
End Date Time:
Dec/14/2020 UNK:
UNK
 Repeating
Pages
 2.ADVERSE
EVENT 2  Cholelithiasis  Dec/7/2020 U
NK:UNK NO
End Date Time:
Jan/12/2021 UNK:
UNK
 Repeating
Pages
 3.ADVERSE
EVENT 3  Intra abdominal infection p
ost cholecystectomy Feb/22/2021 U
NK:UNK YES  Repeating
Pages
 4.ADVERSE
EVENT 4  possible GI Bleed  Feb/22/2021 U
NK:UNK NO
End Date Time:
Feb/22/2021 UNK:
UNK
 Repeating
Pages
 5.ADVERSE
EVENT 5  Small bowel strangulation  Dec/7/2020 U
NK:UNK NO
End Date Time:
Mar/7/2021 UNK:
UNK
 Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913210
Page 63 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Abdominal hernia]
4.Start Date Time: Dec/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Dec/14/2020 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913211
Page 64 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[abdominal hernia]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021259894]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913212
Page 65 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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)[Cholelithiasis]
4.Start Date Time: Dec/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Jan/12/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).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
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913213
Page 66 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[Gallstones formed]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913214
Page 67 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [3]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Intra abdominal infection post cholecystectomy]
4.Start Date Time: Feb/22/2021 UNK:UNK
5.Is the adverse event still
ongoing?YES
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913215
Page 68 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[post op complication of infection with 3 types of e coli]
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?:NOT RECOVERED/NOT 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[2021259908]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913216
Page 69 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [4]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[possible GI Bleed]
4.Start Date Time: Feb/22/2021 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Feb/22/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).NO
8.Is this adverse event the result of
a study Medication Error?
If Yes, record the type of
medication error on the
Medication Error Log.NO
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913217
Page 70 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[NSAID use for pain]
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[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913218
Page 71 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
eCRF Audit Trail History
Form Audit Trail
Adverse Event Report
1.Category: ADVERSE EVENT
2.AE ID: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Small bowel strangulation]
4.Start Date Time: Dec/7/2020 UNK:UNK
5.Is the adverse event still
ongoing?NO
End Date Time:
Mar/7/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization;
Persistent or significant
disability/incapacity; Congenital
anomaly/birth defect; Important
medical event (i.e. may
jeopardize subject and may
require medical/surgical
intervention to prevent above
outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant
disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913219
Page 72 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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:
[hernia entrapment]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment
given?YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from
the study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021259894]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913220
Page 73 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Catego
ryMedication E
rrorStart D
ateIs the medication error Still
OngoingStudy Medication Error
s ActionForm Instanc
e
 1.          Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913221
Page 74 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Medication Error
1.Category:
2.Medication Error (Type of
Medication Error):[ ]
3.Start Date: //
4.Is the medication error still
ongoing?
5.Latest Action Taken with Study
Treatment:
6.Was a Concomitant Medication
given?
7.Was a Non-Drug Treatment
given?
8.Did the Medication Error cause
the subject to be discontinued
from the study?
9.Was this medication error
associated with any adverse
events?
10.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913222
Page 75 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Med
icationStart
DateForm Instanc
e
 1.          Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913223
Page 76 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Date: //
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913224
Page 77 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Sponsor-Defined
IdentifierCategory for M
edicationConcomitant Medication
s Pre-specifiedName of Me
dicationDose Descr
iptionForm Instan
ce
 1.          Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913225
Page 78 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Concomitant Medications
1.What is the medication
identifier?[ ]
2.Category:
3.Concomitant Medications
Pre-specified:
4.Medication:
Provide the complete generic
drug name (including salt form,
where applicable). Where generic
name is unknown, enter the full
trade or proprietary name.
Include clarifying information in
the Medication text (e.g.,
Ingredient(s), route, use,
formulation).[ ]
5.Dose: [ ]
6.Dose Unit:
7.Dose Frequency:
8.Route:
9.Start Date: //
10.Ongoing?
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913226
Page 79 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
#Categor
yTreatment Identif
ierCon Non-Drug Treatments Pre-spe
cifiedTreatme
ntStart Dat
eForm Instance
 1.          Repeating
Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913227
Page 80 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Radiation Treatment
1.Category:
2.What is the treatment Identifier? [ ]
3.Concomitant Non-drug
Treatment Pre-specified:
4.Treatment: [ ]
5.Start Date: //
6.Ongoing?
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913228
Page 81 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913229
Page 82 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913230
Page 83 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Disposition - Treatment
1.Date of
Completion/Discontinuation
/Death :Nov/10/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913231
Page 84 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913232
Page 85 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913233
Page 86 of 221
***Confidential***
 
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Vaccination
1.Was there a temporary delay of
vaccination?
2.Treatment Name [ ]
3.Formulation:
4.Dose Date Time: //
5.Anatomical Location:
6.Body Side:
7.Route:
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was
Observed
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913234
Page 87 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913235
Page 88 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913236
Page 89 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913237
Page 90 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913238
Page 91 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913239
Page 92 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Electronic Sample Tracking
1.Data Origin
2.Sample Type
3.Sample Collected?
4.If no sample was collected or
sample was not collected
according to protocol, please
provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913240
Page 93 of 221
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Disposition - Follow-Up
1.Date of
Completion/Discontinuation
/Death ://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913241
Page 94 of 221
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Date of Visit
1.Date of Visit Feb/3/2021
2.Erroneous Visit
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913242
Page 95 of 221
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible and NOT confirmed to have received only placebo at Vaccination
1/2
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913243
Page 96 of 221
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Feb/3/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913244
Page 97 of 221
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913245
Page 98 of 221
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Death Details
1.Date of Collection / Notification
of Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913246
Page 99 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Nov/10/2020
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913247
Page 100 of 221
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913248
Page 101 of 221
***Confidential***
 
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Audit Trail
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913249
Page 102 of 221
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormSep-24-2020 14:26:43 (UTC-06:00) Central
Time (US & Canada)Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913250
Page 103 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-09-2021 09:45:22 (UTC-06:00) Central
Time (US & Canada)pt was asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913251
Page 104 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
Comments
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-09-2021 09:45:55 (UTC-06:00) Central
Time (US & Canada)subject was asypmtomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913252
Page 105 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-09-2021 09:52:09 (UTC-06:00) Central
Time (US & Canada)Subject is Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913253
Page 106 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-09-2021 09:52:09 (UTC-06:00) Central
Time (US & Canada)Subject is Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913254
Page 107 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-09-2021 09:52:09 (UTC-06:00) Central
Time (US & Canada)Subject is Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913255
Page 108 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-09-2021 09:52:09 (UTC-06:00) Central
Time (US & Canada)Subject is Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913256
Page 109 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Mar-09-2021 09:52:09 (UTC-06:00) Central
Time (US & Canada)Subject is Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913257
Page 110 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
FormMar-09-2021 09:53:20 (UTC-06:00) Central
Time (US & Canada)Subject Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913258
Page 111 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
1Mar-09-2021 09:53:20 (UTC-06:00) Central
Time (US & Canada)Subject Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913259
Page 112 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
2Mar-09-2021 09:53:20 (UTC-06:00) Central
Time (US & Canada)Subject Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913260
Page 113 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
3Mar-09-2021 09:53:20 (UTC-06:00) Central
Time (US & Canada)Subject Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913261
Page 114 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
ItemDate User Comment
4Mar-09-2021 09:53:20 (UTC-06:00) Central
Time (US & Canada)Subject Asymptomatic
Not Applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913262
Page 115 of 221
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
This form requires signing by a member of each of the following signature groups:
CRF_Sign
CRF_Sign_1
Name Signature
MeaningDate Type Action
 N/A Mar-12-2021 08:32:51 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Mar-10-2021 13:19:23 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
 N/A Feb-04-2021 09:46:55 (UTC-06:00) Central
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
 Approved Nov-10-2020 16:14:31 (UTC-06:00) Central
Time (US & Canada)BOOK Signed
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913263
Page 116 of 221
***Confidential***
Header Text: c4591001
Visit: Investigator Signature - Unscheduled Form: CASEBOOK SIGNATURE FORM - Signature History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Affidavit:
By my dated signature below, I,  verify that all case report form pages accurately display the
results of the examinations, tests, evaluations and treatments performed on this subject.
Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this
electronic signature is to be the legally binding equivalent of my handwritten signature.
To this I do attest by supplying my user name and password and clicking the button marked Submit below.
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
FDA-CBER-2021-5683-0913264
Page 117 of 221
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-24-2020 14:26:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
08 SEP 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-24-2020 14:26:07
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913265
Page 118 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-24-2020 14:26:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OBTAINED
Date Written Consent Obtai
ned
Sep/24/2020Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913266
Page 119 of 221
***Confidential***
 
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-24-2020 14:25:59
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10471290Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-24-2020 14:25:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1964Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-24-2020 14:26:26
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
MALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-25-2020 10:41:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT HISPANIC OR LATIN
O(A) OR OF SPANISH ORI
GINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-25-2020 10:41:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
WHITEInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913267
Page 120 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Sep-24-2020 14:26:34
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913268
Page 121 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:52 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-24-2020 14:26:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-24-2020 14:26:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-24-2020 14:26:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
COMPLETEDInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913269
Page 122 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Sep-25-2020 10:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:1
Medical Histor
y Term:tonsillitis
Start Date: UNK/UNK/19
80
Ongoing: NO
End Date:
UNK/UNK
/1980Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:43:21
(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-25-2020 10:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
tonsillitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-25-2020 10:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913270
Page 123 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.a Ongoing:
Date Location User Value Reason
Sep-25-2020 10:43:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
1.b
Date Location User Value Reason
Sep-25-2020 10:43:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:2
Medical Histor
y Term:left arm fractu
re
Start Date: UNK/UNK/19
78
Ongoing: NO
End Date:
UNK/UNK
/1978Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913271
Page 124 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:43:45
(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-25-2020 10:43:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left arm fractureInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-25-2020 10:43:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1978Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-25-2020 10:43:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1978Initial Entry
1.c
Date Location User Value Reason
Sep-25-2020 10:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:lumbar disc e
xtrusionInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913272
Page 125 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/2
016
Ongoing: YES
1.c Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
1.c Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 10:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
lumbar disc extrusionInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-25-2020 10:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2016Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-25-2020 10:44:25
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-25-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913273
Page 126 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Medical Histo
ry Term:osteoarthrosis
right foot
Start Date: UNK/UNK/20
14
Ongoing: YES
1.d Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
1.d Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
osteoarthrosis right footInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-25-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-25-2020 10:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-25-2020 10:46:30 ACV0PFEINFP6000  auto calc Data Entry: Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913274
Page 127 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
(UTC-06:00) Central
Time (US & Canada)(autocalc) Line/MH Num
ber:5
Medical Histor
y Term:left knee osteo
arthritis
Start Date: UNK/UNK/2
010
Ongoing: YES
1.e Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 10:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
left knee osteoarthritisInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-25-2020 10:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-25-2020 10:46:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913275
Page 128 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020 10:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:6
Medical Histor
y Term:tonsillectomy
Start Date: UNK/UNK/19
80
Ongoing: NO
End Date:
UNK/UNK
/1980Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
FDA-CBER-2021-5683-0913276
Page 129 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 10:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
tonsillectomyInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-25-2020 10:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1980Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-25-2020 10:47:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1980Initial Entry
1.g
Date Location User Value Reason
Sep-25-2020 10:47:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH N
umber:7
Medical His
tory Term:correction of left
arm fractureInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913277
Page 130 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Start Date: UNK/UNK/1978
Ongoing: NO
End Date:
UNK/UNK/1
978
1.g Line/MH Number:
Date Location User Value Reason
Sep-25-2020 10:47:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
7Initial Entry
1.g Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-25-2020 10:47:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
correction of left arm fractureInitial Entry
1.g Start Date:
Date Location User Value Reason
Sep-25-2020 10:47:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
UNK/UNK/1978Initial Entry
1.g Ongoing:
Date Location User Value Reason
Sep-25-2020 10:47:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date:
UNK/UNK/1978Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913278
Page 131 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: HIV STATUS - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:57 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - What is the subject HIV status?
Date Location User Value Reason
Sep-25-2020 10:42:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
The subject is NOT known to
be HIV POSITIVEInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913279
Page 132 of 221
***Confidential***
 
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Sep-25-2020 10:42:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-25-2020 10:42:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Transcription
Error
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Vital signs Date
25/Sep/2020 is not
same as Date of
Visit 24/Sep/2020.
Please review and
update as
appropriate or
clarify.
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/25/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
300.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LBInitial Entry
4. Height:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913280
Page 133 of 221
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
76.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
36.5Initial Entry
7.a
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 98.6
Temperature Uni
t:F
Temperature Lo
cation::FOREHE
ADInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
7.a Temperature:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913281
Page 134 of 221
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:56 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
98.6Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-25-2020 10:41:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913282
Page 135 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-24-2020 14:27:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-24-2020 14:27:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
265075Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913283
Page 136 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 11:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 11:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-25-2020 11:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 11:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 11:54:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913284
Page 137 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020 11:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BK8YW1Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 11:54:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BK8YW1Initial Entry
5.b
Date Location User Value Reason
Sep-25-2020 11:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM955JInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-25-2020 11:56:29
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM955JInitial Entry
5.c
Date Location User Value Reason
Sep-25-2020 11:56:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM955KInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-25-2020 11:56:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM955KInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (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) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913285
Page 138 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Sep-25-2020 11:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM955LInitial Entry
5.d Sample ID
Date Location User Value Reason
Sep-25-2020 11:56:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM955LInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913286
Page 139 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-25-2020 11:55:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-25-2020 11:55:12
(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-25-2020 11:55:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Sep-25-2020 11:55:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-25-2020 11:55:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Sep/24/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913287
Page 140 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Sep-25-2020 11:55:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BM9561Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-25-2020 11:55:31
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BM9561Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913288
Page 141 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-24-2020 14:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-24-2020 14:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-24-2020 14:27:21
(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-24-2020 14:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sep/24/2020 14:17Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-24-2020 14:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913289
Page 142 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Sep-24-2020 14:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Sep-24-2020 14:27:21
(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-24-2020 14:27:21
(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-24-2020 14:27:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913290
Page 143 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-24-2020 14:27:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO - REACTOGENICITY E
-DIARY NOT COLLECTED
FOR THIS SUBJECTInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913291
Page 144 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-13-2020 14:16:46
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913292
Page 145 of 221
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date:
Date Location User Value Reason
Oct-14-2020 08:33:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020Initial Entry
2.a
Date Location User Value Reason
Oct-14-2020 08:33:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Record Identifie
r::1
Temperature: 97.7
Temperature Uni
t:F
Temperature Lo
cation::FOREHE
ADInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Oct-14-2020 08:33:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Oct-14-2020 08:33:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
97.7Initial Entry
2.a Unit:
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913293
Page 146 of 221
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 10-Oct-2020 16:01 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-14-2020 08:33:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FInitial Entry
2.a Temperature Location:
Date Location User Value Reason
Oct-14-2020 08:33:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FOREHEADInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913294
Page 147 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Oct-13-2020 14:17:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-13-2020 14:17:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-13-2020 14:17:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Oct-13-2020 14:17:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate 'Sample
Collected?' is Yes,
however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-13-2020 14:17:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Oct/13/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913295
Page 148 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Oct-13-2020 14:17:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BR8FP8Initial Entry
5.a Sample ID
Date Location User Value Reason
Oct-13-2020 14:17:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BR8FP8Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913296
Page 149 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Oct/13/2020 14:21Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913297
Page 150 of 221
***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: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
LEFTInitial Entry
7. Route:
Date Location User Value Reason
Oct-13-2020 14:42:38
(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
Oct-13-2020 14:42:38
(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
Oct-13-2020 14:42:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913298
Page 151 of 221
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-10-2020 14:21:45
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Nov/10/2020Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
FDA-CBER-2021-5683-0913299
Page 152 of 221
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-10-2020 14:44:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-10-2020 14:44:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-10-2020 14:44:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-10-2020 14:44:44
(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.
Nov-10-2020 14:44:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Date of Collection:
Nov/10/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913300
Page 153 of 221
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Nov-10-2020 14:44:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPSXR7Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-10-2020 14:44:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPSXR7Initial Entry
5.b
Date Location User Value Reason
Nov-10-2020 14:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPSXR8Initial Entry
5.b Sample ID
Date Location User Value Reason
Nov-10-2020 14:45:08
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPSXR8Initial Entry
5.c
Date Location User Value Reason
Nov-10-2020 14:45:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BPSXR9Initial Entry
5.c Sample ID
Date Location User Value Reason
Nov-10-2020 14:45:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BPSXR9Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913301
Page 154 of 221
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING -
IMMUNOGENICITY - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
5.d
Date Location User Value Reason
Nov-10-2020 14:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sample ID: BSHP34Initial Entry
5.d Sample ID
Date Location User Value Reason
Nov-10-2020 14:45:36
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
BSHP34Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913302
Page 155 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Visit
Date Location User Value Reason
Mar-11-2021 10:16:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed forms updated
Mar-10-2021 14:45:33
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered This two pages
were completed
following the
guideline slides
that were sent me
on how to report
an asymptomatic
positive covid
swab.
Mar-10-2021 12:52:24
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Thank you for
your response.
Please complete
self swab and nasal
swab forms and
indicate the sample
was no done due to
subject being
asymptomatic.
Mar-10-2021 12:46:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Closed data updated
Mar-10-2021 08:19:12
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Answered completed
Mar-10-2021 08:18:13
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered subject ws
asymptomatic and
per study
guidelines this is
not required
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913303
Page 156 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-10-2021 07:26:53
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 4: Opened DM: Kindly
review and
complete ‘Health
Care Utilization
form' at this visit.
Thank you.
Mar-10-2021 01:17:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Mar-09-2021 09:47:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Closed Close Auto Query
Mar-09-2021 09:47:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021Transcription Error
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Mar-09-2021 09:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 3: Opened Date of Visit,
23/Mar/2021 is a
future date relative
to when it was
entered on 09/Mar
/2021. Please
correct.
Mar-09-2021 09:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Candidate Date of Visit is
completed but
Date of
Assessment in the
Signs and
Symptoms form is
missing. Please
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913304
Page 157 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail
History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
review and update
as appropriate.
Mar-09-2021 09:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but
Date of Collection
in both Nasal
Swab Self and
Nasal Swab are
missing. Please
review and update
as appropriate.
Mar-09-2021 09:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/23/2021Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Mar-09-2021 09:43:57
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913305
Page 158 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Mar-09-2021 13:03:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed data okay as is
Mar-09-2021 09:51:42
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Answered Original value is
correct
Mar-09-2021 09:51:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-09-2021 09:51:21
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021Transcription Error
Mar-09-2021 09:47:17
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Date of assessment
is not same as Date
Visit. Please check
and correct.
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened All symptoms are
reported as Not
Present and there
is no Other
Symptom reported.
Please review and
update as
appropriate.
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Mar/23/2021Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), 
(b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913306
Page 159 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
2. Date of First Symptom Started:
Date Location User Value Reason
Mar-09-2021 09:45:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Mar-09-2021 09:45:55
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4.a
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: FEVER
Symptom Present:Initial Entry
4.a Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913307
Page 160 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW OR INCRE
ASED COUGH
Symptom
Present:Initial Entry
4.b Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED COU
GHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913308
Page 161 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Prese
nt:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SHORTNESS
OF BREATH
Sympto
m Prese
nt:Initial Entry
4.c Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SHO
RTNESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present: NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913309
Page 162 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: CHILLS
Symptom Present:Initial Entry
4.d Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PA
IN
Sympto
m Presen
t:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED MUSCLE PA
IN
Sympto
m Presen
t:Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913310
Page 163 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.e Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED MUS
CLE PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptom
s:NEW LOSS OF T
ASTE OR SMEL
L
Symptom
Present:Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913311
Page 164 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.f Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW LOSS OF TASTE OR S
MELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Prese
nt:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Sympto
ms:NEW OR INCREA
SED SORE THRO
AT
Sympto
m Prese
nt:Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913312
Page 165 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.g Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NEW OR INCREASED SOR
E THROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.h
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: DIARRHE
A
Symptom Prese
nt:Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913313
Page 166 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.h Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:NOInitial Entry
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Symptoms: VOMITIN
G
Symptom Prese
nt:Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913314
Page 167 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 -
eCRF Audit Trail History
Form Version: 20-Feb-2021 02:17 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
4.i Symptoms:
Date Location User Value Reason
Mar-09-2021 09:44:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Mar-09-2021 09:46:48
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913315
Page 168 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913316
Page 169 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021Initial Entry
2. Specimen Type:
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC T
ESTInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913317
Page 170 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Trade Name:
Date Location User Value Reason
Mar-09-2021 09:50:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
7. Test Result:
Date Location User Value Reason
Mar-09-2021 09:50:32
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
POSITIVEInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Mar-09-2021 09:50:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Xpert Xpress SARS-Cov2 Ass
ay CLIA certified labInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913318
Page 171 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
SELF - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021 09:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 09:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 09:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-09-2021 09:52:09
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913319
Page 172 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Data Origin
Date Location User Value Reason
Mar-09-2021 09:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
2. Sample Type
Date Location User Value Reason
Mar-09-2021 09:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
3. Sample Collected?
Date Location User Value Reason
Mar-09-2021 09:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Mar-09-2021 09:53:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Not ApplicableInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913320
Page 173 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1.a
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitione
r:SPECIA
LIST
Occurrence of Visit
s or Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practiti
oner:EMERGEN
CY ROOM
Occurrence of V
isits or Contacts
:NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913321
Page 174 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:PRIMARY C
ARE PHYSI
CIAN
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913322
Page 175 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
PRIMARY CARE PHYSICIA
NInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.d
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practition
er:URGEN
T CARE
Occurrence of Vis
its or Contacts:NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913323
Page 176 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practi
tioner:TELEPHON
E CONSULT
ATION
Occurrence of
Visits or Cont
acts:NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913324
Page 177 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
TELEPHONE CONSULTATI
ONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits o
r Contacts:NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913325
Page 178 of 221
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 20-Feb-2021 02:19 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Mar-10-2021 08:18:49
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913326
Page 179 of 221
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled
Visit on Feb/23/2021Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Mar-09-2021 09:54:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLN
ESSInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Mar-09-2021 09:54:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 09:54:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
0Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913327
Page 180 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913328
Page 181 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913329
Page 182 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913330
Page 183 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913331
Page 184 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
Date Location User Value Reason
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000 Form Created
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913332
Page 185 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User ValueReason
Mar-12-2021
13:57:17
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Clo
sedupdate to
#2021259908
contains lap choly
date
Mar-12-2021
13:45:01
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Rei
ssued:
Open
edClinical Thank you
for clarifying; please
submit date and
indication for Lap
Cholecystectomy to
Abd Infection SAE
(#2021259908)
Mar-12-2021
09:02:44
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: An
swere
dSubject had
laparoscopic as an
outpatient prior to
the second ae. He did
not have it with the
hernia surgery
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913333
Page 186 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-11-2021
19:12:24
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Query
2: Op
enedClinical - subsequent
abscess SAE report
states subject had a
laparoscopic
cholecystectomy
during the surgery
for this SAE;
however, hernia SAE
report does not
mention
cholecystectomy.
Please clarify, and
update where
required
Mar-09-2021
16:31:29
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Clo
sedDiscrepancy has
been closed.
Mar-09-2021
15:12:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  auto query
(autoquery)Query
1: An
swere
dUpdated per query
Mar-09-2021
15:12:11
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Abdo
minal
herniaUpdated per query
Mar-09-2021
12:21:41
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
OracleQuery
1: Op
enedMultiple concepts in
the term
ABDOMINAL
HERNIA WITH
SMALL BOWEL
STRANGULAITON.
Split the term into
ABDOMINAL
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913334
Page 187 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
HERNIA and
SMALL BOWEL
STRANGULAITON
and submit
separately. Thank
you.
Mar-09-2021
10:27:56
(UTC-06:00)
Central Time
(US &
Canada)ACV0PFEINFP6000  Data
Entry
:
Abdo
minal
hernia
with s
mall b
owel s
trangu
laitonInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 13:43:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Reissued:Opened Clinical End date
is 07Dec20;
however, SAE
report
(#2021259894)
does not report an
End date. Please
review, harmonize
reporting, and
update where
applicable
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913335
Page 188 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-12-2021 09:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Mar-12-2021 09:31:04
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/14/2020 UNK:UNKTranscription Error
Mar-11-2021 19:14:22
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical End date
is 07Dec20;
however, SAE
report
(#2021259894)
does not report an
End date. Please
review, harmonize
reporting, and
update where
applicable
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/7/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913336
Page 189 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-12-2021 13:47:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Closed Query closed; will
follow for
requested COVID
test information.
Mar-12-2021 09:31:39
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Answered no covid test was
done on this
admission this is
included in the
coming updated
SAE
Mar-11-2021 19:15:14
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 3: Opened Clinical COVID
test status (yes/no)
during this Hosp
was not reported in
the SAE. Please
submit a follow-up
SAE form
[#2021259894] to
document if
COVID testing
was performed
(YES/NO or info
not available) and
if yes, the date and
results.
Mar-10-2021 06:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 15:12:11
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Abdominal
hernia : Response
to "Is the adverse
event serious?" is
'Yes' but "Serious
Adverse Event
Number" is blank.
Mar-09-2021 10:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913337
Page 190 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 10:37:30
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associ
ated with congenital anom
aly or birth defect?
NO
Did this serious event resu
lt in death?
NO
Did this serious event requ
ire or prolong hospitalizati
on?
YES
Did this serious event resu
lt in persistent or significa
nt disability/incapacity?
NO
Is this serious event life th
reatening?
NO
Other medically important
serious event
NOTranscription Error
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse
event serious?' is
reported 'Yes', but
at least one
seriousness criteria
is missing. Please
review and update
as appropriate.
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
FDA-CBER-2021-5683-0913338
Page 191 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Abdominal
hernia with small
bowel
strangulaiton:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event requ
ire or prolong hospitalizati
on?
YESInitial Entry
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
Mar-09-2021 10:27:56
(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
Mar-09-2021 10:27:56
(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:
abdominal herniaInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913339
Page 192 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 10:27:56
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-12-2021
09:32:42
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Answered updated sae form to udate
this to recovered resloved.
Mar-12-2021
08:34:35
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Query 1: Opened SAE
RECON:AER#2021259894
outcome was updated to
RECOVERED/RESOLVED
on AE CRF while reported
as Recovering/resolving in
Safety database. Please
confirm correct outcome. If
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0913340
Page 193 of 221
***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, Queries, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
safety update is required,
please submit a follow-up
form.
Mar-09-2021
10:27:56
(UTC-06:00)
Central Time (US &
Canada)ACV0PFEINFP6000  Data Entry:
RECOVERED/RESOL
VEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-09-2021 10:27:56
(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
Mar-10-2021 06:41:44
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021259894Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0913341
Page 194 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 10:30:18
(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
Mar-11-2021 02:56:27
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-10-2021 11:08:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered updated term
Mar-10-2021 11:08:20
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Cholelithiasisupdated term
Mar-10-2021 09:52:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN:
Gallbladder
disease- please
clarify the term,
specifying what
was the medical
condition/disease
involving the
gallbladder and
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0913342
Page 195 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
consider updating
the term
accordingly. Else,
please clarify.
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Gallbladder diseaseInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Jan/12/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2Initial 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
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913343
Page 196 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
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
Mar-09-2021 10:30:18
(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
Mar-11-2021 02:56:43
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-10-2021 11:06:58
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Changed
Information
Mar-10-2021 11:06:58
(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:
Gallstones formedChanged
Information
Mar-10-2021 09:53:35
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened GPDCLIN: hx of
gi problems-
please clarify as
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0913344
Page 197 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
no associated
medical history
terms are
recorded.
Mar-09-2021 10:30:18
(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:
hx of gi problemsInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
13. What was the outcome of this adverse event?:
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913345
Page 198 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Date Location User Value Reason
Mar-09-2021 10:30:18
(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
Mar-09-2021 10:30:18
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913346
Page 199 of 221
***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, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
3Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Intra abdominal infection post
cholecystectomyInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/22/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913347
Page 200 of 221
***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, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-10-2021 06:42:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 10:38:03
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Closed Close Auto Query
Mar-09-2021 10:38:03
(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?
YESTranscription Error
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913348
Page 201 of 221
***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, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Did this serious event result
in persistent or significant d
isability/incapacity?
NO
Is this serious event life thr
eatening?
NO
Other medically important s
erious event
NO
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Opened Is this adverse event
serious?' is reported
'Yes', but at least
one seriousness
criteria is missing.
Please review and
update as
appropriate.
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Intra
abdominal infection
post
cholecystectomy:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Did this serious event requi
re or prolong hospitalizatio
n?
YESInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913349
Page 202 of 221
***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, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
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.
Date Location User Value Reason
Mar-09-2021 10:33:51
(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
Mar-12-2021
13:52:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Closed Response satisfies
query
Mar-12-2021
09:07:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered updated per query
Mar-12-2021
09:07:10
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is d
ue to:
OTHER
If Other, specify:
post op complication
of infection with 3 ty
pes of e coliupdated per query
Mar-11-2021
19:19:52
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Query 1: Opened Clinical Other
relationship is to
post operative
status/complication;
however SAE also
reports infection
with 3 E coli
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4), (b) (6)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) (4), 
(b) (6)
(b) (4), (b) (6)
(b) (4), 
(b) (6)
FDA-CBER-2021-5683-0913350
Page 203 of 221
***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, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
species. Please
review for potential
relationship, and
update if appropriate
Mar-09-2021
10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RELATED
If Not Related to study tr
eatment(s), this event is d
ue to:
OTHER
If Other, specify:
post op complicationInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4), (b) (6)
(b) (4)
(b) (4), (b) (6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913351
Page 204 of 221
***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, Not Complete
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Mar-09-2021 10:33:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT RECOVERED/NOT RE
SOLVEDInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Mar-09-2021 10:33:51
(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
Mar-10-2021 06:42:00
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
2021259908Initial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) (4), (b) 
(6)
FDA-CBER-2021-5683-0913352
Page 205 of 221
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
4Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
possible GI BleedInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 10:36:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/22/2021 UNK:UNKTranscription Error
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Feb/23/2021 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913353
Page 206 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 10:36:05
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened For possible GI
Bleed End Date &
Time 22/Feb/2021
UNK:UNK is
before the Start
Date & Time
23/Feb/2021
UNK:UNK.
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Feb/22/2021 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
1Initial 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
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
8. Is this adverse event the result of a study Medication Error?
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913354
Page 207 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
If Yes, record the type of medication error on the Medication Error Log.
Date Location User Value Reason
Mar-09-2021 10:35:28
(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
Mar-09-2021 10:35:28
(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:
NSAID use for painInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOT APPLICABLEInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YESInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913355
Page 208 of 221
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar-09-2021 10:35:28
(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
Mar-09-2021 10:35:28
(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
Mar-09-2021 10:35:28
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NOInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913356
Page 209 of 221
***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, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Back to Form
1. Category:
Date Location User Value Reason
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
5Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Small bowel strangulationInitial Entry
4. Start Date Time:
Date Location User Value Reason
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
Dec/7/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Mar-12-2021 08:58:38
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:Transcription Error
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
(b) 
(4), 
(b) 
(6)
FDA-CBER-2021-5683-0913357
Page 210 of 221
***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, Answered Queries, Verified
Site No: 1047 Site Name: (1047) Medical Affiliated Research Center
Subject No: 10471290 Subject Initials: ---
Generated By: Generated Time (GMT): 29-Mar-2021 04:44
Mar/7/2021 UNK:UNK
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
NO
End Date Time:
Dec/7/2020 UNK:UNKInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
3Initial Entry
7. Is the adverse event serious?
If Yes, NOTIFY PFIZER IMMEDIATELY.
Fatal; Life-threatening; Inpatient hospitalization or prolongation of existing hospitalization; Persistent or
significant disability/incapacity; Congenital anomaly/birth defect; Important medical event (i.e. may jeopardize
subject and may require medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Mar-12-2021 08:32:51
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate For AE Small
bowel
strangulation:
Response to "Is the
adverse event
serious?" is 'Yes'
but "Serious
Adverse Event
Number" is blank.
Mar-09-2021 15:15:40
(UTC-06:00) Central
Time (US & Canada)ACV0PFEINFP6000  Data Entry:
YES
Is this serious event associat
ed with congenital anomalyInitial Entry
090177e196ae3085\Final\Final On: 01-Apr-2021 04:08 (GMT)
(b) (4)
(b) 
(4), 
(b) 
(6)
(b) 
(4),
…[truncated]