Document text
Page 1 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Cohort Selection
DO NOT USE THE OPTIONS STAGE 1 NONSENTINEL and STAGE 2 from this CRF. As per protocol amendment 5, STAGE
3 option is equivalent to PHASE 2/3.
1.Select appropriate response -
Protocol version24 JUL 2020
2.Select appropriate response - What
cohort does the subject belong to?STAGE 3 COHORTS
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135707
Page 2 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent
1.Consent Was: OBTAINED
Date Written Consent Obtained
Sep/9/2020
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135708
Page 3 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10121163]
2.Birth Date: 1979
3.Sex: FEMALE
4.Ethnicity: NOT HISPANIC OR LATINO(A) OR OF SPANISH ORIGIN
5.Race: (Check X all that apply): WHITE
6.Racial Designation:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135709
Page 4 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/9/2020
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135710
Page 5 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
Inclusion Criteria Not Met
1.Description of Inclusion Criterion
Not MetNot Applicable
Exclusion Criteria Met
2.Description of Exclusion Criterion
MetNot Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135711
Page 6 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening
1.Date of Completion/Discontinuation
/DeathSep/9/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135712
Page 7 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Medical History Details
1.aLine/MH Number: [1]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Allergic Atopic Dermatitis]
Start Date: UNK/UNK/2016
Ongoing: YES
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Penicillin Allergy (Anaphylactic Shock)]
Start Date: UNK/UNK/1984
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Codeine Allergy]
Start Date: UNK/UNK/1984
Ongoing: YES
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Iodine Allergy]
Start Date: UNK/UNK/2017
Ongoing: YES
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Cat Scratch Disease]
Start Date: UNK/UNK/1982
Ongoing: YES
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135713
Page 8 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/9/2020
2.Weight: [139.0]
3.Unit: LB
4.Height: [69.0]
5.Unit: in
6.Body Mass Index: [20.5]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.7]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135714
Page 9 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: URINALYSIS
2.Lab Sub-Panel: PREGNANCY
3.Collection Date: Sep/9/2020
4.Laboratory Name and Address
(Derived)[STUDY SITE]
5.Specimen Type: URINE
Lab Result
6.aSponsor ID: [113]
Test: Choriogonadotropin Beta_PX113
Result: NEGATIVE
Not Done:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135715
Page 10 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Sep/9/2020
2.Randomization Number: [85512]
3.Randomization Group: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135716
Page 11 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type SERUM
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BPL1VT]
5.bSample ID [BPL1VV]
5.cSample ID [BPL1VW]
5.dSample ID [BP43XW]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135717
Page 12 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? YES
Date of Collection:
Sep/9/2020
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 [BP43XV]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135718
Page 13 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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/9/2020 16:58
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [ ]
9.Unit:
10.Timeframe Subject Was Observed THE PROTOCOL SPECIFIED OBSERVATION PERIOD
11.Was the subject observed for at least
the protocol specified observation
period after investigational product
administration?YES
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135719
Page 14 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Reactogenicity Diary
1.Select appropriate response -
Reactogenicity diary collectionNO - REACTOGENICITY E-DIARY NOT COLLECTED FOR THIS SUBJECT
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135720
Page 15 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135721
Page 16 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 20-Feb-2021 02:16 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135722
Page 17 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135723
Page 18 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135724
Page 19 of 225
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135725
Page 20 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135726
Page 21 of 225
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135727
Page 22 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135728
Page 23 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135729
Page 24 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135730
Page 25 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135731
Page 26 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135732
Page 27 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135733
Page 28 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Date of Visit
1.Date of Visit Sep/16/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135734
Page 29 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Signs and Symptoms
1.Date of Assessment: Sep/16/2020
2.Date of First Symptom Started: Sep/11/2020
3.Symptoms Ongoing? YES
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? YES
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
4.hSymptoms: DIARRHEA
Was symptom present? NO
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.Symptoms - Other Text: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135735
Page 30 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Collecti
onSpecimen Ty
peSpecimen Collection Locat
ionAssay Code and Descript
ionDevice Typ
eForm Instance
1.Not Done Not Done Not Done Not Done Not Done Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135736
Page 31 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Form Comments
eCRF Audit Trail History
Microbiology Specimen
1.Actual Date of Collection: Not Done
//Comments
2.Specimen Type: Not Done Comments
3.Specimen Collection Location: Not Done Comments
4.Assay Code and Description: Not Done Comments
5.Device Type: Not Done Comments
6.Trade Name: Not Done Comments
7.Test Result: Not Done Comments
8.Comments/Findings/Details: Not Done
[ ]Comments
9.Trade Name Other, Specify: Not Done
[ ]Comments
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135737
Page 32 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB SELF
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB_SELF
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Visit not done per protocol. PD has been created]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135738
Page 33 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Electronic Sample Tracking
1.Data Origin SITE
2.Sample Type NASAL_SWAB
3.Sample Collected? NO
4.If no sample was collected or sample
was not collected according to
protocol, please provide reason:[Visit not done per protocol. PD created]
Aliquot
Please enter barcode for each aliquot.
5.Sample ID [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135739
Page 34 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO Comments
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO Comments
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]Comments
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO Comments
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]Comments
1 fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO Comments
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ] Comments
Health Care Utilization
3.Has the subject been hospitalized due
to potential COVID-19 illness?NO Comments
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135740
Page 35 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Treatment Start Date Form Instance
1. Repeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135741
Page 36 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135742
Page 37 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS Comments
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO Comments
3.Toxicity Grade: 2 Comments
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135743
Page 38 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Event: Subcategory of Clinical Event Diagnosis Obtained Toxicity Grade Form Instance
1. Repeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135744
Page 39 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS - SEVERE
Form Version: 17-Jul-2020 21:55 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Illness Details
1.Category of Clinical Event:
2.Subcategory of Clinical Event:
3.Was a diagnosis obtained?
4.Toxicity Grade:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135745
Page 40 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for Lab
TestVendor Na
meCollection Da
te:Specimen T
ypeLab Result Form Instance
1. Sponsor-Defined Iden
tifierTest
:Resul
t:Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135746
Page 41 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: LOCAL LABORATORY DATA - REPEATING CHEMISTRY
Form Version: 21-Aug-2020 02:49 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135747
Page 42 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for La
b TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
1. Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135748
Page 43 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: LOCAL LABORATORY DATA - REPEATING Hematology
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135749
Page 44 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
1. Record Identifier: Systolic: Diastolic:Repeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135750
Page 45 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - COVID
Form Version: 21-Aug-2020 02:50 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135751
Page 46 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date: Vital Signs Details Form Instance
1. Record Identifier: Oxygen SaturationRepeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135752
Page 47 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: VITAL SIGNS - PULSE OX ROOM AIR
Form Version: 21-Aug-2020 02:51 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
SPO2 Pulse Oximetry % [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135753
Page 48 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date Time of Assessment Arterial Blood Gases PaO2 FiO2 (Fraction of Inhaled Oxygen) Form Instance
1. Repeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135754
Page 49 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Oxygenation Parameters
1.Date Time of Assessment: //
2.Arterial Blood Gases PaO2 (mmHg): [ ]
3.FiO2 (Fraction of Inhaled Oxygen): [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135755
Page 50 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135756
Page 51 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: CONCOMITANT MEDICATIONS - VASOPRESSORS
Form Version: 06-Jul-2020 21:55 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135757
Page 52 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: IMAGING
Form Version: 06-Jul-2020 21:53
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of Assessment Location of Assessment Imaging Method Overall Assessment Form Instance
1. Repeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135758
Page 53 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Imaging
1.Date of Assessment: //
2.Location of Assessment:
3.Type of Imaging Exam:
4.Assessment:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135759
Page 54 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135760
Page 55 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135761
Page 56 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135762
Page 57 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135763
Page 58 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Treatment
1.Date of Completion/Discontinuation
/Death :Sep/24/2020
2.Phase of Disposition: VACCINATION
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135764
Page 59 of 225
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Follow-Up
1.Date of Completion/Discontinuation
/Death :Oct/17/2020
2.Phase of Disposition: FOLLOW-UP
3.Status: ADVERSE EVENT
4.Specify Status: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135765
Page 60 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
COVID-19 Repeat Swab
3.COVID-19 Repeat Swab:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135766
Page 61 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135767
Page 62 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# CategoryAE Ide
ntifierAdverse Event Start DateIs the Adverse Even
t Still OngoingForm Instan
ce
1. ADVERSE
EVENT 1 LEFT UPPER ARM DERMATI
TIS AT INJECTION SITE Sep/11/2020
UNK:UNK YES Repeating
Pages
2. DELETED ADVERSE
EVENT 2 SHORTNESS OF BREATHE Sep/11/2020
UNK:UNK YES Repeating
Pages
3. ADVERSE
EVENT 3 INSOMNIA Sep/12/2020
UNK:UNK YES Repeating
Pages
4. ADVERSE
EVENT 4 WEIGHT LOSS Sep/14/2020
UNK:UNK NO
End Date Time:
Oct/4/2020 UNK:
UNK
Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135768
Page 63 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[LEFT UPPER ARM DERMATITIS AT INJECTION SITE]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135769
Page 64 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
14.Did the adverse event cause the
subject to be discontinued from the
study?YES
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
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)[SHORTNESS OF BREATHE ]
4.Start Date Time: Sep/11/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:DRUG WITHDRAWN
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
13.What was the outcome of this
adverse event?:RECOVERING/RESOLVING
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
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Page 67 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[INSOMNIA]
4.Start Date Time: Sep/12/2020 UNK:UNK
5.Is the adverse event still ongoing? YES
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
9.Is this event related to study
treatment:RELATED
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
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Page 68 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number: For
Pfizer Use Only[ ]
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Page 69 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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)[WEIGHT LOSS]
4.Start Date Time: Sep/14/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Oct/4/2020 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).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of medication
error on the Medication Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
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Page 70 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
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***Confidential***
Header Text: c4591001
Visit: Logs Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yMedication Err
orStart Da
teIs the medication error Still On
goingStudy Medication Errors Ac
tionForm Instance
1. Repeating
Pages
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: MEDICATION ERROR
Form Version: 17-Jul-2020 21:54 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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[ ]
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Page 73 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
Form Version: 22-Apr-2020 21:03
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Ide
ntifierCategory for Medi
cationConcomitant Medications Pre
-specifiedName of Medic
ationStart D
ateForm Instanc
e
1. Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135779
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***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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: //
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***Confidential***
Header Text: c4591001
Visit: Logs Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined Id
entifierCategory for Med
icationConcomitant Medications Pr
e-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
1. Repeating
Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - PROHIBITED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
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***Confidential***
Header Text: c4591001
Visit: Logs Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category Treatment Identifier Con Non-Drug Treatments Pre-specified Treatment Start Date Form Instance
1. Repeating Pages
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: RADIATION TREATMENT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 79 of 225
***Confidential***
Header Text: c4591001
Visit: Logs Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
1. Repeating Pages
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135785
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***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: TRANSFUSIONS
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135786
Page 81 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135787
Page 82 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Vital Signs
1.Date: //
Vital Signs Details
2.Record Identifier:
Temperature: [ ]
Unit:
Temperature Location:
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***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 20-Feb-2021 02:14 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Lab Urinalysis
1.Lab Panel:
2.Lab Sub-Panel:
3.Collection Date: //
4.Laboratory Name and Address
(Derived)[ ]
5.Specimen Type:
Lab Result
6.Sponsor ID: [ ]
Test:
Result:
Not Done:
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Page 84 of 225
***Confidential***
Header Text: c4591001
Visit: Unplanned Vaccination - Unscheduled Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 85 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135791
Page 86 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Contact Outcome
1.Contact Type:
2.Was contact made?
3.Comments: [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135792
Page 87 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
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***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: INFORMED CONSENT - ASYMPTOMATIC SURVEILLANCE
Form Version: 14-Jan-2021 02:29 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Informed Consent - Asymptomatic Surveillance
1.Consent Was:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 89 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135795
Page 90 of 225
***Confidential***
Header Text: c4591001
Visit: V201_SURVEIL_CONSENT - Unscheduled Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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 [ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135796
Page 91 of 225
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135797
Page 92 of 225
***Confidential***
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135798
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***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Not Applicable
//Comments
2.Primary Reason for Unblinding: Not Applicable Comments
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135799
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***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Withdrawal Of Consent
1.Withdrawal of Consent Date : Sep/24/2020
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135800
Page 95 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Death Details
1.Date of Collection / Notification of
Death:Not Applicable
//Comments
Cause of Death
2.Cause of Death Status: Not Applicable
Cause of Death: Not Applicable
[ ]
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135801
Page 96 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status DISCONTINUED
2.Subject Status Date Oct/17/2020
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135802
Page 97 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Casebook Signature Form
1.Casebook Signature Click Here to Enable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135803
Page 98 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135804
Page 99 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: INCLUSION/EXCLUSION CRITERIA - Comments
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-10-2020 18:42:24 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject qualified for enrollment
Not Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135805
Page 100 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135806
Page 101 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135807
Page 102 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135808
Page 103 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135809
Page 104 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135810
Page 105 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135811
Page 106 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135812
Page 107 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
7Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135813
Page 108 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
8Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135814
Page 109 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - Comments
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
9Nov-03-2020 14:50:08 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit entry being done to capture shortness of
breath reported during a phone call on 9/16/2020.
Not an actual possible covid illness visit.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135815
Page 110 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
FormNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135816
Page 111 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1.aNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1.aNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135817
Page 112 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1.bNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1.bNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135818
Page 113 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1.cNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1.cNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135819
Page 114 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1.dNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1.dNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135820
Page 115 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1.eNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1.eNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135821
Page 116 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1.fNov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1.fNov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135822
Page 117 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
2Nov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135823
Page 118 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: HEALTH CARE UTILIZATION - Comments
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-09-2020 09:24:46 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
3Nov-04-2020 16:39:56 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit missed
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135824
Page 119 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormNov-09-2020 09:28:53 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
FormNov-05-2020 17:08:33 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit not done. CRF completed to capture cough
which cannot be added to AE log.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135825
Page 120 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Nov-09-2020 09:28:53 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
1Nov-05-2020 17:08:33 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit not done. CRF completed to capture cough
which cannot be added to AE log.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135826
Page 121 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Nov-09-2020 09:28:53 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
2Nov-05-2020 17:08:33 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit not done. CRF completed to capture cough
which cannot be added to AE log.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135827
Page 122 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ILLNESS DETAILS - Comments
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Nov-09-2020 09:28:53 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)
3Nov-05-2020 17:08:33 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Visit not done. CRF completed to capture cough
which cannot be added to AE log.
Not Done
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135828
Page 123 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-06-2020 13:00:05 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Not Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135829
Page 124 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-06-2020 13:00:05 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Not Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135830
Page 125 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition Form: TREATMENT UNBLINDED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Oct-06-2020 13:00:05 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Not Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135831
Page 126 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormOct-06-2020 13:00:17 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Not Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135832
Page 127 of 225
***Confidential***
Header Text: c4591001
Visit: Disposition Form: DEATH DETAILS CODED - Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Oct-06-2020 13:00:17 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Not Applicable
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135833
Page 128 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
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
Stephanie
Catanzaro N/A Feb-24-2021 12:13:36 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust Approved Nov-12-2020 13:39:48 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
Selma Leudtke N/A Nov-11-2020 16:43:00 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust Approved Nov-11-2020 08:08:21 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
Sahara Vega N/A Nov-03-2020 14:45:47 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135834
Page 129 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Affidavit:
N/A
Matthew Doust Approved Oct-30-2020 12:18:09 (UTC-07:00) Mountain
Time (US & Canada)BOOK Signed
Affidavit:
By my dated signature below, I, MatthewDoust, 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.
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135835
Page 130 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: COHORT SELECTION - eCRF Audit Trail History
Form Version: 30-Jul-2020 21:29 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Protocol version
Date Location User Value Reason
Sep-10-2020 12:32:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
24 JUL 2020Initial Entry
2. Select appropriate response - What cohort does the subject belong to?
Date Location User Value Reason
Sep-10-2020 12:32:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135836
Page 131 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Consent Was:
Date Location User Value Reason
Sep-10-2020 12:32:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
OBTAINED
Date Written Consent Obtained
Sep/9/2020Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135837
Page 132 of 225
***Confidential***
Header Text: c4591001
Visit: COHORT_SELECTION Form: DEMOGRAPHY - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Subject ID
Date Location User Value Reason
Sep-10-2020 12:32:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
10121163Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-10-2020 12:32:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
/1979Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-10-2020 12:32:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-10-2020 12:32:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOT HISPANIC OR LATINO(A) O
R OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-10-2020 12:32:59
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
WHITEInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135838
Page 133 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Oct-07-2020 06:12:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe.ks66)Query 1: Closed As per site response
Oct-06-2020 11:18:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Subject withdrew
consent on
9/24/2020.
Oct-05-2020 22:51:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Amol Shinde
(pfe.shinda18)Query 1: Opened DM: Details on visit
‘V2VX2L’ are
missing. Kindly
consider to update or
else clarify. Thank
you.
Sep-10-2020 18:42:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/9/2020Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135839
Page 134 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: DISPOSITION - SCREENING - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death
Date Location User Value Reason
Sep-10-2020 18:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/9/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-10-2020 18:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-10-2020 18:42:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
COMPLETEDInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135840
Page 135 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Sep-16-2020 16:49:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Numb
er:1
Medical History
Term:Allergic Atopic D
ermatitis
Start Date: UNK/UNK/2016
Ongoing: YESInitial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:49:48
(UTC-07:00) Mountain
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-30-2020 11:45:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gary Steven
Friedman
(pfe.friedg01)Query 2: Closed Response satisfies query
Sep-30-2020 11:42:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gary Steven
Friedman
(pfe.friedg01)Query 1: Closed Response satisfies query
Sep-29-2020 16:54:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Query 1: Answered Subject is using topical
medication only
Sep-29-2020 16:54:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Query 2: Answered Subject is using topical
medication only
Sep-29-2020 12:36:20
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gary Steven
Friedman
(pfe.friedg01)Query 2: Opened QUERY OUTSTANDING
X 7 days: please address.
Thank you.
Sep-22-2020 07:33:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gary Steven
Friedman
(pfe.friedg01)Query 1: Opened ATOPIC DERMATITIS
(ONGOING): please
confirm the participant IS
or IS NOT receiving
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135841
Page 136 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
ORAL
CORTICOSTEROIDS or
ORAL OR PARENTERAL
IMMUNOMODULATORS
currently.
Sep-16-2020 16:49:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma Leudtke
(pfe.sleudtke)Data Entry:
Allergic Atopic DermatitisInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-16-2020 16:49:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2016Initial Entry
1.a Ongoing:
Date Location User Value Reason
Sep-16-2020 16:49:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
1.b
Date Location User Value Reason
Sep-16-2020 16:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:2
Medical Hist
ory Term:Penicillin Allergy (An
aphylactic Shock)
Start Date: UNK/UNK/1984
Ongoing: YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135842
Page 137 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
2Initial Entry
1.b Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Penicillin Allergy (Anaphylactic Sh
ock)Initial Entry
1.b Start Date:
Date Location User Value Reason
Sep-16-2020 16:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/1984Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-16-2020 16:51:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-21-2020 15:10:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Line/MH Number: 3
Medical History T
erm:Codeine Aller
gy
Start Date: UNK/UNK/1
984
Ongoing: YESTranscription Error
Sep-17-2020 09:17:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Line/MH Number: 3
Medical History T
erm:Codeine Aller
gy
Start Date: UNK/UNK/1
984Changed Information
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135843
Page 138 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: YES
Sep-16-2020 16:52:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:3
Medical Hist
ory Term:Codeine Allergy (
Hallucinations)
Start Date: UNK/UNK/1984
Ongoing: YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135844
Page 139 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.c Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:52:24
(UTC-07:00) Mountain
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-22-2020
03:17:19
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 2: Clos
edResponse satisfies
query
Sep-21-2020
15:10:27
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Ans
weredTranscription Error
Sep-21-2020
15:10:27
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Selma Leudtke
(pfe.sleudtke)Data Entry:
Codeine Aller
gyTranscription Error
Sep-21-2020
11:30:51
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Swaranjali
Subhash
Pawar
(pfe.pawars01)Query 2: Ope
nedDM: A trailing space is
identified. To avoid
processing errors,
please remove the
identified character by
deleting the entry and
re-entering the data
(without using copy
and paste).
Sep-17-2020
11:27:10
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Clos
edDiscrepancy has been
closed.
Sep-17-2020
09:17:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Ans
weredChanged Information
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135845
Page 140 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-17-2020
09:17:43
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Selma Leudtke
(pfe.sleudtke)Data Entry:
Codeine Aller
gyChanged Information
Sep-17-2020
03:32:22
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Ope
nedMultiple concepts in
the term CODEINE
ALLERGY
(HALLUCINATIONS).
Split the term into
CODEINE ALLERGY
and DRUG INDUCED
HALLUCINATIONS
and submit separately.
Thank you.
Sep-16-2020
16:52:24
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Selma Leudtke
(pfe.sleudtke)Data Entry:
Codeine Aller
gy (Hallucina
tions)Initial Entry
1.c Start Date:
Date Location User Value Reason
Sep-16-2020 16:52:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/1984Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-16-2020 16:52:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
1.d
Date Location User Value Reason
Sep-17-2020 09:18:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Line/MH Number: 4
Medical History T
erm:Iodine Allerg
y
Start Date: UNK/UNK/2
017
Ongoing: YESChanged Information
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135846
Page 141 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-16-2020 16:53:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:4
Medical Hist
ory Term:Iodine Allergy (Res
piratory, Sneezing)
Start Date: UNK/UNK/2017
Ongoing: YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135847
Page 142 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.d Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:53:21
(UTC-07:00) Mountain
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-17-2020
11:27:20
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Closed Discrepancy has
been closed.
Sep-17-2020
09:18:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answe
redChanged
Information
Sep-17-2020
09:18:11
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Iodine AllergyChanged
Information
Sep-17-2020
03:32:37
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy PFETMS
Oracle
(pfe.PFETMS)Query 1: Opene
dMultiple concepts
in the term
IODINE
ALLERGY
(RESPIRATORY,
SNEEZING). Split
the term into
IODINE
ALLERGY and
RESPIRATORY,
SNEEZING and
submit separately.
Thank you.
Sep-16-2020
16:53:21
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Iodine Allergy (
Respiratory, Sne
ezing)Initial Entry
1.d Start Date:
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135848
Page 143 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-16-2020 16:53:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2017Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-16-2020 16:53:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
1.e
Date Location User Value Reason
Sep-16-2020 16:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Line/MH Number: 5
Medical History T
erm:Cat Scratch Dis
ease
Start Date: UNK/UNK/198
2
Ongoing: YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135849
Page 144 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Line/MH Number:
Date Location User Value Reason
Sep-16-2020 16:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
5Initial Entry
1.e Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-16-2020 16:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Cat Scratch DiseaseInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-16-2020 16:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/1982Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-16-2020 16:54:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135850
Page 145 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/9/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
139.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
69.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
inInitial Entry
6. Body Mass Index:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
20.5Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135851
Page 146 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: VITAL SIGNS - BASELINE - eCRF Audit Trail History
Form Version: 21-Aug-2020 02:51 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7.a
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Record Identifier:: 1
Temperature: 97.7
Temperature Unit: F
Temperature Locati
on::ORAL CAVI
TYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
1Initial Entry
7.a Temperature:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
97.7Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
FInitial Entry
7.a Temperature Location:
Date Location User Value Reason
Sep-10-2020 18:45:19
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135852
Page 147 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Lab Panel:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINALYSISInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
PREGNANCYInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/9/2020Initial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
STUDY SITEInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
URINEInitial Entry
6.a
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
Sponsor-Define
d Identifier:113Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135853
Page 148 of 225
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - eCRF Audit Trail
History
Form Version: 21-Aug-2020 02:49 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Test:: Choriogonadotropi
n Beta_PX113
Result:: NEGATIVE
Not Done::
6.a Sponsor ID:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
113Initial Entry
6.a Test:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Choriogonadotropin Beta_PX113Initial Entry
6.a Result:
Date Location User Value Reason
Sep-10-2020 18:45:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NEGATIVEInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135854
Page 149 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Randomization Date :
Date Location User Value Reason
Sep-10-2020 18:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/9/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-10-2020 18:45:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
85512Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135855
Page 150 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 18:45:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 18:45:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-13-2020 14:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 02:14:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-10-2020 18:45:53
(UTC-07:00) Mountain
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-10-2020 18:45:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135856
Page 151 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-13-2020 14:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL1VTInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-13-2020 14:46:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL1VTInitial Entry
5.b
Date Location User Value Reason
Sep-13-2020 14:46:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL1VVInitial Entry
5.b Sample ID
Date Location User Value Reason
Sep-13-2020 14:46:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL1VVInitial Entry
5.c
Date Location User Value Reason
Sep-13-2020 14:46:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL1VWInitial Entry
5.c Sample ID
Date Location User Value Reason
Sep-13-2020 14:46:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BPL1VWInitial Entry
5.d
Date Location User Value Reason
Oct-06-2020 17:16:28
(UTC-07:00) MountainACV0PFEINFP6000 Sahara
VegaData Entry:
Sample ID: BP43XWInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135857
Page 152 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.svega)
5.d Sample ID
Date Location User Value Reason
Oct-06-2020 17:16:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BP43XWInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135858
Page 153 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Sep-10-2020 18:46:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-10-2020 18:46:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-13-2020 12:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-11-2020 02:11:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are entered.
Please review and
correct as
appropriate.
Sep-10-2020 18:46:03
(UTC-07:00) Mountain
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-10-2020 18:46:03
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Sep/9/2020Initial Entry
5.a
Date Location User Value Reason
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135859
Page 154 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-13-2020 12:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BP43XVInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-13-2020 12:11:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
BP43XVInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135860
Page 155 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Was there a temporary delay of vaccination?
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOInitial Entry
2. Treatment Name
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INJECTIONInitial Entry
4. Dose Date Time:
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/9/2020 16:58Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
DELTOID MUSCLEInitial Entry
6. Body Side:
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
LEFTInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135861
Page 156 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Route:
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
INTRAMUSCULARInitial Entry
10. Timeframe Subject Was Observed
Date Location User Value Reason
Sep-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED OBS
ERVATION 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-10-2020 18:48:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135862
Page 157 of 225
***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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Select appropriate response - Reactogenicity diary collection
Date Location User Value Reason
Sep-10-2020 18:48:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Data Entry:
NO - REACTOGENICITY E-DIAR
Y NOT COLLECTED FOR THIS S
UBJECTInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135863
Page 158 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Visit
Date Location User Value Reason
Nov-06-2020 01:14:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Astrud van der
Merwe
(pfe.vandea62)Query 3: Closed Response satisfies
query
Nov-05-2020 17:08:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 3: Answered Changed data per
query
Nov-05-2020 02:03:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Usha Ogirala
(pfe.ogirau)Query 1: Closed Response satisfies
query
Nov-05-2020 01:08:45
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Usha Ogirala
(pfe.ogirau)Query 3: Reissued:Opened DM1: Kindly review
and complete 'Illness
Details form' at this
visit. Thank you.
Nov-04-2020 16:40:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 3: Answered Changed data per
query
Nov-04-2020 16:39:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Changed data per
query
Nov-04-2020 03:23:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe ks66)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.
Nov-04-2020 03:18:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Rajashekhar
Reddy
(pfe reddyr51)Query 3: Opened DM: Kindly review
and complete ‘Health
Care Utilization,
Illness Details form'
at this visit. Thank
you.
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Deleted Close Auto Query
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135864
Page 159 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: DATE OF VISIT - ILLNESS ONSET - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-03-2020 14:48:09
(UTC-07:00) Mountain
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 review and
update as
appropriate.
Nov-03-2020 14:48:09
(UTC-07:00) Mountain
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.
Nov-03-2020 14:48:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Sep/16/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-03-2020 14:48:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135865
Page 160 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Assessment:
Date Location User Value Reason
Feb-26-2021 18:29:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Closed late entry uploaded
in chart noted.
Feb-25-2021 13:31:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Query 1: Answered This has been
uploaded.
Feb-24-2021 23:22:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Opened Unable to verify,
please provide
source
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Sep/16/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sep/11/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Feb-24-2021 22:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Azeemuddin
Mohammed
(pfemohaa117)Query 1: Closed Response satisfies
query
Feb-24-2021 12:02:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Query 1: Answered This symptoms are
still ongoing.
Feb-15-2021 04:15:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ashwini Devi
Subhash
(pfe.subhaa)Query 1: Opened Please confirm the
symptoms are still
ongoing for this
COVID Illness. If all
symptoms for this
illness are resolved;
please update the
Last Symptoms
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135866
Page 161 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Resolved Date else
clarify.
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: FEVER
Symptom Present: NOInitial Entry
4.a Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
FEVERInitial Entry
4.a Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: NEW OR INCREASE
D COUGH
Symptom Pr
esent:NOInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135867
Page 162 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.b Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED COUGHInitial Entry
4.b Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptom
s:NEW OR INCREASED
SHORTNESS OF BREA
TH
Symptom
Present:YESInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED SHORTNES
S OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.d
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: CHILLSInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135868
Page 163 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Symptom Present: NO
4.d Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
CHILLSInitial Entry
4.d Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.e
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: NEW OR INCREASED
MUSCLE PAIN
Symptom
Present:NOInitial Entry
4.e Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED MUSCLE P
AINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-03-2020 14:48:57 ACV0PFEINFP6000 Sahara Data Entry: Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135869
Page 164 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-07:00) Mountain
Time (US & Canada)Vega
(pfe.svega)Symptoms: NEW LOSS OF TAST
E OR SMELL
Symptom P
resent:NO
4.f Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW LOSS OF TASTE OR SMELLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.g
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms
:NEW OR INCREASED
SORE THROAT
Symptom
Present:NOInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED SORE THR
OATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.h
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135870
Page 165 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
4.h Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
DIARRHEAInitial Entry
4.h Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: VOMITING
Symptom Present: NOInitial Entry
4.i Symptoms:
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
VOMITINGInitial Entry
4.i Was symptom present?
Date Location User Value Reason
Nov-03-2020 14:48:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135871
Page 166 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Actual Date of Collection:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
5. Device Type:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135872
Page 167 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: MICROBIOLOGY SPECIMEN - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:54 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
7. Test Result:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-03-2020 14:50:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135873
Page 168 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: 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: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 16:39:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 16:39:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWAB_SELFInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 16:39:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-04-2020 16:39:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Visit not done per protocol. PD has be
en createdInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135874
Page 169 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Data Origin
Date Location User Value Reason
Nov-04-2020 16:39:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-04-2020 16:39:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
NASAL_SWABInitial Entry
3. Sample Collected?
Date Location User Value Reason
Nov-04-2020 16:39:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4. If no sample was collected or sample was not collected according to protocol, please provide reason:
Date Location User Value Reason
Nov-04-2020 16:39:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Visit not done per protocol. PD create
dInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135875
Page 170 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Feb-24-2021 12:13:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or
Contacts:NOSubject talked on
the phone with
specialist but did not
have an actual visit
with them.
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Type of Practiti
oner:Not Done
Occurrence of
Visits or Contac
ts:YES
Number of Visi
ts or Contacts:
1Initial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or
Contacts:Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or
Contacts:Not Do
neInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-26-2021 18:22:09
(UTC-07:00) MountainACV0PFEINFP6000 Aloma
RatnasomaQuery 1: Closed verified
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135876
Page 171 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe ratnaa05)
Feb-25-2021 13:28:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Query 1: Answered This has been
uploaded.
Feb-24-2021 23:20:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Reissued:Opened The response not is
not in the source.
please provide for
verification
purposes.
Feb-24-2021 12:13:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Subject talked on the
phone with specialist
but did not have an
actual visit with
them.
Feb-24-2021 12:13:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NOSubject talked on the
phone with specialist
but did not have an
actual visit with
them.
Feb-22-2021 15:38:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Aloma
Ratnasoma
(pfe ratnaa05)Query 1: Opened source unavailable to
verify the data,
please revisit and
update if available
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry: Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.b
Date Location User Value Reason
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
neInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135877
Page 172 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Occurrence of Visits or Co
ntacts:NO
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Not Do
neInitial Entry
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.c
Date Location User Value Reason
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitio
ner:Not DoneInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135878
Page 173 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Occurrence of Vi
sits or Contacts:YES
Number of Visit
s or Contacts:
1
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Not Do
neInitial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.d
Date Location User Value Reason
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135879
Page 174 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:NOInitial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Not Do
neInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.e
Date Location User Value Reason
Feb-24-2021 12:13:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Type of Practiti Not DoneChanged
Information
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135880
Page 175 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
oner:
Occurrence of
Visits or Contac
ts:YES
Number of Visi
ts or Contacts:
1
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or
Contacts:NOInitial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or
Contacts:Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or
Contacts:Not Do
neInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135881
Page 176 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.e Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Feb-24-2021 12:13:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
YES
Number of Visits or Contacts:
1Changed
Information
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
NOInitial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry: Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.f
Date Location User Value Reason
Nov-09-2020 09:26:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:NOInitial Entry
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
ne
Occurrence of Visits or Co
ntacts:Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: Not Do
neInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135882
Page 177 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Occurrence of Visits or Co
ntacts:Not Do
ne
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-09-2020
14:10:42
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1: C
losedAuto closed by
Validation Check:
VC_HOHCU002_01
Nov-09-2020
09:26:14
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1:
AnsweredInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135883
Page 178 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.f Occurrence of Visits or Contacts:
Date Location User ValueReason
Nov-09-2020
09:26:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data
Entry
:
NOInitial Entry
Nov-09-2020
09:24:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data
Entry
:Initial Entry
Nov-06-2020
02:21:58
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Ashwini Devi
Subhash (pfe.subhaa)Query
1: Rei
ssued:
Opene
dDM: Per CCG 8.35, this is
a required CRF. If subject
didn't utilize any of the
listed healthcare services,
complete the form with
answering as "No".
Provide appropriate
answers to each question
asked even if subject didn't
utilize healthcare services.
Nov-05-2020
17:06:23
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query
1: Ans
weredOriginal value is correct
Nov-05-2020
05:05:54
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query
1: Op
enedDMW5289640;Occurrence
of Visits or Contacts is not
expected to be Not Done
or Not Applicable or
Unknown. Please review
and update appropriately
or clarify
Nov-04-2020
16:39:56
(UTC-07:00)
MountainACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data
Entry
:
Not DInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135884
Page 179 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US &
Canada)one
2. Other Type of Practitioner Specify:
Date Location User Value Reason
Nov-09-2020 09:24:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Initial Entry
Nov-04-2020 16:39:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-09-2020
14:11:21
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1
: ClosedAuto closed by
Validation Check:
VC_HOHCU002_02
Nov-09-2020
09:26:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1
: Answe
redInitial Entry
Nov-09-2020
09:26:14
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data E
ntry:
NOInitial Entry
Nov-09-2020
09:24:46
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data E
ntry:Initial Entry
Nov-06-2020
02:19:29
(UTC-07:00)ACV0PFEINFP6000.InFormAdapter.Discrepancy DMW QUERY
(pfe.DMW_QUERY)Query 1
: Opene
dDMW5289683;Response
to 'Has the subject been
hospitalized due to
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135885
Page 180 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: HEALTH CARE UTILIZATION - eCRF Audit Trail History
Form Version: 10-Oct-2020 15:59 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Mountain
Time (US &
Canada)potential COVID-19
illness?' is not expected
to be Not Done or Not
Applicable or Unknown.
Please review and update
appropriately or clarify
Nov-04-2020
16:39:56
(UTC-07:00)
Mountain
Time (US &
Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data E
ntry:
Not Do
neInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135886
Page 181 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category of Clinical Event:
Date Location User Value Reason
Nov-09-2020 11:40:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Vrunda
Parikh
(pfe.parikv06)Query 1: Closed Response satisfies
query
Nov-09-2020 09:29:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Changed data per
query
Nov-09-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
Nov-09-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry: Initial Entry
Nov-07-2020 07:17:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Vrunda
Parikh
(pfe.parikv06)Query 1: Opened CLINQUERY: Per
CCG, this form is a
required CRF. Please
complete as
appropriate. If
Diagnosis is not
obtained, answer the
question as "NO" in
CRF and enter
toxicity grade
between 1-5 in per
CCG section 8.33.5
in relation to reported
symptoms.
Nov-05-2020 17:08:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-09-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135887
Page 182 of 225
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit on
Sep/16/2020Form: ILLNESS DETAILS - eCRF Audit Trail History
Form Version: 06-Jul-2020 21:52 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-09-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Initial Entry
Nov-05-2020 17:08:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-09-2020 09:29:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
2Initial Entry
Nov-09-2020 09:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Initial Entry
Nov-05-2020 17:08:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135888
Page 183 of 225
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-06-2020 11:47:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-06-2020 11:47:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-09-2020 23:27:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe.ks66)Query 2: Closed Response satisfies
query
Oct-09-2020 15:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Closed Close Auto Query
Oct-09-2020 15:28:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 3: Opened Response to "Status"
is ADVERSE
EVENT but "Specify
Status" is Provided.
Oct-09-2020 15:28:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Changed Information
Oct-09-2020 15:28:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
ADVERSE EVENTChanged Information
Oct-08-2020 07:54:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Derrick
Newton
(pfe.newtod07)Query 2: Opened DM: The Adverse
Event Action Taken is
DRUG
WITHDRAWN but
reason for treatment
discontinuation is not
reported as
ADVERSE EVENT
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135889
Page 184 of 225
***Confidential***
Header Text: c4591001
Visit: End of Treatment - Unscheduled Form: DISPOSITION - TREATMENT - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:55 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
or DEATH. Please
review and clarify.
Oct-06-2020 11:48:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-06-2020 11:47:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened Response to "Status"
is WITHDRAWAL
BY SUBJECT but
"Specify Status" is
missing.
Oct-06-2020 11:47:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
WITHDRAWAL BY SUBJECTInitial Entry
4. Specify Status:
Date Location User Value Reason
Oct-09-2020 15:28:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry: Changed Information
Oct-06-2020 11:48:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Due to AE related to vaccine #1 subj
ect withdrew consent.Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135890
Page 185 of 225
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Date of Completion/Discontinuation/Death :
Date Location User Value Reason
Oct-30-2020 01:33:22
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Kirti Bhangale
(pfe.bhangk01)Query 1: Closed Response satisfies query
Oct-29-2020 22:45:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 2: Closed Response satisfies query
Oct-29-2020 17:35:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered Withdrew consent
9/24/2020. Willing to speak
with site after for follow-up.
Last date of contact
10/17/2020.
Oct-29-2020 17:34:36
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Yes last date of contact
10/17/2020
Oct-29-2020 05:55:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
Suryawanshi
(pfe.suryas18)Query 2: Reissued:Opened Withdrawal of consent
24Sep20 is before date of
completion 20Oct20.
Kindly verify both the dates
and update the last contact
date of subject here. Thank
you.
Oct-29-2020 05:54:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
Suryawanshi
(pfe.suryas18)Query 1: Reissued:Opened Kindly verify and confirm
entered date 17Oct20 is the
last day of contact to
subjects if yes confirm via
query response or else
update CRF. Thank you.
Oct-28-2020 16:31:55
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered Data has been changed to
reflect last date site spoke
with subject regarding AE
follow-up
Oct-28-2020 16:31:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened Date of
Completion/Discontinuation
/Death on the Follow-Up
Disposition form is after
"Withdrawal of consent"
date. Please review and
correct as appropriate.
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135891
Page 186 of 225
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-28-2020 16:31:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered New Information
Oct-28-2020 16:31:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Oct/17/2020New Information
Oct-27-2020 13:46:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 1: Reissued:Opened Thank you for your
response. Please note the
End of Study date must be
the last date of contact with
the subject. As you noted it
was 06 OCT 2020, please
consider updating the
Follow up End of Study
date to this last date of
Contact with Subject.
Oct-27-2020 12:17:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Written WOC provided
9/24/2020. Site contacted
subject on 10/6/2020 to get
end date since she was
willing to speak with us
post WOC. Date will
remain the same.
Oct-24-2020 06:04:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Balaji Prabu R
(pfe rb01)Query 1: Opened Adverse Event Weight Loss
resolved on 04-Oct-2020,
but disposition follow up
date is recorded as
24-Sep-2020. Please
confirm whether the subject
was contacted on
04-Oct-2020. If yes, please
consider updating the
disposition date in this CRF.
Else clarify
Oct-14-2020 12:03:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
Sep/24/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-14-2020 12:03:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
FOLLOW-UPInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135892
Page 187 of 225
***Confidential***
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:53 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
3. Status:
Date Location User Value Reason
Oct-14-2020 12:03:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
ADVERSE EVENTInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135893
Page 188 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135894
Page 189 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
Date Location User Value Reason
Nov-03-2020 14:45:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Deleted Changed
Information
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135895
Page 190 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-06-2020 13:04:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135896
Page 191 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:02 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Oct-06-2020 13:05:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135897
Page 192 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1. Category:
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
1Initial Entry
3. Adverse Event:
(If possible specify diagnosis, not individual symptoms)
Date Location User Value Reason
Oct-18-2020 18:36:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Closed Response satisfies
query
Oct-17-2020 11:56:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-17-2020 11:56:32
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
LEFT UPPER ARM DERMATITIS
AT INJECTION SITEChanged Information
Oct-14-2020 19:02:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Reissued:Opened GPDCLIN: Thank
you for your
response. Please
confirm if dermatitis
is located at injection
site. If yes please
consider updating the
verbatim term as
applicable, or clarify.
Oct-14-2020 12:01:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-14-2020 12:01:52
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
LEFT UPPER ARM DERMATITISChanged Information
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135898
Page 193 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-11-2020 08:31:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Patricia
Banchero
(pfe.banchp)Query 1: Opened GPDCLIN: Please
review and consider
updating to include
dermatitis location.
Thank you.
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
DERMATITISInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sep/11/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
Date Location User Value Reason
Oct-29-2020 23:39:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Malla Reddy
Chevella
(pfe.chevem01)Query 2: Closed Response satisfies
query
Oct-29-2020 17:38:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered End of study is
10/17/2020 which is
the last contact date
made with subject.
AE will remain as
ongoing.
Oct-29-2020 05:57:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
Suryawanshi
(pfe.suryas18)Query 2: Reissued:Opened End of study
20Oct20 is entered
but AE is still
ongoing. Kindly
verify and confirm
the status of AE and
update CRF or else
confirm. Thank you.
Oct-28-2020 16:32:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered Original value is
correct
Oct-28-2020 16:31:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135899
Page 194 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
review and update as
appropriate.
Oct-23-2020 13:14:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Erik Sundgaard
(pfe.sundgaardea)Query 1: Closed Response satisfies
query
Oct-23-2020 12:23:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered This is left ongoing
because it is ongoing
at this time.
Oct-18-2020 05:10:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 S Vijaya Kumar
(pfe kumas557)Query 1: Reissued:Opened DM Re-query:
'Disposition
Follow-up form is
completed and this
Adverse Event is
still reported as
ongoing. Kindly
review and update
Ongoing as
appropriate and
respond to this
query.
Oct-17-2020 11:56:42
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Changed data per
query
Oct-15-2020 06:42:38
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Reissued:Opened DM: Per query
provided response,
please update
database accordingly
as 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Thank
you.
Oct-14-2020 12:04:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Changed data per
query
Oct-14-2020 12:03:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update as
appropriate.
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135900
Page 195 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)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 subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)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
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Nov-12-2020 09:56:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
DRUG WITHDRAWNTranscription Error
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135901
Page 196 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-11-2020 23:34:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Pratiksha
Mahadik
(pfe mahadp07)Query 2: Closed Closed as data
updated.
Nov-11-2020 16:43:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Response to query
Nov-11-2020 16:43:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma Leudtke
(pfe.sleudtke)Data Entry:
NOT APPLICABLEResponse to query
Nov-10-2020 20:07:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 2: Opened Only one primary
Adverse Event should
be chosen to have
question 'LATEST
ACTION TAKEN
WITH STUDY
DRUG' that would
indicate DRUG
WITHDRAWN.
Multiple are selected
at this time, please
select ONLY Primary
Adverse Event.
Nov-10-2020 20:06:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 1: Closed issued in error
Nov-10-2020 19:19:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Ute Frantz
(pfe frantu)Query 1: Opened Only one primary
Adverse Event should
be chosen to have
question 'Did the
adverse event cause
the subject to be
discontinued from the
study? answered as
YES if applicable.
Please chose Primary
Adverse Event.
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-06-2020 13:02:04 ACV0PFEINFP6000 Sahara Data Entry: Initial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135902
Page 197 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
(UTC-07:00) Mountain
Time (US & Canada)Vega
(pfe.svega)NO
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-14-2020 12:03:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-10-2020 04:55:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened DM: 'Did the adverse
event cause the
subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as 'ADVERSE
EVENT'. Please
review and update as
appropriate. Thank
you.
Oct-09-2020 15:28:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135903
Page 198 of 225
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-08-2020 06:27:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Roshni Nair
(pfe.nairr29)Query 1: Opened DM: 'Did the adverse
event cause the
subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as 'ADVERSE
EVENT'. Please
review and update as
appropriate. Thank
you.
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Candidate 'Did the adverse event
cause the subject to be
discontinued from the
study?' is Yes but
neither
DISPOSITION -
TREATMENT form
nor DISPOSITION -
FOLLOW-UP has
Status as ''ADVERSE
EVENT''. Please
review and update as
appropriate.
Oct-06-2020 13:02:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YESInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135904
Page 199 of 225
***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, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Back to Form
1. Category:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto calc
(autocalc)Data Entry:
ADVERSE EVENTInitial Entry
2. AE ID:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
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
Nov-03-2020 19:34:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Salim
Bouguermouh
(pfe.bougus)Query 1: Closed Response satisfies
query
Nov-03-2020 14:45:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Answered Changed Information
Oct-31-2020 13:13:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Salim
Bouguermouh
(pfe.bougus)Query 1: Reissued:Opened Clin: Please move
this event to the
potential COVID-19
Illness Visit SOD
CRF form (should no
be on the AE form)
and enter all the
information available.
Please provide the
reason why a nasal
swab was not
collected
Oct-27-2020 12:06:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Thank you. PD has
been created for
missed visit.
Oct-25-2020 13:59:29 ACV0PFEINFP6000 Salim Query 1: Reissued:Opened Clin: Per protocol
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135905
Page 200 of 225
***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, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
(UTC-07:00) Mountain
Time (US & Canada)Bouguermouh
(pfe.bougus)section 8.13.,
SHORTNESS OF
BREATH do not
overlap with specific
systemic events (ie,
fever, chills, new or
increased muscle
pain, diarrhea,
vomiting) should
have please triggered
a COVID-19 visit
and captured only on
the SOD form
Oct-23-2020 11:58:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered This was assessed as
related to vaccine and
not possible covid
which did not require
triggering in this
instance.
Oct-18-2020 16:51:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Salim
Bouguermouh
(pfe.bougus)Query 1: Opened Clin: Per protocol
section 8.1.,
COVID-19 listed
symptom
SHORTNESS OF
BREATH, not a
specific systemic
event, should have
please triggered a
potential COVID
Illness Visit
irrespective of
perceived etiology or
clinical significance.
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
SHORTNESS OF BREATHEInitial Entry
4. Start Date Time:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
Sep/11/2020 UNK:UNKInitial Entry
5. Is the adverse event still ongoing?
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135906
Page 201 of 225
***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, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Date Location User Value Reason
Oct-30-2020 07:25:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Pratiksha
Mahadik
(pfe mahadp07)Query 2: Closed Closed as per site
response.
Oct-29-2020 17:38:37
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered End of study is
10/17/2020 which is
the last contact date
made with subject.
AE will remain as
ongoing.
Oct-29-2020 05:57:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sandip
Namdeorao
Suryawanshi
(pfe.suryas18)Query 2: Reissued:Opened End of study
20Oct20 is entered
but AE is still
ongoing. Kindly
verify and confirm
the status of AE and
update CRF or else
confirm. Thank you.
Oct-28-2020 16:33:57
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 2: Answered AE is ongoing no
further action
Oct-28-2020 16:31:25
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 2: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update as
appropriate.
Oct-18-2020 22:09:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Gajanan
Deshmukh
(pfe.deshmg08)Query 1: Closed Response satisfies
query
Oct-17-2020 11:57:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered AE remains ongoing
as of 10/17/2020
Oct-15-2020 06:43:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Cavin van
Schalkwyk
(pfe.vanscc01)Query 1: Reissued:Opened DM: Per query
provided response,
please update
database accordingly
as 'Disposition
Follow-up form is
completed and this
Adverse Event is
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135907
Page 202 of 225
***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, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
still ongoing. Thank
you.
Oct-14-2020 12:04:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Query 1: Answered Changed data per
query
Oct-14-2020 12:03:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Opened 'Disposition
Follow-up form is
completed and this
Adverse Event is
still ongoing. Please
review and update as
appropriate.
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara Vega
(pfe.svega)Data Entry:
YESInitial Entry
6. Toxicity Grade:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)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 subject and may require
medical/surgical intervention to prevent above outcomes).
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)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
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135908
Page 203 of 225
***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, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
9. Is this event related to study treatment:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
RELATEDInitial Entry
10. Latest Action Taken with Study Treatment:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
DRUG WITHDRAWNInitial Entry
11. Was a Concomitant Medication given?
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
12. Was a Non-Drug Treatment given?
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
13. What was the outcome of this adverse event?:
Date Location User Value Reason
Oct-06-2020 13:03:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
RECOVERING/RESOLVINGInitial Entry
14. Did the adverse event cause the subject to be discontinued from the study?
Date Location User Value Reason
Oct-09-2020 23:29:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sonal K
(pfe.ks66)Query 2: Closed Response satisfies
query
Oct-09-2020 15:31:08
(UTC-07:00) MountainACV0PFEINFP6000 auto query
(autoquery)Query 2: Answered Answer Auto Query
090177e196ae401c\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135909
Page 204 of 225
***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, Deleted
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121163 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
*** THIS REPEATING FORM HAS BEEN DELETED ***
Time (US & Canada)
Oct-09-2020 15:31:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-09-2020 15:31:08
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Data Entry:
NOChanged Information
Oct-07-2020 06:14:50
(UTC-07:00) Mountain
Time (US & Canada)A
…[truncated]