125742 S1 M5 CRF c4591001 1012 10121097

Document text

Page 1 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135175
Page 2 of 286
***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: 10121097 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
Aug/31/2020
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135176
Page 3 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Demography
1.Subject ID [10121097]
2.Birth Date: 1948
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:
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135177
Page 4 of 286
***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: 10121097 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 Aug/31/2020
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135178
Page 5 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135179
Page 6 of 286
***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: 10121097 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/DeathAug/31/2020
2.Phase of Disposition: SCREENING
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135180
Page 7 of 286
***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: 10121097 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:[Basal Cell Carcinoma Nose]
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/2018
1.bLine/MH Number: [2]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoporosis]
Start Date: UNK/UNK/2016
Ongoing: YES
1.cLine/MH Number: [3]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Left Knee Arthroplasty]
Start Date: UNK/UNK/2017
Ongoing: NO
End Date:
UNK/UNK/2017
1.dLine/MH Number: [4]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Osteoarthritis Left Knee]
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2017
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135181
Page 8 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.eLine/MH Number: [5]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Insomnia]
Start Date: UNK/UNK/2010
Ongoing: YES
1.fLine/MH Number: [6]
Disease/Syndrome/Surgery
/Non-Drug Allergies/Drug
Allergies:[Sleep Apnea]
Start Date: UNK/UNK/2010
Ongoing: YES
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135182
Page 9 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Aug/31/2020
2.Weight: [135.0]
3.Unit: LB
4.Height: [64.0]
5.Unit: in
6.Body Mass Index: [23.2]
Vital Signs Details
7.aRecord Identifier: 1
Temperature: [97.2]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135183
Page 10 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135184
Page 11 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition
1.Randomization Date : Aug/31/2020
2.Randomization Number: [245283]
3.Randomization Group: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135185
Page 12 of 286
***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: 10121097 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:
Aug/31/2020
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 [BP43RH]
5.bSample ID [BPL1P4]
5.cSample ID [BPL1P5]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135186
Page 13 of 286
***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: 10121097 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:
Aug/31/2020
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 [BP43RG]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135187
Page 14 of 286
***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: 10121097 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: Aug/31/2020 14:16
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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135188
Page 15 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135189
Page 16 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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/21/2020
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135190
Page 17 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Vital Signs
1.Date: Sep/21/2020
Vital Signs Details
2.aRecord Identifier: 1
Temperature: [97.6]
Unit: F
Temperature Location: ORAL CAVITY
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135191
Page 18 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135192
Page 19 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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/21/2020
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 [BP4414]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135193
Page 20 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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/21/2020 13:15
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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135194
Page 21 of 286
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 Oct/20/2020
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135195
Page 22 of 286
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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:
Oct/20/2020
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 [BPL25D]
5.bSample ID [BPL25F]
5.cSample ID [BP9JCJ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135196
Page 23 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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 Nov/11/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135197
Page 24 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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: Nov/11/2020
2.Date of First Symptom Started: Nov/8/2020
3.Symptoms Ongoing? NO
Date of Last Symptom Resolved:
Nov/12/2020
Symptoms
4.aSymptoms: FEVER
Was symptom present? NO
4.bSymptoms: NEW OR INCREASED COUGH
Was symptom present? NO
4.cSymptoms: NEW OR INCREASED SHORTNESS OF BREATH
Was symptom present? NO
4.dSymptoms: CHILLS
Was symptom present? 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? YES
4.hSymptoms: DIARRHEA
Was symptom present? NO
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135198
Page 25 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.iSymptoms: VOMITING
Was symptom present? NO
Symptoms - Other
5.aSymptoms - Other Text: [BODY ACHES]
5.bSymptoms - Other Text: [FATIGUE]
5.cSymptoms - Other Text: [NASAL CONGESTION]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135199
Page 26 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Date of C
ollectionSpecimen Ty
peSpecimen Collec
tion LocationAssay Code and Description Device TypeForm Instan
ce
 1.Nov/11/20
20 SWABBED
MATERIAL NASOPHARYN
X SEVERE ACUTE RESP SYND
ROME CORONAVIRUS 2 SARS-COV-2 DIA
GNOSTIC TEST Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135200
Page 27 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Microbiology Specimen
1.Actual Date of Collection: Nov/11/2020
2.Specimen Type: SWABBED MATERIAL
3.Specimen Collection Location: NASOPHARYNX
4.Assay Code and Description: SEVERE ACUTE RESP SYNDROME CORONAVIRUS 2
5.Device Type: SARS-COV-2 DIAGNOSTIC TEST
6.Trade Name: OTHER
7.Test Result: NEGATIVE
8.Comments/Findings/Details: [Methodology: Real-Time RT-PCR; Quest lab]
9.Trade Name Other, Specify: [NALT Unknown]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135201
Page 28 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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? YES
Date of Collection:
Nov/11/2020
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [RW87460]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135202
Page 29 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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:[Telehealth visit]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID Not Done
[ ]Comments
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135203
Page 30 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Health Care Utilization
1.aPhysician or Healthcare
Professional:SPECIALIST
Occurrence of Visits or Contacts: NO
1.bPhysician or Healthcare
Professional:EMERGENCY ROOM
Occurrence of Visits or Contacts: NO
1.cPhysician or Healthcare
Professional:PRIMARY CARE PHYSICIAN
Occurrence of Visits or Contacts: YES
Number of Visits or Contacts:
[1]
1.dPhysician or Healthcare
Professional:URGENT CARE
Occurrence of Visits or Contacts: NO
1.ePhysician or Healthcare
Professional:TELEPHONE CONSULTATION
Occurrence of Visits or Contacts: NO
1.fPhysician or Healthcare
Professional:OTHER
Occurrence of Visits or Contacts: NO
Health Care Utilization Other
2.Other Type of Practitioner Specify: [ ]
Health Care Utilization
3.Has the subject been hospitalized
due to potential COVID-19 illness?NO
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135204
Page 31 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Treatment Identifi
erCon Non-Drug Treatments Pre-specifi
edTreatmen
tTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135205
Page 32 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: RESPIRATORY TREATMENT
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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?
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135206
Page 33 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Illness Details
1.Category of Clinical Event: POTENTIAL COVID-19 ILLNESS
2.Was a diagnosis obtained for
Potential COVID-19 Illness?NO
3.Toxicity Grade: 1
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135207
Page 34 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category of Clinical Even
t:Subcategory of Clinical Eve
ntDiagnosis Obtaine
dToxicity Grad
eForm Instance
 1.        Repeating Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135208
Page 35 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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:
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135209
Page 36 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for La
b TestVendor Na
meCollection D
ate:Specimen T
ypeLab ResultForm Instanc
e
 1.       Sponsor-Defined Id
entifierTes
t:Resul
t:Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135210
Page 37 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135211
Page 38 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Category for L
ab TestVendor Name (DE
RIVED)Collection
Date:Specimen
TypeLab ResultForm Instanc
e
 1.       Sponsor-Defined I
dentifierTes
t:Resu
lt:Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135212
Page 39 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135213
Page 40 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135214
Page 41 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135215
Page 42 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135216
Page 43 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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 % [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135217
Page 44 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135218
Page 45 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: OXYGENATION PARAMETERS
Form Version: 06-Jul-2020 21:52 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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): [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135219
Page 46 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Med
icationConcomitant Medications P
re-specifiedName of Medi
cationStart D
ateForm Instanc
e
 1.          Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135220
Page 47 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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?
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Page 48 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135222
Page 49 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: IMAGING
Form Version: 06-Jul-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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:
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 50 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 Dec/9/2020
2.Erroneous Visit
COVID-19 Illness Visit
3.COVID-19 Illness Visit: COVID_A1
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135224
Page 51 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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:
Dec/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 [BRYKHX]
5.bSample ID [BRYKHY]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135225
Page 52 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135226
Page 53 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Unplanned Assessments
1.Assessments
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135227
Page 54 of 286
***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: 10121097 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
:Oct/20/2020
2.Phase of Disposition: VACCINATION
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135228
Page 55 of 286
***Confidential***
 
Header Text: c4591001
Visit: Follow-Up - Unscheduled Form: DISPOSITION - FOLLOW-UP
Form Version: 15-Sep-2020 21:53 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Disposition - Follow-Up
1.Date of
Completion/Discontinuation/Death
://
2.Phase of Disposition:
3.Status:
4.Specify Status: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135229
Page 56 of 286
***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: 10121097 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:
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135230
Page 57 of 286
***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: 10121097 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 [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135231
Page 58 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#CategoryAE Ident
ifierAdverse Event Start DateIs the Adverse Event St
ill OngoingForm Instanc
e
 1.ADVERSE E
VENT 1  Left arm localized soreness
at injection site Sep/2/2020 UN
K:UNK NO
End Date Time:
Sep/3/2020 UNK:UN
K
 Repeating
Pages
 2.ADVERSE E
VENT 2  Vertigo  Feb/3/2021 00:0
0 NO
End Date Time:
Feb/5/2021 13:55
 Repeating
Pages
 3.ADVERSE E
VENT 3  Chills  Feb/2/2021 21:3
0 NO
End Date Time:
Feb/3/2021 UNK:UN
K
 Repeating
Pages
 4.ADVERSE E
VENT 4  Laceration on Head  Feb/3/2021 00:0
2 NO
End Date Time:
Feb/11/2021 UNK:U
NK
 Repeating
Pages
 5.ADVERSE E
VENT 5  Dizziness  Jan/24/2021 UN
K:UNK NO
End Date Time:
Jan/24/2021 UNK:U
NK
 Repeating
Pages
 6.ADVERSE E
VENT 6  Fever  Feb/3/2021 UN
K:UNK NO
End Date Time:
Feb/3/2021 UNK:UN
K
 Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135232
Page 59 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 arm localized soreness at injection site]
4.Start Date Time: Sep/2/2020 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Sep/3/2020 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135233
Page 60 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
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FDA-CBER-2021-5683-0135234
Page 61 of 286
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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: [2]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Vertigo]
4.Start Date Time: Feb/3/2021 00:00
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/5/2021 13:55
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).YES
Is this serious event associated with congenital anomaly or birth defect?
NO
Did this serious event result in death?
NO
Did this serious event require or prolong hospitalization?
YES
Did this serious event result in persistent or significant disability/incapacity?
NO
Is this serious event life threatening?
NO
Other medically important serious event
NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
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Page 62 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[2021112566]
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FDA-CBER-2021-5683-0135236
Page 63 of 286
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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)[Chills]
4.Start Date Time: Feb/2/2021 21:30
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/3/2021 UNK:UNK
6.Toxicity Grade: 3
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135237
Page 64 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135238
Page 65 of 286
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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)[Laceration on Head]
4.Start Date Time: Feb/3/2021 00:02
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/11/2021 UNK:UNK
6.Toxicity Grade: 2
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Vertigo]
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Page 66 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?YES
12.Was a Non-Drug Treatment given? YES
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135240
Page 67 of 286
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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: [5]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Dizziness]
4.Start Date Time: Jan/24/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Jan/24/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:NOT RELATED
If Not Related to study treatment(s), this event is due to:
OTHER
If Other, specify:
[Unknown]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 68 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135242
Page 69 of 286
***Confidential***
 
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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: [6]
3.Adverse Event:
(If possible specify diagnosis, not
individual symptoms)[Fever]
4.Start Date Time: Feb/3/2021 UNK:UNK
5.Is the adverse event still ongoing? NO
End Date Time:
Feb/3/2021 UNK:UNK
6.Toxicity Grade: 1
7.Is the adverse event serious?
If Yes, NOTIFY PFIZER
IMMEDIATELY.
Fatal; Life-threatening; Inpatient
hospitalization or prolongation of
existing hospitalization; Persistent
or significant disability/incapacity;
Congenital anomaly/birth defect;
Important medical event (i.e. may
jeopardize subject and may require
medical/surgical intervention to
prevent above outcomes).NO
8.Is this adverse event the result of a
study Medication Error?
If Yes, record the type of
medication error on the Medication
Error Log.NO
9.Is this event related to study
treatment:RELATED
10.Latest Action Taken with Study
Treatment:NOT APPLICABLE
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
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Page 70 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
11.Was a Concomitant Medication
given?NO
12.Was a Non-Drug Treatment given? NO
13.What was the outcome of this
adverse event?:RECOVERED/RESOLVED
14.Did the adverse event cause the
subject to be discontinued from the
study?NO
15.Serious Adverse Event Number:
For Pfizer Use Only[ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135244
Page 71 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Catego
ryMedication Er
rorStart Da
teIs the medication error Still O
ngoingStudy Medication Errors
ActionForm 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: 10121097 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[ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135246
Page 73 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medicati
onStart Da
teForm Instanc
e
 1.1  VACCINATIONS
 NO  Seasonal Influenza
Vaccine Oct/16/2
020 Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135247
Page 74 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: CONCOMITANT MEDICATIONS - NON STUDY
VACCINATIONS
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
eCRF Audit Trail History
Form Audit Trail
Concomitant Medications
1.What is the medication identifier? [1]
2.Category: VACCINATIONS
3.Concomitant Medications
Pre-specified:NO
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).[Seasonal Influenza Vaccine]
5.Date: Oct/16/2020
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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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Sponsor-Defined I
dentifierCategory for Me
dicationConcomitant Medications
Pre-specifiedName of Medi
cationDose Descri
ptionForm Instanc
e
 1.          Repeating
Pages
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135249
Page 76 of 286
***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: 10121097 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
#Categor
yTreatment Identifie
rCon Non-Drug Treatments Pre-specifi
edTreatmen
tStart Dat
eForm Instance
 1.          Repeating Pages
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FDA-CBER-2021-5683-0135251
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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: 10121097 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?
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Page 79 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
# Transfusion Type Date of Transfusion Form Instance
 1.    Repeating Pages
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FDA-CBER-2021-5683-0135253
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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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.Transfusion Type:
2.Date of Transfusion: //
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135254
Page 81 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
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***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: 10121097 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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FDA-CBER-2021-5683-0135256
Page 83 of 286
***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: 10121097 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:
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135257
Page 84 of 286
***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: 10121097 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?
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135258
Page 85 of 286
***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: 10121097 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: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135259
Page 86 of 286
***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: 10121097 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: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135260
Page 87 of 286
***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 Jan/13/2021
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135261
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***Confidential***
 
Header Text: c4591001
Visit: Potential ReVax Initial Contact -
UnscheduledForm: FURTHER VACCINATION CONFIRMATION
Form Version: 10-Dec-2020 02:25 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Further Vaccination Confirmation
1.Select appropriate response - Is
participant willing to return for
Vaccination 3?Participant is willing to return for Vaccination 3
Participant is:
eligible per other protocol allowance(s) and confirmed to have received only
placebo at Vaccination 1/2
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135262
Page 89 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Treatment Unblinded
1.Date Treatment Unblinded : Jan/13/2021
2.Primary Reason for Unblinding: ASSESS ELIGIBILITY FOR ADDITIONAL VACCINATION
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135263
Page 90 of 286
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: WITHDRAWAL OF CONSENT
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Withdrawal Of Consent
1.Withdrawal of Consent Date : //
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135264
Page 91 of 286
***Confidential***
 
Header Text: c4591001
Visit: Disposition - Unscheduled Form: DEATH DETAILS CODED
Form Version: 22-Apr-2020 21:03 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Death Details
1.Date of Collection / Notification of
Death://
Cause of Death
2.Cause of Death Status:
Cause of Death: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135265
Page 92 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 Jan/13/2021
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135266
Page 93 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INFORMED CONSENT - FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Informed Consent - Further Vaccination
1.Consent Was: OBTAINED
Date Written Consent Obtained
Jan/13/2021
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135267
Page 94 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135268
Page 95 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: DISPOSITION - SCREENING FOR FURTHER VACCINATION
Form Version: 10-Dec-2020 02:31 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Disposition - Screening for Further Vaccination
1.Date of
Completion/Discontinuation/Death
:Jan/13/2021
2.Phase of Disposition: REPEAT SCREENING 1
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135269
Page 96 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135270
Page 97 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9JJF]
5.bSample ID [BRYKKN]
5.cSample ID [BRYKKM]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135271
Page 98 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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:
Jan/13/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BP9JJD]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135272
Page 99 of 286
***Confidential***
 
Header Text: c4591001
Visit: V101_VAX3 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Jan/13/2021 15:48
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135273
Page 100 of 286
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 Feb/2/2021
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135274
Page 101 of 286
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Form Comments
eCRF Audit Trail History
Lab Urinalysis
1.Lab Panel: Not Applicable Comments
2.Lab Sub-Panel: Not Applicable Comments
3.Collection Date: Not Applicable
//Comments
4.Laboratory Name and Address
(Derived)Not Applicable
[ ]Comments
5.Specimen Type: Not Applicable Comments
Lab Result
6.aSponsor ID: Not Applicable
[ ]Comments
Test: Not Applicable
Choriogonadotropin Beta_PX113
Result: Not Applicable Comments
Not Done: Not Applicable Comments
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135275
Page 102 of 286
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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:
Feb/2/2021
4.If no sample was collected or
sample was not collected according
to protocol, please provide reason:[ ]
Aliquot
Please enter barcode for each aliquot.
5.aSample ID [BR8XCL]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135276
Page 103 of 286
***Confidential***
 
Header Text: c4591001
Visit: V102_VAX4 Form: VACCINATION
Form Version: 10-Dec-2020 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 [BNT162b2]
3.Formulation: INJECTION
4.Dose Date Time: Feb/2/2021 11:50
5.Anatomical Location: DELTOID MUSCLE
6.Body Side: LEFT
7.Route: INTRAMUSCULAR
8.Actual Dose: [30.0]
9.Unit: ug
10.Timeframe Subject Was Observed 30 MINUTES
11.Was the subject observed for at
least the protocol specified
observation period after
investigational product
administration?YES
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135277
Page 104 of 286
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: DATE OF VISIT
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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 Mar/2/2021
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135278
Page 105 of 286
***Confidential***
 
Header Text: c4591001
Visit: V103_MONTH1 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Contact Outcome
1.Contact Type: TELEPHONE VISIT
2.Was contact made? YES
Date of Contact:
Mar/2/2021
3.Comments: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135279
Page 106 of 286
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135280
Page 107 of 286
***Confidential***
 
Header Text: c4591001
Visit: V104_MONTH6 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135281
Page 108 of 286
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date of Visit
1.Date of Visit //
2.Erroneous Visit
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135282
Page 109 of 286
***Confidential***
 
Header Text: c4591001
Visit: V105_MONTH18 Form: CONTACT OUTCOME
Form Version: 22-Apr-2020 21:04 Form Status: Not Started
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135283
Page 110 of 286
***Confidential***
 
Header Text: c4591001
Visit: FURTHER_VACCINATION_EOT -
UnscheduledForm: DISPOSITION - TREATMENT
Form Version: 20-Feb-2021 02:26 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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
:Mar/2/2021
2.Phase of Disposition: OPEN LABEL TREATMENT
3.Status: COMPLETED
4.Specify Status: [ ]
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135284
Page 111 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
eCRF Audit Trail History
Subject Status
1.Subject Status FOLLOW-UP
2.Subject Status Date Oct/20/2020
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135285
Page 112 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135286
Page 113 of 286
***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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135287
Page 114 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-01-2020 13:29:25 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Not Applicable
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135288
Page 115 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135289
Page 116 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135290
Page 117 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Sep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135291
Page 118 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Sep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135292
Page 119 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Sep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135293
Page 120 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Sep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135294
Page 121 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135295
Page 122 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135296
Page 123 of 286
***Confidential***
Header Text: c4591001
Visit: V1_DAY1_VAX1_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-01-2020 13:31:26 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135297
Page 124 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormSep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135298
Page 125 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Sep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135299
Page 126 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Sep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135300
Page 127 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Sep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135301
Page 128 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Sep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135302
Page 129 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Sep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135303
Page 130 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135304
Page 131 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135305
Page 132 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: LAB URINALYSIS - PREGNANCY TEST - Comments
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aSep-21-2020 15:57:33 (UTC-07:00) Mountain
Time (US & Canada)Selma Leudtke
(pfe.sleudtke)Subject is not of childbearing potential
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135306
Page 133 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB -
Comments
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5.aNov-12-2020 09:12:14 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Not Done
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135307
Page 134 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: INCLUSION/EXCLUSION CRITERIA - FURTHER
VACCINATION - Comments
Form Version: 10-Dec-2020 02:30 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormJan-14-2021 17:36:19 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Met all criteria
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135308
Page 135 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormJan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135309
Page 136 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Jan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135310
Page 137 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Jan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135311
Page 138 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Jan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135312
Page 139 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Jan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135313
Page 140 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Jan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135314
Page 141 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aJan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135315
Page 142 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aJan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135316
Page 143 of 286
***Confidential***
Header Text: c4591001
Visit: V101_VAX3 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aJan-14-2021 17:37:16 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)Hysterectomy
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135317
Page 144 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
FormFeb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135318
Page 145 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
1Feb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135319
Page 146 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
2Feb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135320
Page 147 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
3Feb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135321
Page 148 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
4Feb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135322
Page 149 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
5Feb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135323
Page 150 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135324
Page 151 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135325
Page 152 of 286
***Confidential***
Header Text: c4591001
Visit: V102_VAX4 Form: LAB URINALYSIS - PREGNANCY TEST - Comments
Form Version: 14-Jan-2021 02:21 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
ItemDate User Comment
6.aFeb-03-2021 09:44:09 (UTC-07:00) Mountain
Time (US & Canada)Sahara Vega
(pfe.svega)SURGICALLY STERILE
Not Applicable
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135326
Page 153 of 286
***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: 10121097 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
Sahara Vega  N/A Jan-25-2021 16:36:36 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust  Approved Jan-22-2021 08:46:51 (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 Jan-14-2021 17:35:20 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust  Approved Dec-11-2020 10:57:26 (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.
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135327
Page 154 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sahara Vega  N/A Dec-09-2020 14:59:27 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust  Approved Nov-16-2020 17:44:38 (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-16-2020 13:33:13 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust  Approved Nov-16-2020 09:05:46 (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-12-2020 16:40:23 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135328
Page 155 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Matthew Doust  Approved Nov-12-2020 13:38:12 (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-12-2020 09:09:10 (UTC-07:00) Mountain
Time (US & Canada)Edit - All
signatures
invalidated
Affidavit:
N/A
Matthew Doust  Approved Oct-26-2020 16:10:40 (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.
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135329
Page 156 of 286
***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: 10121097 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-01-2020 13:28:17
(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-01-2020 13:28:17
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
STAGE 3 COHORTSInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135330
Page 157 of 286
***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: 10121097 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-01-2020 13:28:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
OBTAINED
Date Written Consent Obtained
Aug/31/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135331
Page 158 of 286
***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: 10121097 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-01-2020 13:28:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
10121097Item copied from
previous form
2. Birth Date:
Date Location User Value Reason
Sep-01-2020 13:28:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
/1948Enrollment Entry
3. Sex:
Date Location User Value Reason
Sep-01-2020 13:28:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
FEMALEInitial Entry
4. Ethnicity:
Date Location User Value Reason
Sep-01-2020 13:28:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOT HISPANIC OR LATINO(A
) OR OF SPANISH ORIGINInitial Entry
5. Race: (Check X all that apply):
Date Location User Value Reason
Sep-01-2020 13:28:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
WHITEInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
(b) (6)
FDA-CBER-2021-5683-0135332
Page 159 of 286
***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: 10121097 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
Sep-01-2020 13:29:11
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Aug/31/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135333
Page 160 of 286
***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: 10121097 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-01-2020 13:30:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Aug/31/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Sep-01-2020 13:30:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SCREENINGInitial Entry
3. Status:
Date Location User Value Reason
Sep-14-2020 23:05:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ricardo
DAbreau
(pfe.dabrer02)Query 1: Closed Response satisfies
query
Sep-06-2020 10:58:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Query 1: Answered Will confirm start
date of insomnia at
next visit.
Sep-04-2020 10:45:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ricardo
DAbreau
(pfe.dabrer02)Query 1: Opened Concomitant
medication log list
Ambien with a start
date of 2010 for
insomnia. Please
confirm medical
history.
Sep-01-2020 13:30:12
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
COMPLETEDInitial Entry
4. Specify Status:
Date Location User Value Reason
Sep-04-2020 10:46:12
(UTC-07:00) MountainACV0PFEINFP6000  Ricardo
DAbreauQuery 1: Closed Response satisfies
query
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135334
Page 161 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.dabrer02)
Sep-04-2020 10:43:47
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Ricardo
DAbreau
(pfe.dabrer02)Query 1: Opened Source list
documented
hysterectomy 1990.
Please verify.
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135335
Page 162 of 286
***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: 10121097 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-03-2020 17:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Nu
mber:1
Medical Histo
ry Term:Basal Cell Carcin
oma Nose
Start Date: UNK/UNK/2018
Ongoing: NO
End Date:
UNK/UNK/20
18Initial Entry
1.a Line/MH Number:
Date Location User Value Reason
Sep-03-2020 17:32:29
(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-03-2020 17:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Basal Cell Carcinoma NoseInitial Entry
1.a Start Date:
Date Location User Value Reason
Sep-03-2020 17:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2018Initial Entry
1.a Ongoing:
Date Location User Value Reason
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135336
Page 163 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-03-2020 17:32:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
NO
End Date:
UNK/UNK/2018Initial Entry
1.b
Date Location User Value Reason
Sep-03-2020 17:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:2
Medical History T
erm:Osteoporosis
Start Date: UNK/UNK/2
016
Ongoing: YESInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135337
Page 164 of 286
***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: 10121097 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-03-2020 17:32:56
(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-03-2020 17:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
OsteoporosisInitial Entry
1.b Start Date:
Date Location User Value Reason
Sep-03-2020 17:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2016Initial Entry
1.b Ongoing:
Date Location User Value Reason
Sep-03-2020 17:32:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
1.c
Date Location User Value Reason
Sep-03-2020 17:34:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:3
Medical Histor
y Term:Left Knee Arthr
oplasty
Start Date: UNK/UNK/201
7Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135338
Page 165 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Ongoing: NO
End Date:
UNK/UNK/2
017
1.c Line/MH Number:
Date Location User Value Reason
Sep-03-2020 17:34:09
(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-03-2020 17:34:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Left Knee ArthroplastyInitial Entry
1.c Start Date:
Date Location User Value Reason
Sep-03-2020 17:34:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2017Initial Entry
1.c Ongoing:
Date Location User Value Reason
Sep-03-2020 17:34:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.d
Date Location User Value Reason
Sep-03-2020 17:35:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Num
ber:4Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135339
Page 166 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Medical Histor
y Term:Osteoarthritis Le
ft Knee
Start Date: UNK/UNK/2014
Ongoing: NO
End Date:
UNK/UNK/2
017
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135340
Page 167 of 286
***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: 10121097 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-03-2020 17:35:06
(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
Oct-01-2020 06:50:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Charlene
Kimmel
(pfe.kimmec)Query 1: Closed Response satisfies
query
Sep-28-2020 12:19:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Query 1: Answered Insomnia and sleep
apnea have been
added to medical
history
Sep-28-2020 06:41:40
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Charlene
Kimmel
(pfe.kimmec)Query 1: Opened confirm if insomnia
and sleep apnea
should be added
Sep-03-2020 17:35:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Osteoarthritis Left KneeInitial Entry
1.d Start Date:
Date Location User Value Reason
Sep-03-2020 17:35:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2014Initial Entry
1.d Ongoing:
Date Location User Value Reason
Sep-03-2020 17:35:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
NO
End Date:
UNK/UNK/2017Initial Entry
1.e
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135341
Page 168 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Date Location User Value Reason
Sep-28-2020 12:18:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:5
Medical History T
erm:Insomnia
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.e Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:18:01
(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-28-2020 12:18:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
InsomniaInitial Entry
1.e Start Date:
Date Location User Value Reason
Sep-28-2020 12:18:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2010Initial Entry
1.e Ongoing:
Date Location User Value Reason
Sep-28-2020 12:18:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
1.f
Date Location User Value Reason
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135342
Page 169 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-28-2020 12:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
Line/MH Number
:6
Medical History T
erm:Sleep Apnea
Start Date: UNK/UNK/2
010
Ongoing: YESInitial Entry
1.f Line/MH Number:
Date Location User Value Reason
Sep-28-2020 12:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
6Initial Entry
1.f Disease/Syndrome/Surgery/Non-Drug Allergies/Drug Allergies:
Date Location User Value Reason
Sep-28-2020 12:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sleep ApneaInitial Entry
1.f Start Date:
Date Location User Value Reason
Sep-28-2020 12:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
UNK/UNK/2010Initial Entry
1.f Ongoing:
Date Location User Value Reason
Sep-28-2020 12:18:34
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135343
Page 170 of 286
***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: 10121097 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-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Aug/31/2020Initial Entry
2. Weight:
Date Location User Value Reason
Sep-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
135.0Initial Entry
3. Unit:
Date Location User Value Reason
Sep-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
LBInitial Entry
4. Height:
Date Location User Value Reason
Sep-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
64.0Initial Entry
5. Unit:
Date Location User Value Reason
Sep-01-2020 13:30:58
(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-01-2020 13:30:58
(UTC-07:00) MountainACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
23.2Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135344
Page 171 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada)
7.a
Date Location User Value Reason
Sep-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Record Identifier:
:1
Temperature: 97.2
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
7.a Record Identifier:
Date Location User Value Reason
Sep-01-2020 13:30:58
(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-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
97.2Initial Entry
7.a Unit:
Date Location User Value Reason
Sep-01-2020 13:30:58
(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-01-2020 13:30:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135345
Page 172 of 286
***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: 10121097 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-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135346
Page 173 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-01-2020 13:31:26
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135347
Page 174 of 286
***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: 10121097 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-01-2020 13:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Aug/31/2020Initial Entry
2. Randomization Number:
Date Location User Value Reason
Sep-01-2020 13:33:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
245283Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135348
Page 175 of 286
***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: 10121097 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-01-2020 13:33:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 13:33:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Sep-02-2020 14:12:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-02-2020 00:53:34
(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-01-2020 13:33:39
(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-01-2020 13:33:39
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135349
Page 176 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-02-2020 14:12:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Sample ID: BP43RHInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 14:12:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
BP43RHInitial Entry
5.b
Date Location User Value Reason
Sep-02-2020 14:13:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Sample ID: BPL1P4Initial Entry
5.b Sample ID
Date Location User Value Reason
Sep-02-2020 14:13:21
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
BPL1P4Initial Entry
5.c
Date Location User Value Reason
Sep-02-2020 14:13:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Sample ID: BPL1P5Initial Entry
5.c Sample ID
Date Location User Value Reason
Sep-02-2020 14:13:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
BPL1P5Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135350
Page 177 of 286
***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: 10121097 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-01-2020 13:34:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-01-2020 13:34:02
(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-02-2020 14:12:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-02-2020 00:58:44
(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-01-2020 13:34:02
(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-01-2020 13:34:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Aug/31/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135351
Page 178 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-02-2020 14:12:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Sample ID: BP43RGInitial Entry
5.a Sample ID
Date Location User Value Reason
Sep-02-2020 14:12:07
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
BP43RGInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135352
Page 179 of 286
***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: 10121097 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-01-2020 13:34:35
(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-01-2020 13:34:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-01-2020 13:34:35
(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-01-2020 13:34:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Aug/31/2020 14:16Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-01-2020 13:34:35
(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-01-2020 13:34:35
(UTC-07:00) MountainACV0PFEINFP6000  Selma
LeudtkeData Entry:
LEFTInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135353
Page 180 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.sleudtke)
7. Route:
Date Location User Value Reason
Sep-01-2020 13:34:35
(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-01-2020 13:34:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION PERIODInitial Entry
11. Was the subject observed for at least the protocol specified observation period after investigational product
administration?
Date Location User Value Reason
Sep-01-2020 13:34:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135354
Page 181 of 286
***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: 10121097 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-01-2020 13:34:41
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
NO - REACTOGENICITY E-DI
ARY NOT COLLECTED FOR T
HIS SUBJECTInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135355
Page 182 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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
Sep-21-2020 15:56:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/21/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135356
Page 183 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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-21-2020 15:57:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/21/2020Initial Entry
2.a
Date Location User Value Reason
Sep-21-2020 15:57:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Record Identifier:
:1
Temperature: 97.6
Temperature Unit
:F
Temperature Loc
ation::ORAL CAV
ITYInitial Entry
2.a Record Identifier:
Date Location User Value Reason
Sep-21-2020 15:57:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
1Initial Entry
2.a Temperature:
Date Location User Value Reason
Sep-21-2020 15:57:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
97.6Initial Entry
2.a Unit:
Date Location User Value Reason
Sep-21-2020 15:57:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
FInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135357
Page 184 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VITAL SIGNS - TEMP - eCRF Audit Trail History
Form Version: 15-Sep-2020 21:54 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
2.a Temperature Location:
Date Location User Value Reason
Sep-21-2020 15:57:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
ORAL CAVITYInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135358
Page 185 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_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: 10121097 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-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
2. Lab Sub-Panel:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
3. Collection Date:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
4. Laboratory Name and Address (Derived)
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
5. Specimen Type:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a
Date Location User Value Reason
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135359
Page 186 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sponsor-Defined Id
entifier:Not Applic
able
Test:: Not Applic
able
Result:: Not Applic
able
Not Done:: Not Applic
ableInitial Entry
6.a Sponsor ID:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a Test:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a Result:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
6.a Not Done:
Date Location User Value Reason
Sep-21-2020 15:57:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Not ApplicableInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135360
Page 187 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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-21-2020 15:58:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Sep-21-2020 15:58:04
(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-29-2020 16:01:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Sep-22-2020 01:49:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Sep-21-2020 15:58:04
(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-21-2020 15:58:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Sep/21/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135361
Page 188 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: ELECTRONIC SAMPLE TRACKING - NASAL SWAB - eCRF
Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Sep-29-2020 16:01:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Shana
Harshell
(pfe.sharshell)Data Entry:
Sample ID: BP4414Initial Entry
5.a Sample ID
Date Location User Value Reason
Sep-29-2020 16:01:56
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Shana
Harshell
(pfe.sharshell)Data Entry:
BP4414Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135362
Page 189 of 286
***Confidential***
 
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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-21-2020 15:58:49
(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-21-2020 15:58:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
BLINDED THERAPYInitial Entry
3. Formulation:
Date Location User Value Reason
Sep-21-2020 15:58:49
(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-21-2020 15:58:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Sep/21/2020 13:15Initial Entry
5. Anatomical Location:
Date Location User Value Reason
Sep-21-2020 15:58:49
(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-21-2020 15:58:49
(UTC-07:00) MountainACV0PFEINFP6000  Selma
LeudtkeData Entry:
LEFTInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135363
Page 190 of 286
***Confidential***
Header Text: c4591001
Visit: V2_VAX2_L Form: VACCINATION - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.sleudtke)
7. Route:
Date Location User Value Reason
Sep-21-2020 15:58:49
(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-21-2020 15:58:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
THE PROTOCOL SPECIFIED O
BSERVATION 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-21-2020 15:58:49
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YESInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135364
Page 191 of 286
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: DATE OF VISIT - eCRF Audit Trail History
Form Version: 22-Apr-2020 21:02 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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-20-2020 15:10:16
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Oct/20/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135365
Page 192 of 286
***Confidential***
 
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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
Oct-20-2020 15:10:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Oct-20-2020 15:10:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Oct-21-2020 11:33:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Oct-21-2020 04:34:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Oct-20-2020 15:10:30
(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.
Oct-20-2020 15:10:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
YES
Date of Collection:
Oct/20/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135366
Page 193 of 286
***Confidential***
Header Text: c4591001
Visit: V3_MONTH1_POSTVAX2_L Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
eCRF Audit Trail History
Form Version: 22-Apr-2020 21:03 Form Status: Data Complete, Locked, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Oct-21-2020 11:33:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL25DInitial Entry
5.a Sample ID
Date Location User Value Reason
Oct-21-2020 11:33:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
BPL25DInitial Entry
5.b
Date Location User Value Reason
Oct-21-2020 11:34:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BPL25FInitial Entry
5.b Sample ID
Date Location User Value Reason
Oct-21-2020 11:34:48
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
BPL25FInitial Entry
5.c
Date Location User Value Reason
Oct-21-2020 11:35:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: BP9JCJInitial Entry
5.c Sample ID
Date Location User Value Reason
Oct-21-2020 11:35:10
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
BP9JCJInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135367
Page 194 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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-16-2020 14:09:04
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Erik Sundgaard
(pfe.sundgaardea)Query 3: Closed Response satisfies
query
Nov-16-2020 13:33:24
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Query 3: Answered Changed data per
query
Nov-13-2020 12:17:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Mary Campbell
(pfe.campbm25)Query 3: Opened Per CCGs the
COVID Test is a
required form
within this visit.
Please complete
the data as required
in CCG section
8.31. If the test was
not done please
add a FORM
LEVEL comment
of NOT DONE
else clarify.
Nov-12-2020 09:11:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 2: Deleted Close Auto Query
Nov-12-2020 09:09:09
(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-12-2020 09:09:09
(UTC-07:00) MountainACV0PFEINFP6000  auto query
(autoquery)Query 1: Candidate Date of Visit is
completed but Date
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135368
Page 195 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) of Collection in
both Nasal Swab
Self and Nasal
Swab are missing.
Please review and
update as
appropriate.
Nov-12-2020 09:09:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
Nov/11/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Nov-12-2020 09:09:09
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
COVID_AInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135369
Page 196 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Nov/11/2020Initial Entry
2. Date of First Symptom Started:
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Nov/8/2020Initial Entry
3. Symptoms Ongoing?
Date Location User Value Reason
Jan-21-2021 10:39:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Closed Response satisfies
query
Jan-20-2021 12:58:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Jan-20-2021 12:58:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
NO
Date of Last Symptom Resol
ved:
Nov/12/2020Transcription Error
Dec-29-2020 11:56:31
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Opened per the
Convalescent visit
source symptoms
resolved on 12 Nov
2020. Please revisit
and update.
Dec-09-2020 14:59:27
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
NO
Date of Last Symptom ResolNew Information
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135370
Page 197 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
ved:
Nov/11/2020
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.a
Date Location User Value Reason
Nov-12-2020 09:10:28
(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-12-2020 09:10:28
(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-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.b
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: NEW OR INCREA
SED COUGH
Symptom P
resent:NOInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135371
Page 198 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.b Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(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-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.c
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sympto
ms:NEW OR INCREASE
D SHORTNESS OF B
REATH
Sympto
m Prese
nt:NOInitial Entry
4.c Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED SHORTN
ESS OF BREATHInitial Entry
4.c Was symptom present?
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.d
Date Location User Value Reason
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135372
Page 199 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-13-2020 15:47:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Symptoms: CHILLS
Symptom Present: NOTranscription Error
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
Symptoms: CHILLS
Symptom Present: YESInitial Entry
4.d Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(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-14-2020 09:31:00
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Kimberly
Forbus
(pfe.forbuk)Query 1: Closed Response satisfies
query
Nov-13-2020 15:47:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Answered Transcription Error
Nov-13-2020 15:47:53
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
NOTranscription Error
Nov-13-2020 13:55:15
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Aloma
Ratnasoma
(pfe.ratnaa05)Query 1: Opened per source denies
chills, please revisit
and update.
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.e
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptom NEW OR INCREASInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135373
Page 200 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
s: ED MUSCLE PAIN
Symptom
Present:NO
4.e Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED MUSCL
E PAINInitial Entry
4.e Was symptom present?
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.f
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms
:NEW LOSS OF TAS
TE OR SMELL
Symptom
Present:NOInitial Entry
4.f Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NEW LOSS OF TASTE OR SME
LLInitial Entry
4.f Was symptom present?
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135374
Page 201 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.g
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptom
s:NEW OR INCREAS
ED SORE THROAT
Symptom
Present:YESInitial Entry
4.g Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NEW OR INCREASED SORE T
HROATInitial Entry
4.g Was symptom present?
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
YESInitial Entry
4.h
Date Location User Value Reason
Nov-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms: DIARRHEA
Symptom Present: NOInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135375
Page 202 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
4.h Symptoms:
Date Location User Value Reason
Nov-12-2020 09:10:28
(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-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
4.i
Date Location User Value Reason
Nov-12-2020 09:10:28
(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-12-2020 09:10:28
(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-12-2020 09:10:28
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
5.a
Date Location User Value Reason
Nov-12-2020 09:10:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms - Othe
r:BODY ACHE
SInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135376
Page 203 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Symptoms - Other Text:
Date Location User Value Reason
Nov-12-2020 09:10:43
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
BODY ACHESInitial Entry
5.b
Date Location User Value Reason
Nov-12-2020 09:10:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms - Other: FATIGUEInitial Entry
5.b Symptoms - Other Text:
Date Location User Value Reason
Nov-12-2020 09:10:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
FATIGUEInitial Entry
5.c
Date Location User Value Reason
Nov-12-2020 16:40:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms -
Other:NASAL CONGE
STIONChanged
Information
Nov-12-2020 09:11:02
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Symptoms - Othe
r:CONGESTIO
NInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135377
Page 204 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.c Symptoms - Other Text:
Date Location User Value Reason
Nov-13-2020
00:43:39
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Clo
sedDiscrepancy has
been closed.
Nov-12-2020
16:40:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Ans
weredChanged
Information
Nov-12-2020
16:40:23
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
NASAL CO
NGESTIONChanged
Information
Nov-12-2020
11:43:13
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000.InFormAdapter.Discrepancy  PFETMS
Oracle
(pfe.PFETMS)Query 1: Op
enedClarify
CONGESTION
as follows...The
term appears
incomplete. Are
you reporting
NASAL
CONGESTION?
SINUS
CONGESTION?
HEPATIC
CONGESTION?
Other? If so, edit
as such. If there is
no further
information,
update the current
term to
CONGESTION
NFI. Otherwise
please note the
term remains
uncoded in the
database. Thank
you.
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135378
Page 205 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: SIGNS AND SYMPTOMS OF POTENTIAL COVID-19 - eCRF
Audit Trail History
Form Version: 10-Oct-2020 16:02 Form Status: Data Complete, Frozen, Not Complete
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-12-2020
09:11:02
(UTC-07:00)
Mountain Time
(US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
CONGESTI
ONInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135379
Page 206 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: MICROBIOLOGY SPECIMEN - Audit Trail
Form Version: 06-Jul-2020 21:54 Form Status:
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Sahara
Vega
(pfe.svega)Form Created
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135380
Page 207 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Nov/11/2020Initial Entry
2. Specimen Type:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
SWABBED MATERIALInitial Entry
3. Specimen Collection Location:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NASOPHARYNXInitial Entry
4. Assay Code and Description:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SEVERE ACUTE RESP SYNDR
OME CORONAVIRUS 2Initial Entry
5. Device Type:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SARS-COV-2 DIAGNOSTIC TES
TInitial Entry
6. Trade Name:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) MountainACV0PFEINFP6000  Sahara
VegaData Entry:
OTHERInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135381
Page 208 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Time (US & Canada) (pfe.svega)
7. Test Result:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NEGATIVEInitial Entry
8. Comments/Findings/Details:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Methodology: Real-Time RT-PCR;
Quest labInitial Entry
9. Trade Name Other, Specify:
Date Location User Value Reason
Nov-16-2020 13:33:13
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NALT UnknownInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135382
Page 209 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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-12-2020 09:11:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 09:11:18
(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-12-2020 09:12:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Deleted Close Auto Query
Nov-12-2020 09:11:18
(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.
Nov-12-2020 09:11:18
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
YES
Date of Collection:
Nov/11/2020Initial Entry
5.a
Date Location User Value Reason
Nov-12-2020 09:12:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: RW87460Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135383
Page 210 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 09:12:33
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
RW87460Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135384
Page 211 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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-12-2020 09:12:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Nov-12-2020 09:12:05
(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-12-2020 09:12:05
(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-12-2020 09:12:05
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Telehealth visitInitial Entry
5.a
Date Location User Value Reason
Nov-12-2020 09:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: Not DoneInitial Entry
Nov-12-2020 09:11:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID:Transcription Error
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135385
Page 212 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Nov-12-2020 09:11:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Sample ID: RW87460Initial Entry
5.a Sample ID
Date Location User Value Reason
Nov-12-2020 09:12:14
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Not DoneInitial Entry
Nov-12-2020 09:11:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Nov-12-2020 09:11:50
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry: Transcription Error
Nov-12-2020 09:11:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Opened Barcode is not 6
characters in length.
Please review and
correct as
appropriate.
Nov-12-2020 09:11:35
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
RW87460Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135386
Page 213 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
1.a
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: SPECIA
LIST
Occurrence of Visits o
r Contacts:NOInitial Entry
1.a Physician or Healthcare Professional:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
SPECIALISTInitial Entry
1.a Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.b
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Type of Practition
er:EMERGEN
CY ROOM
Occurrence of Visi
ts or Contacts:NOInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135387
Page 214 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.b Physician or Healthcare Professional:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
EMERGENCY ROOMInitial Entry
1.b Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.c
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Type of Practiti
oner:PRIMARY CA
RE PHYSICIA
N
Occurrence of
Visits or Conta
cts:YES
Number of Visi
ts or Contacts:
1Initial Entry
1.c Physician or Healthcare Professional:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
PRIMARY CARE PHYSICIANInitial Entry
1.c Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
YES
Number of Visits or Contacts:
1Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135388
Page 215 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
1.d
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner
:URGENT
CARE
Occurrence of Visits
or Contacts:NOInitial Entry
1.d Physician or Healthcare Professional:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
URGENT CAREInitial Entry
1.d Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.e
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Type of Practiti
oner:TELEPHONE
CONSULTATI
ON
Occurrence of
Visits or Contac
ts:NOInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135389
Page 216 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
TELEPHONE CONSULTATIONInitial Entry
1.e Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
1.f
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Type of Practitioner: OTH
ER
Occurrence of Visits or
Contacts:NOInitial Entry
1.f Physician or Healthcare Professional:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
OTHERInitial Entry
1.f Occurrence of Visits or Contacts:
Date Location User Value Reason
Nov-12-2020 09:13:30
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
3. Has the subject been hospitalized due to potential COVID-19 illness?
Date Location User Value Reason
Nov-12-2020 09:13:30 ACV0PFEINFP6000  Sahara Data Entry: Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135390
Page 217 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135391
Page 218 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_ILL 1 - Unscheduled Visit
on Nov/11/2020Form: 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: 10121097 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-12-2020 09:13:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
POTENTIAL COVID-19 ILLNES
SInitial Entry
2. Was a diagnosis obtained for Potential COVID-19 Illness?
Date Location User Value Reason
Nov-12-2020 09:13:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
NOInitial Entry
3. Toxicity Grade:
Date Location User Value Reason
Nov-12-2020 09:13:51
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
1Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135392
Page 219 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: DATE OF VISIT - ILLNESS CONVALESCENT - eCRF Audit
Trail History
Form Version: 22-Apr-2020 21:04 Form Status: Data Complete, Frozen, Verified
Site No: 1012 Site Name: (1012) HOPE Research Institute
Subject No: 10121097 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
Dec-09-2020 14:59:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
Dec/9/2020Initial Entry
3. COVID-19 Illness Visit:
Date Location User Value Reason
Dec-09-2020 14:59:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara
Vega
(pfe.svega)Data Entry:
COVID_A1Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135393
Page 220 of 286
***Confidential***
 
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10121097 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
Dec-09-2020 14:59:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SITEInitial Entry
2. Sample Type
Date Location User Value Reason
Dec-09-2020 14:59:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
SERUMInitial Entry
3. Sample Collected?
Date Location User Value Reason
Jan-20-2021 13:05:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto query
(autoquery)Query 1: Closed Close Auto Query
Dec-11-2020 10:41:46
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Roshni Nair
(pfe nairr29)Query 1: Opened 'Sample Collected?'
is Yes, however no
barcodes are
entered. Please
review and correct
as appropriate.
Dec-09-2020 14:59:58
(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.
Dec-09-2020 14:59:58
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Sahara Vega
(pfe.svega)Data Entry:
YES
Date of Collection:
Dec/9/2020Initial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135394
Page 221 of 286
***Confidential***
Header Text: c4591001
Visit: POT_COVID_CONVA 1 - Unscheduled
Visit on Dec/09/2020Form: ELECTRONIC SAMPLE TRACKING - IMMUNOGENICITY -
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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
5.a
Date Location User Value Reason
Jan-20-2021 13:05:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Sample ID: BRYKHXInitial Entry
5.a Sample ID
Date Location User Value Reason
Jan-20-2021 13:05:54
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
BRYKHXInitial Entry
5.b
Date Location User Value Reason
Jan-20-2021 13:06:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
Sample ID: BRYKHYInitial Entry
5.b Sample ID
Date Location User Value Reason
Jan-20-2021 13:06:06
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Stephanie
Catanzaro
(pfe.scatanzaro)Data Entry:
BRYKHYInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135395
Page 222 of 286
***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: 10121097 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-20-2020 15:10:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
Oct/20/2020Initial Entry
2. Phase of Disposition:
Date Location User Value Reason
Oct-20-2020 15:10:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  auto calc
(autocalc)Data Entry:
VACCINATIONInitial Entry
3. Status:
Date Location User Value Reason
Oct-20-2020 15:10:44
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000  Selma
Leudtke
(pfe.sleudtke)Data Entry:
COMPLETEDInitial Entry
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135396
Page 223 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Sep-23-2020 16:39:23
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Selma
Leudtke
(pfe.sleudtke)Form Created
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135397
Page 224 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-05-2021 14:08:29
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Form Created
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135398
Page 225 of 286
***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: 10121097 Subject Initials: ---
Generated By: pfe.levissc Generated Time (GMT): 29-Mar-2021 04:21
Back to Form
Date Location User Value Reason
Feb-05-2021 14:10:01
(UTC-07:00) Mountain
Time (US & Canada)ACV0PFEINFP6000 Stephanie
Catanzaro
(pfe.scatanzaro)Form Created
090177e196ae401d\Final\Final On: 01-Apr-2021 05:30 (GMT)
FDA-CBER-2021-5683-0135399
Page 226 of 286
***Confidential***
Header Text: c4591001
Visit: Logs - Unscheduled Form: ADVERSE EVENT REPORT - Audit Trail
Form Version: 22-Apr-2020 21:0
…[truncated]